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Published in: Journal of Experimental & Clinical Cancer Research 1/2017

Open Access 01-12-2017 | Meeting Report

The changing face of clinical trials in the personalized medicine and immuno-oncology era: report from the international congress on clinical trials in Oncology & Hemato-Oncology (ICTO 2017)

Authors: Talia Golan, Michele Milella, Aliza Ackerstein, Ranaan Berger

Published in: Journal of Experimental & Clinical Cancer Research | Issue 1/2017

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Abstract

In the past decade, the oncology community has witnessed major advances in the understanding of cancer biology and major breakthroughs in several different therapeutic areas, from solid tumors to hematological malignancies; moreover, the advent of effective immunotherapy approaches, such as immune-checkpoint blockade, is revolutionizing treatment algorithms in almost all oncology disease areas. As knowledge evolves and new weapons emerge in the “war against cancer”, clinical and translational research need to adapt to a rapidly changing environment to effectively translate novel concepts into sustainable and accessible therapeutic options for cancer patients.
With this in mind, translational cancer researchers, oncology professionals, treatment experts, CRO and industry leaders, as well as patient representatives gathered in London, 16-17 March 2017, for The International Congress on Clinical Trials in Oncology and Hemato-Oncology (ICTO2017), to discuss the changing face of oncology clinical trials in the new era of personalized medicine and immuno-oncology. A wide range of topics, including clinical trial design in immuno-oncology, biomarker-oriented drug development paths, statistical design and endpoint selection, challenges in the design and conduct of personalized medicine clinical trials, risk-based monitoring, financing and reimbursement, as well as best operational practices, were discussed in an open, highly interactive format, favoring networking among all relevant stakeholders. The most relevant data, approaches and issues emerged and discussed during the conference are summarized in this report.
Literature
1.
go back to reference D'Errico G, Machado HL, Sainz B Jr. A current perspective on cancer immune therapy: step-by-step approach to constructing the magic bullet. Clin Transl Med. 2017;6(1):3.CrossRefPubMedPubMedCentral D'Errico G, Machado HL, Sainz B Jr. A current perspective on cancer immune therapy: step-by-step approach to constructing the magic bullet. Clin Transl Med. 2017;6(1):3.CrossRefPubMedPubMedCentral
3.
go back to reference Bria E, Di Maio M, Carlini P, Cuppone F, Giannarelli D, Cognetti F, Milella M. Targeting targeted agents: open issues for clinical trial design. J Exp ClinCancer Res. 2009;28:66.CrossRef Bria E, Di Maio M, Carlini P, Cuppone F, Giannarelli D, Cognetti F, Milella M. Targeting targeted agents: open issues for clinical trial design. J Exp ClinCancer Res. 2009;28:66.CrossRef
4.
go back to reference Mirnezami R, Nicholson J, Darzi A. Preparing for precision medicine. N Engl J Med. 2012;366(6):489–91.CrossRefPubMed Mirnezami R, Nicholson J, Darzi A. Preparing for precision medicine. N Engl J Med. 2012;366(6):489–91.CrossRefPubMed
5.
go back to reference Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32(1):40–51.CrossRefPubMed Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32(1):40–51.CrossRefPubMed
6.
go back to reference Jardim DL, Groves ES, Breitfeld PP, Kurzrock R. Factors associated with failure of oncology drugs in late-stage clinical development: a systematic review. Cancer Treat Rev. 2017 Jan;52:12–21.CrossRefPubMed Jardim DL, Groves ES, Breitfeld PP, Kurzrock R. Factors associated with failure of oncology drugs in late-stage clinical development: a systematic review. Cancer Treat Rev. 2017 Jan;52:12–21.CrossRefPubMed
7.
go back to reference Postel-Vinay S, Aspeslagh S, Lanoy E, Robert C, Soria JC, Marabelle A. Challenges of phase 1 clinical trials evaluating immune checkpoint-targeted antibodies. Ann Oncol. 2016;27(2):214–24.CrossRefPubMed Postel-Vinay S, Aspeslagh S, Lanoy E, Robert C, Soria JC, Marabelle A. Challenges of phase 1 clinical trials evaluating immune checkpoint-targeted antibodies. Ann Oncol. 2016;27(2):214–24.CrossRefPubMed
8.
