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Published in: Clinical Pharmacokinetics 10/2018

Open Access 01-10-2018 | Review article

Individualization of Irinotecan Treatment: A Review of Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics

Authors: Femke M. de Man, Andrew K. L. Goey, Ron H. N. van Schaik, Ron H. J. Mathijssen, Sander Bins

Published in: Clinical Pharmacokinetics | Issue 10/2018

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Abstract

Since its clinical introduction in 1998, the topoisomerase I inhibitor irinotecan has been widely used in the treatment of solid tumors, including colorectal, pancreatic, and lung cancer. Irinotecan therapy is characterized by several dose-limiting toxicities and large interindividual pharmacokinetic variability. Irinotecan has a highly complex metabolism, including hydrolyzation by carboxylesterases to its active metabolite SN-38, which is 100- to 1000-fold more active compared with irinotecan itself. Several phase I and II enzymes, including cytochrome P450 (CYP) 3A4 and uridine diphosphate glucuronosyltransferase (UGT) 1A, are involved in the formation of inactive metabolites, making its metabolism prone to environmental and genetic influences. Genetic variants in the DNA of these enzymes and transporters could predict a part of the drug-related toxicity and efficacy of treatment, which has been shown in retrospective and prospective trials and meta-analyses. Patient characteristics, lifestyle and comedication also influence irinotecan pharmacokinetics. Other factors, including dietary restriction, are currently being studied. Meanwhile, a more tailored approach to prevent excessive toxicity and optimize efficacy is warranted. This review provides an updated overview on today’s literature on irinotecan pharmacokinetics, pharmacodynamics, and pharmacogenetics.
Literature
1.
go back to reference Hsiang YH, Liu LF. Identification of mammalian DNA topoisomerase I as an intracellular target of the anticancer drug camptothecin. Cancer Res. 1988;48(7):1722–6.PubMed Hsiang YH, Liu LF. Identification of mammalian DNA topoisomerase I as an intracellular target of the anticancer drug camptothecin. Cancer Res. 1988;48(7):1722–6.PubMed
2.
go back to reference Shao RG, Cao CX, Zhang H, Kohn KW, Wold MS, Pommier Y. Replication-mediated DNA damage by camptothecin induces phosphorylation of RPA by DNA-dependent protein kinase and dissociates RPA:DNA-PK complexes. EMBO J. 1999;18(5):1397–406.PubMedPubMedCentralCrossRef Shao RG, Cao CX, Zhang H, Kohn KW, Wold MS, Pommier Y. Replication-mediated DNA damage by camptothecin induces phosphorylation of RPA by DNA-dependent protein kinase and dissociates RPA:DNA-PK complexes. EMBO J. 1999;18(5):1397–406.PubMedPubMedCentralCrossRef
3.
go back to reference Rivory LP, Robert J. Molecular, cellular, and clinical aspects of the pharmacology of 20(S)camptothecin and its derivatives. Pharmacol Ther. 1995;68(2):269–96.PubMedCrossRef Rivory LP, Robert J. Molecular, cellular, and clinical aspects of the pharmacology of 20(S)camptothecin and its derivatives. Pharmacol Ther. 1995;68(2):269–96.PubMedCrossRef
4.
go back to reference Xie R, Mathijssen RH, Sparreboom A, Verweij J, Karlsson MO. Clinical pharmacokinetics of irinotecan and its metabolites: a population analysis. J Clin Oncol. 2002;20(15):3293–301.PubMedCrossRef Xie R, Mathijssen RH, Sparreboom A, Verweij J, Karlsson MO. Clinical pharmacokinetics of irinotecan and its metabolites: a population analysis. J Clin Oncol. 2002;20(15):3293–301.PubMedCrossRef
5.
go back to reference Fassberg J, Stella VJ. A kinetic and mechanistic study of the hydrolysis of camptothecin and some analogues. J Pharm Sci. 1992;81(7):676–84.PubMedCrossRef Fassberg J, Stella VJ. A kinetic and mechanistic study of the hydrolysis of camptothecin and some analogues. J Pharm Sci. 1992;81(7):676–84.PubMedCrossRef
6.
go back to reference Hertzberg RP, Caranfa MJ, Holden KG, Jakas DR, Gallagher G, Mattern MR, et al. Modification of the hydroxy lactone ring of camptothecin: inhibition of mammalian topoisomerase I and biological activity. J Med Chem. 1989;32(3):715–20.PubMedCrossRef Hertzberg RP, Caranfa MJ, Holden KG, Jakas DR, Gallagher G, Mattern MR, et al. Modification of the hydroxy lactone ring of camptothecin: inhibition of mammalian topoisomerase I and biological activity. J Med Chem. 1989;32(3):715–20.PubMedCrossRef
7.
go back to reference Rivory LP, Chatelut E, Canal P, Mathieu-Boue A, Robert J. Kinetics of the in vivo interconversion of the carboxylate and lactone forms of irinotecan (CPT-11) and of its metabolite SN-38 in patients. Cancer Res. 1994;54(24):6330–3.PubMed Rivory LP, Chatelut E, Canal P, Mathieu-Boue A, Robert J. Kinetics of the in vivo interconversion of the carboxylate and lactone forms of irinotecan (CPT-11) and of its metabolite SN-38 in patients. Cancer Res. 1994;54(24):6330–3.PubMed
8.
go back to reference Sasaki Y, Yoshida Y, Sudoh K, Hakusui H, Fujii H, Ohtsu T, et al. Pharmacological correlation between total drug concentration and lactones of CPT-11 and SN-38 in patients treated with CPT-11. Jpn J Cancer Res. 1995;86(1):111–6.PubMedPubMedCentralCrossRef Sasaki Y, Yoshida Y, Sudoh K, Hakusui H, Fujii H, Ohtsu T, et al. Pharmacological correlation between total drug concentration and lactones of CPT-11 and SN-38 in patients treated with CPT-11. Jpn J Cancer Res. 1995;86(1):111–6.PubMedPubMedCentralCrossRef
9.
go back to reference Haaz MC, Rivory LP, Riche C, Robert J. The transformation of irinotecan (CPT-11) to its active metabolite SN-38 by human liver microsomes. Differential hydrolysis for the lactone and carboxylate forms. Naunyn Schmiedebergs Arch Pharmacol. 1997;356(2):257–62.PubMedCrossRef Haaz MC, Rivory LP, Riche C, Robert J. The transformation of irinotecan (CPT-11) to its active metabolite SN-38 by human liver microsomes. Differential hydrolysis for the lactone and carboxylate forms. Naunyn Schmiedebergs Arch Pharmacol. 1997;356(2):257–62.PubMedCrossRef
10.
go back to reference Burke TG, Mi Z. The structural basis of camptothecin interactions with human serum albumin: impact on drug stability. J Med Chem. 1994;37(1):40–6.PubMedCrossRef Burke TG, Mi Z. The structural basis of camptothecin interactions with human serum albumin: impact on drug stability. J Med Chem. 1994;37(1):40–6.PubMedCrossRef
11.
go back to reference Combes O, Barre J, Duche JC, Vernillet L, Archimbaud Y, Marietta MP, et al. In vitro binding and partitioning of irinotecan (CPT-11) and its metabolite, SN-38, in human blood. Invest New Drugs. 2000;18(1):1–5.PubMedCrossRef Combes O, Barre J, Duche JC, Vernillet L, Archimbaud Y, Marietta MP, et al. In vitro binding and partitioning of irinotecan (CPT-11) and its metabolite, SN-38, in human blood. Invest New Drugs. 2000;18(1):1–5.PubMedCrossRef
12.
go back to reference Chabot GG, Abigerges D, Catimel G, Culine S, de Forni M, Extra JM, et al. Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials. Ann Oncol. 1995;6(2):141–51.PubMedCrossRef Chabot GG, Abigerges D, Catimel G, Culine S, de Forni M, Extra JM, et al. Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials. Ann Oncol. 1995;6(2):141–51.PubMedCrossRef
13.
go back to reference Klein CE, Gupta E, Reid JM, Atherton PJ, Sloan JA, Pitot HC, et al. Population pharmacokinetic model for irinotecan and two of its metabolites, SN-38 and SN-38 glucuronide. Clin Pharmacol Ther. 2002;72(6):638–47.PubMedCrossRef Klein CE, Gupta E, Reid JM, Atherton PJ, Sloan JA, Pitot HC, et al. Population pharmacokinetic model for irinotecan and two of its metabolites, SN-38 and SN-38 glucuronide. Clin Pharmacol Ther. 2002;72(6):638–47.PubMedCrossRef
14.
go back to reference Poujol S, Pinguet F, Ychou M, Abderrahim AG, Duffour J, Bressolle FM. A limited sampling strategy to estimate the pharmacokinetic parameters of irinotecan and its active metabolite, SN-38, in patients with metastatic digestive cancer receiving the FOLFIRI regimen. Oncol Rep. 2007;18(6):1613–21.PubMed Poujol S, Pinguet F, Ychou M, Abderrahim AG, Duffour J, Bressolle FM. A limited sampling strategy to estimate the pharmacokinetic parameters of irinotecan and its active metabolite, SN-38, in patients with metastatic digestive cancer receiving the FOLFIRI regimen. Oncol Rep. 2007;18(6):1613–21.PubMed
15.
go back to reference Younis IR, Malone S, Friedman HS, Schaaf LJ, Petros WP. Enterohepatic recirculation model of irinotecan (CPT-11) and metabolite pharmacokinetics in patients with glioma. Cancer Chemother Pharmacol. 2009;63(3):517–24.PubMedCrossRef Younis IR, Malone S, Friedman HS, Schaaf LJ, Petros WP. Enterohepatic recirculation model of irinotecan (CPT-11) and metabolite pharmacokinetics in patients with glioma. Cancer Chemother Pharmacol. 2009;63(3):517–24.PubMedCrossRef
16.
go back to reference Xie R, Mathijssen RH, Sparreboom A, Verweij J, Karlsson MO. Clinical pharmacokinetics of irinotecan and its metabolites in relation with diarrhea. Clin Pharmacol Ther. 2002;72(3):265–75.PubMedCrossRef Xie R, Mathijssen RH, Sparreboom A, Verweij J, Karlsson MO. Clinical pharmacokinetics of irinotecan and its metabolites in relation with diarrhea. Clin Pharmacol Ther. 2002;72(3):265–75.PubMedCrossRef
17.
go back to reference Loos WJ, Verweij J, Gelderblom HJ, de Jonge MJ, Brouwer E, Dallaire BK, et al. Role of erythrocytes and serum proteins in the kinetic profile of total 9-amino-20(S)-camptothecin in humans. Anticancer Drugs. 1999;10(8):705–10.PubMedCrossRef Loos WJ, Verweij J, Gelderblom HJ, de Jonge MJ, Brouwer E, Dallaire BK, et al. Role of erythrocytes and serum proteins in the kinetic profile of total 9-amino-20(S)-camptothecin in humans. Anticancer Drugs. 1999;10(8):705–10.PubMedCrossRef
18.
go back to reference Slatter JG, Su P, Sams JP, Schaaf LJ, Wienkers LC. Bioactivation of the anticancer agent CPT-11 to SN-38 by human hepatic microsomal carboxylesterases and the in vitro assessment of potential drug interactions. Drug Metab Dispos. 1997;25(10):1157–64.PubMed Slatter JG, Su P, Sams JP, Schaaf LJ, Wienkers LC. Bioactivation of the anticancer agent CPT-11 to SN-38 by human hepatic microsomal carboxylesterases and the in vitro assessment of potential drug interactions. Drug Metab Dispos. 1997;25(10):1157–64.PubMed
19.
go back to reference Morton CL, Wadkins RM, Danks MK, Potter PM. The anticancer prodrug CPT-11 is a potent inhibitor of acetylcholinesterase but is rapidly catalyzed to SN-38 by butyrylcholinesterase. Cancer Res. 1999;59(7):1458–63.PubMed Morton CL, Wadkins RM, Danks MK, Potter PM. The anticancer prodrug CPT-11 is a potent inhibitor of acetylcholinesterase but is rapidly catalyzed to SN-38 by butyrylcholinesterase. Cancer Res. 1999;59(7):1458–63.PubMed
20.
go back to reference Rudakova EV, Boltneva NP, Makhaeva GF. Comparative analysis of esterase activities of human, mouse, and rat blood. Bull Exp Biol Med. 2011;152(1):73–5.PubMedCrossRef Rudakova EV, Boltneva NP, Makhaeva GF. Comparative analysis of esterase activities of human, mouse, and rat blood. Bull Exp Biol Med. 2011;152(1):73–5.PubMedCrossRef
21.
go back to reference Humerickhouse R, Lohrbach K, Li L, Bosron WF, Dolan ME. Characterization of CPT-11 hydrolysis by human liver carboxylesterase isoforms hCE-1 and hCE-2. Cancer Res. 2000;60(5):1189–92.PubMed Humerickhouse R, Lohrbach K, Li L, Bosron WF, Dolan ME. Characterization of CPT-11 hydrolysis by human liver carboxylesterase isoforms hCE-1 and hCE-2. Cancer Res. 2000;60(5):1189–92.PubMed
22.
go back to reference Bencharit S, Morton CL, Howard-Williams EL, Danks MK, Potter PM, Redinbo MR. Structural insights into CPT-11 activation by mammalian carboxylesterases. Nat Struct Biol. 2002;9(5):337–42.PubMedCrossRef Bencharit S, Morton CL, Howard-Williams EL, Danks MK, Potter PM, Redinbo MR. Structural insights into CPT-11 activation by mammalian carboxylesterases. Nat Struct Biol. 2002;9(5):337–42.PubMedCrossRef
23.
go back to reference Rivory LP, Bowles MR, Robert J, Pond SM. Conversion of irinotecan (CPT-11) to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38), by human liver carboxylesterase. Biochem Pharmacol. 1996;52(7):1103–11.PubMedCrossRef Rivory LP, Bowles MR, Robert J, Pond SM. Conversion of irinotecan (CPT-11) to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38), by human liver carboxylesterase. Biochem Pharmacol. 1996;52(7):1103–11.PubMedCrossRef
24.
go back to reference Nozawa T, Minami H, Sugiura S, Tsuji A, Tamai I. Role of organic anion transporter OATP1B1 (OATP-C) in hepatic uptake of irinotecan and its active metabolite, 7-ethyl-10-hydroxycamptothecin: in vitro evidence and effect of single nucleotide polymorphisms. Drug Metab Dispos. 2005;33(3):434–9.PubMedCrossRef Nozawa T, Minami H, Sugiura S, Tsuji A, Tamai I. Role of organic anion transporter OATP1B1 (OATP-C) in hepatic uptake of irinotecan and its active metabolite, 7-ethyl-10-hydroxycamptothecin: in vitro evidence and effect of single nucleotide polymorphisms. Drug Metab Dispos. 2005;33(3):434–9.PubMedCrossRef
25.
go back to reference Kawato Y, Furuta T, Aonuma M, Yasuoka M, Yokokura T, Matsumoto K. Antitumor activity of a camptothecin derivative, CPT-11, against human tumor xenografts in nude mice. Cancer Chemother Pharmacol. 1991;28(3):192–8.PubMedCrossRef Kawato Y, Furuta T, Aonuma M, Yasuoka M, Yokokura T, Matsumoto K. Antitumor activity of a camptothecin derivative, CPT-11, against human tumor xenografts in nude mice. Cancer Chemother Pharmacol. 1991;28(3):192–8.PubMedCrossRef
26.
go back to reference van Ark-Otte J, Kedde MA, van der Vijgh WJ, Dingemans AM, Jansen WJ, Pinedo HM, et al. Determinants of CPT-11 and SN-38 activities in human lung cancer cells. Br J Cancer. 1998;77(12):2171–6.PubMedPubMedCentralCrossRef van Ark-Otte J, Kedde MA, van der Vijgh WJ, Dingemans AM, Jansen WJ, Pinedo HM, et al. Determinants of CPT-11 and SN-38 activities in human lung cancer cells. Br J Cancer. 1998;77(12):2171–6.PubMedPubMedCentralCrossRef
27.
go back to reference Ohtsuka K, Inoue S, Kameyama M, Kanetoshi A, Fujimoto T, Takaoka K, et al. Intracellular conversion of irinotecan to its active form, SN-38, by native carboxylesterase in human non-small cell lung cancer. Lung Cancer. 2003;41(2):187–98.PubMedCrossRef Ohtsuka K, Inoue S, Kameyama M, Kanetoshi A, Fujimoto T, Takaoka K, et al. Intracellular conversion of irinotecan to its active form, SN-38, by native carboxylesterase in human non-small cell lung cancer. Lung Cancer. 2003;41(2):187–98.PubMedCrossRef
28.
go back to reference Guichard S, Terret C, Hennebelle I, Lochon I, Chevreau P, Fretigny E, et al. CPT-11 converting carboxylesterase and topoisomerase activities in tumour and normal colon and liver tissues. Br J Cancer. 1999;80(3–4):364–70.PubMedPubMedCentralCrossRef Guichard S, Terret C, Hennebelle I, Lochon I, Chevreau P, Fretigny E, et al. CPT-11 converting carboxylesterase and topoisomerase activities in tumour and normal colon and liver tissues. Br J Cancer. 1999;80(3–4):364–70.PubMedPubMedCentralCrossRef
29.
go back to reference Xu G, Zhang W, Ma MK, McLeod HL. Human carboxylesterase 2 is commonly expressed in tumor tissue and is correlated with activation of irinotecan. Clin Cancer Res. 2002;8(8):2605–11.PubMed Xu G, Zhang W, Ma MK, McLeod HL. Human carboxylesterase 2 is commonly expressed in tumor tissue and is correlated with activation of irinotecan. Clin Cancer Res. 2002;8(8):2605–11.PubMed
30.
go back to reference Hsieh YT, Lin HP, Chen BM, Huang PT, Roffler SR. Effect of cellular location of human carboxylesterase 2 on CPT-11 hydrolysis and anticancer activity. PLoS One. 2015;10(10):e0141088.PubMedPubMedCentralCrossRef Hsieh YT, Lin HP, Chen BM, Huang PT, Roffler SR. Effect of cellular location of human carboxylesterase 2 on CPT-11 hydrolysis and anticancer activity. PLoS One. 2015;10(10):e0141088.PubMedPubMedCentralCrossRef
31.
go back to reference Yi BR, Kim SU, Choi KC. Co-treatment with therapeutic neural stem cells expressing carboxyl esterase and CPT-11 inhibit growth of primary and metastatic lung cancers in mice. Oncotarget. 2014;5(24):12835–48.PubMedPubMedCentralCrossRef Yi BR, Kim SU, Choi KC. Co-treatment with therapeutic neural stem cells expressing carboxyl esterase and CPT-11 inhibit growth of primary and metastatic lung cancers in mice. Oncotarget. 2014;5(24):12835–48.PubMedPubMedCentralCrossRef
32.
go back to reference Basel MT, Balivada S, Shrestha TB, Seo GM, Pyle MM, Tamura M, et al. A cell-delivered and cell-activated SN38-dextran prodrug increases survival in a murine disseminated pancreatic cancer model. Small. 2012;8(6):913–20.PubMedPubMedCentralCrossRef Basel MT, Balivada S, Shrestha TB, Seo GM, Pyle MM, Tamura M, et al. A cell-delivered and cell-activated SN38-dextran prodrug increases survival in a murine disseminated pancreatic cancer model. Small. 2012;8(6):913–20.PubMedPubMedCentralCrossRef
33.
