Skip to main content
Top
Published in: Supportive Care in Cancer 1/2013

01-01-2013 | Special Article

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

Authors: Judith E. Raber-Durlacher, Inger von Bültzingslöwen, Richard M. Logan, Joanne Bowen, Abdul Rahman Al-Azri, Hele Everaus, Erich Gerber, Jesùs Garcia Gomez, Bo G. Pettersson, Yoshihiko Soga, Fred K. L. Spijkervet, Wim J. E. Tissing, Joel B. Epstein, Sharon Elad, Rajesh V. Lalla, For the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO)

Published in: Supportive Care in Cancer | Issue 1/2013

Login to get access

Abstract

Purpose

The aim of this project was to review the literature and define clinical practice guidelines for the use of cytokines and growth factor agents for the prevention or treatment of oral mucositis induced by cancer chemotherapy or radiotherapy.

Methods

A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO). The body of evidence for each intervention, in each cancer treatment setting, was assigned an evidence level. Based on the evidence level, one of the following three guideline determinations was possible: Recommendation, Suggestion, No guideline possible.

Results

Sixty-four clinical studies across 11 interventions were evaluated. A recommendation was made for the use of recombinant human KGF-1 (palifermin) at a dose of 60 μg/kg per day for 3 days prior to conditioning treatment and for 3 days post-transplant for prevention of oral mucositis in patients receiving high-dose chemotherapy and total body irradiation followed by autologous stem cell transplantation for hematological malignancies. A suggestion was made against using granulocyte macrophage colony-stimulating factor mouthwash for the prevention of oral mucositis in the setting of high-dose chemotherapy followed by autologous or allogeneic stem cell transplantation. No guideline was possible for any other cytokine or growth factor agents due to inconclusive evidence.

Conclusions

Of the cytokine and growth factor agents studied for oral mucositis, the evidence only supports use of palifermin in the specific population listed above. Additional well-designed research is needed on other cytokine and growth factor interventions and in other cancer treatment settings.
Literature
1.
go back to reference Logan RM, Stringer AM, Bowen JM, Yeoh AS, Gibson RJ, Sonis ST, Keefe DM (2007) The role of pro-inflammatory cytokines in cancer treatment-induced alimentary tract mucositis: pathobiology, animal models and cytotoxic drugs. Cancer Treat Rev 33(5):448–460PubMedCrossRef Logan RM, Stringer AM, Bowen JM, Yeoh AS, Gibson RJ, Sonis ST, Keefe DM (2007) The role of pro-inflammatory cytokines in cancer treatment-induced alimentary tract mucositis: pathobiology, animal models and cytotoxic drugs. Cancer Treat Rev 33(5):448–460PubMedCrossRef
2.
go back to reference Farrell CL, Rex KL, Chen JN, Bready JV, DiPalma CR, Kaufman SA, Rattan A, Scully S, Lacey DL (2002) The effects of keratinocyte growth factor in preclinical models of mucositis. Cell Prolif 35(Suppl 1):78–85PubMedCrossRef Farrell CL, Rex KL, Chen JN, Bready JV, DiPalma CR, Kaufman SA, Rattan A, Scully S, Lacey DL (2002) The effects of keratinocyte growth factor in preclinical models of mucositis. Cell Prolif 35(Suppl 1):78–85PubMedCrossRef
3.
go back to reference Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB (2004) Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer 100(9 Suppl):1995–2025PubMedCrossRef Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB (2004) Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer 100(9 Suppl):1995–2025PubMedCrossRef
5.
go back to reference Krijanovski OI, Hill GR, Cooke KR, Teshima T, Crawford JM, Brinson YS, Ferrara JL (1999) Keratinocyte growth factor separates graft-versus-leukemia effects from graft-versus-host disease. Blood 94(2):825–831PubMed Krijanovski OI, Hill GR, Cooke KR, Teshima T, Crawford JM, Brinson YS, Ferrara JL (1999) Keratinocyte growth factor separates graft-versus-leukemia effects from graft-versus-host disease. Blood 94(2):825–831PubMed
6.
go back to reference Panoskaltsis-Mortari A, Lacey DL, Vallera DA, Blazar BR (1998) Keratinocyte growth factor administered before conditioning ameliorates graft-versus-host disease after allogeneic bone marrow transplantation in mice. Blood 92(10):3960–3967PubMed Panoskaltsis-Mortari A, Lacey DL, Vallera DA, Blazar BR (1998) Keratinocyte growth factor administered before conditioning ameliorates graft-versus-host disease after allogeneic bone marrow transplantation in mice. Blood 92(10):3960–3967PubMed
7.