go back to reference Theoret MR, Pai-Scherf LH, Chuk MK, Prowell TM, Balasubramaniam S, Kim T, et al. Expansion cohorts in first-in-human solid tumor oncology trials. Clin Cancer Res. 2015;21(20):4545–51.CrossRefPubMed Theoret MR, Pai-Scherf LH, Chuk MK, Prowell TM, Balasubramaniam S, Kim T, et al. Expansion cohorts in first-in-human solid tumor oncology trials. Clin Cancer Res. 2015;21(20):4545–51.CrossRefPubMed
9.
go back to reference Hunger SP, Mullighan CG. Acute lymphoblastic leukemia in children. N Engl J Med. 2015;373(16):1541–52.CrossRefPubMed Hunger SP, Mullighan CG. Acute lymphoblastic leukemia in children. N Engl J Med. 2015;373(16):1541–52.CrossRefPubMed
10.
go back to reference Lo-Coco F, Avvisati G, Vignetti M, Breccia M, Gallo E, Rambaldi A, et al. Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA group. Blood. 2010;116(17):3171–9.CrossRefPubMed Lo-Coco F, Avvisati G, Vignetti M, Breccia M, Gallo E, Rambaldi A, et al. Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA group. Blood. 2010;116(17):3171–9.CrossRefPubMed
11.
go back to reference Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, et al. Improved outcomes with retinoic acid and arsenic trioxide compared with retinoic acid and chemotherapy in non-high-risk acute Promyelocytic leukemia: final results of the randomized Italian-German APL0406 trial. J Clin Oncol. 2017;35(6):605–12.CrossRefPubMed Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, et al. Improved outcomes with retinoic acid and arsenic trioxide compared with retinoic acid and chemotherapy in non-high-risk acute Promyelocytic leukemia: final results of the randomized Italian-German APL0406 trial. J Clin Oncol. 2017;35(6):605–12.CrossRefPubMed
12.
go back to reference Diverio D, Rossi V, Avvisati G, De Santis S, Pistilli A, Pane F, et al. Early detection of relapse by prospective reverse transcriptase-polymerase chain reaction analysis of the PML/RARalpha fusion gene in patients with acute promyelocytic leukemia enrolled in the GIMEMA-AIEOP multicenter "AIDA" trial. GIMEMA-AIEOP multicenter "AIDA" trial. Blood. 1998;92(3):784–9.PubMed Diverio D, Rossi V, Avvisati G, De Santis S, Pistilli A, Pane F, et al. Early detection of relapse by prospective reverse transcriptase-polymerase chain reaction analysis of the PML/RARalpha fusion gene in patients with acute promyelocytic leukemia enrolled in the GIMEMA-AIEOP multicenter "AIDA" trial. GIMEMA-AIEOP multicenter "AIDA" trial. Blood. 1998;92(3):784–9.PubMed
13.
go back to reference Bower H, Björkholm M, Dickman PW, Höglund M, Lambert PC, Andersson TM. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the general population. J Clin Oncol. 2016;34(24):2851–7.CrossRefPubMed Bower H, Björkholm M, Dickman PW, Höglund M, Lambert PC, Andersson TM. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the general population. J Clin Oncol. 2016;34(24):2851–7.CrossRefPubMed
14.
go back to reference Rousselot P, Charbonnier A, Cony-Makhoul P, Agape P, Nicolini FE, Varet B, et al. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol. 2014;32(5):424–30.CrossRefPubMed Rousselot P, Charbonnier A, Cony-Makhoul P, Agape P, Nicolini FE, Varet B, et al. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol. 2014;32(5):424–30.CrossRefPubMed
15.