go back to reference Gutova M, Najbauer J, Chen MY, Potter PM, Kim SU, Aboody KS. Therapeutic targeting of melanoma cells using neural stem cells expressing carboxylesterase, a CPT-11 activating enzyme. Curr Stem Cell Res Ther. 2010;5(3):273–6.PubMedCrossRef Gutova M, Najbauer J, Chen MY, Potter PM, Kim SU, Aboody KS. Therapeutic targeting of melanoma cells using neural stem cells expressing carboxylesterase, a CPT-11 activating enzyme. Curr Stem Cell Res Ther. 2010;5(3):273–6.PubMedCrossRef
34.
go back to reference Uchino J, Takayama K, Harada A, Sone T, Harada T, Curiel DT, et al. Tumor targeting carboxylesterase fused with anti-CEA scFv improve the anticancer effect with a less toxic dose of irinotecan. Cancer Gene Ther. 2008;15(2):94–100.PubMedCrossRef Uchino J, Takayama K, Harada A, Sone T, Harada T, Curiel DT, et al. Tumor targeting carboxylesterase fused with anti-CEA scFv improve the anticancer effect with a less toxic dose of irinotecan. Cancer Gene Ther. 2008;15(2):94–100.PubMedCrossRef
35.
go back to reference Oosterhoff D, Overmeer RM, de Graaf M, van der Meulen IH, Giaccone G, van Beusechem VW, et al. Adenoviral vector-mediated expression of a gene encoding secreted, EpCAM-targeted carboxylesterase-2 sensitises colon cancer spheroids to CPT-11. Br J Cancer. 2005;92(5):882–7.PubMedPubMedCentralCrossRef Oosterhoff D, Overmeer RM, de Graaf M, van der Meulen IH, Giaccone G, van Beusechem VW, et al. Adenoviral vector-mediated expression of a gene encoding secreted, EpCAM-targeted carboxylesterase-2 sensitises colon cancer spheroids to CPT-11. Br J Cancer. 2005;92(5):882–7.PubMedPubMedCentralCrossRef
36.
go back to reference Meck MM, Wierdl M, Wagner LM, Burger RA, Guichard SM, Krull EJ, et al. A virus-directed enzyme prodrug therapy approach to purging neuroblastoma cells from hematopoietic cells using adenovirus encoding rabbit carboxylesterase and CPT-11. Cancer Res. 2001;61(13):5083–9.PubMed Meck MM, Wierdl M, Wagner LM, Burger RA, Guichard SM, Krull EJ, et al. A virus-directed enzyme prodrug therapy approach to purging neuroblastoma cells from hematopoietic cells using adenovirus encoding rabbit carboxylesterase and CPT-11. Cancer Res. 2001;61(13):5083–9.PubMed
37.
go back to reference Wierdl M, Morton CL, Weeks JK, Danks MK, Harris LC, Potter PM. Sensitization of human tumor cells to CPT-11 via adenoviral-mediated delivery of a rabbit liver carboxylesterase. Cancer Res. 2001;61(13):5078–82.PubMed Wierdl M, Morton CL, Weeks JK, Danks MK, Harris LC, Potter PM. Sensitization of human tumor cells to CPT-11 via adenoviral-mediated delivery of a rabbit liver carboxylesterase. Cancer Res. 2001;61(13):5078–82.PubMed
38.
go back to reference Choi SS, Yoon K, Choi SA, Yoon SB, Kim SU, Lee HJ. Tumor-specific gene therapy for pancreatic cancer using human neural stem cells encoding carboxylesterase. Oncotarget. 2016;7(46):75319–27.PubMedPubMedCentral Choi SS, Yoon K, Choi SA, Yoon SB, Kim SU, Lee HJ. Tumor-specific gene therapy for pancreatic cancer using human neural stem cells encoding carboxylesterase. Oncotarget. 2016;7(46):75319–27.PubMedPubMedCentral
39.
go back to reference Laizure SC, Herring V, Hu Z, Witbrodt K, Parker RB. The role of human carboxylesterases in drug metabolism: have we overlooked their importance? Pharmacotherapy. 2013;33(2):210–22.PubMedPubMedCentralCrossRef Laizure SC, Herring V, Hu Z, Witbrodt K, Parker RB. The role of human carboxylesterases in drug metabolism: have we overlooked their importance? Pharmacotherapy. 2013;33(2):210–22.PubMedPubMedCentralCrossRef
40.
go back to reference Rivory LP, Robert J. Identification and kinetics of a beta-glucuronide metabolite of SN-38 in human plasma after administration of the camptothecin derivative irinotecan. Cancer Chemother Pharmacol. 1995;36(2):176–9.PubMedCrossRef Rivory LP, Robert J. Identification and kinetics of a beta-glucuronide metabolite of SN-38 in human plasma after administration of the camptothecin derivative irinotecan. Cancer Chemother Pharmacol. 1995;36(2):176–9.PubMedCrossRef
41.
go back to reference Haaz MC, Rivory L, Jantet S, Ratanasavanh D, Robert J. Glucuronidation of SN-38, the active metabolite of irinotecan, by human hepatic microsomes. Pharmacol Toxicol. 1997;80(2):91–6.PubMedCrossRef Haaz MC, Rivory L, Jantet S, Ratanasavanh D, Robert J. Glucuronidation of SN-38, the active metabolite of irinotecan, by human hepatic microsomes. Pharmacol Toxicol. 1997;80(2):91–6.PubMedCrossRef
42.
go back to reference Iyer L, King CD, Whitington PF, Green MD, Roy SK, Tephly TR, et al. Genetic predisposition to the metabolism of irinotecan (CPT-11). Role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN-38) in human liver microsomes. J Clin Invest. 1998;101(4):847–54.PubMedPubMedCentralCrossRef Iyer L, King CD, Whitington PF, Green MD, Roy SK, Tephly TR, et al. Genetic predisposition to the metabolism of irinotecan (CPT-11). Role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN-38) in human liver microsomes. J Clin Invest. 1998;101(4):847–54.PubMedPubMedCentralCrossRef
43.
go back to reference Ciotti M, Basu N, Brangi M, Owens IS. Glucuronidation of 7-ethyl-10-hydroxycamptothecin (SN-38) by the human UDP-glucuronosyltransferases encoded at the UGT1 locus. Biochem Biophys Res Commun. 1999;260(1):199–202.PubMedCrossRef Ciotti M, Basu N, Brangi M, Owens IS. Glucuronidation of 7-ethyl-10-hydroxycamptothecin (SN-38) by the human UDP-glucuronosyltransferases encoded at the UGT1 locus. Biochem Biophys Res Commun. 1999;260(1):199–202.PubMedCrossRef
44.
go back to reference Strassburg CP, Oldhafer K, Manns MP, Tukey RH. Differential expression of the UGT1A locus in human liver, biliary, and gastric tissue: identification of UGT1A7 and UGT1A10 transcripts in extrahepatic tissue. Mol Pharmacol. 1997;52(2):212–20.PubMedCrossRef Strassburg CP, Oldhafer K, Manns MP, Tukey RH. Differential expression of the UGT1A locus in human liver, biliary, and gastric tissue: identification of UGT1A7 and UGT1A10 transcripts in extrahepatic tissue. Mol Pharmacol. 1997;52(2):212–20.PubMedCrossRef
45.
go back to reference Hanioka N, Ozawa S, Jinno H, Ando M, Saito Y, Sawada J. Human liver UDP-glucuronosyltransferase isoforms involved in the glucuronidation of 7-ethyl-10-hydroxycamptothecin. Xenobiotica. 2001;31(10):687–99.PubMedCrossRef Hanioka N, Ozawa S, Jinno H, Ando M, Saito Y, Sawada J. Human liver UDP-glucuronosyltransferase isoforms involved in the glucuronidation of 7-ethyl-10-hydroxycamptothecin. Xenobiotica. 2001;31(10):687–99.PubMedCrossRef
46.
go back to reference Tallman MN, Ritter JK, Smith PC. Differential rates of glucuronidation for 7-ethyl-10-hydroxy-camptothecin (SN-38) lactone and carboxylate in human and rat microsomes and recombinant UDP-glucuronosyltransferase isoforms. Drug Metab Dispos. 2005;33(7):977–83.PubMedCrossRef Tallman MN, Ritter JK, Smith PC. Differential rates of glucuronidation for 7-ethyl-10-hydroxy-camptothecin (SN-38) lactone and carboxylate in human and rat microsomes and recombinant UDP-glucuronosyltransferase isoforms. Drug Metab Dispos. 2005;33(7):977–83.PubMedCrossRef
47.
go back to reference Rivory LP, Haaz MC, Canal P, Lokiec F, Armand JP, Robert J. Pharmacokinetic interrelationships of irinotecan (CPT-11) and its three major plasma metabolites in patients enrolled in phase I/II trials. Clin Cancer Res. 1997;3(8):1261–6.PubMed Rivory LP, Haaz MC, Canal P, Lokiec F, Armand JP, Robert J. Pharmacokinetic interrelationships of irinotecan (CPT-11) and its three major plasma metabolites in patients enrolled in phase I/II trials. Clin Cancer Res. 1997;3(8):1261–6.PubMed
48.
go back to reference Wasserman E, Myara A, Lokiec F, Goldwasser F, Trivin F, Mahjoubi M, et al. Severe CPT-11 toxicity in patients with Gilbert’s syndrome: two case reports. Ann Oncol. 1997;8(10):1049–51.PubMedCrossRef Wasserman E, Myara A, Lokiec F, Goldwasser F, Trivin F, Mahjoubi M, et al. Severe CPT-11 toxicity in patients with Gilbert’s syndrome: two case reports. Ann Oncol. 1997;8(10):1049–51.PubMedCrossRef
49.
go back to reference Santos A, Zanetta S, Cresteil T, Deroussent A, Pein F, Raymond E, et al. Metabolism of irinotecan (CPT-11) by CYP3A4 and CYP3A5 in humans. Clin Cancer Res. 2000;6(5):2012–20.PubMed Santos A, Zanetta S, Cresteil T, Deroussent A, Pein F, Raymond E, et al. Metabolism of irinotecan (CPT-11) by CYP3A4 and CYP3A5 in humans. Clin Cancer Res. 2000;6(5):2012–20.PubMed
50.
go back to reference Dodds HM, Haaz MC, Riou JF, Robert J, Rivory LP. Identification of a new metabolite of CPT-11 (irinotecan): pharmacological properties and activation to SN-38. J Pharmacol Exp Ther. 1998;286(1):578–83.PubMed Dodds HM, Haaz MC, Riou JF, Robert J, Rivory LP. Identification of a new metabolite of CPT-11 (irinotecan): pharmacological properties and activation to SN-38. J Pharmacol Exp Ther. 1998;286(1):578–83.PubMed
51.
go back to reference Mathijssen RH, de Jong FA, van Schaik RH, Lepper ER, Friberg LE, Rietveld T, et al. Prediction of irinotecan pharmacokinetics by use of cytochrome P450 3A4 phenotyping probes. J Natl Cancer Inst. 2004;96(21):1585–92.PubMedCrossRef Mathijssen RH, de Jong FA, van Schaik RH, Lepper ER, Friberg LE, Rietveld T, et al. Prediction of irinotecan pharmacokinetics by use of cytochrome P450 3A4 phenotyping probes. J Natl Cancer Inst. 2004;96(21):1585–92.PubMedCrossRef
52.
go back to reference van der Bol JM, Mathijssen RH, Creemers GJ, Planting AS, Loos WJ, Wiemer EA, et al. A CYP3A4 phenotype-based dosing algorithm for individualized treatment of irinotecan. Clin Cancer Res. 2010;16(2):736–42.PubMedCrossRef van der Bol JM, Mathijssen RH, Creemers GJ, Planting AS, Loos WJ, Wiemer EA, et al. A CYP3A4 phenotype-based dosing algorithm for individualized treatment of irinotecan. Clin Cancer Res. 2010;16(2):736–42.PubMedCrossRef
53.
go back to reference Sperker B, Backman JT, Kroemer HK. The role of beta-glucuronidase in drug disposition and drug targeting in humans. Clin Pharmacokinet. 1997;33(1):18–31.PubMedCrossRef Sperker B, Backman JT, Kroemer HK. The role of beta-glucuronidase in drug disposition and drug targeting in humans. Clin Pharmacokinet. 1997;33(1):18–31.PubMedCrossRef
54.
go back to reference Fujisawa T, Mori M. Influence of various bile salts on beta-glucuronidase activity of intestinal bacteria. Lett Appl Microbiol. 1997;25(2):95–7.PubMedCrossRef Fujisawa T, Mori M. Influence of various bile salts on beta-glucuronidase activity of intestinal bacteria. Lett Appl Microbiol. 1997;25(2):95–7.PubMedCrossRef
55.
go back to reference Cole CB, Fuller R, Mallet AK, Rowland IR. The influence of the host on expression of intestinal microbial enzyme activities involved in metabolism of foreign compounds. J Appl Bacteriol. 1985;59(6):549–53.PubMedCrossRef Cole CB, Fuller R, Mallet AK, Rowland IR. The influence of the host on expression of intestinal microbial enzyme activities involved in metabolism of foreign compounds. J Appl Bacteriol. 1985;59(6):549–53.PubMedCrossRef
56.
go back to reference Takasuna K, Hagiwara T, Hirohashi M, Kato M, Nomura M, Nagai E, et al. Involvement of beta-glucuronidase in intestinal microflora in the intestinal toxicity of the antitumor camptothecin derivative irinotecan hydrochloride (CPT-11) in rats. Cancer Res. 1996;56(16):3752–7.PubMed Takasuna K, Hagiwara T, Hirohashi M, Kato M, Nomura M, Nagai E, et al. Involvement of beta-glucuronidase in intestinal microflora in the intestinal toxicity of the antitumor camptothecin derivative irinotecan hydrochloride (CPT-11) in rats. Cancer Res. 1996;56(16):3752–7.PubMed
57.
go back to reference Kong R, Liu T, Zhu X, Ahmad S, Williams AL, Phan AT, et al. Old drug new use–amoxapine and its metabolites as potent bacterial beta-glucuronidase inhibitors for alleviating cancer drug toxicity. Clin Cancer Res. 2014;20(13):3521–30.PubMedPubMedCentralCrossRef Kong R, Liu T, Zhu X, Ahmad S, Williams AL, Phan AT, et al. Old drug new use–amoxapine and its metabolites as potent bacterial beta-glucuronidase inhibitors for alleviating cancer drug toxicity. Clin Cancer Res. 2014;20(13):3521–30.PubMedPubMedCentralCrossRef
58.
go back to reference de Jong FA, Kehrer DF, Mathijssen RH, Creemers GJ, de Bruijn P, van Schaik RH, et al. Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: a double-blind, randomized, placebo-controlled study. Oncologist. 2006;11(8):944–54.PubMedCrossRef de Jong FA, Kehrer DF, Mathijssen RH, Creemers GJ, de Bruijn P, van Schaik RH, et al. Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: a double-blind, randomized, placebo-controlled study. Oncologist. 2006;11(8):944–54.PubMedCrossRef
59.
go back to reference Slatter JG, Schaaf LJ, Sams JP, Feenstra KL, Johnson MG, Bombardt PA, et al. Pharmacokinetics, metabolism, and excretion of irinotecan (CPT-11) following I.V. infusion of [(14)C]CPT-11 in cancer patients. Drug Metab Dispos. 2000;28(4):423–33.PubMed Slatter JG, Schaaf LJ, Sams JP, Feenstra KL, Johnson MG, Bombardt PA, et al. Pharmacokinetics, metabolism, and excretion of irinotecan (CPT-11) following I.V. infusion of [(14)C]CPT-11 in cancer patients. Drug Metab Dispos. 2000;28(4):423–33.PubMed
60.
go back to reference Mathijssen RH, van Alphen RJ, Verweij J, Loos WJ, Nooter K, Stoter G, et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res. 2001;7(8):2182–94.PubMed Mathijssen RH, van Alphen RJ, Verweij J, Loos WJ, Nooter K, Stoter G, et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res. 2001;7(8):2182–94.PubMed
61.
go back to reference Sugiyama Y, Kato Y, Chu X. Multiplicity of biliary excretion mechanisms for the camptothecin derivative irinotecan (CPT-11), its metabolite SN-38, and its glucuronide: role of canalicular multispecific organic anion transporter and P-glycoprotein. Cancer Chemother Pharmacol. 1998;42(Suppl):S44–9.PubMedCrossRef Sugiyama Y, Kato Y, Chu X. Multiplicity of biliary excretion mechanisms for the camptothecin derivative irinotecan (CPT-11), its metabolite SN-38, and its glucuronide: role of canalicular multispecific organic anion transporter and P-glycoprotein. Cancer Chemother Pharmacol. 1998;42(Suppl):S44–9.PubMedCrossRef
62.
go back to reference Chu XY, Kato Y, Ueda K, Suzuki H, Niinuma K, Tyson CA, et al. Biliary excretion mechanism of CPT-11 and its metabolites in humans: involvement of primary active transporters. Cancer Res. 1998;58(22):5137–43.PubMed Chu XY, Kato Y, Ueda K, Suzuki H, Niinuma K, Tyson CA, et al. Biliary excretion mechanism of CPT-11 and its metabolites in humans: involvement of primary active transporters. Cancer Res. 1998;58(22):5137–43.PubMed
63.
go back to reference Nakatomi K, Yoshikawa M, Oka M, Ikegami Y, Hayasaka S, Sano K, et al. Transport of 7-ethyl-10-hydroxycamptothecin (SN-38) by breast cancer resistance protein ABCG2 in human lung cancer cells. Biochem Biophys Res Commun. 2001;288(4):827–32.PubMedCrossRef Nakatomi K, Yoshikawa M, Oka M, Ikegami Y, Hayasaka S, Sano K, et al. Transport of 7-ethyl-10-hydroxycamptothecin (SN-38) by breast cancer resistance protein ABCG2 in human lung cancer cells. Biochem Biophys Res Commun. 2001;288(4):827–32.PubMedCrossRef
64.
go back to reference Goldwirt L, Beccaria K, Carpentier A, Farinotti R, Fernandez C. Irinotecan and temozolomide brain distribution: a focus on ABCB1. Cancer Chemother Pharmacol. 2014;74(1):185–93.PubMedCrossRef Goldwirt L, Beccaria K, Carpentier A, Farinotti R, Fernandez C. Irinotecan and temozolomide brain distribution: a focus on ABCB1. Cancer Chemother Pharmacol. 2014;74(1):185–93.PubMedCrossRef
65.
go back to reference Rowinsky EK, Grochow LB, Ettinger DS, Sartorius SE, Lubejko BG, Chen TL, et al. Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res. 1994;54(2):427–36.PubMed Rowinsky EK, Grochow LB, Ettinger DS, Sartorius SE, Lubejko BG, Chen TL, et al. Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res. 1994;54(2):427–36.PubMed
66.
go back to reference de Jonge MJ, Verweij J, de Bruijn P, Brouwer E, Mathijssen RH, van Alphen RJ, et al. Pharmacokinetic, metabolic, and pharmacodynamic profiles in a dose-escalating study of irinotecan and cisplatin. J Clin Oncol. 2000;18(1):195–203.PubMedCrossRef de Jonge MJ, Verweij J, de Bruijn P, Brouwer E, Mathijssen RH, van Alphen RJ, et al. Pharmacokinetic, metabolic, and pharmacodynamic profiles in a dose-escalating study of irinotecan and cisplatin. J Clin Oncol. 2000;18(1):195–203.PubMedCrossRef
67.