go back to reference Seggewiss R, Lore K, Guenaga FJ, Pittaluga S, Mattapallil J, Chow CK, Koup RA, Camphausen K, Nason MC, Meier-Schellersheim M, Donahue RE, Blazar BR, Dunbar CE, Douek DC (2007) Keratinocyte growth factor augments immune reconstitution after autologous hematopoietic progenitor cell transplantation in rhesus macaques. Blood 110(1):441–449PubMedCrossRef Seggewiss R, Lore K, Guenaga FJ, Pittaluga S, Mattapallil J, Chow CK, Koup RA, Camphausen K, Nason MC, Meier-Schellersheim M, Donahue RE, Blazar BR, Dunbar CE, Douek DC (2007) Keratinocyte growth factor augments immune reconstitution after autologous hematopoietic progenitor cell transplantation in rhesus macaques. Blood 110(1):441–449PubMedCrossRef
8.
go back to reference Schuster MW, Shore TB, Harpel JG, Greenberg J, Jalilizeinali B, Possley S, Gerwien RW, Hahne W, Halvorsen YD (2008) Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant. Support Care Cancer 16(5):477–483PubMedCrossRef Schuster MW, Shore TB, Harpel JG, Greenberg J, Jalilizeinali B, Possley S, Gerwien RW, Hahne W, Halvorsen YD (2008) Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant. Support Care Cancer 16(5):477–483PubMedCrossRef
9.
go back to reference Freytes CO, Ratanatharathorn V, Taylor C, Abboud C, Chesser N, Restrepo A, Arango J, Odenheimer D (2004) Phase I/II randomized trial evaluating the safety and clinical effects of repifermin administered to reduce mucositis in patients undergoing autologous hematopoietic stem cell transplantation. Clin Cancer Res 10(24):8318–8324PubMedCrossRef Freytes CO, Ratanatharathorn V, Taylor C, Abboud C, Chesser N, Restrepo A, Arango J, Odenheimer D (2004) Phase I/II randomized trial evaluating the safety and clinical effects of repifermin administered to reduce mucositis in patients undergoing autologous hematopoietic stem cell transplantation. Clin Cancer Res 10(24):8318–8324PubMedCrossRef
10.
go back to reference Jyung RW, Wu L, Pierce GF, Mustoe TA (1994) Granulocyte-macrophage colony-stimulating factor and granulocyte colony-stimulating factor: differential action on incisional wound healing. Surgery 115(3):325–334PubMed Jyung RW, Wu L, Pierce GF, Mustoe TA (1994) Granulocyte-macrophage colony-stimulating factor and granulocyte colony-stimulating factor: differential action on incisional wound healing. Surgery 115(3):325–334PubMed
11.
go back to reference Noguchi S, Ohba Y, Oka T (1991) Effect of salivary epidermal growth factor on wound healing of tongue in mice. Am J Physiol 260(4):E620–E625PubMed Noguchi S, Ohba Y, Oka T (1991) Effect of salivary epidermal growth factor on wound healing of tongue in mice. Am J Physiol 260(4):E620–E625PubMed
12.
go back to reference Epstein JB, Emerton S, Guglietta A, Le N (1997) Assessment of epidermal growth factor in oral secretions of patients receiving radiation therapy for cancer. Oral Oncol 33(5):359–363PubMedCrossRef Epstein JB, Emerton S, Guglietta A, Le N (1997) Assessment of epidermal growth factor in oral secretions of patients receiving radiation therapy for cancer. Oral Oncol 33(5):359–363PubMedCrossRef
13.
go back to reference Epstein JB, Gorsky M, Guglietta A, Le N, Sonis ST (2000) The correlation between epidermal growth factor levels in saliva and the severity of oral mucositis during oropharyngeal radiation therapy. Cancer 89(11):2258–2265PubMedCrossRef Epstein JB, Gorsky M, Guglietta A, Le N, Sonis ST (2000) The correlation between epidermal growth factor levels in saliva and the severity of oral mucositis during oropharyngeal radiation therapy. Cancer 89(11):2258–2265PubMedCrossRef
14.