go back to reference Etienne G, Guilhot J, Rea D, Rigal-Huguet F, Nicolini F, Charbonnier A, et al. Long-term follow-up of the French stop Imatinib (STIM1) study in patients with chronic myeloid leukemia. J Clin Oncol. 2017;35(3):298–305.CrossRefPubMed Etienne G, Guilhot J, Rea D, Rigal-Huguet F, Nicolini F, Charbonnier A, et al. Long-term follow-up of the French stop Imatinib (STIM1) study in patients with chronic myeloid leukemia. J Clin Oncol. 2017;35(3):298–305.CrossRefPubMed
16.
go back to reference Chiaretti S, Vitale A, Vignetti M, Piciocchi A, Fazi P, Elia L, et al. A sequential approach with imatinib, chemotherapy and transplant for adult ph+ acute lymphoblastic leukemia: final results of the GIMEMA LAL 0904 study. Haematologica. 2016;101(12):1544–52.CrossRefPubMedPubMedCentral Chiaretti S, Vitale A, Vignetti M, Piciocchi A, Fazi P, Elia L, et al. A sequential approach with imatinib, chemotherapy and transplant for adult ph+ acute lymphoblastic leukemia: final results of the GIMEMA LAL 0904 study. Haematologica. 2016;101(12):1544–52.CrossRefPubMedPubMedCentral
17.
go back to reference Rossi D, Rasi S, Spina V, Bruscaggin A, Monti S, Ciardullo C, et al. Integrated mutational and cytogenetic analysis identifies new prognostic subgroups in chronic lymphocytic leukemia. Blood. 2013;121(8):1403–12.CrossRefPubMedPubMedCentral Rossi D, Rasi S, Spina V, Bruscaggin A, Monti S, Ciardullo C, et al. Integrated mutational and cytogenetic analysis identifies new prognostic subgroups in chronic lymphocytic leukemia. Blood. 2013;121(8):1403–12.CrossRefPubMedPubMedCentral
18.
go back to reference Tiacci E, Park JH, De Carolis L, Chung SS, Broccoli A, Scott S, et al. Targeting mutant BRAF in relapsed or refractory hairy-cell leukemia. N Engl J Med. 2015;373:1733–47.CrossRefPubMedPubMedCentral Tiacci E, Park JH, De Carolis L, Chung SS, Broccoli A, Scott S, et al. Targeting mutant BRAF in relapsed or refractory hairy-cell leukemia. N Engl J Med. 2015;373:1733–47.CrossRefPubMedPubMedCentral
19.
go back to reference Love D, Stratton E, Stocum M. Best practices for companion diagnostic and therapeutic development: translating between the stakeholders. New Biotechnol. 2012;29(6):689–94.CrossRef Love D, Stratton E, Stocum M. Best practices for companion diagnostic and therapeutic development: translating between the stakeholders. New Biotechnol. 2012;29(6):689–94.CrossRef
20.
go back to reference Dracopoli NC, Boguski MS. The evolution of oncology companion diagnostics from signal transduction to Immuno-oncology. Trends Pharmacol Sci. 2017;38(1):41–54.CrossRefPubMed Dracopoli NC, Boguski MS. The evolution of oncology companion diagnostics from signal transduction to Immuno-oncology. Trends Pharmacol Sci. 2017;38(1):41–54.CrossRefPubMed
21.
go back to reference Milne CP, Cohen JP, Chakravarthy R. Market watch: where is personalized medicine in industry heading? Nat Rev Drug Discov. 2015;14(12):812–3.CrossRefPubMed Milne CP, Cohen JP, Chakravarthy R. Market watch: where is personalized medicine in industry heading? Nat Rev Drug Discov. 2015;14(12):812–3.CrossRefPubMed
22.
go back to reference Wistuba II, Gelovani JG, Jacoby JJ, Davis SE, Herbst RS. Methodological and practical challenges for personalized cancer therapies. Nat Rev Clin Oncol. 2011 Mar;8(3):135–41.CrossRefPubMed Wistuba II, Gelovani JG, Jacoby JJ, Davis SE, Herbst RS. Methodological and practical challenges for personalized cancer therapies. Nat Rev Clin Oncol. 2011 Mar;8(3):135–41.CrossRefPubMed
23.