go back to reference Catimel G, Chabot GG, Guastalla JP, Dumortier A, Cote C, Engel C, et al. Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for three consecutive days every three weeks in patients with advanced solid tumors. Ann Oncol. 1995;6(2):133–40.PubMedCrossRef Catimel G, Chabot GG, Guastalla JP, Dumortier A, Cote C, Engel C, et al. Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for three consecutive days every three weeks in patients with advanced solid tumors. Ann Oncol. 1995;6(2):133–40.PubMedCrossRef
68.
go back to reference Canal P, Gay C, Dezeuze A, Douillard JY, Bugat R, Brunet R, et al. Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer. Pharmacology and molecular mechanisms group of the European Organization for Research and Treatment of Cancer. J Clin Oncol. 1996;14(10):2688–95.PubMedCrossRef Canal P, Gay C, Dezeuze A, Douillard JY, Bugat R, Brunet R, et al. Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer. Pharmacology and molecular mechanisms group of the European Organization for Research and Treatment of Cancer. J Clin Oncol. 1996;14(10):2688–95.PubMedCrossRef
69.
go back to reference Poujol S, Pinguet F, Malosse F, Astre C, Ychou M, Culine S, et al. Sensitive HPLC-fluorescence method for irinotecan and four major metabolites in human plasma and saliva: application to pharmacokinetic studies. Clin Chem. 2003;49(11):1900–8.PubMedCrossRef Poujol S, Pinguet F, Malosse F, Astre C, Ychou M, Culine S, et al. Sensitive HPLC-fluorescence method for irinotecan and four major metabolites in human plasma and saliva: application to pharmacokinetic studies. Clin Chem. 2003;49(11):1900–8.PubMedCrossRef
70.
go back to reference Saltz LB, Kanowitz J, Kemeny NE, Schaaf L, Spriggs D, Staton BA, et al. Phase I clinical and pharmacokinetic study of irinotecan, fluorouracil, and leucovorin in patients with advanced solid tumors. J Clin Oncol. 1996;14(11):2959–67.PubMedCrossRef Saltz LB, Kanowitz J, Kemeny NE, Schaaf L, Spriggs D, Staton BA, et al. Phase I clinical and pharmacokinetic study of irinotecan, fluorouracil, and leucovorin in patients with advanced solid tumors. J Clin Oncol. 1996;14(11):2959–67.PubMedCrossRef
71.
go back to reference Sparreboom A, de Jonge MJ, de Bruijn P, Brouwer E, Nooter K, Loos WJ, et al. Irinotecan (CPT-11) metabolism and disposition in cancer patients. Clin Cancer Res. 1998;4(11):2747–54.PubMed Sparreboom A, de Jonge MJ, de Bruijn P, Brouwer E, Nooter K, Loos WJ, et al. Irinotecan (CPT-11) metabolism and disposition in cancer patients. Clin Cancer Res. 1998;4(11):2747–54.PubMed
72.
go back to reference Kehrer DF, Yamamoto W, Verweij J, de Jonge MJ, de Bruijn P, Sparreboom A. Factors involved in prolongation of the terminal disposition phase of SN-38: clinical and experimental studies. Clin Cancer Res. 2000;6(9):3451–8.PubMed Kehrer DF, Yamamoto W, Verweij J, de Jonge MJ, de Bruijn P, Sparreboom A. Factors involved in prolongation of the terminal disposition phase of SN-38: clinical and experimental studies. Clin Cancer Res. 2000;6(9):3451–8.PubMed
73.
go back to reference Mathijssen RH, Verweij J, Loos WJ, de Bruijn P, Nooter K, Sparreboom A. Irinotecan pharmacokinetics-pharmacodynamics: the clinical relevance of prolonged exposure to SN-38. Br J Cancer. 2002;87(2):144–50.PubMedPubMedCentralCrossRef Mathijssen RH, Verweij J, Loos WJ, de Bruijn P, Nooter K, Sparreboom A. Irinotecan pharmacokinetics-pharmacodynamics: the clinical relevance of prolonged exposure to SN-38. Br J Cancer. 2002;87(2):144–50.PubMedPubMedCentralCrossRef
74.
go back to reference Mathijssen RH, Verweij J, de Jonge MJ, Nooter K, Stoter G, Sparreboom A. Impact of body-size measures on irinotecan clearance: alternative dosing recommendations. J Clin Oncol. 2002;20(1):81–7.PubMedCrossRef Mathijssen RH, Verweij J, de Jonge MJ, Nooter K, Stoter G, Sparreboom A. Impact of body-size measures on irinotecan clearance: alternative dosing recommendations. J Clin Oncol. 2002;20(1):81–7.PubMedCrossRef
75.
go back to reference Berg AK, Buckner JC, Galanis E, Jaeckle KA, Ames MM, Reid JM. Quantification of the impact of enzyme-inducing antiepileptic drugs on irinotecan pharmacokinetics and SN-38 exposure. J Clin Pharmacol. 2015;55(11):1303–12.PubMedPubMedCentralCrossRef Berg AK, Buckner JC, Galanis E, Jaeckle KA, Ames MM, Reid JM. Quantification of the impact of enzyme-inducing antiepileptic drugs on irinotecan pharmacokinetics and SN-38 exposure. J Clin Pharmacol. 2015;55(11):1303–12.PubMedPubMedCentralCrossRef
76.
go back to reference Gupta E, Mick R, Ramirez J, Wang X, Lestingi TM, Vokes EE, et al. Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. J Clin Oncol. 1997;15(4):1502–10.PubMedCrossRef Gupta E, Mick R, Ramirez J, Wang X, Lestingi TM, Vokes EE, et al. Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. J Clin Oncol. 1997;15(4):1502–10.PubMedCrossRef
77.
go back to reference Sparreboom A, Wolff AC, Mathijssen RH, Chatelut E, Rowinsky EK, Verweij J, et al. Evaluation of alternate size descriptors for dose calculation of anticancer drugs in the obese. J Clin Oncol. 2007;25(30):4707–13.PubMedCrossRef Sparreboom A, Wolff AC, Mathijssen RH, Chatelut E, Rowinsky EK, Verweij J, et al. Evaluation of alternate size descriptors for dose calculation of anticancer drugs in the obese. J Clin Oncol. 2007;25(30):4707–13.PubMedCrossRef
78.
go back to reference de Jong FA, Mathijssen RH, Xie R, Verweij J, Sparreboom A. Flat-fixed dosing of irinotecan: influence on pharmacokinetic and pharmacodynamic variability. Clin Cancer Res. 2004;10(12 Pt 1):4068–71.PubMedCrossRef de Jong FA, Mathijssen RH, Xie R, Verweij J, Sparreboom A. Flat-fixed dosing of irinotecan: influence on pharmacokinetic and pharmacodynamic variability. Clin Cancer Res. 2004;10(12 Pt 1):4068–71.PubMedCrossRef
79.
go back to reference Soepenberg O, Dumez H, Verweij J, Semiond D, deJonge MJ, Eskens FA, et al. Phase I and pharmacokinetic study of oral irinotecan given once daily for 5 days every 3 weeks in combination with capecitabine in patients with solid tumors. J Clin Oncol. 2005;23(4):889–98.PubMedCrossRef Soepenberg O, Dumez H, Verweij J, Semiond D, deJonge MJ, Eskens FA, et al. Phase I and pharmacokinetic study of oral irinotecan given once daily for 5 days every 3 weeks in combination with capecitabine in patients with solid tumors. J Clin Oncol. 2005;23(4):889–98.PubMedCrossRef
80.
go back to reference Pitot HC, Adjei AA, Reid JM, Sloan JA, Atherton PJ, Rubin J, et al. A phase I and pharmacokinetic study of a powder-filled capsule formulation of oral irinotecan (CPT-11) given daily for 5 days every 3 weeks in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2006;58(2):165–72.PubMedCrossRef Pitot HC, Adjei AA, Reid JM, Sloan JA, Atherton PJ, Rubin J, et al. A phase I and pharmacokinetic study of a powder-filled capsule formulation of oral irinotecan (CPT-11) given daily for 5 days every 3 weeks in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2006;58(2):165–72.PubMedCrossRef
81.
go back to reference Goff LW, Benson AB 3rd, LoRusso PM, Tan AR, Berlin JD, Denis LJ, et al. Phase I study of oral irinotecan as a single-agent and given sequentially with capecitabine. Invest New Drugs. 2012;30(1):290–8.PubMedCrossRef Goff LW, Benson AB 3rd, LoRusso PM, Tan AR, Berlin JD, Denis LJ, et al. Phase I study of oral irinotecan as a single-agent and given sequentially with capecitabine. Invest New Drugs. 2012;30(1):290–8.PubMedCrossRef
82.
go back to reference Wagner LM. Oral irinotecan for treatment of pediatric solid tumors: ready for prime time? Pediatr Blood Cancer. 2010;54(5):661–2.PubMed Wagner LM. Oral irinotecan for treatment of pediatric solid tumors: ready for prime time? Pediatr Blood Cancer. 2010;54(5):661–2.PubMed
83.
go back to reference Taylor RR, Tang Y, Gonzalez MV, Stratford PW, Lewis AL. Irinotecan drug eluting beads for use in chemoembolization: in vitro and in vivo evaluation of drug release properties. Eur J Pharm Sci. 2007;30(1):7–14.PubMedCrossRef Taylor RR, Tang Y, Gonzalez MV, Stratford PW, Lewis AL. Irinotecan drug eluting beads for use in chemoembolization: in vitro and in vivo evaluation of drug release properties. Eur J Pharm Sci. 2007;30(1):7–14.PubMedCrossRef
84.
go back to reference Martin RC 2nd, Scoggins CR, Tomalty D, Schreeder M, Metzger T, Tatum C, et al. Irinotecan drug-eluting beads in the treatment of chemo-naive unresectable colorectal liver metastasis with concomitant systemic fluorouracil and oxaliplatin: results of pharmacokinetics and phase I trial. J Gastrointest Surg. 2012;16(8):1531–8.PubMedCrossRef Martin RC 2nd, Scoggins CR, Tomalty D, Schreeder M, Metzger T, Tatum C, et al. Irinotecan drug-eluting beads in the treatment of chemo-naive unresectable colorectal liver metastasis with concomitant systemic fluorouracil and oxaliplatin: results of pharmacokinetics and phase I trial. J Gastrointest Surg. 2012;16(8):1531–8.PubMedCrossRef
85.
go back to reference Rao PP, Pascale F, Seck A, Auperin A, Drouard-Troalen L, Deschamps F, et al. Irinotecan loaded in eluting beads: preclinical assessment in a rabbit VX2 liver tumor model. Cardiovasc Intervent Radiol. 2012;35(6):1448–59.PubMedCrossRef Rao PP, Pascale F, Seck A, Auperin A, Drouard-Troalen L, Deschamps F, et al. Irinotecan loaded in eluting beads: preclinical assessment in a rabbit VX2 liver tumor model. Cardiovasc Intervent Radiol. 2012;35(6):1448–59.PubMedCrossRef
86.
go back to reference Akinwande O, Dendy M, Ludwig JM, Kim HS. Hepatic intra-arterial injection of irinotecan drug eluting beads (DEBIRI) for patients with unresectable colorectal liver metastases: a systematic review. Surg Oncol. 2017;26(3):268–75.PubMedCrossRef Akinwande O, Dendy M, Ludwig JM, Kim HS. Hepatic intra-arterial injection of irinotecan drug eluting beads (DEBIRI) for patients with unresectable colorectal liver metastases: a systematic review. Surg Oncol. 2017;26(3):268–75.PubMedCrossRef
87.
go back to reference Lamb YN, Scott LJ. Liposomal irinotecan: a review in metastatic pancreatic adenocarcinoma. Drugs. 2017;77(7):785–92.PubMedCrossRef Lamb YN, Scott LJ. Liposomal irinotecan: a review in metastatic pancreatic adenocarcinoma. Drugs. 2017;77(7):785–92.PubMedCrossRef
88.
go back to reference Garufi C, Torsello A, Tumolo S, Ettorre GM, Zeuli M, Campanella C, et al. Cetuximab plus chronomodulated irinotecan, 5-fluorouracil, leucovorin and oxaliplatin as neoadjuvant chemotherapy in colorectal liver metastases: POCHER trial. Br J Cancer. 2010;103(10):1542–7.PubMedPubMedCentralCrossRef Garufi C, Torsello A, Tumolo S, Ettorre GM, Zeuli M, Campanella C, et al. Cetuximab plus chronomodulated irinotecan, 5-fluorouracil, leucovorin and oxaliplatin as neoadjuvant chemotherapy in colorectal liver metastases: POCHER trial. Br J Cancer. 2010;103(10):1542–7.PubMedPubMedCentralCrossRef
89.
go back to reference Gholam D, Giacchetti S, Brezault-Bonnet C, Bouchahda M, Hauteville D, Adam R, et al. Chronomodulated irinotecan, oxaliplatin, and leucovorin-modulated 5-Fluorouracil as ambulatory salvage therapy in patients with irinotecan- and oxaliplatin-resistant metastatic colorectal cancer. Oncologist. 2006;11(10):1072–80.PubMedCrossRef Gholam D, Giacchetti S, Brezault-Bonnet C, Bouchahda M, Hauteville D, Adam R, et al. Chronomodulated irinotecan, oxaliplatin, and leucovorin-modulated 5-Fluorouracil as ambulatory salvage therapy in patients with irinotecan- and oxaliplatin-resistant metastatic colorectal cancer. Oncologist. 2006;11(10):1072–80.PubMedCrossRef
90.
go back to reference Garufi C, Vanni B, Aschelter AM, Zappala AR, Bria E, Nistico C, et al. Randomised phase II study of standard versus chronomodulated CPT-11 plus chronomodulated 5-fluorouracil and folinic acid in advanced colorectal cancer patients. Eur J Cancer. 2006;42(5):608–16.PubMedCrossRef Garufi C, Vanni B, Aschelter AM, Zappala AR, Bria E, Nistico C, et al. Randomised phase II study of standard versus chronomodulated CPT-11 plus chronomodulated 5-fluorouracil and folinic acid in advanced colorectal cancer patients. Eur J Cancer. 2006;42(5):608–16.PubMedCrossRef
92.
go back to reference Dulong S, Ballesta A, Okyar A, Levi F. Identification of circadian determinants of cancer chronotherapy through in vitro chronopharmacology and mathematical modeling. Mol Cancer Ther. 2015;14(9):2154–64.PubMedCrossRef Dulong S, Ballesta A, Okyar A, Levi F. Identification of circadian determinants of cancer chronotherapy through in vitro chronopharmacology and mathematical modeling. Mol Cancer Ther. 2015;14(9):2154–64.PubMedCrossRef
93.
go back to reference Levi F, Okyar A, Dulong S, Innominato PF, Clairambault J. Circadian timing in cancer treatments. Annu Rev Pharmacol Toxicol. 2010;50:377–421.PubMedCrossRef Levi F, Okyar A, Dulong S, Innominato PF, Clairambault J. Circadian timing in cancer treatments. Annu Rev Pharmacol Toxicol. 2010;50:377–421.PubMedCrossRef
94.
go back to reference Giacchetti S, Cure H, Adenis A, Tubiana N, Vernillet L, Chedouba-Messali L, et al. Chronomodulated (Chrono) irinotecan (CPT) versus standard (STD) infusion in patients (pts) with metastatic colorectal cancer (MCC), a randomized multicenter trial. Eur J Cancer. 2001;37:S309.CrossRef Giacchetti S, Cure H, Adenis A, Tubiana N, Vernillet L, Chedouba-Messali L, et al. Chronomodulated (Chrono) irinotecan (CPT) versus standard (STD) infusion in patients (pts) with metastatic colorectal cancer (MCC), a randomized multicenter trial. Eur J Cancer. 2001;37:S309.CrossRef
95.
go back to reference Said R, Kurzrock R, Naing A, Hong DS, Fu S, Piha-Paul SA, et al. Dose-finding study of hepatic arterial infusion of irinotecan-based treatment in patients with advanced cancers metastatic to the liver. Invest New Drugs. 2015;33(4):911–20.PubMedPubMedCentralCrossRef Said R, Kurzrock R, Naing A, Hong DS, Fu S, Piha-Paul SA, et al. Dose-finding study of hepatic arterial infusion of irinotecan-based treatment in patients with advanced cancers metastatic to the liver. Invest New Drugs. 2015;33(4):911–20.PubMedPubMedCentralCrossRef
96.
go back to reference Levi F, Karaboue A, Etienne-Grimaldi MC, Paintaud G, Focan C, Innominato P, et al. Pharmacokinetics of irinotecan, oxaliplatin and 5-fluorouracil during hepatic artery chronomodulated infusion: a translational european OPTILIV Study. Clin Pharmacokinet. 2017;56(2):165–77.PubMedCrossRef Levi F, Karaboue A, Etienne-Grimaldi MC, Paintaud G, Focan C, Innominato P, et al. Pharmacokinetics of irinotecan, oxaliplatin and 5-fluorouracil during hepatic artery chronomodulated infusion: a translational european OPTILIV Study. Clin Pharmacokinet. 2017;56(2):165–77.PubMedCrossRef
97.
go back to reference van Riel JM, van Groeningen CJ, Kedde MA, Gall H, Leisink JM, Gruia G, et al. Continuous administration of irinotecan by hepatic arterial infusion: a phase I and pharmacokinetic study. Clin Cancer Res. 2002;8(2):405–12.PubMed van Riel JM, van Groeningen CJ, Kedde MA, Gall H, Leisink JM, Gruia G, et al. Continuous administration of irinotecan by hepatic arterial infusion: a phase I and pharmacokinetic study. Clin Cancer Res. 2002;8(2):405–12.PubMed
98.
go back to reference Elias D, Matsuhisa T, Sideris L, Liberale G, Drouard-Troalen L, Raynard B, et al. Heated intra-operative intraperitoneal oxaliplatin plus irinotecan after complete resection of peritoneal carcinomatosis: pharmacokinetics, tissue distribution and tolerance. Ann Oncol. 2004;15(10):1558–65.PubMedCrossRef Elias D, Matsuhisa T, Sideris L, Liberale G, Drouard-Troalen L, Raynard B, et al. Heated intra-operative intraperitoneal oxaliplatin plus irinotecan after complete resection of peritoneal carcinomatosis: pharmacokinetics, tissue distribution and tolerance. Ann Oncol. 2004;15(10):1558–65.PubMedCrossRef
99.
go back to reference Elias D, Raynard B, Bonnay M, Pocard M. Heated intra-operative intraperitoneal oxaliplatin alone and in combination with intraperitoneal irinotecan: pharmacologic studies. Eur J Surg Oncol. 2006;32(6):607–13.PubMedCrossRef Elias D, Raynard B, Bonnay M, Pocard M. Heated intra-operative intraperitoneal oxaliplatin alone and in combination with intraperitoneal irinotecan: pharmacologic studies. Eur J Surg Oncol. 2006;32(6):607–13.PubMedCrossRef
100.
go back to reference Ahn BJ, Choi MK, Park YS, Lee J, Park SH, Park JO, et al. Population pharmacokinetics of CPT-11 (irinotecan) in gastric cancer patients with peritoneal seeding after its intraperitoneal administration. Eur J Clin Pharmacol. 2010;66(12):1235–45.PubMedCrossRef Ahn BJ, Choi MK, Park YS, Lee J, Park SH, Park JO, et al. Population pharmacokinetics of CPT-11 (irinotecan) in gastric cancer patients with peritoneal seeding after its intraperitoneal administration. Eur J Clin Pharmacol. 2010;66(12):1235–45.PubMedCrossRef
101.