go back to reference Sonis ST, Van Vugt AG, Brien JP, Muska AD, Bruskin AM, Rose A, Haley JD (1997) Transforming growth factor-beta 3 mediated modulation of cell cycling and attenuation of 5-fluorouracil induced oral mucositis. Oral Oncol 33(1):47–54PubMedCrossRef Sonis ST, Van Vugt AG, Brien JP, Muska AD, Bruskin AM, Rose A, Haley JD (1997) Transforming growth factor-beta 3 mediated modulation of cell cycling and attenuation of 5-fluorouracil induced oral mucositis. Oral Oncol 33(1):47–54PubMedCrossRef
15.
go back to reference Taylor VL, Goddard C, Read LC (2001) A milk growth factor extract reduces chemotherapeutic drug toxicity in epithelial cells in vitro. In Vitro Cell Dev Biol Anim 37(5):310–318PubMed Taylor VL, Goddard C, Read LC (2001) A milk growth factor extract reduces chemotherapeutic drug toxicity in epithelial cells in vitro. In Vitro Cell Dev Biol Anim 37(5):310–318PubMed
16.
go back to reference Orazi A, Du X, Yang Z, Kashai M, Williams DA (1996) Interleukin-11 prevents apoptosis and accelerates recovery of small intestinal mucosa in mice treated with combined chemotherapy and radiation. Lab Invest 75(1):33–42PubMed Orazi A, Du X, Yang Z, Kashai M, Williams DA (1996) Interleukin-11 prevents apoptosis and accelerates recovery of small intestinal mucosa in mice treated with combined chemotherapy and radiation. Lab Invest 75(1):33–42PubMed
17.
go back to reference Sonis ST, Peterson RL, Edwards LJ, Lucey CA, Wang L, Mason L, Login G, Ymamkawa M, Moses G, Bouchard P, Hayes LL, Bedrosian C, Dorner AJ (2000) Defining mechanisms of action of interleukin-11 on the progression of radiation-induced oral mucositis in hamsters. Oral Oncol 36(4):373–381PubMedCrossRef Sonis ST, Peterson RL, Edwards LJ, Lucey CA, Wang L, Mason L, Login G, Ymamkawa M, Moses G, Bouchard P, Hayes LL, Bedrosian C, Dorner AJ (2000) Defining mechanisms of action of interleukin-11 on the progression of radiation-induced oral mucositis in hamsters. Oral Oncol 36(4):373–381PubMedCrossRef
18.
go back to reference Linderoth A, Biernat M, Prykhodko O, Kornilovska I, Pusztai A, Pierzynowski SG, Bjorn WR (2005) Induced growth and maturation of the gastrointestinal tract after Phaseolus vulgaris lectin exposure in suckling rats. J Pediatr Gastroenterol Nutr 41(2):195–203PubMedCrossRef Linderoth A, Biernat M, Prykhodko O, Kornilovska I, Pusztai A, Pierzynowski SG, Bjorn WR (2005) Induced growth and maturation of the gastrointestinal tract after Phaseolus vulgaris lectin exposure in suckling rats. J Pediatr Gastroenterol Nutr 41(2):195–203PubMedCrossRef
19.
go back to reference Kjellev S (2009) The trefoil factor family—small peptides with multiple functionalities. Cell Mol Life Sci 66(8):1350–1369PubMedCrossRef Kjellev S (2009) The trefoil factor family—small peptides with multiple functionalities. Cell Mol Life Sci 66(8):1350–1369PubMedCrossRef
20.
go back to reference von Bultzingslowen I, Brennan MT, Spijkervet FK, Logan R, Stringer A, Raber-Durlacher JE, Keefe D (2006) Growth factors and cytokines in the prevention and treatment of oral and gastrointestinal mucositis. Support Care Cancer 14(6):519–527CrossRef von Bultzingslowen I, Brennan MT, Spijkervet FK, Logan R, Stringer A, Raber-Durlacher JE, Keefe D (2006) Growth factors and cytokines in the prevention and treatment of oral and gastrointestinal mucositis. Support Care Cancer 14(6):519–527CrossRef
21.
go back to reference Keefe DM, Schubert MM, Elting LS, Sonis ST, Epstein JB, Raber-Durlacher JE, Migliorati CA, McGuire DB, Hutchins RD, Peterson DE (2007) Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer 109(5):820–831PubMedCrossRef Keefe DM, Schubert MM, Elting LS, Sonis ST, Epstein JB, Raber-Durlacher JE, Migliorati CA, McGuire DB, Hutchins RD, Peterson DE (2007) Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer 109(5):820–831PubMedCrossRef
22.