go back to reference Berry DA, Herbst RS, Rubin EH. Reports from the 2010 clinical and translational cancer research think tank meeting: design strategies for personalized therapy trials. Clin Cancer Res. 2012;18(3):638–44.CrossRefPubMedPubMedCentral Berry DA, Herbst RS, Rubin EH. Reports from the 2010 clinical and translational cancer research think tank meeting: design strategies for personalized therapy trials. Clin Cancer Res. 2012;18(3):638–44.CrossRefPubMedPubMedCentral
24.
go back to reference Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, et al. Lung master protocol (lung-MAP)-a biomarker-driven protocol for accelerating development of therapies for Squamous cell lung cancer: SWOG S1400. Clin Cancer Res. 2015;21(7):1514–24.CrossRefPubMedPubMedCentral Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, et al. Lung master protocol (lung-MAP)-a biomarker-driven protocol for accelerating development of therapies for Squamous cell lung cancer: SWOG S1400. Clin Cancer Res. 2015;21(7):1514–24.CrossRefPubMedPubMedCentral
25.
go back to reference Carbognin L, Pilotto S, Milella M, Vaccaro V, Brunelli M, Caliò A, et al. Differential activity of Nivolumab, Pembrolizumab and MPDL3280A according to the tumor expression of programmed death-Ligand-1 (PD-L1): sensitivity analysis of trials in melanoma, lung and genitourinary cancers. PLoS One. 2015;10(6):e0130142.CrossRefPubMedPubMedCentral Carbognin L, Pilotto S, Milella M, Vaccaro V, Brunelli M, Caliò A, et al. Differential activity of Nivolumab, Pembrolizumab and MPDL3280A according to the tumor expression of programmed death-Ligand-1 (PD-L1): sensitivity analysis of trials in melanoma, lung and genitourinary cancers. PLoS One. 2015;10(6):e0130142.CrossRefPubMedPubMedCentral
26.
go back to reference Grizzi G, Caccese M, Gkountakos A, Carbognin L, Tortora G, Bria E, et al. Putative predictors of efficacy for immune checkpoint inhibitors in non-small-cell lung cancer: facing the complexity of the immune system. Expert Rev Mol Diagn. 2017;2017:1–15. Grizzi G, Caccese M, Gkountakos A, Carbognin L, Tortora G, Bria E, et al. Putative predictors of efficacy for immune checkpoint inhibitors in non-small-cell lung cancer: facing the complexity of the immune system. Expert Rev Mol Diagn. 2017;2017:1–15.
27.
go back to reference Cowley MJ, Chang DK, Pajic M, Johns AL, Waddell N, Grimmond SM, et al. Understanding pancreatic cancer genomes. J Hepatobiliary Pancreat Sci. 2013;20(6):549–56.CrossRefPubMed Cowley MJ, Chang DK, Pajic M, Johns AL, Waddell N, Grimmond SM, et al. Understanding pancreatic cancer genomes. J Hepatobiliary Pancreat Sci. 2013;20(6):549–56.CrossRefPubMed
28.
29.
go back to reference Goetz L, Bethel K, Topol EJ. Rebooting cancer tissue handling in the sequencing era: toward routine use of frozen tumor tissue. JAMA. 2013;309(1):37–8.CrossRefPubMed Goetz L, Bethel K, Topol EJ. Rebooting cancer tissue handling in the sequencing era: toward routine use of frozen tumor tissue. JAMA. 2013;309(1):37–8.CrossRefPubMed
30.
go back to reference Bria E, Pilotto S, Amato E, Fassan M, Novello S, Peretti U, et al. Molecular heterogeneity assessment by next-generation sequencing and response to gefitinib of EGFR mutant advanced lung adenocarcinoma. Oncotarget. 2015;6(14):12783–95.CrossRefPubMedPubMedCentral Bria E, Pilotto S, Amato E, Fassan M, Novello S, Peretti U, et al. Molecular heterogeneity assessment by next-generation sequencing and response to gefitinib of EGFR mutant advanced lung adenocarcinoma. Oncotarget. 2015;6(14):12783–95.CrossRefPubMedPubMedCentral
31.