go back to reference Choi MK, Ahn BJ, Yim DS, Park YS, Kim S, Sohn TS, et al. Phase I study of intraperitoneal irinotecan in patients with gastric adenocarcinoma with peritoneal seeding. Cancer Chemother Pharmacol. 2011;67(1):5–11.PubMedCrossRef Choi MK, Ahn BJ, Yim DS, Park YS, Kim S, Sohn TS, et al. Phase I study of intraperitoneal irinotecan in patients with gastric adenocarcinoma with peritoneal seeding. Cancer Chemother Pharmacol. 2011;67(1):5–11.PubMedCrossRef
102.
go back to reference Cotte E, Passot G, Tod M, Bakrin N, Gilly FN, Steghens A, et al. Closed abdomen hyperthermic intraperitoneal chemotherapy with irinotecan and mitomycin C: a phase I study. Ann Surg Oncol. 2011;18(9):2599–603.PubMedCrossRef Cotte E, Passot G, Tod M, Bakrin N, Gilly FN, Steghens A, et al. Closed abdomen hyperthermic intraperitoneal chemotherapy with irinotecan and mitomycin C: a phase I study. Ann Surg Oncol. 2011;18(9):2599–603.PubMedCrossRef
103.
go back to reference Glockzin G, Gerken M, Lang SA, Klinkhammer-Schalke M, Piso P, Schlitt HJ. Oxaliplatin-based versus irinotecan-based hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastasis from appendiceal and colorectal cancer: a retrospective analysis. BMC Cancer. 2014;14:807.PubMedPubMedCentralCrossRef Glockzin G, Gerken M, Lang SA, Klinkhammer-Schalke M, Piso P, Schlitt HJ. Oxaliplatin-based versus irinotecan-based hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastasis from appendiceal and colorectal cancer: a retrospective analysis. BMC Cancer. 2014;14:807.PubMedPubMedCentralCrossRef
104.
go back to reference Couteau C, Risse ML, Ducreux M, Lefresne-Soulas F, Riva A, Lebecq A, et al. Phase I and pharmacokinetic study of docetaxel and irinotecan in patients with advanced solid tumors. J Clin Oncol. 2000;18(20):3545–52.PubMedCrossRef Couteau C, Risse ML, Ducreux M, Lefresne-Soulas F, Riva A, Lebecq A, et al. Phase I and pharmacokinetic study of docetaxel and irinotecan in patients with advanced solid tumors. J Clin Oncol. 2000;18(20):3545–52.PubMedCrossRef
105.
go back to reference de Jonge MJ, Sparreboom A, Planting AS, van der Burg ME, de Boer-Dennert MM, ter Steeg J, et al. Phase I study of 3-week schedule of irinotecan combined with cisplatin in patients with advanced solid tumors. J Clin Oncol. 2000;18(1):187–94.PubMedCrossRef de Jonge MJ, Sparreboom A, Planting AS, van der Burg ME, de Boer-Dennert MM, ter Steeg J, et al. Phase I study of 3-week schedule of irinotecan combined with cisplatin in patients with advanced solid tumors. J Clin Oncol. 2000;18(1):187–94.PubMedCrossRef
106.
go back to reference DeVore RF, Johnson DH, Crawford J, Garst J, Dimery IW, Eckardt J, et al. Phase II study of irinotecan plus cisplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol. 1999;17(9):2710–20.PubMedCrossRef DeVore RF, Johnson DH, Crawford J, Garst J, Dimery IW, Eckardt J, et al. Phase II study of irinotecan plus cisplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol. 1999;17(9):2710–20.PubMedCrossRef
107.
go back to reference Kudoh S, Fukuoka M, Masuda N, Yoshikawa A, Kusunoki Y, Matsui K, et al. Relationship between the pharmacokinetics of irinotecan and diarrhea during combination chemotherapy with cisplatin. Jpn J Cancer Res. 1995;86(4):406–13.PubMedPubMedCentralCrossRef Kudoh S, Fukuoka M, Masuda N, Yoshikawa A, Kusunoki Y, Matsui K, et al. Relationship between the pharmacokinetics of irinotecan and diarrhea during combination chemotherapy with cisplatin. Jpn J Cancer Res. 1995;86(4):406–13.PubMedPubMedCentralCrossRef
108.
go back to reference Czejka M, Schueller J, Hauer K, Ostermann E. Pharmacokinetics and metabolism of irinotecan combined with capecitabine in patients with advanced colorectal cancer. Anticancer Res. 2005;25(4):2985–90.PubMed Czejka M, Schueller J, Hauer K, Ostermann E. Pharmacokinetics and metabolism of irinotecan combined with capecitabine in patients with advanced colorectal cancer. Anticancer Res. 2005;25(4):2985–90.PubMed
109.
go back to reference Delord JP, Pierga JY, Dieras V, Bertheault-Cvitkovic F, Turpin FL, Lokiec F, et al. A phase I clinical and pharmacokinetic study of capecitabine (Xeloda) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours. Br J Cancer. 2005;92(5):820–6.PubMedPubMedCentralCrossRef Delord JP, Pierga JY, Dieras V, Bertheault-Cvitkovic F, Turpin FL, Lokiec F, et al. A phase I clinical and pharmacokinetic study of capecitabine (Xeloda) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours. Br J Cancer. 2005;92(5):820–6.PubMedPubMedCentralCrossRef
110.
go back to reference Rea DW, Nortier JW, Ten Bokkel Huinink WW, Falk S, Richel DJ, Maughan T, et al. A phase I/II and pharmacokinetic study of irinotecan in combination with capecitabine as first-line therapy for advanced colorectal cancer. Ann Oncol. 2005;16(7):1123–32.PubMedCrossRef Rea DW, Nortier JW, Ten Bokkel Huinink WW, Falk S, Richel DJ, Maughan T, et al. A phase I/II and pharmacokinetic study of irinotecan in combination with capecitabine as first-line therapy for advanced colorectal cancer. Ann Oncol. 2005;16(7):1123–32.PubMedCrossRef
111.
go back to reference Goel S, Desai K, Karri S, Gollamudi R, Chaudhary I, Bulgaru A, et al. Pharmacokinetic and safety study of weekly irinotecan and oral capecitabine in patients with advanced solid cancers. Invest New Drugs. 2007;25(3):237–45.PubMedCrossRef Goel S, Desai K, Karri S, Gollamudi R, Chaudhary I, Bulgaru A, et al. Pharmacokinetic and safety study of weekly irinotecan and oral capecitabine in patients with advanced solid cancers. Invest New Drugs. 2007;25(3):237–45.PubMedCrossRef
112.
go back to reference Shinkai T, Arioka H, Kunikane H, Eguchi K, Sasaki Y, Tamura T, et al. Phase I clinical trial of irinotecan (CPT-11), 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothecin, and cisplatin in combination with fixed dose of vindesine in advanced non-small cell lung cancer. Cancer Res. 1994;54(10):2636–42.PubMed Shinkai T, Arioka H, Kunikane H, Eguchi K, Sasaki Y, Tamura T, et al. Phase I clinical trial of irinotecan (CPT-11), 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothecin, and cisplatin in combination with fixed dose of vindesine in advanced non-small cell lung cancer. Cancer Res. 1994;54(10):2636–42.PubMed
113.
go back to reference Adjei AA, Klein CE, Kastrissios H, Goldberg RM, Alberts SR, Pitot HC, et al. Phase I and pharmacokinetic study of irinotecan and docetaxel in patients with advanced solid tumors: preliminary evidence of clinical activity. J Clin Oncol. 2000;18(5):1116–23.PubMedCrossRef Adjei AA, Klein CE, Kastrissios H, Goldberg RM, Alberts SR, Pitot HC, et al. Phase I and pharmacokinetic study of irinotecan and docetaxel in patients with advanced solid tumors: preliminary evidence of clinical activity. J Clin Oncol. 2000;18(5):1116–23.PubMedCrossRef
114.
go back to reference Masuda N, Fukuoka M, Kudoh S, Matsui K, Kusunoki Y, Takada M, et al. Phase I and pharmacologic study of irinotecan and etoposide with recombinant human granulocyte colony-stimulating factor support for advanced lung cancer. J Clin Oncol. 1994;12(9):1833–41.PubMedCrossRef Masuda N, Fukuoka M, Kudoh S, Matsui K, Kusunoki Y, Takada M, et al. Phase I and pharmacologic study of irinotecan and etoposide with recombinant human granulocyte colony-stimulating factor support for advanced lung cancer. J Clin Oncol. 1994;12(9):1833–41.PubMedCrossRef
115.
go back to reference Vanhoefer U, Harstrick A, Kohne CH, Achterrath W, Rustum YM, Seeber S, et al. Phase I study of a weekly schedule of irinotecan, high-dose leucovorin, and infusional fluorouracil as first-line chemotherapy in patients with advanced colorectal cancer. J Clin Oncol. 1999;17(3):907–13.PubMedCrossRef Vanhoefer U, Harstrick A, Kohne CH, Achterrath W, Rustum YM, Seeber S, et al. Phase I study of a weekly schedule of irinotecan, high-dose leucovorin, and infusional fluorouracil as first-line chemotherapy in patients with advanced colorectal cancer. J Clin Oncol. 1999;17(3):907–13.PubMedCrossRef
116.
go back to reference Saltz L, Shimada Y, Khayat D. CPT-11 (irinotecan) and 5-fluorouracil: a promising combination for therapy of colorectal cancer. Eur J Cancer. 1996;32A(Suppl 3):S24–31.PubMedCrossRef Saltz L, Shimada Y, Khayat D. CPT-11 (irinotecan) and 5-fluorouracil: a promising combination for therapy of colorectal cancer. Eur J Cancer. 1996;32A(Suppl 3):S24–31.PubMedCrossRef
117.
go back to reference Wasserman E, Cuvier C, Lokiec F, Goldwasser F, Kalla S, Mery-Mignard D, et al. Combination of oxaliplatin plus irinotecan in patients with gastrointestinal tumors: results of two independent phase I studies with pharmacokinetics. J Clin Oncol. 1999;17(6):1751–9.PubMedCrossRef Wasserman E, Cuvier C, Lokiec F, Goldwasser F, Kalla S, Mery-Mignard D, et al. Combination of oxaliplatin plus irinotecan in patients with gastrointestinal tumors: results of two independent phase I studies with pharmacokinetics. J Clin Oncol. 1999;17(6):1751–9.PubMedCrossRef
118.
go back to reference Ford HE, Cunningham D, Ross PJ, Rao S, Aherne GW, Benepal TS, et al. Phase I study of irinotecan and raltitrexed in patients with advanced gastrointestinal tract adenocarcinoma. Br J Cancer. 2000;83(2):146–52.PubMedPubMedCentralCrossRef Ford HE, Cunningham D, Ross PJ, Rao S, Aherne GW, Benepal TS, et al. Phase I study of irinotecan and raltitrexed in patients with advanced gastrointestinal tract adenocarcinoma. Br J Cancer. 2000;83(2):146–52.PubMedPubMedCentralCrossRef
119.
go back to reference Garcia AA, Pujari M, Jeffers S, Iqbal S, Lenz HJ, Beringer P, et al. Phase I clinical and pharmacokinetic trial of docetaxel and irinotecan administered on a weekly schedule. Cancer Chemother Pharmacol. 2005;56(1):75–82.PubMedCrossRef Garcia AA, Pujari M, Jeffers S, Iqbal S, Lenz HJ, Beringer P, et al. Phase I clinical and pharmacokinetic trial of docetaxel and irinotecan administered on a weekly schedule. Cancer Chemother Pharmacol. 2005;56(1):75–82.PubMedCrossRef
120.
go back to reference Ettlinger DE, Mitterhauser M, Wadsak W, Ostermann E, Farkouh A, Schueller J, et al. In vivo disposition of irinotecan (CPT-11) and its metabolites in combination with the monoclonal antibody cetuximab. Anticancer Res. 2006;26(2B):1337–41.PubMed Ettlinger DE, Mitterhauser M, Wadsak W, Ostermann E, Farkouh A, Schueller J, et al. In vivo disposition of irinotecan (CPT-11) and its metabolites in combination with the monoclonal antibody cetuximab. Anticancer Res. 2006;26(2B):1337–41.PubMed
121.
go back to reference Denlinger CS, Blanchard R, Xu L, Bernaards C, Litwin S, Spittle C, et al. Pharmacokinetic analysis of irinotecan plus bevacizumab in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2009;65(1):97–105.PubMedPubMedCentralCrossRef Denlinger CS, Blanchard R, Xu L, Bernaards C, Litwin S, Spittle C, et al. Pharmacokinetic analysis of irinotecan plus bevacizumab in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2009;65(1):97–105.PubMedPubMedCentralCrossRef
122.
go back to reference Horita Y, Yamada Y, Hirashima Y, Kato K, Nakajima T, Hamaguchi T, et al. Effects of bevacizumab on plasma concentration of irinotecan and its metabolites in advanced colorectal cancer patients receiving FOLFIRI with bevacizumab as second-line chemotherapy. Cancer Chemother Pharmacol. 2010;65(3):467–71.PubMedCrossRef Horita Y, Yamada Y, Hirashima Y, Kato K, Nakajima T, Hamaguchi T, et al. Effects of bevacizumab on plasma concentration of irinotecan and its metabolites in advanced colorectal cancer patients receiving FOLFIRI with bevacizumab as second-line chemotherapy. Cancer Chemother Pharmacol. 2010;65(3):467–71.PubMedCrossRef
123.
go back to reference Wang D, Braiteh F, Lee JJ, Denlinger CS, Shepard DR, Chaudhary A, et al. Lack of pharmacokinetic drug-drug interaction between ramucirumab and irinotecan in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016;78(4):727–33.PubMedCrossRef Wang D, Braiteh F, Lee JJ, Denlinger CS, Shepard DR, Chaudhary A, et al. Lack of pharmacokinetic drug-drug interaction between ramucirumab and irinotecan in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016;78(4):727–33.PubMedCrossRef
124.
go back to reference Asai G, Yamamoto N, Kurata T, Tamura K, Uejima H, Nakagawa K, et al. Phase I and pharmacokinetic study of combination chemotherapy using irinotecan and paclitaxel in patients with lung cancer. J Thorac Oncol. 2006;1(3):226–30.PubMedCrossRef Asai G, Yamamoto N, Kurata T, Tamura K, Uejima H, Nakagawa K, et al. Phase I and pharmacokinetic study of combination chemotherapy using irinotecan and paclitaxel in patients with lung cancer. J Thorac Oncol. 2006;1(3):226–30.PubMedCrossRef
125.
go back to reference Murren JR, Peccerillo K, DiStasio SA, Li X, Leffert JJ, Pizzorno G, et al. Dose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer. Cancer Chemother Pharmacol. 2000;46(1):43–50.PubMedCrossRef Murren JR, Peccerillo K, DiStasio SA, Li X, Leffert JJ, Pizzorno G, et al. Dose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer. Cancer Chemother Pharmacol. 2000;46(1):43–50.PubMedCrossRef
126.
go back to reference Hotta K, Ueoka H, Kiura K, Tabata M, Kuyama S, Satoh K, et al. A phase I study and pharmacokinetics of irinotecan (CPT-11) and paclitaxel in patients with advanced non-small cell lung cancer. Lung Cancer. 2004;45(1):77–84.PubMedCrossRef Hotta K, Ueoka H, Kiura K, Tabata M, Kuyama S, Satoh K, et al. A phase I study and pharmacokinetics of irinotecan (CPT-11) and paclitaxel in patients with advanced non-small cell lung cancer. Lung Cancer. 2004;45(1):77–84.PubMedCrossRef
127.
go back to reference Yokoo K, Hamada A, Watanabe H, Matsuzaki T, Imai T, Fujimoto H, et al. Involvement of up-regulation of hepatic breast cancer resistance protein in decreased plasma concentration of 7-ethyl-10-hydroxycamptothecin (SN-38) by coadministration of S-1 in rats. Drug Metab Dispos. 2007;35(9):1511–7.PubMedCrossRef Yokoo K, Hamada A, Watanabe H, Matsuzaki T, Imai T, Fujimoto H, et al. Involvement of up-regulation of hepatic breast cancer resistance protein in decreased plasma concentration of 7-ethyl-10-hydroxycamptothecin (SN-38) by coadministration of S-1 in rats. Drug Metab Dispos. 2007;35(9):1511–7.PubMedCrossRef
128.
go back to reference Yokoo K, Hamada A, Tazoe K, Sasaki Y, Saito H. Effects of oral administration of S-1 on the pharmacokinetics of SN-38, irinotecan active metabolite, in patients with advanced colorectal cancer. Ther Drug Monit. 2009;31(3):400–3.PubMedCrossRef Yokoo K, Hamada A, Tazoe K, Sasaki Y, Saito H. Effects of oral administration of S-1 on the pharmacokinetics of SN-38, irinotecan active metabolite, in patients with advanced colorectal cancer. Ther Drug Monit. 2009;31(3):400–3.PubMedCrossRef
129.
go back to reference Okamoto H, Nagatomo A, Kunitoh H, Kunikane H, Watanabe K. A phase I clinical and pharmacologic study of a carboplatin and irinotecan regimen combined with recombinant human granulocyte-colony stimulating factor in the treatment of patients with advanced nonsmall cell lung carcinoma. Cancer. 1998;82(11):2166–72.PubMedCrossRef Okamoto H, Nagatomo A, Kunitoh H, Kunikane H, Watanabe K. A phase I clinical and pharmacologic study of a carboplatin and irinotecan regimen combined with recombinant human granulocyte-colony stimulating factor in the treatment of patients with advanced nonsmall cell lung carcinoma. Cancer. 1998;82(11):2166–72.PubMedCrossRef
130.
go back to reference Allegrini G, Di Paolo A, Cerri E, Cupini S, Amatori F, Masi G, et al. Irinotecan in combination with thalidomide in patients with advanced solid tumors: a clinical study with pharmacodynamic and pharmacokinetic evaluation. Cancer Chemother Pharmacol. 2006;58(5):585–93.PubMedCrossRef Allegrini G, Di Paolo A, Cerri E, Cupini S, Amatori F, Masi G, et al. Irinotecan in combination with thalidomide in patients with advanced solid tumors: a clinical study with pharmacodynamic and pharmacokinetic evaluation. Cancer Chemother Pharmacol. 2006;58(5):585–93.PubMedCrossRef
131.
go back to reference Villalona-Calero M, Schaaf L, Phillips G, Otterson G, Panico K, Duan W, et al. Thalidomide and celecoxib as potential modulators of irinotecan’s activity in cancer patients. Cancer Chemother Pharmacol. 2007;59(1):23–33.PubMedCrossRef Villalona-Calero M, Schaaf L, Phillips G, Otterson G, Panico K, Duan W, et al. Thalidomide and celecoxib as potential modulators of irinotecan’s activity in cancer patients. Cancer Chemother Pharmacol. 2007;59(1):23–33.PubMedCrossRef
132.
go back to reference Ramirez J, Wu K, Janisch L, Karrison T, House LK, Innocenti F, et al. The effect of thalidomide on the pharmacokinetics of irinotecan and metabolites in advanced solid tumor patients. Cancer Chemother Pharmacol. 2011;68(6):1629–32.PubMedPubMedCentralCrossRef Ramirez J, Wu K, Janisch L, Karrison T, House LK, Innocenti F, et al. The effect of thalidomide on the pharmacokinetics of irinotecan and metabolites in advanced solid tumor patients. Cancer Chemother Pharmacol. 2011;68(6):1629–32.PubMedPubMedCentralCrossRef
133.