go back to reference Bowen JM, Elad S, Hutchins RD, Lalla RV (2012) Methodology for the MASCC/ISOO Mucositis Clinical Practice Guidelines Update. Supportive Care in Cancer (in press) Bowen JM, Elad S, Hutchins RD, Lalla RV (2012) Methodology for the MASCC/ISOO Mucositis Clinical Practice Guidelines Update. Supportive Care in Cancer (in press)
23.
go back to reference Elad S, Bowen JM, Zadik Y, Lalla RV (2012) Development of the MASCC/ISOO Mucositis Guidelines: Considerations Underlying the Process. Supportive Care in Cancer (in press) Elad S, Bowen JM, Zadik Y, Lalla RV (2012) Development of the MASCC/ISOO Mucositis Guidelines: Considerations Underlying the Process. Supportive Care in Cancer (in press)
24.
go back to reference Somerfield MR, Einhaus K, Hagerty KL, Brouwers MC, Seidenfeld J, Lyman GH (2008) American Society of Clinical Oncology clinical practice guidelines: opportunities and challenges. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 26(24):4022–4026CrossRef Somerfield MR, Einhaus K, Hagerty KL, Brouwers MC, Seidenfeld J, Lyman GH (2008) American Society of Clinical Oncology clinical practice guidelines: opportunities and challenges. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 26(24):4022–4026CrossRef
25.
go back to reference Hadorn DC, Baker D, Hodges JS, Hicks N (1996) Rating the quality of evidence for clinical practice guidelines. J Clin Epidemiol 49(7):749–754PubMedCrossRef Hadorn DC, Baker D, Hodges JS, Hicks N (1996) Rating the quality of evidence for clinical practice guidelines. J Clin Epidemiol 49(7):749–754PubMedCrossRef
26.
go back to reference Spielberger R, Stiff P, Bensinger W, Gentile T, Weisdorf D, Kewalramani T, Shea T, Yanovich S, Hansen K, Noga S, McCarty J, LeMaistre CF, Sung EC, Blazar BR, Elhardt D, Chen MG, Emmanouilides C (2004) Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med 351(25):2590–2598PubMedCrossRef Spielberger R, Stiff P, Bensinger W, Gentile T, Weisdorf D, Kewalramani T, Shea T, Yanovich S, Hansen K, Noga S, McCarty J, LeMaistre CF, Sung EC, Blazar BR, Elhardt D, Chen MG, Emmanouilides C (2004) Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med 351(25):2590–2598PubMedCrossRef
27.
go back to reference Stiff PJ, Emmanouilides C, Bensinger WI, Gentile T, Blazar B, Shea TC, Lu J, Isitt J, Cesano A, Spielberger R (2006) Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 24(33):5186–5193CrossRef Stiff PJ, Emmanouilides C, Bensinger WI, Gentile T, Blazar B, Shea TC, Lu J, Isitt J, Cesano A, Spielberger R (2006) Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 24(33):5186–5193CrossRef
28.
go back to reference Nasilowska-Adamska B, Rzepecki P, Manko J, Czyz A, Markiewicz M, Federowicz I, Tomaszewska A, Piatkowska-Jakubas B, Wrzesien-Kus A, Bieniaszewska M, Duda D, Szydlo R, Halaburda K, Szczepinski A, Lange A, Hellman A, Robak T, Skotnicki A, Jedrzejczak WW, Walewski J, Holowiecki J, Komarnicki M, Dmoszynska A, Warzocha K, Marianska B (2007) The influence of palifermin (Kepivance) on oral mucositis and acute graft versus host disease in patients with hematological diseases undergoing hematopoietic stem cell transplant. Bone Marrow Transplant 40(10):983–988PubMedCrossRef Nasilowska-Adamska B, Rzepecki P, Manko J, Czyz A, Markiewicz M, Federowicz I, Tomaszewska A, Piatkowska-Jakubas B, Wrzesien-Kus A, Bieniaszewska M, Duda D, Szydlo R, Halaburda K, Szczepinski A, Lange A, Hellman A, Robak T, Skotnicki A, Jedrzejczak WW, Walewski J, Holowiecki J, Komarnicki M, Dmoszynska A, Warzocha K, Marianska B (2007) The influence of palifermin (Kepivance) on oral mucositis and acute graft versus host disease in patients with hematological diseases undergoing hematopoietic stem cell transplant. Bone Marrow Transplant 40(10):983–988PubMedCrossRef
29.