go back to reference Mafficini A, Simbolo M, Parisi A, Rusev B, Luchini C, Cataldo I, et al. BRCA somatic and germline mutation detection in paraffin embedded ovarian cancers by next-generation sequencing. Oncotarget. 2016;7(2):1076–83.CrossRefPubMedPubMedCentral Mafficini A, Simbolo M, Parisi A, Rusev B, Luchini C, Cataldo I, et al. BRCA somatic and germline mutation detection in paraffin embedded ovarian cancers by next-generation sequencing. Oncotarget. 2016;7(2):1076–83.CrossRefPubMedPubMedCentral
32.
go back to reference Waddell N, Pajic M, Patch AM, Chang DK, Kassahn KS, Bailey P, Johns AL, et al. Whole genomes redefine the mutational landscape of pancreatic cancer. Nature. 2015;518(7540):495–501.CrossRefPubMedPubMedCentral Waddell N, Pajic M, Patch AM, Chang DK, Kassahn KS, Bailey P, Johns AL, et al. Whole genomes redefine the mutational landscape of pancreatic cancer. Nature. 2015;518(7540):495–501.CrossRefPubMedPubMedCentral
33.
go back to reference Bailey P, Chang DK, Nones K, Johns AL, Patch AM, Gingras MC, et al. Genomic analyses identify molecular subtypes of pancreatic cancer. Nature. 2016;531(7592):47–52.CrossRefPubMed Bailey P, Chang DK, Nones K, Johns AL, Patch AM, Gingras MC, et al. Genomic analyses identify molecular subtypes of pancreatic cancer. Nature. 2016;531(7592):47–52.CrossRefPubMed
34.
go back to reference Moorcraft SY, Marriott C, Peckitt C, Cunningham D, Chau I, Starling N, et al. Patients' willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials. 2016;17:17.CrossRefPubMedPubMedCentral Moorcraft SY, Marriott C, Peckitt C, Cunningham D, Chau I, Starling N, et al. Patients' willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials. 2016;17:17.CrossRefPubMedPubMedCentral
35.
go back to reference Kao CY, Aranda S, Krishnasamy M, Hamilton B. Interventions to improve patient understanding of cancer clinical trial participation: a systematic review. Eur J Cancer Care (Engl). 2017;26:2.CrossRef Kao CY, Aranda S, Krishnasamy M, Hamilton B. Interventions to improve patient understanding of cancer clinical trial participation: a systematic review. Eur J Cancer Care (Engl). 2017;26:2.CrossRef
36.
go back to reference Han G, Schell MJ, Zhang H, Zelterman D, Pusztai L, Adelson K, et al. Testing violations of the exponential assumption in cancer clinical trials with survival endpoints. Biometrics. 2017;73(2):687–95.CrossRefPubMed Han G, Schell MJ, Zhang H, Zelterman D, Pusztai L, Adelson K, et al. Testing violations of the exponential assumption in cancer clinical trials with survival endpoints. Biometrics. 2017;73(2):687–95.CrossRefPubMed
37.
go back to reference Wilson MK, Karakasis K, Oza AM. Outcomes and endpoints in trials of cancer treatment: the past, present, and future. Lancet Oncol. 2015;16(1):e32–42.CrossRefPubMed Wilson MK, Karakasis K, Oza AM. Outcomes and endpoints in trials of cancer treatment: the past, present, and future. Lancet Oncol. 2015;16(1):e32–42.CrossRefPubMed
38.
go back to reference Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010;28(11):1958–62.CrossRefPubMed Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010;28(11):1958–62.CrossRefPubMed
39.