go back to reference van Leeuwen RW, van Gelder T, Mathijssen RH, Jansman FG. Drug-drug interactions with tyrosine-kinase inhibitors: a clinical perspective. Lancet Oncol. 2014;15(8):e315–26.PubMedCrossRef van Leeuwen RW, van Gelder T, Mathijssen RH, Jansman FG. Drug-drug interactions with tyrosine-kinase inhibitors: a clinical perspective. Lancet Oncol. 2014;15(8):e315–26.PubMedCrossRef
134.
go back to reference Johnson FM, Krug LM, Tran HT, Shoaf S, Prieto VG, Tamboli P, et al. Phase I studies of imatinib mesylate combined with cisplatin and irinotecan in patients with small cell lung carcinoma. Cancer. 2006;106(2):366–74.PubMedCrossRef Johnson FM, Krug LM, Tran HT, Shoaf S, Prieto VG, Tamboli P, et al. Phase I studies of imatinib mesylate combined with cisplatin and irinotecan in patients with small cell lung carcinoma. Cancer. 2006;106(2):366–74.PubMedCrossRef
135.
go back to reference Bennouna J, Deslandres M, Senellart H, de Labareyre C, Ruiz-Soto R, Wixon C, et al. A phase I open-label study of the safety, tolerability, and pharmacokinetics of pazopanib in combination with irinotecan and cetuximab for relapsed or refractory metastatic colorectal cancer. Invest New Drugs. 2015;33(1):138–47.PubMedCrossRef Bennouna J, Deslandres M, Senellart H, de Labareyre C, Ruiz-Soto R, Wixon C, et al. A phase I open-label study of the safety, tolerability, and pharmacokinetics of pazopanib in combination with irinotecan and cetuximab for relapsed or refractory metastatic colorectal cancer. Invest New Drugs. 2015;33(1):138–47.PubMedCrossRef
136.
go back to reference Boven E, Massard C, Armand JP, Tillier C, Hartog V, Brega NM, et al. A phase I, dose-finding study of sunitinib in combination with irinotecan in patients with advanced solid tumours. Br J Cancer. 2010;103(7):993–1000.PubMedPubMedCentralCrossRef Boven E, Massard C, Armand JP, Tillier C, Hartog V, Brega NM, et al. A phase I, dose-finding study of sunitinib in combination with irinotecan in patients with advanced solid tumours. Br J Cancer. 2010;103(7):993–1000.PubMedPubMedCentralCrossRef
137.
go back to reference Midgley RS, Kerr DJ, Flaherty KT, Stevenson JP, Pratap SE, Koch KM, et al. A phase I and pharmacokinetic study of lapatinib in combination with infusional 5-fluorouracil, leucovorin and irinotecan. Ann Oncol. 2007;18(12):2025–9.PubMedCrossRef Midgley RS, Kerr DJ, Flaherty KT, Stevenson JP, Pratap SE, Koch KM, et al. A phase I and pharmacokinetic study of lapatinib in combination with infusional 5-fluorouracil, leucovorin and irinotecan. Ann Oncol. 2007;18(12):2025–9.PubMedCrossRef
138.
go back to reference Meyerhardt JA, Clark JW, Supko JG, Eder JP, Ogino S, Stewart CF, et al. Phase I study of gefitinib, irinotecan, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2007;60(5):661–70.PubMedCrossRef Meyerhardt JA, Clark JW, Supko JG, Eder JP, Ogino S, Stewart CF, et al. Phase I study of gefitinib, irinotecan, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2007;60(5):661–70.PubMedCrossRef
139.
go back to reference Santoro A, Comandone A, Rimassa L, Granetti C, Lorusso V, Oliva C, et al. A phase II randomized multicenter trial of gefitinib plus FOLFIRI and FOLFIRI alone in patients with metastatic colorectal cancer. Ann Oncol. 2008;19(11):1888–93.PubMedCrossRef Santoro A, Comandone A, Rimassa L, Granetti C, Lorusso V, Oliva C, et al. A phase II randomized multicenter trial of gefitinib plus FOLFIRI and FOLFIRI alone in patients with metastatic colorectal cancer. Ann Oncol. 2008;19(11):1888–93.PubMedCrossRef
140.
go back to reference Veronese ML, Sun W, Giantonio B, Berlin J, Shults J, Davis L, et al. A phase II trial of gefitinib with 5-fluorouracil, leucovorin, and irinotecan in patients with colorectal cancer. Br J Cancer. 2005;92(10):1846–9.PubMedPubMedCentralCrossRef Veronese ML, Sun W, Giantonio B, Berlin J, Shults J, Davis L, et al. A phase II trial of gefitinib with 5-fluorouracil, leucovorin, and irinotecan in patients with colorectal cancer. Br J Cancer. 2005;92(10):1846–9.PubMedPubMedCentralCrossRef
141.
go back to reference Hofheinz RD, Kubicka S, Wollert J, Arnold D, Hochhaus A. Gefitinib in combination with 5-fluorouracil (5-FU)/folinic acid and irinotecan in patients with 5-FU/oxaliplatin- refractory colorectal cancer: a phase I/II study of the Arbeitsgemeinschaft fur Internistische Onkologie (AIO). Onkologie. 2006;29(12):563–7.PubMed Hofheinz RD, Kubicka S, Wollert J, Arnold D, Hochhaus A. Gefitinib in combination with 5-fluorouracil (5-FU)/folinic acid and irinotecan in patients with 5-FU/oxaliplatin- refractory colorectal cancer: a phase I/II study of the Arbeitsgemeinschaft fur Internistische Onkologie (AIO). Onkologie. 2006;29(12):563–7.PubMed
142.
go back to reference Kehrer DF, Mathijssen RH, Verweij J, de Bruijn P, Sparreboom A. Modulation of irinotecan metabolism by ketoconazole. J Clin Oncol. 2002;20(14):3122–9.PubMedCrossRef Kehrer DF, Mathijssen RH, Verweij J, de Bruijn P, Sparreboom A. Modulation of irinotecan metabolism by ketoconazole. J Clin Oncol. 2002;20(14):3122–9.PubMedCrossRef
143.
go back to reference Richards S, Umbreit JN, Fanucchi MP, Giblin J, Khuri F. Selective serotonin reuptake inhibitor-induced rhabdomyolysis associated with irinotecan. South Med J. 2003;96(10):1031–3.PubMedCrossRef Richards S, Umbreit JN, Fanucchi MP, Giblin J, Khuri F. Selective serotonin reuptake inhibitor-induced rhabdomyolysis associated with irinotecan. South Med J. 2003;96(10):1031–3.PubMedCrossRef
144.
go back to reference Caraci F, Crupi R, Drago F, Spina E. Metabolic drug interactions between antidepressants and anticancer drugs: focus on selective serotonin reuptake inhibitors and hypericum extract. Curr Drug Metab. 2011;12(6):570–7.PubMedCrossRef Caraci F, Crupi R, Drago F, Spina E. Metabolic drug interactions between antidepressants and anticancer drugs: focus on selective serotonin reuptake inhibitors and hypericum extract. Curr Drug Metab. 2011;12(6):570–7.PubMedCrossRef
145.
go back to reference Tanaka E. Clinically significant pharmacokinetic drug interactions between antiepileptic drugs. J Clin Pharm Ther. 1999;24(2):87–92.PubMedCrossRef Tanaka E. Clinically significant pharmacokinetic drug interactions between antiepileptic drugs. J Clin Pharm Ther. 1999;24(2):87–92.PubMedCrossRef
146.
go back to reference Mathijssen RH, Sparreboom A, Dumez H, van Oosterom AT, de Bruijn EA. Altered irinotecan metabolism in a patient receiving phenytoin. Anticancer Drugs. 2002;13(2):139–40.PubMedCrossRef Mathijssen RH, Sparreboom A, Dumez H, van Oosterom AT, de Bruijn EA. Altered irinotecan metabolism in a patient receiving phenytoin. Anticancer Drugs. 2002;13(2):139–40.PubMedCrossRef
147.
go back to reference Innocenti F, Undevia SD, Ramirez J, Mani S, Schilsky RL, Vogelzang NJ, et al. A phase I trial of pharmacologic modulation of irinotecan with cyclosporine and phenobarbital. Clin Pharmacol Ther. 2004;76(5):490–502.PubMedCrossRef Innocenti F, Undevia SD, Ramirez J, Mani S, Schilsky RL, Vogelzang NJ, et al. A phase I trial of pharmacologic modulation of irinotecan with cyclosporine and phenobarbital. Clin Pharmacol Ther. 2004;76(5):490–502.PubMedCrossRef
148.
go back to reference Corona G, Vaccher E, Sandron S, Sartor I, Tirelli U, Innocenti F, et al. Lopinavir-ritonavir dramatically affects the pharmacokinetics of irinotecan in HIV patients with Kaposi’s sarcoma. Clin Pharmacol Ther. 2008;83(4):601–6.PubMedCrossRef Corona G, Vaccher E, Sandron S, Sartor I, Tirelli U, Innocenti F, et al. Lopinavir-ritonavir dramatically affects the pharmacokinetics of irinotecan in HIV patients with Kaposi’s sarcoma. Clin Pharmacol Ther. 2008;83(4):601–6.PubMedCrossRef
149.
go back to reference Busti AJ, Hall RG, Margolis DM. Atazanavir for the treatment of human immunodeficiency virus infection. Pharmacotherapy. 2004;24(12):1732–47.PubMedCrossRef Busti AJ, Hall RG, Margolis DM. Atazanavir for the treatment of human immunodeficiency virus infection. Pharmacotherapy. 2004;24(12):1732–47.PubMedCrossRef
150.
go back to reference van der Bol JM, Visser TJ, Loos WJ, de Jong FA, Wiemer EA, van Aken MO, et al. Effects of methimazole on the elimination of irinotecan. Cancer Chemother Pharmacol. 2011;67(1):231–6.PubMedCrossRef van der Bol JM, Visser TJ, Loos WJ, de Jong FA, Wiemer EA, van Aken MO, et al. Effects of methimazole on the elimination of irinotecan. Cancer Chemother Pharmacol. 2011;67(1):231–6.PubMedCrossRef
151.
go back to reference Argiris A, Kut V, Luong L, Avram MJ. Phase I and pharmacokinetic study of docetaxel, irinotecan, and celecoxib in patients with advanced non-small cell lung cancer. Invest New Drugs. 2006;24(3):203–12.PubMedCrossRef Argiris A, Kut V, Luong L, Avram MJ. Phase I and pharmacokinetic study of docetaxel, irinotecan, and celecoxib in patients with advanced non-small cell lung cancer. Invest New Drugs. 2006;24(3):203–12.PubMedCrossRef
152.
go back to reference Javle MM, Cao S, Durrani FA, Pendyala L, Lawrence DD, Smith PF, et al. Celecoxib and mucosal protection: translation from an animal model to a phase I clinical trial of celecoxib, irinotecan, and 5-fluorouracil. Clin Cancer Res. 2007;13(3):965–71.PubMedCrossRef Javle MM, Cao S, Durrani FA, Pendyala L, Lawrence DD, Smith PF, et al. Celecoxib and mucosal protection: translation from an animal model to a phase I clinical trial of celecoxib, irinotecan, and 5-fluorouracil. Clin Cancer Res. 2007;13(3):965–71.PubMedCrossRef
153.
go back to reference Xu Y, Kolesar JM, Schaaf LJ, Drengler R, Duan W, Otterson G, et al. Phase I and pharmacokinetic study of mitomycin C and celecoxib as potential modulators of tumor resistance to irinotecan in patients with solid malignancies. Cancer Chemother Pharmacol. 2009;63(6):1073–82.PubMedCrossRef Xu Y, Kolesar JM, Schaaf LJ, Drengler R, Duan W, Otterson G, et al. Phase I and pharmacokinetic study of mitomycin C and celecoxib as potential modulators of tumor resistance to irinotecan in patients with solid malignancies. Cancer Chemother Pharmacol. 2009;63(6):1073–82.PubMedCrossRef
154.
go back to reference van der Bol JM, Loos WJ, de Jong FA, van Meerten E, Konings IR, Lam MH, et al. Effect of omeprazole on the pharmacokinetics and toxicities of irinotecan in cancer patients: a prospective cross-over drug-drug interaction study. Eur J Cancer. 2011;47(6):831–8.PubMedCrossRef van der Bol JM, Loos WJ, de Jong FA, van Meerten E, Konings IR, Lam MH, et al. Effect of omeprazole on the pharmacokinetics and toxicities of irinotecan in cancer patients: a prospective cross-over drug-drug interaction study. Eur J Cancer. 2011;47(6):831–8.PubMedCrossRef
155.
go back to reference Richardson MA, Sanders T, Palmer JL, Greisinger A, Singletary SE. Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. J Clin Oncol. 2000;18(13):2505–14.PubMedCrossRef Richardson MA, Sanders T, Palmer JL, Greisinger A, Singletary SE. Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. J Clin Oncol. 2000;18(13):2505–14.PubMedCrossRef
156.
go back to reference Sparreboom A, Cox MC, Acharya MR, Figg WD. Herbal remedies in the United States: potential adverse interactions with anticancer agents. J Clin Oncol. 2004;22(12):2489–503.PubMedCrossRef Sparreboom A, Cox MC, Acharya MR, Figg WD. Herbal remedies in the United States: potential adverse interactions with anticancer agents. J Clin Oncol. 2004;22(12):2489–503.PubMedCrossRef
157.
go back to reference Goey AK, Beijnen JH, Schellens JH. Herb-drug interactions in oncology. Clin Pharmacol Ther. 2014;95(4):354–5.PubMedCrossRef Goey AK, Beijnen JH, Schellens JH. Herb-drug interactions in oncology. Clin Pharmacol Ther. 2014;95(4):354–5.PubMedCrossRef
158.
go back to reference Mathijssen RH, Verweij J, de Bruijn P, Loos WJ, Sparreboom A. Effects of St. John’s wort on irinotecan metabolism. J Natl Cancer Inst. 2002;94(16):1247–9.PubMedCrossRef Mathijssen RH, Verweij J, de Bruijn P, Loos WJ, Sparreboom A. Effects of St. John’s wort on irinotecan metabolism. J Natl Cancer Inst. 2002;94(16):1247–9.PubMedCrossRef
159.
go back to reference van Erp NP, Baker SD, Zhao M, Rudek MA, Guchelaar HJ, Nortier JW, et al. Effect of milk thistle (Silybum marianum) on the pharmacokinetics of irinotecan. Clin Cancer Res. 2005;11(21):7800–6.PubMedCrossRef van Erp NP, Baker SD, Zhao M, Rudek MA, Guchelaar HJ, Nortier JW, et al. Effect of milk thistle (Silybum marianum) on the pharmacokinetics of irinotecan. Clin Cancer Res. 2005;11(21):7800–6.PubMedCrossRef
160.
go back to reference Lin LC, Wang MN, Tsai TH. Food-drug interaction of (-)-epigallocatechin-3-gallate on the pharmacokinetics of irinotecan and the metabolite SN-38. Chem Biol Interact. 2008;174(3):177–82.PubMedCrossRef Lin LC, Wang MN, Tsai TH. Food-drug interaction of (-)-epigallocatechin-3-gallate on the pharmacokinetics of irinotecan and the metabolite SN-38. Chem Biol Interact. 2008;174(3):177–82.PubMedCrossRef
161.
go back to reference Mirkov S, Komoroski BJ, Ramirez J, Graber AY, Ratain MJ, Strom SC, et al. Effects of green tea compounds on irinotecan metabolism. Drug Metab Dispos. 2007;35(2):228–33.PubMedCrossRef Mirkov S, Komoroski BJ, Ramirez J, Graber AY, Ratain MJ, Strom SC, et al. Effects of green tea compounds on irinotecan metabolism. Drug Metab Dispos. 2007;35(2):228–33.PubMedCrossRef
162.
go back to reference van der Bol JM, Mathijssen RH, Loos WJ, Friberg LE, van Schaik RH, de Jonge MJ, et al. Cigarette smoking and irinotecan treatment: pharmacokinetic interaction and effects on neutropenia. J Clin Oncol. 2007;25(19):2719–26.PubMedCrossRef van der Bol JM, Mathijssen RH, Loos WJ, Friberg LE, van Schaik RH, de Jonge MJ, et al. Cigarette smoking and irinotecan treatment: pharmacokinetic interaction and effects on neutropenia. J Clin Oncol. 2007;25(19):2719–26.PubMedCrossRef
163.
go back to reference Engels FK, de Jong FA, Sparreboom A, Mathot RA, Loos WJ, Kitzen JJ, et al. Medicinal cannabis does not influence the clinical pharmacokinetics of irinotecan and docetaxel. Oncologist. 2007;12(3):291–300.PubMedCrossRef Engels FK, de Jong FA, Sparreboom A, Mathot RA, Loos WJ, Kitzen JJ, et al. Medicinal cannabis does not influence the clinical pharmacokinetics of irinotecan and docetaxel. Oncologist. 2007;12(3):291–300.PubMedCrossRef
164.
go back to reference National Institutes of Health. Common terminology criteria for adverse events (CTCAE). Bethesda: National Institutes of Health; 2010. National Institutes of Health. Common terminology criteria for adverse events (CTCAE). Bethesda: National Institutes of Health; 2010.