go back to reference Keefe D, Lees J, Horvath N (2006) Palifermin for oral mucositis in the high-dose chemotherapy and stem cell transplant setting: the Royal Adelaide Hospital Cancer Centre experience. Support Care Cancer 14(6):580–582PubMedCrossRef Keefe D, Lees J, Horvath N (2006) Palifermin for oral mucositis in the high-dose chemotherapy and stem cell transplant setting: the Royal Adelaide Hospital Cancer Centre experience. Support Care Cancer 14(6):580–582PubMedCrossRef
30.
go back to reference Tsirigotis P, Triantafyllou K, Girkas K, Giannopoulou V, Ioannidou E, Chondropoulos S, Kalli T, Papaxoinis G, Pappa V, Papageorgiou E, Economopoulos T, Ladas SD, Dervenoulas J (2008) Keratinocyte growth factor is effective in the prevention of intestinal mucositis in patients with hematological malignancies treated with high-dose chemotherapy and autologous hematopoietic SCT: a video-capsule endoscopy study. Bone Marrow Transplant 42(5):337–343PubMedCrossRef Tsirigotis P, Triantafyllou K, Girkas K, Giannopoulou V, Ioannidou E, Chondropoulos S, Kalli T, Papaxoinis G, Pappa V, Papageorgiou E, Economopoulos T, Ladas SD, Dervenoulas J (2008) Keratinocyte growth factor is effective in the prevention of intestinal mucositis in patients with hematological malignancies treated with high-dose chemotherapy and autologous hematopoietic SCT: a video-capsule endoscopy study. Bone Marrow Transplant 42(5):337–343PubMedCrossRef
31.
go back to reference Horsley P, Bauer JD, Mazkowiack R, Gardner R, Bashford J (2007) Palifermin improves severe mucositis, swallowing problems, nutrition impact symptoms, and length of stay in patients undergoing hematopoietic stem cell transplantation. Support Care Cancer 15(1):105–109PubMedCrossRef Horsley P, Bauer JD, Mazkowiack R, Gardner R, Bashford J (2007) Palifermin improves severe mucositis, swallowing problems, nutrition impact symptoms, and length of stay in patients undergoing hematopoietic stem cell transplantation. Support Care Cancer 15(1):105–109PubMedCrossRef
32.
go back to reference Johansson JE, Hasseus B, Johansson P, Eklof C, Ohman D, Stockelberg D (2009) Gut protection by palifermin during autologous haematopoietic SCT. Bone Marrow Transplant 43(10):807–811PubMedCrossRef Johansson JE, Hasseus B, Johansson P, Eklof C, Ohman D, Stockelberg D (2009) Gut protection by palifermin during autologous haematopoietic SCT. Bone Marrow Transplant 43(10):807–811PubMedCrossRef
33.
go back to reference Verhagen MP, Wondergem MJ, Visser O (2009) Palifermin dose should be adjusted to different therapy regimens. Bone Marrow Transplant 43(8):665PubMedCrossRef Verhagen MP, Wondergem MJ, Visser O (2009) Palifermin dose should be adjusted to different therapy regimens. Bone Marrow Transplant 43(8):665PubMedCrossRef
34.
go back to reference Kobbe G, Bruns I, Schroeder T, Czibere A, Warnecke J, Hieronimus N, Safaian N, Kondakci M, Saure C, Germing U, Haas R, Fenk R (2010) A 3-day short course of palifermin before HDT reduces toxicity and need for supportive care after autologous blood stem-cell transplantation in patients with multiple myeloma. Ann Oncol 21(9):1898–1904PubMedCrossRef Kobbe G, Bruns I, Schroeder T, Czibere A, Warnecke J, Hieronimus N, Safaian N, Kondakci M, Saure C, Germing U, Haas R, Fenk R (2010) A 3-day short course of palifermin before HDT reduces toxicity and need for supportive care after autologous blood stem-cell transplantation in patients with multiple myeloma. Ann Oncol 21(9):1898–1904PubMedCrossRef
35.
go back to reference Blazar BR, Weisdorf DJ, Defor T, Goldman A, Braun T, Silver S, Ferrara JL (2006) Phase 1/2 randomized, placebo-control trial of palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood 108(9):3216–3222PubMedCrossRef Blazar BR, Weisdorf DJ, Defor T, Goldman A, Braun T, Silver S, Ferrara JL (2006) Phase 1/2 randomized, placebo-control trial of palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood 108(9):3216–3222PubMedCrossRef
36.