go back to reference Hotta K, Suzuki E, Di Maio M, Chiodini P, Fujiwara Y, Takigawa N, et al. Progression-free survival and overall survival in phase III trials of molecular-targeted agents in advanced non-small-cell lung cancer. Lung Cancer. 2013;79(1):20–6.CrossRefPubMed Hotta K, Suzuki E, Di Maio M, Chiodini P, Fujiwara Y, Takigawa N, et al. Progression-free survival and overall survival in phase III trials of molecular-targeted agents in advanced non-small-cell lung cancer. Lung Cancer. 2013;79(1):20–6.CrossRefPubMed
40.
go back to reference Wilson MK, Collyar D, Chingos DT, Friedlander M, Ho TW, Karakasis K, et al. Outcomes and endpoints in cancer trials: bridging the divide. Lancet Oncol. 2015;16(1):e43–52.CrossRefPubMed Wilson MK, Collyar D, Chingos DT, Friedlander M, Ho TW, Karakasis K, et al. Outcomes and endpoints in cancer trials: bridging the divide. Lancet Oncol. 2015;16(1):e43–52.CrossRefPubMed
41.
go back to reference Mick R, Chen T-T. Statistical Challenges in the Design of Late-Stage Cancer Immunotherapy Studies.Cancer Immunol Res. 2015;3(12):1292–8. Mick R, Chen T-T. Statistical Challenges in the Design of Late-Stage Cancer Immunotherapy Studies.Cancer Immunol Res. 2015;3(12):1292–8.
44.
go back to reference Cuffe RL, Lawrence D, Stone A, Vandemeulebroecke M. When is a seamless study desirable? Case studies from different pharmaceutical sponsors. Pharm Stat. 2014;13(4):229–37.CrossRefPubMed Cuffe RL, Lawrence D, Stone A, Vandemeulebroecke M. When is a seamless study desirable? Case studies from different pharmaceutical sponsors. Pharm Stat. 2014;13(4):229–37.CrossRefPubMed
45.
go back to reference Jenkins M, Stone A, Jennison C. An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints. Pharm Stat. 2011;10(4):347–56.CrossRefPubMed Jenkins M, Stone A, Jennison C. An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints. Pharm Stat. 2011;10(4):347–56.CrossRefPubMed
46.
go back to reference Denne JS, Stone AM, Bailey-Iacona R, Chen TT. Missing data and censoring in the analysis of progression-free survival in oncology clinical trials. J Biopharm Stat. 2013;23(5):951–46.CrossRefPubMed Denne JS, Stone AM, Bailey-Iacona R, Chen TT. Missing data and censoring in the analysis of progression-free survival in oncology clinical trials. J Biopharm Stat. 2013;23(5):951–46.CrossRefPubMed
47.
go back to reference Robinson DR, Wu YM, Lonigro RJ, Vats P, Cobain E, Everett J, et al. Integrative clinical genomics of metastatic cancer. Nature. 2017;548(7667):297–303.CrossRefPubMed Robinson DR, Wu YM, Lonigro RJ, Vats P, Cobain E, Everett J, et al. Integrative clinical genomics of metastatic cancer. Nature. 2017;548(7667):297–303.CrossRefPubMed
48.
go back to reference Mody RJ, Wu YM, Lonigro RJ, Cao X, Roychowdhury S, Vats P, et al. Integrative clinical sequencing in the Management of Refractory or relapsed cancer in youth. JAMA. 2015;314(9):913–25.CrossRefPubMedPubMedCentral Mody RJ, Wu YM, Lonigro RJ, Cao X, Roychowdhury S, Vats P, et al. Integrative clinical sequencing in the Management of Refractory or relapsed cancer in youth. JAMA. 2015;314(9):913–25.CrossRefPubMedPubMedCentral
49.
go back to reference Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov. 2011;1(1):44–53.CrossRefPubMedPubMedCentral Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov. 2011;1(1):44–53.CrossRefPubMedPubMedCentral
50.
go back to reference Chouaid C, Dujon C, Do P, Monnet I, Madroszyk A, Le Caer H, et al. Feasibility and clinical impact of re-biopsy in advanced non small-cell lung cancer: a prospective multicenter study in a real-world setting (GFPC study 12-01). Lung Cancer. 2014;86(2):170–3.CrossRefPubMed Chouaid C, Dujon C, Do P, Monnet I, Madroszyk A, Le Caer H, et al. Feasibility and clinical impact of re-biopsy in advanced non small-cell lung cancer: a prospective multicenter study in a real-world setting (GFPC study 12-01). Lung Cancer. 2014;86(2):170–3.CrossRefPubMed
51.