165.
go back to reference Sobrero AF, Maurel J, Fehrenbacher L, Scheithauer W, Abubakr YA, Lutz MP, et al. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(14):2311–9.PubMedCrossRef Sobrero AF, Maurel J, Fehrenbacher L, Scheithauer W, Abubakr YA, Lutz MP, et al. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(14):2311–9.PubMedCrossRef
166.
go back to reference Cunningham D, Pyrhonen S, James RD, Punt CJ, Hickish TF, Heikkila R, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1998;352(9138):1413–8.PubMedCrossRef Cunningham D, Pyrhonen S, James RD, Punt CJ, Hickish TF, Heikkila R, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1998;352(9138):1413–8.PubMedCrossRef
167.
go back to reference Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet. 1998;352(9138):1407–12.PubMedCrossRef Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet. 1998;352(9138):1407–12.PubMedCrossRef
168.
go back to reference Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000;343(13):905–14.PubMedCrossRef Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000;343(13):905–14.PubMedCrossRef
169.
go back to reference Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000;355(9209):1041–7.PubMedCrossRef Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000;355(9209):1041–7.PubMedCrossRef
170.
go back to reference Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360(14):1408–17.PubMedCrossRef Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360(14):1408–17.PubMedCrossRef
171.
go back to reference Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010;28(31):4706–13.PubMedCrossRef Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010;28(31):4706–13.PubMedCrossRef
172.
go back to reference Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015;16(5):499–508.PubMedCrossRef Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015;16(5):499–508.PubMedCrossRef
173.
go back to reference Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012;30(28):3499–506.PubMedCrossRef Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012;30(28):3499–506.PubMedCrossRef
174.
go back to reference Innocenti F, Kroetz DL, Schuetz E, Dolan ME, Ramirez J, Relling M, et al. Comprehensive pharmacogenetic analysis of irinotecan neutropenia and pharmacokinetics. J Clin Oncol. 2009;27(16):2604–14.PubMedPubMedCentralCrossRef Innocenti F, Kroetz DL, Schuetz E, Dolan ME, Ramirez J, Relling M, et al. Comprehensive pharmacogenetic analysis of irinotecan neutropenia and pharmacokinetics. J Clin Oncol. 2009;27(16):2604–14.PubMedPubMedCentralCrossRef
175.
go back to reference Gandia D, Abigerges D, Armand JP, Chabot G, Da Costa L, De Forni M, et al. CPT-11-induced cholinergic effects in cancer patients. J Clin Oncol. 1993;11(1):196–7.PubMedCrossRef Gandia D, Abigerges D, Armand JP, Chabot G, Da Costa L, De Forni M, et al. CPT-11-induced cholinergic effects in cancer patients. J Clin Oncol. 1993;11(1):196–7.PubMedCrossRef
176.
go back to reference Yumuk PF, Aydin SZ, Dane F, Gumus M, Ekenel M, Aliustaoglu M, et al. The absence of early diarrhea with atropine premedication during irinotecan therapy in metastatic colorectal patients. Int J Colorectal Dis. 2004;19(6):609–10.PubMedCrossRef Yumuk PF, Aydin SZ, Dane F, Gumus M, Ekenel M, Aliustaoglu M, et al. The absence of early diarrhea with atropine premedication during irinotecan therapy in metastatic colorectal patients. Int J Colorectal Dis. 2004;19(6):609–10.PubMedCrossRef
177.
go back to reference Cheng C, Lau JE, Earl MA. Use of atropine-diphenoxylate compared with hyoscyamine to decrease rates of irinotecan-related cholinergic syndrome. J Community Support Oncol. 2015;13(1):3–7.PubMedCrossRef Cheng C, Lau JE, Earl MA. Use of atropine-diphenoxylate compared with hyoscyamine to decrease rates of irinotecan-related cholinergic syndrome. J Community Support Oncol. 2015;13(1):3–7.PubMedCrossRef
178.
go back to reference Gupta E, Lestingi TM, Mick R, Ramirez J, Vokes EE, Ratain MJ. Metabolic fate of irinotecan in humans: correlation of glucuronidation with diarrhea. Cancer Res. 1994;54(14):3723–5.PubMed Gupta E, Lestingi TM, Mick R, Ramirez J, Vokes EE, Ratain MJ. Metabolic fate of irinotecan in humans: correlation of glucuronidation with diarrhea. Cancer Res. 1994;54(14):3723–5.PubMed
179.
go back to reference Rtibi K, Selmi S, Grami D, Sebai H, Amri M, Marzouki L. Irinotecan chemotherapy-induced intestinal oxidative stress: underlying causes of disturbed mucosal water and electrolyte transport. Pathophysiology. 2017;24(4):275–9.PubMedCrossRef Rtibi K, Selmi S, Grami D, Sebai H, Amri M, Marzouki L. Irinotecan chemotherapy-induced intestinal oxidative stress: underlying causes of disturbed mucosal water and electrolyte transport. Pathophysiology. 2017;24(4):275–9.PubMedCrossRef
180.
go back to reference Brandi G, Dabard J, Raibaud P, Di Battista M, Bridonneau C, Pisi AM, et al. Intestinal microflora and digestive toxicity of irinotecan in mice. Clin Cancer Res. 2006;12(4):1299–307.PubMedCrossRef Brandi G, Dabard J, Raibaud P, Di Battista M, Bridonneau C, Pisi AM, et al. Intestinal microflora and digestive toxicity of irinotecan in mice. Clin Cancer Res. 2006;12(4):1299–307.PubMedCrossRef
181.
go back to reference Peterson DE, Bensadoun RJ, Roila F, Group EGW. Management of oral and gastrointestinal mucositis: ESMO Clinical Practice Guidelines. Ann Oncol. 2011;22(6):vi78–84. Peterson DE, Bensadoun RJ, Roila F, Group EGW. Management of oral and gastrointestinal mucositis: ESMO Clinical Practice Guidelines. Ann Oncol. 2011;22(6):vi78–84.
182.
go back to reference Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014;120(10):1453–61.PubMedPubMedCentralCrossRef Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014;120(10):1453–61.PubMedPubMedCentralCrossRef
183.
go back to reference Mick R, Gupta E, Vokes EE, Ratain MJ. Limited-sampling models for irinotecan pharmacokinetics-pharmacodynamics: prediction of biliary index and intestinal toxicity. J Clin Oncol. 1996;14(7):2012–9.PubMedCrossRef Mick R, Gupta E, Vokes EE, Ratain MJ. Limited-sampling models for irinotecan pharmacokinetics-pharmacodynamics: prediction of biliary index and intestinal toxicity. J Clin Oncol. 1996;14(7):2012–9.PubMedCrossRef
184.
go back to reference Herben VM, Schellens JH, Swart M, Gruia G, Vernillet L, Beijnen JH, et al. Phase I and pharmacokinetic study of irinotecan administered as a low-dose, continuous intravenous infusion over 14 days in patients with malignant solid tumors. J Clin Oncol. 1999;17(6):1897–905.PubMedCrossRef Herben VM, Schellens JH, Swart M, Gruia G, Vernillet L, Beijnen JH, et al. Phase I and pharmacokinetic study of irinotecan administered as a low-dose, continuous intravenous infusion over 14 days in patients with malignant solid tumors. J Clin Oncol. 1999;17(6):1897–905.PubMedCrossRef
185.
go back to reference Ohe Y, Sasaki Y, Shinkai T, Eguchi K, Tamura T, Kojima A, et al. Phase I study and pharmacokinetics of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst. 1992;84(12):972–4.PubMedCrossRef Ohe Y, Sasaki Y, Shinkai T, Eguchi K, Tamura T, Kojima A, et al. Phase I study and pharmacokinetics of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst. 1992;84(12):972–4.PubMedCrossRef
186.
go back to reference de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, et al. Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res. 1994;54(16):4347–54.PubMed de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, et al. Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res. 1994;54(16):4347–54.PubMed
187.
go back to reference Abigerges D, Chabot GG, Armand JP, Herait P, Gouyette A, Gandia D. Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol. 1995;13(1):210–21.PubMedCrossRef Abigerges D, Chabot GG, Armand JP, Herait P, Gouyette A, Gandia D. Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol. 1995;13(1):210–21.PubMedCrossRef
188.
go back to reference Rothenberg ML, Eckardt JR, Kuhn JG, Burris HA 3rd, Nelson J, Hilsenbeck SG, et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol. 1996;14(4):1128–35.PubMedCrossRef Rothenberg ML, Eckardt JR, Kuhn JG, Burris HA 3rd, Nelson J, Hilsenbeck SG, et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol. 1996;14(4):1128–35.PubMedCrossRef
189.
go back to reference Middleton G, Brown S, Lowe C, Maughan T, Gwyther S, Oliver A, et al. A randomised phase III trial of the pharmacokinetic biomodulation of irinotecan using oral ciclosporin in advanced colorectal cancer: results of the Panitumumab, Irinotecan and Ciclosporin in COLOrectal cancer therapy trial (PICCOLO). Eur J Cancer. 2013;49(16):3507–16.PubMedCrossRef Middleton G, Brown S, Lowe C, Maughan T, Gwyther S, Oliver A, et al. A randomised phase III trial of the pharmacokinetic biomodulation of irinotecan using oral ciclosporin in advanced colorectal cancer: results of the Panitumumab, Irinotecan and Ciclosporin in COLOrectal cancer therapy trial (PICCOLO). Eur J Cancer. 2013;49(16):3507–16.PubMedCrossRef
190.
go back to reference Ychou M, Douillard JY, Rougier P, Adenis A, Mousseau M, Dufour P, et al. Randomized comparison of prophylactic antidiarrheal treatment versus no prophylactic antidiarrheal treatment in patients receiving CPT-11 (irinotecan) for advanced 5-FU-resistant colorectal cancer: an open-label multicenter phase II study. Am J Clin Oncol. 2000;23(2):143–8.PubMedCrossRef Ychou M, Douillard JY, Rougier P, Adenis A, Mousseau M, Dufour P, et al. Randomized comparison of prophylactic antidiarrheal treatment versus no prophylactic antidiarrheal treatment in patients receiving CPT-11 (irinotecan) for advanced 5-FU-resistant colorectal cancer: an open-label multicenter phase II study. Am J Clin Oncol. 2000;23(2):143–8.PubMedCrossRef
191.
go back to reference Michael M, Brittain M, Nagai J, Feld R, Hedley D, Oza A, et al. Phase II study of activated charcoal to prevent irinotecan-induced diarrhea. J Clin Oncol. 2004;22(21):4410–7.PubMedCrossRef Michael M, Brittain M, Nagai J, Feld R, Hedley D, Oza A, et al. Phase II study of activated charcoal to prevent irinotecan-induced diarrhea. J Clin Oncol. 2004;22(21):4410–7.PubMedCrossRef
192.
go back to reference Kee BK, Morris JS, Slack RS, Crocenzi T, Wong L, Esparaz B, et al. A phase II, randomized, double blind trial of calcium aluminosilicate clay versus placebo for the prevention of diarrhea in patients with metastatic colorectal cancer treated with irinotecan. Support Care Cancer. 2015;23(3):661–70.PubMedCrossRef Kee BK, Morris JS, Slack RS, Crocenzi T, Wong L, Esparaz B, et al. A phase II, randomized, double blind trial of calcium aluminosilicate clay versus placebo for the prevention of diarrhea in patients with metastatic colorectal cancer treated with irinotecan. Support Care Cancer. 2015;23(3):661–70.PubMedCrossRef
193.
go back to reference Mori K, Kondo T, Kamiyama Y, Kano Y, Tominaga K. Preventive effect of Kampo medicine (Hangeshashin-to) against irinotecan-induced diarrhea in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol. 2003;51(5):403–6.PubMed Mori K, Kondo T, Kamiyama Y, Kano Y, Tominaga K. Preventive effect of Kampo medicine (Hangeshashin-to) against irinotecan-induced diarrhea in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol. 2003;51(5):403–6.PubMed
194.
go back to reference Flieger D, Klassert C, Hainke S, Keller R, Kleinschmidt R, Fischbach W. Phase II clinical trial for prevention of delayed diarrhea with cholestyramine/levofloxacin in the second-line treatment with irinotecan biweekly in patients with metastatic colorectal carcinoma. Oncology. 2007;72(1–2):10–6.PubMedCrossRef Flieger D, Klassert C, Hainke S, Keller R, Kleinschmidt R, Fischbach W. Phase II clinical trial for prevention of delayed diarrhea with cholestyramine/levofloxacin in the second-line treatment with irinotecan biweekly in patients with metastatic colorectal carcinoma. Oncology. 2007;72(1–2):10–6.PubMedCrossRef
195.
go back to reference Mego M, Chovanec J, Vochyanova-Andrezalova I, Konkolovsky P, Mikulova M, Reckova M, et al. Prevention of irinotecan induced diarrhea by probiotics: a randomized double blind, placebo controlled pilot study. Complement Ther Med. 2015;23(3):356–62.PubMedCrossRef Mego M, Chovanec J, Vochyanova-Andrezalova I, Konkolovsky P, Mikulova M, Reckova M, et al. Prevention of irinotecan induced diarrhea by probiotics: a randomized double blind, placebo controlled pilot study. Complement Ther Med. 2015;23(3):356–62.PubMedCrossRef
196.
go back to reference Takeda Y, Kobayashi K, Akiyama Y, Soma T, Handa S, Kudoh S, et al. Prevention of irinotecan (CPT-11)-induced diarrhea by oral alkalization combined with control of defecation in cancer patients. Int J Cancer. 2001;92(2):269–75.PubMedCrossRef Takeda Y, Kobayashi K, Akiyama Y, Soma T, Handa S, Kudoh S, et al. Prevention of irinotecan (CPT-11)-induced diarrhea by oral alkalization combined with control of defecation in cancer patients. Int J Cancer. 2001;92(2):269–75.PubMedCrossRef
197.
go back to reference Valenti Moreno V, Brunet Vidal J, Manzano Alemany H, Salud Salvia A, Llobera Serentill M, Cabezas Montero I, et al. Prevention of irinotecan associated diarrhea by intestinal alkalization. A pilot study in gastrointestinal cancer patients. Clin Transl Oncol. 2006;8(3):208–12.PubMedCrossRef Valenti Moreno V, Brunet Vidal J, Manzano Alemany H, Salud Salvia A, Llobera Serentill M, Cabezas Montero I, et al. Prevention of irinotecan associated diarrhea by intestinal alkalization. A pilot study in gastrointestinal cancer patients. Clin Transl Oncol. 2006;8(3):208–12.PubMedCrossRef
198.
go back to reference Lenfers BH, Loeffler TM, Droege CM, Hausamen TU. Substantial activity of budesonide in patients with irinotecan (CPT-11) and 5-fluorouracil induced diarrhea and failure of loperamide treatment. Ann Oncol. 1999;10(10):1251–3.PubMedCrossRef Lenfers BH, Loeffler TM, Droege CM, Hausamen TU. Substantial activity of budesonide in patients with irinotecan (CPT-11) and 5-fluorouracil induced diarrhea and failure of loperamide treatment. Ann Oncol. 1999;10(10):1251–3.PubMedCrossRef
199.
go back to reference Karthaus M, Ballo H, Abenhardt W, Steinmetz T, Geer T, Schimke J, et al. Prospective, double-blind, placebo-controlled, multicenter, randomized phase III study with orally administered budesonide for prevention of irinotecan (CPT-11)-induced diarrhea in patients with advanced colorectal cancer. Oncology. 2005;68(4–6):326–32.PubMedCrossRef Karthaus M, Ballo H, Abenhardt W, Steinmetz T, Geer T, Schimke J, et al. Prospective, double-blind, placebo-controlled, multicenter, randomized phase III study with orally administered budesonide for prevention of irinotecan (CPT-11)-induced diarrhea in patients with advanced colorectal cancer. Oncology. 2005;68(4–6):326–32.PubMedCrossRef
200.
go back to reference Delioukina ML, Prager D, Parson M, Hecht JR, Rosen P, Rosen LS. Phase II trial of irinotecan in combination with amifostine in patients with advanced colorectal carcinoma. Cancer. 2002;94(8):2174–9.PubMedCrossRef Delioukina ML, Prager D, Parson M, Hecht JR, Rosen P, Rosen LS. Phase II trial of irinotecan in combination with amifostine in patients with advanced colorectal carcinoma. Cancer. 2002;94(8):2174–9.PubMedCrossRef
201.
go back to reference Pan CX, Loehrer P, Seitz D, Helft P, Juliar B, Ansari R, et al. A phase II trial of irinotecan, 5-fluorouracil and leucovorin combined with celecoxib and glutamine as first-line therapy for advanced colorectal cancer. Oncology. 2005;69(1):63–70.PubMedCrossRef Pan CX, Loehrer P, Seitz D, Helft P, Juliar B, Ansari R, et al. A phase II trial of irinotecan, 5-fluorouracil and leucovorin combined with celecoxib and glutamine as first-line therapy for advanced colorectal cancer. Oncology. 2005;69(1):63–70.PubMedCrossRef
202.
go back to reference Huisman SA, Bijman-Lagcher W, IJzermans JN, Smits R, de Bruin RW. Fasting protects against the side effects of irinotecan but preserves its anti-tumor effect in Apc15lox mutant mice. Cell Cycle. 2015;14(14):2333–9.PubMedPubMedCentralCrossRef Huisman SA, Bijman-Lagcher W, IJzermans JN, Smits R, de Bruin RW. Fasting protects against the side effects of irinotecan but preserves its anti-tumor effect in Apc15lox mutant mice. Cell Cycle. 2015;14(14):2333–9.PubMedPubMedCentralCrossRef
203.
go back to reference Huisman SA, de Bruijn P, Ghobadi Moghaddam-Helmantel IM, IJzermans JN, Wiemer EA, Mathijssen RH, et al. Fasting protects against the side effects of irinotecan treatment but does not affect anti-tumour activity in mice. Br J Pharmacol. 2016;173(5):804–14.PubMedPubMedCentralCrossRef Huisman SA, de Bruijn P, Ghobadi Moghaddam-Helmantel IM, IJzermans JN, Wiemer EA, Mathijssen RH, et al. Fasting protects against the side effects of irinotecan treatment but does not affect anti-tumour activity in mice. Br J Pharmacol. 2016;173(5):804–14.PubMedPubMedCentralCrossRef
204.
go back to reference Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007;25(13):1670–6.PubMedCrossRef Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007;25(13):1670–6.PubMedCrossRef
205.
go back to reference Masi G, Vasile E, Loupakis F, Cupini S, Fornaro L, Baldi G, et al. Randomized trial of two induction chemotherapy regimens in metastatic colorectal cancer: an updated analysis. J Natl Cancer Inst. 2011;103(1):21–30.PubMedCrossRef Masi G, Vasile E, Loupakis F, Cupini S, Fornaro L, Baldi G, et al. Randomized trial of two induction chemotherapy regimens in metastatic colorectal cancer: an updated analysis. J Natl Cancer Inst. 2011;103(1):21–30.PubMedCrossRef
206.
go back to reference Jang HJ, Kim BJ, Kim JH, Kim HS. The addition of bevacizumab in the first-line treatment for metastatic colorectal cancer: an updated meta-analysis of randomized trials. Oncotarget. 2017;8(42):73009–16.PubMedPubMedCentralCrossRef Jang HJ, Kim BJ, Kim JH, Kim HS. The addition of bevacizumab in the first-line treatment for metastatic colorectal cancer: an updated meta-analysis of randomized trials. Oncotarget. 2017;8(42):73009–16.PubMedPubMedCentralCrossRef
207.
go back to reference Cremolini C, Loupakis F, Antoniotti C, Lupi C, Sensi E, Lonardi S, et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol. 2015;16(13):1306–15.PubMedCrossRef Cremolini C, Loupakis F, Antoniotti C, Lupi C, Sensi E, Lonardi S, et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol. 2015;16(13):1306–15.PubMedCrossRef
208.
go back to reference Saltz LB, Niedzwiecki D, Hollis D, Goldberg RM, Hantel A, Thomas JP, et al. Irinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: results of CALGB 89803. J Clin Oncol. 2007;25(23):3456–61.PubMedCrossRef Saltz LB, Niedzwiecki D, Hollis D, Goldberg RM, Hantel A, Thomas JP, et al. Irinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: results of CALGB 89803. J Clin Oncol. 2007;25(23):3456–61.PubMedCrossRef
209.
go back to reference Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, et al. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009;20(4):674–80.PubMedCrossRef Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, et al. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009;20(4):674–80.PubMedCrossRef
210.
go back to reference Fallik D, Borrini F, Boige V, Viguier J, Jacob S, Miquel C, et al. Microsatellite instability is a predictive factor of the tumor response to irinotecan in patients with advanced colorectal cancer. Cancer Res. 2003;63(18):5738–44.PubMed Fallik D, Borrini F, Boige V, Viguier J, Jacob S, Miquel C, et al. Microsatellite instability is a predictive factor of the tumor response to irinotecan in patients with advanced colorectal cancer. Cancer Res. 2003;63(18):5738–44.PubMed
211.
go back to reference Bertagnolli MM, Niedzwiecki D, Compton CC, Hahn HP, Hall M, Damas B, et al. Microsatellite instability predicts improved response to adjuvant therapy with irinotecan, fluorouracil, and leucovorin in stage III colon cancer: cancer and Leukemia Group B Protocol 89803. J Clin Oncol. 2009;27(11):1814–21.PubMedPubMedCentralCrossRef Bertagnolli MM, Niedzwiecki D, Compton CC, Hahn HP, Hall M, Damas B, et al. Microsatellite instability predicts improved response to adjuvant therapy with irinotecan, fluorouracil, and leucovorin in stage III colon cancer: cancer and Leukemia Group B Protocol 89803. J Clin Oncol. 2009;27(11):1814–21.PubMedPubMedCentralCrossRef
212.
go back to reference Des Guetz G, Uzzan B, Nicolas P, Schischmanoff O, Perret GY, Morere JF. Microsatellite instability does not predict the efficacy of chemotherapy in metastatic colorectal cancer. A systematic review and meta-analysis. Anticancer Res. 2009;29(5):1615–20.PubMed Des Guetz G, Uzzan B, Nicolas P, Schischmanoff O, Perret GY, Morere JF. Microsatellite instability does not predict the efficacy of chemotherapy in metastatic colorectal cancer. A systematic review and meta-analysis. Anticancer Res. 2009;29(5):1615–20.PubMed
213.