go back to reference Rzepecki P, Sarosiek T, Barzal J, Oborska S, Nurzynski P, Wasko A, Szczylik C (2007) Palifermin for prevention of oral mucositis after haematopoietic stem cell transplantation—single centre experience. J BUON 12(4):477–482PubMed Rzepecki P, Sarosiek T, Barzal J, Oborska S, Nurzynski P, Wasko A, Szczylik C (2007) Palifermin for prevention of oral mucositis after haematopoietic stem cell transplantation—single centre experience. J BUON 12(4):477–482PubMed
37.
go back to reference Langner S, Staber P, Schub N, Gramatzki M, Grothe W, Behre G, Rabitsch W, Urban C, Linkesch W, Neumeister P (2008) Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients. Bone Marrow Transplant 42(4):275–279PubMedCrossRef Langner S, Staber P, Schub N, Gramatzki M, Grothe W, Behre G, Rabitsch W, Urban C, Linkesch W, Neumeister P (2008) Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients. Bone Marrow Transplant 42(4):275–279PubMedCrossRef
38.
go back to reference Meropol NJ, Somer RA, Gutheil J, Pelley RJ, Modiano MR, Rowinsky EK, Rothenberg ML, Redding SW, Serdar CM, Yao B, Heard R, Rosen LS (2003) Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 21(8):1452–1458CrossRef Meropol NJ, Somer RA, Gutheil J, Pelley RJ, Modiano MR, Rowinsky EK, Rothenberg ML, Redding SW, Serdar CM, Yao B, Heard R, Rosen LS (2003) Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 21(8):1452–1458CrossRef
39.
go back to reference Rosen LS, Abdi E, Davis ID, Gutheil J, Schnell FM, Zalcberg J, Cesano A, Gayko U, Chen MG, Clarke S (2006) Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 24(33):5194–5200CrossRef Rosen LS, Abdi E, Davis ID, Gutheil J, Schnell FM, Zalcberg J, Cesano A, Gayko U, Chen MG, Clarke S (2006) Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 24(33):5194–5200CrossRef
40.
go back to reference Schmidt E, Thoennissen NH, Rudat A, Bieker R, Schliemann C, Mesters RM, Zuhlsdorf M, Muller-Tidow C, Berdel WE (2008) Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Ann Oncol 19(9):1644–1649PubMedCrossRef Schmidt E, Thoennissen NH, Rudat A, Bieker R, Schliemann C, Mesters RM, Zuhlsdorf M, Muller-Tidow C, Berdel WE (2008) Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Ann Oncol 19(9):1644–1649PubMedCrossRef
41.
go back to reference Vadhan-Raj S, Trent J, Patel S, Zhou X, Johnson MM, Araujo D, Ludwig JA, O'Roark S, Gillenwater AM, Bueso-Ramos C, El-Naggar AK, Benjamin RS (2010) Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomized trial. Ann Intern Med 153(6):358–367PubMed Vadhan-Raj S, Trent J, Patel S, Zhou X, Johnson MM, Araujo D, Ludwig JA, O'Roark S, Gillenwater AM, Bueso-Ramos C, El-Naggar AK, Benjamin RS (2010) Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomized trial. Ann Intern Med 153(6):358–367PubMed
42.
go back to reference Brizel DM, Murphy BA, Rosenthal DI, Pandya KJ, Gluck S, Brizel HE, Meredith RF, Berger D, Chen MG, Mendenhall W (2008) Phase II study of palifermin and concurrent chemoradiation in head and neck squamous cell carcinoma. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 26(15):2489–2496CrossRef Brizel DM, Murphy BA, Rosenthal DI, Pandya KJ, Gluck S, Brizel HE, Meredith RF, Berger D, Chen MG, Mendenhall W (2008) Phase II study of palifermin and concurrent chemoradiation in head and neck squamous cell carcinoma. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 26(15):2489–2496CrossRef
43.
go back to reference Worthington HV, Clarkson JE, Bryan G, Furness S, Glenny AM, Littlewood A, McCabe MG, Meyer S, Khalid T (2010) Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev (12):CD000978 Worthington HV, Clarkson JE, Bryan G, Furness S, Glenny AM, Littlewood A, McCabe MG, Meyer S, Khalid T (2010) Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev (12):CD000978
44.