go back to reference Simon R, Roychowdhury S. Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov. 2013;12:358–69.CrossRefPubMed Simon R, Roychowdhury S. Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov. 2013;12:358–69.CrossRefPubMed
52.
go back to reference Sweis RF, Drazer MW, Ratain MJ. Analysis of impact of post-treatment biopsies in phase I clinical trials. J Clin Oncol. 2016;34(4):369–74.CrossRefPubMed Sweis RF, Drazer MW, Ratain MJ. Analysis of impact of post-treatment biopsies in phase I clinical trials. J Clin Oncol. 2016;34(4):369–74.CrossRefPubMed
53.
go back to reference Kummar S, Kinders R, Rubinstein L, Parchment RE, Murgo AJ, Collins J, et al. Compressing drug development timelines in oncology using phase '0′ trials. Nat Rev Cancer. 2007;7(2):131–9.CrossRefPubMed Kummar S, Kinders R, Rubinstein L, Parchment RE, Murgo AJ, Collins J, et al. Compressing drug development timelines in oncology using phase '0′ trials. Nat Rev Cancer. 2007;7(2):131–9.CrossRefPubMed
54.
go back to reference Agulnik M, Oza AM, Pond GR, Siu LL. Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents. J Clin Oncol. 2006;24(30):4801–7.CrossRefPubMed Agulnik M, Oza AM, Pond GR, Siu LL. Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents. J Clin Oncol. 2006;24(30):4801–7.CrossRefPubMed
56.
go back to reference Siravegna G, Bardelli A. Blood circulating tumor DNA for non-invasive genotyping of colon cancer patients. Mol Oncol. 2016;10(3):475–80.CrossRefPubMed Siravegna G, Bardelli A. Blood circulating tumor DNA for non-invasive genotyping of colon cancer patients. Mol Oncol. 2016;10(3):475–80.CrossRefPubMed
57.
go back to reference Arena S, Bellosillo B, Siravegna G, Martínez A, Cañadas I, Lazzari L, et al. Emergence of multiple EGFR extracellular mutations during Cetuximab treatment in colorectal cancer. Clin Cancer Res. 2015;21(9):2157–66.CrossRefPubMed Arena S, Bellosillo B, Siravegna G, Martínez A, Cañadas I, Lazzari L, et al. Emergence of multiple EGFR extracellular mutations during Cetuximab treatment in colorectal cancer. Clin Cancer Res. 2015;21(9):2157–66.CrossRefPubMed
58.
go back to reference Siravegna G, Mussolin B, Buscarino M, Corti G, Cassingena A, Crisafulli G, et al. Clonal evolution and resistance to EGFR blockade in the blood of colorectal cancer patients. Nat Med. 2015;21(7):827.CrossRefPubMed Siravegna G, Mussolin B, Buscarino M, Corti G, Cassingena A, Crisafulli G, et al. Clonal evolution and resistance to EGFR blockade in the blood of colorectal cancer patients. Nat Med. 2015;21(7):827.CrossRefPubMed
59.
go back to reference Russo M, Siravegna G, Blaszkowsky LS, Corti G, Crisafulli G, Ahronian LG, et al. Tumor heterogeneity and lesion-specific response to targeted therapy in colorectal cancer. Cancer Discov. 2016;6(2):147–53.CrossRefPubMed Russo M, Siravegna G, Blaszkowsky LS, Corti G, Crisafulli G, Ahronian LG, et al. Tumor heterogeneity and lesion-specific response to targeted therapy in colorectal cancer. Cancer Discov. 2016;6(2):147–53.CrossRefPubMed
60.