go back to reference Ilson DH, Saltz L, Enzinger P, Huang Y, Kornblith A, Gollub M, et al. Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer. J Clin Oncol. 1999;17(10):3270–5.PubMedCrossRef Ilson DH, Saltz L, Enzinger P, Huang Y, Kornblith A, Gollub M, et al. Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer. J Clin Oncol. 1999;17(10):3270–5.PubMedCrossRef
214.
go back to reference Pozzo C, Barone C, Szanto J, Padi E, Peschel C, Bukki J, et al. Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: results of a randomized phase II study. Ann Oncol. 2004;15(12):1773–81.PubMedCrossRef Pozzo C, Barone C, Szanto J, Padi E, Peschel C, Bukki J, et al. Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: results of a randomized phase II study. Ann Oncol. 2004;15(12):1773–81.PubMedCrossRef
215.
go back to reference Brell JM, Krishnamurthi SS, Javle M, Saltzman J, Wollner I, Pelley R, et al. A multi-center phase II study of oxaliplatin, irinotecan, and capecitabine in advanced gastric/gastroesophageal junction carcinoma. Cancer Chemother Pharmacol. 2009;63(5):851–7.PubMedCrossRef Brell JM, Krishnamurthi SS, Javle M, Saltzman J, Wollner I, Pelley R, et al. A multi-center phase II study of oxaliplatin, irinotecan, and capecitabine in advanced gastric/gastroesophageal junction carcinoma. Cancer Chemother Pharmacol. 2009;63(5):851–7.PubMedCrossRef
216.
go back to reference Lustberg MB, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, et al. Phase II randomized study of two regimens of sequentially administered mitomycin C and irinotecan in patients with unresectable esophageal and gastroesophageal adenocarcinoma. J Thorac Oncol. 2010;5(5):713–8.PubMedPubMedCentralCrossRef Lustberg MB, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, et al. Phase II randomized study of two regimens of sequentially administered mitomycin C and irinotecan in patients with unresectable esophageal and gastroesophageal adenocarcinoma. J Thorac Oncol. 2010;5(5):713–8.PubMedPubMedCentralCrossRef
217.
go back to reference Moehler M, Kanzler S, Geissler M, Raedle J, Ebert MP, Daum S, et al. A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2010;21(1):71–7.PubMedCrossRef Moehler M, Kanzler S, Geissler M, Raedle J, Ebert MP, Daum S, et al. A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2010;21(1):71–7.PubMedCrossRef
218.
go back to reference Roy A, Cunningham D, Hawkins R, Sorbye H, Adenis A, Barcelo JR, et al. Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer: a randomised phase II study. Br J Cancer. 2012;107(3):435–41.PubMedPubMedCentralCrossRef Roy A, Cunningham D, Hawkins R, Sorbye H, Adenis A, Barcelo JR, et al. Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer: a randomised phase II study. Br J Cancer. 2012;107(3):435–41.PubMedPubMedCentralCrossRef
219.
go back to reference Enzinger PC, Kulke MH, Clark JW, Ryan DP, Kim H, Earle CC, et al. A phase II trial of irinotecan in patients with previously untreated advanced esophageal and gastric adenocarcinoma. Dig Dis Sci. 2005;50(12):2218–23.PubMedCrossRef Enzinger PC, Kulke MH, Clark JW, Ryan DP, Kim H, Earle CC, et al. A phase II trial of irinotecan in patients with previously untreated advanced esophageal and gastric adenocarcinoma. Dig Dis Sci. 2005;50(12):2218–23.PubMedCrossRef
220.
go back to reference Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7.PubMedCrossRef Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7.PubMedCrossRef
222.
go back to reference Yang XQ, Li CY, Xu MF, Zhao H, Wang D. Comparison of first-line chemotherapy based on irinotecan or other drugs to treat non-small cell lung cancer in stage IIIB/IV: a systematic review and meta-analysis. BMC Cancer. 2015;15:949.PubMedPubMedCentralCrossRef Yang XQ, Li CY, Xu MF, Zhao H, Wang D. Comparison of first-line chemotherapy based on irinotecan or other drugs to treat non-small cell lung cancer in stage IIIB/IV: a systematic review and meta-analysis. BMC Cancer. 2015;15:949.PubMedPubMedCentralCrossRef
223.
go back to reference Kalemkerian GP. Advances in pharmacotherapy of small cell lung cancer. Expert Opin Pharmacother. 2014;15(16):2385–96.PubMedCrossRef Kalemkerian GP. Advances in pharmacotherapy of small cell lung cancer. Expert Opin Pharmacother. 2014;15(16):2385–96.PubMedCrossRef
224.
go back to reference Nakano T, Chahinian AP, Shinjo M, Togawa N, Tonomura A, Miyake M, et al. Cisplatin in combination with irinotecan in the treatment of patients with malignant pleural mesothelioma: a pilot phase II clinical trial and pharmacokinetic profile. Cancer. 1999;85(11):2375–84.PubMedCrossRef Nakano T, Chahinian AP, Shinjo M, Togawa N, Tonomura A, Miyake M, et al. Cisplatin in combination with irinotecan in the treatment of patients with malignant pleural mesothelioma: a pilot phase II clinical trial and pharmacokinetic profile. Cancer. 1999;85(11):2375–84.PubMedCrossRef
225.
go back to reference Peters KB, Lou E, Desjardins A, Reardon DA, Lipp ES, Miller E, et al. Phase II trial of upfront bevacizumab, irinotecan, and temozolomide for unresectable glioblastoma. Oncologist. 2015;20(7):727–8.PubMedPubMedCentralCrossRef Peters KB, Lou E, Desjardins A, Reardon DA, Lipp ES, Miller E, et al. Phase II trial of upfront bevacizumab, irinotecan, and temozolomide for unresectable glioblastoma. Oncologist. 2015;20(7):727–8.PubMedPubMedCentralCrossRef
226.
go back to reference Lhomme C, Fumoleau P, Fargeot P, Krakowski Y, Dieras V, Chauvergne J, et al. Results of a European Organization for Research and Treatment of Cancer/Early Clinical Studies Group phase II trial of first-line irinotecan in patients with advanced or recurrent squamous cell carcinoma of the cervix. J Clin Oncol. 1999;17(10):3136–42.PubMedCrossRef Lhomme C, Fumoleau P, Fargeot P, Krakowski Y, Dieras V, Chauvergne J, et al. Results of a European Organization for Research and Treatment of Cancer/Early Clinical Studies Group phase II trial of first-line irinotecan in patients with advanced or recurrent squamous cell carcinoma of the cervix. J Clin Oncol. 1999;17(10):3136–42.PubMedCrossRef
227.
go back to reference Sugiyama T, Nishida T, Kumagai S, Nishio S, Fujiyoshi K, Okura N, et al. Combination therapy with irinotecan and cisplatin as neoadjuvant chemotherapy in locally advanced cervical cancer. Br J Cancer. 1999;81(1):95–8.PubMedPubMedCentralCrossRef Sugiyama T, Nishida T, Kumagai S, Nishio S, Fujiyoshi K, Okura N, et al. Combination therapy with irinotecan and cisplatin as neoadjuvant chemotherapy in locally advanced cervical cancer. Br J Cancer. 1999;81(1):95–8.PubMedPubMedCentralCrossRef
228.
go back to reference Bodurka DC, Levenback C, Wolf JK, Gano J, Wharton JT, Kavanagh JJ, et al. Phase II trial of irinotecan in patients with metastatic epithelial ovarian cancer or peritoneal cancer. J Clin Oncol. 2003;21(2):291–7.PubMedCrossRef Bodurka DC, Levenback C, Wolf JK, Gano J, Wharton JT, Kavanagh JJ, et al. Phase II trial of irinotecan in patients with metastatic epithelial ovarian cancer or peritoneal cancer. J Clin Oncol. 2003;21(2):291–7.PubMedCrossRef
229.
go back to reference Musa F, Pothuri B, Blank SV, Ling HT, Speyer JL, Curtin J, et al. Phase II study of irinotecan in combination with bevacizumab in recurrent ovarian cancer. Gynecol Oncol. 2017;144(2):279–84.PubMedCrossRef Musa F, Pothuri B, Blank SV, Ling HT, Speyer JL, Curtin J, et al. Phase II study of irinotecan in combination with bevacizumab in recurrent ovarian cancer. Gynecol Oncol. 2017;144(2):279–84.PubMedCrossRef
230.
go back to reference Murphy BA, Cmelak A, Burkey B, Netterville J, Shyr Y, Douglas S, et al. Topoisomerase I inhibitors in the treatment of head and neck cancer. Oncology (Williston Park). 2001;15(7 Suppl 8):47–52. Murphy BA, Cmelak A, Burkey B, Netterville J, Shyr Y, Douglas S, et al. Topoisomerase I inhibitors in the treatment of head and neck cancer. Oncology (Williston Park). 2001;15(7 Suppl 8):47–52.
231.
go back to reference Gilbert J, Cmelak A, Shyr Y, Netterville J, Burkey BB, Sinard RJ, et al. Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. Cancer. 2008;113(1):186–92.PubMedCrossRef Gilbert J, Cmelak A, Shyr Y, Netterville J, Burkey BB, Sinard RJ, et al. Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. Cancer. 2008;113(1):186–92.PubMedCrossRef
232.
go back to reference Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817–25.PubMedCrossRef Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817–25.PubMedCrossRef
233.
go back to reference Barbarino JM, Haidar CE, Klein TE, Altman RB. PharmGKB summary: very important pharmacogene information for UGT1A1. Pharmacogenet Genom. 2014;24(3):177–83.CrossRef Barbarino JM, Haidar CE, Klein TE, Altman RB. PharmGKB summary: very important pharmacogene information for UGT1A1. Pharmacogenet Genom. 2014;24(3):177–83.CrossRef
234.
go back to reference Bosma PJ, Chowdhury JR, Bakker C, Gantla S, de Boer A, Oostra BA, et al. The genetic basis of the reduced expression of bilirubin UDP-glucuronosyltransferase 1 in Gilbert’s syndrome. N Engl J Med. 1995;333(18):1171–5.PubMedCrossRef Bosma PJ, Chowdhury JR, Bakker C, Gantla S, de Boer A, Oostra BA, et al. The genetic basis of the reduced expression of bilirubin UDP-glucuronosyltransferase 1 in Gilbert’s syndrome. N Engl J Med. 1995;333(18):1171–5.PubMedCrossRef
235.
go back to reference Hall D, Ybazeta G, Destro-Bisol G, Petzl-Erler ML, Di Rienzo A. Variability at the uridine diphosphate glucuronosyltransferase 1A1 promoter in human populations and primates. Pharmacogenetics. 1999;9(5):591–9.PubMedCrossRef Hall D, Ybazeta G, Destro-Bisol G, Petzl-Erler ML, Di Rienzo A. Variability at the uridine diphosphate glucuronosyltransferase 1A1 promoter in human populations and primates. Pharmacogenetics. 1999;9(5):591–9.PubMedCrossRef
236.
go back to reference Beutler E, Gelbart T, Demina A. Racial variability in the UDP-glucuronosyltransferase 1 (UGT1A1) promoter: a balanced polymorphism for regulation of bilirubin metabolism? Proc Natl Acad Sci USA. 1998;95(14):8170–4.PubMedCrossRef Beutler E, Gelbart T, Demina A. Racial variability in the UDP-glucuronosyltransferase 1 (UGT1A1) promoter: a balanced polymorphism for regulation of bilirubin metabolism? Proc Natl Acad Sci USA. 1998;95(14):8170–4.PubMedCrossRef
237.
go back to reference Akaba K, Kimura T, Sasaki A, Tanabe S, Ikegami T, Hashimoto M, et al. Neonatal hyperbilirubinemia and mutation of the bilirubin uridine diphosphate-glucuronosyltransferase gene: a common missense mutation among Japanese, Koreans and Chinese. Biochem Mol Biol Int. 1998;46(1):21–6.PubMed Akaba K, Kimura T, Sasaki A, Tanabe S, Ikegami T, Hashimoto M, et al. Neonatal hyperbilirubinemia and mutation of the bilirubin uridine diphosphate-glucuronosyltransferase gene: a common missense mutation among Japanese, Koreans and Chinese. Biochem Mol Biol Int. 1998;46(1):21–6.PubMed
238.
go back to reference Sugatani J, Yamakawa K, Yoshinari K, Machida T, Takagi H, Mori M, et al. Identification of a defect in the UGT1A1 gene promoter and its association with hyperbilirubinemia. Biochem Biophys Res Commun. 2002;292(2):492–7.PubMedCrossRef Sugatani J, Yamakawa K, Yoshinari K, Machida T, Takagi H, Mori M, et al. Identification of a defect in the UGT1A1 gene promoter and its association with hyperbilirubinemia. Biochem Biophys Res Commun. 2002;292(2):492–7.PubMedCrossRef
239.
go back to reference Wang Y, Shen L, Xu N, Wang JW, Jiao SC, Liu ZY, et al. UGT1A1 predicts outcome in colorectal cancer treated with irinotecan and fluorouracil. World J Gastroenterol. 2012;18(45):6635–44.PubMedPubMedCentralCrossRef Wang Y, Shen L, Xu N, Wang JW, Jiao SC, Liu ZY, et al. UGT1A1 predicts outcome in colorectal cancer treated with irinotecan and fluorouracil. World J Gastroenterol. 2012;18(45):6635–44.PubMedPubMedCentralCrossRef
240.
go back to reference Iyer L, Hall D, Das S, Mortell MA, Ramirez J, Kim S, et al. Phenotype-genotype correlation of in vitro SN-38 (active metabolite of irinotecan) and bilirubin glucuronidation in human liver tissue with UGT1A1 promoter polymorphism. Clin Pharmacol Ther. 1999;65(5):576–82.PubMedCrossRef Iyer L, Hall D, Das S, Mortell MA, Ramirez J, Kim S, et al. Phenotype-genotype correlation of in vitro SN-38 (active metabolite of irinotecan) and bilirubin glucuronidation in human liver tissue with UGT1A1 promoter polymorphism. Clin Pharmacol Ther. 1999;65(5):576–82.PubMedCrossRef
242.
go back to reference Hoskins JM, Goldberg RM, Qu P, Ibrahim JG, McLeod HL. UGT1A1*28 genotype and irinotecan-induced neutropenia: dose matters. J Natl Cancer Inst. 2007;99(17):1290–5.PubMedCrossRef Hoskins JM, Goldberg RM, Qu P, Ibrahim JG, McLeod HL. UGT1A1*28 genotype and irinotecan-induced neutropenia: dose matters. J Natl Cancer Inst. 2007;99(17):1290–5.PubMedCrossRef
243.
go back to reference Hu ZY, Yu Q, Pei Q, Guo C. Dose-dependent association between UGT1A1*28 genotype and irinotecan-induced neutropenia: low doses also increase risk. Clin Cancer Res. 2010;16(15):3832–42.PubMedCrossRef Hu ZY, Yu Q, Pei Q, Guo C. Dose-dependent association between UGT1A1*28 genotype and irinotecan-induced neutropenia: low doses also increase risk. Clin Cancer Res. 2010;16(15):3832–42.PubMedCrossRef
244.
go back to reference Liu X, Cheng D, Kuang Q, Liu G, Xu W. Association of UGT1A1*28 polymorphisms with irinotecan-induced toxicities in colorectal cancer: a meta-analysis in Caucasians. Pharmacogenom J. 2014;14(2):120–9.CrossRef Liu X, Cheng D, Kuang Q, Liu G, Xu W. Association of UGT1A1*28 polymorphisms with irinotecan-induced toxicities in colorectal cancer: a meta-analysis in Caucasians. Pharmacogenom J. 2014;14(2):120–9.CrossRef
245.
go back to reference Chen X, Liu L, Guo Z, Liang W, He J, Huang L, et al. UGT1A1 polymorphisms with irinotecan-induced toxicities and treatment outcome in Asians with Lung Cancer: a meta-analysis. Cancer Chemother Pharmacol. 2017;79(6):1109–17.PubMedCrossRef Chen X, Liu L, Guo Z, Liang W, He J, Huang L, et al. UGT1A1 polymorphisms with irinotecan-induced toxicities and treatment outcome in Asians with Lung Cancer: a meta-analysis. Cancer Chemother Pharmacol. 2017;79(6):1109–17.PubMedCrossRef
246.
go back to reference Chen YJ, Hu F, Li CY, Fang JM, Chu L, Zhang X, et al. The association of UGT1A1*6 and UGT1A1*28 with irinotecan-induced neutropenia in Asians: a meta-analysis. Biomarkers. 2014;19(1):56–62.PubMedCrossRef Chen YJ, Hu F, Li CY, Fang JM, Chu L, Zhang X, et al. The association of UGT1A1*6 and UGT1A1*28 with irinotecan-induced neutropenia in Asians: a meta-analysis. Biomarkers. 2014;19(1):56–62.PubMedCrossRef
247.
go back to reference Han FF, Guo CL, Yu D, Zhu J, Gong LL, Li GR, et al. Associations between UGT1A1*6 or UGT1A1*6/*28 polymorphisms and irinotecan-induced neutropenia in Asian cancer patients. Cancer Chemother Pharmacol. 2014;73(4):779–88.PubMedCrossRef Han FF, Guo CL, Yu D, Zhu J, Gong LL, Li GR, et al. Associations between UGT1A1*6 or UGT1A1*6/*28 polymorphisms and irinotecan-induced neutropenia in Asian cancer patients. Cancer Chemother Pharmacol. 2014;73(4):779–88.PubMedCrossRef
248.
go back to reference Cheng L, Li M, Hu J, Ren W, Xie L, Sun ZP, et al. UGT1A1*6 polymorphisms are correlated with irinotecan-induced toxicity: a system review and meta-analysis in Asians. Cancer Chemother Pharmacol. 2014;73(3):551–60.PubMedCrossRef Cheng L, Li M, Hu J, Ren W, Xie L, Sun ZP, et al. UGT1A1*6 polymorphisms are correlated with irinotecan-induced toxicity: a system review and meta-analysis in Asians. Cancer Chemother Pharmacol. 2014;73(3):551–60.PubMedCrossRef
249.
go back to reference Hu ZY, Yu Q, Zhao YS. Dose-dependent association between UGT1A1*28 polymorphism and irinotecan-induced diarrhoea: a meta-analysis. Eur J Cancer. 2010;46(10):1856–65.PubMedCrossRef Hu ZY, Yu Q, Zhao YS. Dose-dependent association between UGT1A1*28 polymorphism and irinotecan-induced diarrhoea: a meta-analysis. Eur J Cancer. 2010;46(10):1856–65.PubMedCrossRef
250.
go back to reference Campbell JM, Stephenson MD, Bateman E, Peters MD, Keefe DM, Bowen JM. Irinotecan-induced toxicity pharmacogenetics: an umbrella review of systematic reviews and meta-analyses. Pharmacogenom J. 2017;17(1):21–8.CrossRef Campbell JM, Stephenson MD, Bateman E, Peters MD, Keefe DM, Bowen JM. Irinotecan-induced toxicity pharmacogenetics: an umbrella review of systematic reviews and meta-analyses. Pharmacogenom J. 2017;17(1):21–8.CrossRef
251.