go back to reference Abitbol AA, Sridhar KS, Lewin AA, Schwade JG, Raub W Jr, Wolfson A, Gonzalez-Angulo C, Adessa A, Goodwin WJ, Markoe AM (1997) Hyperfractionated radiation therapy and 5-fluorouracil, cisplatin, and mitomycin-C (+/− granulocyte-colony stimulating factor) in the treatment of patients with locally advanced head and neck carcinoma. Cancer 80(2):266–276PubMedCrossRef Abitbol AA, Sridhar KS, Lewin AA, Schwade JG, Raub W Jr, Wolfson A, Gonzalez-Angulo C, Adessa A, Goodwin WJ, Markoe AM (1997) Hyperfractionated radiation therapy and 5-fluorouracil, cisplatin, and mitomycin-C (+/− granulocyte-colony stimulating factor) in the treatment of patients with locally advanced head and neck carcinoma. Cancer 80(2):266–276PubMedCrossRef
45.
go back to reference Mascarin M, Franchin G, Minatel E, Gobitti C, Talamini R, De Maria D, Trovo MG (1999) The effect of granulocyte colony-stimulating factor on oral mucositis in head and neck cancer patients treated with hyperfractionated radiotherapy. Oral Oncol 35(2):203–208PubMedCrossRef Mascarin M, Franchin G, Minatel E, Gobitti C, Talamini R, De Maria D, Trovo MG (1999) The effect of granulocyte colony-stimulating factor on oral mucositis in head and neck cancer patients treated with hyperfractionated radiotherapy. Oral Oncol 35(2):203–208PubMedCrossRef
46.
go back to reference Schneider SB, Nishimura RD, Zimmerman RP, Tran L, Shiplacoff J, Tormey M, Contreras R, Juillard GF (1999) Filgrastim (r-metHuG-CSF) and its potential use in the reduction of radiation-induced oropharyngeal mucositis: an interim look at a randomized, double-blind, placebo-controlled trial. Cytokines Cell Mol Ther 5(3):175–180PubMed Schneider SB, Nishimura RD, Zimmerman RP, Tran L, Shiplacoff J, Tormey M, Contreras R, Juillard GF (1999) Filgrastim (r-metHuG-CSF) and its potential use in the reduction of radiation-induced oropharyngeal mucositis: an interim look at a randomized, double-blind, placebo-controlled trial. Cytokines Cell Mol Ther 5(3):175–180PubMed
47.
go back to reference Su YB, Vickers AJ, Zelefsky MJ, Kraus DH, Shaha AR, Shah JP, Serio AM, Harrison LB, Bosl GJ, Pfister DG (2006) Double-blind, placebo-controlled, randomized trial of granulocyte-colony stimulating factor during postoperative radiotherapy for squamous head and neck cancer. Cancer J 12(3):182–188PubMedCrossRef Su YB, Vickers AJ, Zelefsky MJ, Kraus DH, Shaha AR, Shah JP, Serio AM, Harrison LB, Bosl GJ, Pfister DG (2006) Double-blind, placebo-controlled, randomized trial of granulocyte-colony stimulating factor during postoperative radiotherapy for squamous head and neck cancer. Cancer J 12(3):182–188PubMedCrossRef
48.
go back to reference Katano M, Nakamura M, Matsuo T, Iyama A, Hisatsugu T (1995) Effect of granulocyte colony-stimulating factor (G-CSF) on chemotherapy-induced oral mucositis. Surg Today 25(3):202–206PubMedCrossRef Katano M, Nakamura M, Matsuo T, Iyama A, Hisatsugu T (1995) Effect of granulocyte colony-stimulating factor (G-CSF) on chemotherapy-induced oral mucositis. Surg Today 25(3):202–206PubMedCrossRef
49.
go back to reference Viens P, Gravis G, Bladou F, Lechevallier E, Baume D, Camerlo J, Cowen D, Coulange C, Serment G, Resbeut M, Maraninchi D (1996) Impact of recombinant human granulocyte colony stimulating factor on dose intensity and toxicity of three cycles of methotrexate, vinblastine, doxorubicin and cisplatin in patients with previously untreated urothelial bladder carcinoma. Eur Cytokine Netw 7(3):395–399PubMed Viens P, Gravis G, Bladou F, Lechevallier E, Baume D, Camerlo J, Cowen D, Coulange C, Serment G, Resbeut M, Maraninchi D (1996) Impact of recombinant human granulocyte colony stimulating factor on dose intensity and toxicity of three cycles of methotrexate, vinblastine, doxorubicin and cisplatin in patients with previously untreated urothelial bladder carcinoma. Eur Cytokine Netw 7(3):395–399PubMed
50.