go back to reference Siravegna G, Marsoni S, Siena S, Bardelli A. Integrating liquid biopsies into the management of cancer. Nat Rev Clin Oncol. 2017;14(9):531–48.CrossRefPubMed Siravegna G, Marsoni S, Siena S, Bardelli A. Integrating liquid biopsies into the management of cancer. Nat Rev Clin Oncol. 2017;14(9):531–48.CrossRefPubMed
61.
go back to reference Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92(3):205–16.CrossRefPubMed Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92(3):205–16.CrossRefPubMed
62.
go back to reference Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–47.CrossRefPubMed Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–47.CrossRefPubMed
63.
go back to reference Schwartz LH, Seymour L, Litière S, Ford R, Gwyther S, Mandrekar S, et al. RECIST 1.1 - standardisation and disease-specific adaptations: perspectives from the RECIST working group. Eur J Cancer. 2016;62:138–45.CrossRefPubMedPubMedCentral Schwartz LH, Seymour L, Litière S, Ford R, Gwyther S, Mandrekar S, et al. RECIST 1.1 - standardisation and disease-specific adaptations: perspectives from the RECIST working group. Eur J Cancer. 2016;62:138–45.CrossRefPubMedPubMedCentral
64.
go back to reference Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017;18(3):e143–52.CrossRefPubMedPubMedCentral Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017;18(3):e143–52.CrossRefPubMedPubMedCentral
65.
go back to reference Macefield RC, Beswick AD, Blazeby JM, Lane JA. A systematic review of on-site monitoring methods for health-care randomised controlled trials. Clin Trials. 2013;10(1):104–24.CrossRefPubMed Macefield RC, Beswick AD, Blazeby JM, Lane JA. A systematic review of on-site monitoring methods for health-care randomised controlled trials. Clin Trials. 2013;10(1):104–24.CrossRefPubMed
66.
go back to reference Oba K. Statistical challenges for central monitoring in clinical trials: a review. Int J Clin Oncol. 2016;21(1):28–37.CrossRefPubMed Oba K. Statistical challenges for central monitoring in clinical trials: a review. Int J Clin Oncol. 2016;21(1):28–37.CrossRefPubMed
67.
go back to reference Olsen R, Bihlet AR, Kalakou F, Andersen JR. The impact of clinical trial monitoring approaches on data integrity and cost--a review of current literature. Eur J Clin Pharmacol. 2016;72(4):399–412.CrossRefPubMed Olsen R, Bihlet AR, Kalakou F, Andersen JR. The impact of clinical trial monitoring approaches on data integrity and cost--a review of current literature. Eur J Clin Pharmacol. 2016;72(4):399–412.CrossRefPubMed
68.
go back to reference Rolfo C, Caglevic C, Bretel D, Hong D, Raez LE, Cardona AF, et al. Cancer clinical research in Latin America: current situation and opportunities. Expert opinion from the first ESMO workshop on clinical trials, lima, 2015. ESMO Open. 2016;1(4):e000055.CrossRefPubMedPubMedCentral Rolfo C, Caglevic C, Bretel D, Hong D, Raez LE, Cardona AF, et al. Cancer clinical research in Latin America: current situation and opportunities. Expert opinion from the first ESMO workshop on clinical trials, lima, 2015. ESMO Open. 2016;1(4):e000055.CrossRefPubMedPubMedCentral
70.
go back to reference Ansmann EB, Hecht A, Henn DK, Leptien S, Stelzer HG. The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles. Ger Med Sci. 2013;11:Doc04.PubMedPubMedCentral Ansmann EB, Hecht A, Henn DK, Leptien S, Stelzer HG. The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles. Ger Med Sci. 2013;11:Doc04.PubMedPubMedCentral
Metadata
Title
The changing face of clinical trials in the personalized medicine and immuno-oncology era: report from the international congress on clinical trials in Oncology & Hemato-Oncology (ICTO 2017)
Authors
Talia Golan
Michele Milella
Aliza Ackerstein
Ranaan Berger
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Journal of Experimental & Clinical Cancer Research / Issue 1/2017
Electronic ISSN: 1756-9966
DOI
https://doi.org/10.1186/s13046-017-0668-0

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