go back to reference Dias MM, Pignon JP, Karapetis CS, Boige V, Glimelius B, Kweekel DM, et al. The effect of the UGT1A1*28 allele on survival after irinotecan-based chemotherapy: a collaborative meta-analysis. Pharmacogenom J. 2014;14(5):424–31.CrossRef Dias MM, Pignon JP, Karapetis CS, Boige V, Glimelius B, Kweekel DM, et al. The effect of the UGT1A1*28 allele on survival after irinotecan-based chemotherapy: a collaborative meta-analysis. Pharmacogenom J. 2014;14(5):424–31.CrossRef
252.
go back to reference Innocenti F, Grimsley C, Das S, Ramirez J, Cheng C, Kuttab-Boulos H, et al. Haplotype structure of the UDP-glucuronosyltransferase 1A1 promoter in different ethnic groups. Pharmacogenetics. 2002;12(9):725–33.PubMedCrossRef Innocenti F, Grimsley C, Das S, Ramirez J, Cheng C, Kuttab-Boulos H, et al. Haplotype structure of the UDP-glucuronosyltransferase 1A1 promoter in different ethnic groups. Pharmacogenetics. 2002;12(9):725–33.PubMedCrossRef
253.
go back to reference Han JY, Lim HS, Shin ES, Yoo YK, Park YH, Lee JE, et al. Comprehensive analysis of UGT1A polymorphisms predictive for pharmacokinetics and treatment outcome in patients with non-small-cell lung cancer treated with irinotecan and cisplatin. J Clin Oncol. 2006;24(15):2237–44.PubMedCrossRef Han JY, Lim HS, Shin ES, Yoo YK, Park YH, Lee JE, et al. Comprehensive analysis of UGT1A polymorphisms predictive for pharmacokinetics and treatment outcome in patients with non-small-cell lung cancer treated with irinotecan and cisplatin. J Clin Oncol. 2006;24(15):2237–44.PubMedCrossRef
254.
go back to reference Kim SY, Hong YS, Shim EK, Kong SY, Shin A, Baek JY, et al. S-1 plus irinotecan and oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: a prospective phase II study and pharmacogenetic analysis. Br J Cancer. 2013;109(6):1420–7.PubMedPubMedCentralCrossRef Kim SY, Hong YS, Shim EK, Kong SY, Shin A, Baek JY, et al. S-1 plus irinotecan and oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: a prospective phase II study and pharmacogenetic analysis. Br J Cancer. 2013;109(6):1420–7.PubMedPubMedCentralCrossRef
255.
go back to reference Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol. 2004;22(8):1382–8.PubMedCrossRef Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol. 2004;22(8):1382–8.PubMedCrossRef
256.
go back to reference Li M, Seiser EL, Baldwin RM, Ramirez J, Ratain MJ, Innocenti F, et al. ABC transporter polymorphisms are associated with irinotecan pharmacokinetics and neutropenia. Pharmacogenom J. 2018;18(1):35–42.CrossRef Li M, Seiser EL, Baldwin RM, Ramirez J, Ratain MJ, Innocenti F, et al. ABC transporter polymorphisms are associated with irinotecan pharmacokinetics and neutropenia. Pharmacogenom J. 2018;18(1):35–42.CrossRef
257.
go back to reference Bian X, Liu B, Yang Y. Pathological complete response following neoadjuvant radiotherapy and intraperitoneal perfusion chemotherapy for recurrent colon carcinoma: a case report and literature review. Oncol Lett. 2016;11(4):2747–50.PubMedPubMedCentralCrossRef Bian X, Liu B, Yang Y. Pathological complete response following neoadjuvant radiotherapy and intraperitoneal perfusion chemotherapy for recurrent colon carcinoma: a case report and literature review. Oncol Lett. 2016;11(4):2747–50.PubMedPubMedCentralCrossRef
258.
go back to reference Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, et al. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007;13(11):3269–75.PubMedCrossRef Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, et al. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007;13(11):3269–75.PubMedCrossRef
259.
go back to reference Levesque E, Belanger AS, Harvey M, Couture F, Jonker D, Innocenti F, et al. Refining the UGT1A haplotype associated with irinotecan-induced hematological toxicity in metastatic colorectal cancer patients treated with 5-fluorouracil/irinotecan-based regimens. J Pharmacol Exp Ther. 2013;345(1):95–101.PubMedPubMedCentralCrossRef Levesque E, Belanger AS, Harvey M, Couture F, Jonker D, Innocenti F, et al. Refining the UGT1A haplotype associated with irinotecan-induced hematological toxicity in metastatic colorectal cancer patients treated with 5-fluorouracil/irinotecan-based regimens. J Pharmacol Exp Ther. 2013;345(1):95–101.PubMedPubMedCentralCrossRef
260.
go back to reference Ferraldeschi R, Minchell LJ, Roberts SA, Tobi S, Hadfield KD, Blackhall FH, et al. UGT1A1*28 genotype predicts gastrointestinal toxicity in patients treated with intermediate-dose irinotecan. Pharmacogenomics. 2009;10(5):733–9.PubMedCrossRef Ferraldeschi R, Minchell LJ, Roberts SA, Tobi S, Hadfield KD, Blackhall FH, et al. UGT1A1*28 genotype predicts gastrointestinal toxicity in patients treated with intermediate-dose irinotecan. Pharmacogenomics. 2009;10(5):733–9.PubMedCrossRef
261.
go back to reference McLeod HL, Sargent DJ, Marsh S, Green EM, King CR, Fuchs CS, et al. Pharmacogenetic predictors of adverse events and response to chemotherapy in metastatic colorectal cancer: results from North American Gastrointestinal Intergroup Trial N9741. J Clin Oncol. 2010;28(20):3227–33.PubMedPubMedCentralCrossRef McLeod HL, Sargent DJ, Marsh S, Green EM, King CR, Fuchs CS, et al. Pharmacogenetic predictors of adverse events and response to chemotherapy in metastatic colorectal cancer: results from North American Gastrointestinal Intergroup Trial N9741. J Clin Oncol. 2010;28(20):3227–33.PubMedPubMedCentralCrossRef
262.
go back to reference Cecchin E, Innocenti F, D’Andrea M, Corona G, De Mattia E, Biason P, et al. Predictive role of the UGT1A1, UGT1A7, and UGT1A9 genetic variants and their haplotypes on the outcome of metastatic colorectal cancer patients treated with fluorouracil, leucovorin, and irinotecan. J Clin Oncol. 2009;27(15):2457–65.PubMedCrossRef Cecchin E, Innocenti F, D’Andrea M, Corona G, De Mattia E, Biason P, et al. Predictive role of the UGT1A1, UGT1A7, and UGT1A9 genetic variants and their haplotypes on the outcome of metastatic colorectal cancer patients treated with fluorouracil, leucovorin, and irinotecan. J Clin Oncol. 2009;27(15):2457–65.PubMedCrossRef
263.
go back to reference Inoue K, Sonobe M, Kawamura Y, Etoh T, Takagi M, Matsumura T, et al. Polymorphisms of the UDP-glucuronosyl transferase 1A genes are associated with adverse events in cancer patients receiving irinotecan-based chemotherapy. Tohoku J Exp Med. 2013;229(2):107–14.PubMedCrossRef Inoue K, Sonobe M, Kawamura Y, Etoh T, Takagi M, Matsumura T, et al. Polymorphisms of the UDP-glucuronosyl transferase 1A genes are associated with adverse events in cancer patients receiving irinotecan-based chemotherapy. Tohoku J Exp Med. 2013;229(2):107–14.PubMedCrossRef
264.
go back to reference Han JY, Lim HS, Park YH, Lee SY, Lee JS. Integrated pharmacogenetic prediction of irinotecan pharmacokinetics and toxicity in patients with advanced non-small cell lung cancer. Lung Cancer. 2009;63(1):115–20.PubMedCrossRef Han JY, Lim HS, Park YH, Lee SY, Lee JS. Integrated pharmacogenetic prediction of irinotecan pharmacokinetics and toxicity in patients with advanced non-small cell lung cancer. Lung Cancer. 2009;63(1):115–20.PubMedCrossRef
265.
go back to reference Paoluzzi L, Singh AS, Price DK, Danesi R, Mathijssen RH, Verweij J, et al. Influence of genetic variants in UGT1A1 and UGT1A9 on the in vivo glucuronidation of SN-38. J Clin Pharmacol. 2004;44(8):854–60.PubMedCrossRef Paoluzzi L, Singh AS, Price DK, Danesi R, Mathijssen RH, Verweij J, et al. Influence of genetic variants in UGT1A1 and UGT1A9 on the in vivo glucuronidation of SN-38. J Clin Pharmacol. 2004;44(8):854–60.PubMedCrossRef
266.
go back to reference Gagne JF, Montminy V, Belanger P, Journault K, Gaucher G, Guillemette C. Common human UGT1A polymorphisms and the altered metabolism of irinotecan active metabolite 7-ethyl-10-hydroxycamptothecin (SN-38). Mol Pharmacol. 2002;62(3):608–17.PubMedCrossRef Gagne JF, Montminy V, Belanger P, Journault K, Gaucher G, Guillemette C. Common human UGT1A polymorphisms and the altered metabolism of irinotecan active metabolite 7-ethyl-10-hydroxycamptothecin (SN-38). Mol Pharmacol. 2002;62(3):608–17.PubMedCrossRef
267.
go back to reference Mathijssen RH, Marsh S, Karlsson MO, Xie R, Baker SD, Verweij J, et al. Irinotecan pathway genotype analysis to predict pharmacokinetics. Clin Cancer Res. 2003;9(9):3246–53.PubMed Mathijssen RH, Marsh S, Karlsson MO, Xie R, Baker SD, Verweij J, et al. Irinotecan pathway genotype analysis to predict pharmacokinetics. Clin Cancer Res. 2003;9(9):3246–53.PubMed
268.
go back to reference Glimelius B, Garmo H, Berglund A, Fredriksson LA, Berglund M, Kohnke H, et al. Prediction of irinotecan and 5-fluorouracil toxicity and response in patients with advanced colorectal cancer. Pharmacogenom J. 2011;11(1):61–71.CrossRef Glimelius B, Garmo H, Berglund A, Fredriksson LA, Berglund M, Kohnke H, et al. Prediction of irinotecan and 5-fluorouracil toxicity and response in patients with advanced colorectal cancer. Pharmacogenom J. 2011;11(1):61–71.CrossRef
269.
go back to reference Levi F, Karaboue A, Saffroy R, Desterke C, Boige V, Smith D, et al. Pharmacogenetic determinants of outcomes on triplet hepatic artery infusion and intravenous cetuximab for liver metastases from colorectal cancer (European trial OPTILIV, NCT00852228). Br J Cancer. 2017;117(7):965–73.PubMedCrossRefPubMedCentral Levi F, Karaboue A, Saffroy R, Desterke C, Boige V, Smith D, et al. Pharmacogenetic determinants of outcomes on triplet hepatic artery infusion and intravenous cetuximab for liver metastases from colorectal cancer (European trial OPTILIV, NCT00852228). Br J Cancer. 2017;117(7):965–73.PubMedCrossRefPubMedCentral
270.
go back to reference de Jong FA, Marsh S, Mathijssen RH, King C, Verweij J, Sparreboom A, et al. ABCG2 pharmacogenetics: ethnic differences in allele frequency and assessment of influence on irinotecan disposition. Clin Cancer Res. 2004;10(17):5889–94.PubMedCrossRef de Jong FA, Marsh S, Mathijssen RH, King C, Verweij J, Sparreboom A, et al. ABCG2 pharmacogenetics: ethnic differences in allele frequency and assessment of influence on irinotecan disposition. Clin Cancer Res. 2004;10(17):5889–94.PubMedCrossRef
271.
go back to reference de Jong FA, Scott-Horton TJ, Kroetz DL, McLeod HL, Friberg LE, Mathijssen RH, et al. Irinotecan-induced diarrhea: functional significance of the polymorphic ABCC2 transporter protein. Clin Pharmacol Ther. 2007;81(1):42–9.PubMedCrossRef de Jong FA, Scott-Horton TJ, Kroetz DL, McLeod HL, Friberg LE, Mathijssen RH, et al. Irinotecan-induced diarrhea: functional significance of the polymorphic ABCC2 transporter protein. Clin Pharmacol Ther. 2007;81(1):42–9.PubMedCrossRef
272.
go back to reference Chen S, Villeneuve L, Jonker D, Couture F, Laverdiere I, Cecchin E, et al. ABCC5 and ABCG1 polymorphisms predict irinotecan-induced severe toxicity in metastatic colorectal cancer patients. Pharmacogenet Genom. 2015;25(12):573–83.CrossRef Chen S, Villeneuve L, Jonker D, Couture F, Laverdiere I, Cecchin E, et al. ABCC5 and ABCG1 polymorphisms predict irinotecan-induced severe toxicity in metastatic colorectal cancer patients. Pharmacogenet Genom. 2015;25(12):573–83.CrossRef
273.
go back to reference Crona DJ, Ramirez J, Qiao W, de Graan AJ, Ratain MJ, van Schaik RH, et al. Clinical validity of new genetic biomarkers of irinotecan neutropenia: an independent replication study. Pharmacogenom J. 2016;16(1):54–9.CrossRef Crona DJ, Ramirez J, Qiao W, de Graan AJ, Ratain MJ, van Schaik RH, et al. Clinical validity of new genetic biomarkers of irinotecan neutropenia: an independent replication study. Pharmacogenom J. 2016;16(1):54–9.CrossRef
274.
go back to reference Teft WA, Welch S, Lenehan J, Parfitt J, Choi YH, Winquist E, et al. OATP1B1 and tumour OATP1B3 modulate exposure, toxicity, and survival after irinotecan-based chemotherapy. Br J Cancer. 2015;112(5):857–65.PubMedPubMedCentralCrossRef Teft WA, Welch S, Lenehan J, Parfitt J, Choi YH, Winquist E, et al. OATP1B1 and tumour OATP1B3 modulate exposure, toxicity, and survival after irinotecan-based chemotherapy. Br J Cancer. 2015;112(5):857–65.PubMedPubMedCentralCrossRef
277.
go back to reference Evaluation of Genomic Applications in P. Prevention Working G. Recommendations from the EGAPP Working Group: can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? Genet Med. 2009;11(1):15–20.CrossRef Evaluation of Genomic Applications in P. Prevention Working G. Recommendations from the EGAPP Working Group: can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? Genet Med. 2009;11(1):15–20.CrossRef
278.
go back to reference Etienne-Grimaldi MC, Boyer JC, Thomas F, Quaranta S, Picard N, Loriot MA, et al. UGT1A1 genotype and irinotecan therapy: general review and implementation in routine practice. Fundam Clin Pharmacol. 2015;29(3):219–37.PubMedCrossRef Etienne-Grimaldi MC, Boyer JC, Thomas F, Quaranta S, Picard N, Loriot MA, et al. UGT1A1 genotype and irinotecan therapy: general review and implementation in routine practice. Fundam Clin Pharmacol. 2015;29(3):219–37.PubMedCrossRef
279.
go back to reference Swen JJ, Nijenhuis M, de Boer A, Grandia L, Maitland-van der Zee AH, Mulder H, et al. Pharmacogenetics: from bench to byte–an update of guidelines. Clin Pharmacol Ther. 2011;89(5):662–73.PubMedCrossRef Swen JJ, Nijenhuis M, de Boer A, Grandia L, Maitland-van der Zee AH, Mulder H, et al. Pharmacogenetics: from bench to byte–an update of guidelines. Clin Pharmacol Ther. 2011;89(5):662–73.PubMedCrossRef
282.
go back to reference Toffoli G, Sharma MR, Marangon E, Posocco B, Gray E, Mai Q, et al. Genotype-guided dosing study of FOLFIRI plus bevacizumab in patients with metastatic colorectal cancer. Clin Cancer Res. 2017;23(4):918–24.PubMedCrossRef Toffoli G, Sharma MR, Marangon E, Posocco B, Gray E, Mai Q, et al. Genotype-guided dosing study of FOLFIRI plus bevacizumab in patients with metastatic colorectal cancer. Clin Cancer Res. 2017;23(4):918–24.PubMedCrossRef
283.
go back to reference Innocenti F, Schilsky RL, Ramirez J, Janisch L, Undevia S, House LK, et al. Dose-finding and pharmacokinetic study to optimize the dosing of irinotecan according to the UGT1A1 genotype of patients with cancer. J Clin Oncol. 2014;32(22):2328–34.PubMedPubMedCentralCrossRef Innocenti F, Schilsky RL, Ramirez J, Janisch L, Undevia S, House LK, et al. Dose-finding and pharmacokinetic study to optimize the dosing of irinotecan according to the UGT1A1 genotype of patients with cancer. J Clin Oncol. 2014;32(22):2328–34.PubMedPubMedCentralCrossRef
284.
go back to reference Toffoli G, Cecchin E, Gasparini G, D’Andrea M, Azzarello G, Basso U, et al. Genotype-driven phase I study of irinotecan administered in combination with fluorouracil/leucovorin in patients with metastatic colorectal cancer. J Clin Oncol. 2010;28(5):866–71.PubMedCrossRef Toffoli G, Cecchin E, Gasparini G, D’Andrea M, Azzarello G, Basso U, et al. Genotype-driven phase I study of irinotecan administered in combination with fluorouracil/leucovorin in patients with metastatic colorectal cancer. J Clin Oncol. 2010;28(5):866–71.PubMedCrossRef
285.
go back to reference Diekstra MH, Klumpen HJ, Lolkema MP, Yu H, Kloth JS, Gelderblom H, et al. Association analysis of genetic polymorphisms in genes related to sunitinib pharmacokinetics, specifically clearance of sunitinib and SU12662. Clin Pharmacol Ther. 2014;96(1):81–9.PubMedCrossRef Diekstra MH, Klumpen HJ, Lolkema MP, Yu H, Kloth JS, Gelderblom H, et al. Association analysis of genetic polymorphisms in genes related to sunitinib pharmacokinetics, specifically clearance of sunitinib and SU12662. Clin Pharmacol Ther. 2014;96(1):81–9.PubMedCrossRef
286.
go back to reference Wang D, Guo Y, Wrighton SA, Cooke GE, Sadee W. Intronic polymorphism in CYP3A4 affects hepatic expression and response to statin drugs. Pharmacogenom J. 2011;11(4):274–86.CrossRef Wang D, Guo Y, Wrighton SA, Cooke GE, Sadee W. Intronic polymorphism in CYP3A4 affects hepatic expression and response to statin drugs. Pharmacogenom J. 2011;11(4):274–86.CrossRef
287.
go back to reference Elens L, Bouamar R, Hesselink DA, Haufroid V, van der Heiden IP, van Gelder T, et al. A new functional CYP3A4 intron 6 polymorphism significantly affects tacrolimus pharmacokinetics in kidney transplant recipients. Clin Chem. 2011;57(11):1574–83.PubMedCrossRef Elens L, Bouamar R, Hesselink DA, Haufroid V, van der Heiden IP, van Gelder T, et al. A new functional CYP3A4 intron 6 polymorphism significantly affects tacrolimus pharmacokinetics in kidney transplant recipients. Clin Chem. 2011;57(11):1574–83.PubMedCrossRef
Metadata
Title
Individualization of Irinotecan Treatment: A Review of Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics
Authors
Femke M. de Man
Andrew K. L. Goey
Ron H. N. van Schaik
Ron H. J. Mathijssen
Sander Bins
Publication date
01-10-2018
Publisher
Springer International Publishing
Published in
Clinical Pharmacokinetics / Issue 10/2018
Print ISSN: 0312-5963
Electronic ISSN: 1179-1926
DOI
https://doi.org/10.1007/s40262-018-0644-7

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