go back to reference Crawford J, Tomita DK, Mazanet R, Glaspy J, Ozer H (1999) Reduction of oral mucositis by filgrastim (r-metHuG-CSF) in patients receiving chemotherapy. Cytokines Cell Mol Ther 5(4):187–193PubMed Crawford J, Tomita DK, Mazanet R, Glaspy J, Ozer H (1999) Reduction of oral mucositis by filgrastim (r-metHuG-CSF) in patients receiving chemotherapy. Cytokines Cell Mol Ther 5(4):187–193PubMed
51.
go back to reference Patte C, Laplanche A, Bertozzi AI, Baruchel A, Frappaz D, Schmitt C, Mechinaud F, Nelken B, Boutard P, Michon J (2002) Granulocyte colony-stimulating factor in induction treatment of children with non-Hodgkin's lymphoma: a randomized study of the French Society of Pediatric Oncology. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 20(2):441–448CrossRef Patte C, Laplanche A, Bertozzi AI, Baruchel A, Frappaz D, Schmitt C, Mechinaud F, Nelken B, Boutard P, Michon J (2002) Granulocyte colony-stimulating factor in induction treatment of children with non-Hodgkin's lymphoma: a randomized study of the French Society of Pediatric Oncology. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 20(2):441–448CrossRef
52.
go back to reference Karthaus M, Rosenthal C, Huebner G, Paul H, Elser C, Hertenstein B, Krauter J, Scharmann T, Geissler RG, Heil G, Ganser A (1998) Effect of topical oral G-CSF on oral mucositis: a randomised placebo-controlled trial. Bone Marrow Transplant 22(8):781–785PubMedCrossRef Karthaus M, Rosenthal C, Huebner G, Paul H, Elser C, Hertenstein B, Krauter J, Scharmann T, Geissler RG, Heil G, Ganser A (1998) Effect of topical oral G-CSF on oral mucositis: a randomised placebo-controlled trial. Bone Marrow Transplant 22(8):781–785PubMedCrossRef
53.
go back to reference Stokman MA, Spijkervet FK, Boezen HM, Schouten JP, Roodenburg JL, de Vries EG (2006) Preventive intervention possibilities in radiotherapy- and chemotherapy-induced oral mucositis: results of meta-analyses. J Dent Res 85(8):690–700PubMedCrossRef Stokman MA, Spijkervet FK, Boezen HM, Schouten JP, Roodenburg JL, de Vries EG (2006) Preventive intervention possibilities in radiotherapy- and chemotherapy-induced oral mucositis: results of meta-analyses. J Dent Res 85(8):690–700PubMedCrossRef
54.
go back to reference Dazzi C, Cariello A, Giovanis P, Monti M, Vertogen B, Leoni M, Tienghi A, Turci D, Rosti G, Nanni O, Rondoni C, Marangolo M (2003) Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study. Ann Oncol 14(4):559–563PubMedCrossRef Dazzi C, Cariello A, Giovanis P, Monti M, Vertogen B, Leoni M, Tienghi A, Turci D, Rosti G, Nanni O, Rondoni C, Marangolo M (2003) Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study. Ann Oncol 14(4):559–563PubMedCrossRef
55.
go back to reference van der Lelie H, Thomas BL, van Oers RH, Ek-Post M, Sjamsoedin SA, van Dijk-Overtoom ML, Timmer JG, von dem Borne AE (2001) Effect of locally applied GM-CSF on oral mucositis after stem cell transplantation: a prospective placebo-controlled double-blind study. Ann Hematol 80(3):150–154PubMedCrossRef van der Lelie H, Thomas BL, van Oers RH, Ek-Post M, Sjamsoedin SA, van Dijk-Overtoom ML, Timmer JG, von dem Borne AE (2001) Effect of locally applied GM-CSF on oral mucositis after stem cell transplantation: a prospective placebo-controlled double-blind study. Ann Hematol 80(3):150–154PubMedCrossRef
56.
go back to reference Cartee L, Petros WP, Rosner GL, Gilbert C, Moore S, Affronti ML, Hoke JA, Hussein AM, Ross M, Rubin P et al (1995) Evaluation of GM-CSF mouthwash for prevention of chemotherapy-induced mucositis: a randomized, double-blind, dose-ranging study. Cytokine 7(5):471–477PubMedCrossRef Cartee L, Petros WP, Rosner GL, Gilbert C, Moore S, Affronti ML, Hoke JA, Hussein AM, Ross M, Rubin P et al (1995) Evaluation of GM-CSF mouthwash for prevention of chemotherapy-induced mucositis: a randomized, double-blind, dose-ranging study. Cytokine 7(5):471–477PubMedCrossRef
57.
go back to reference Nicolatou O, Sotiropoulou-Lontou A, Skarlatos J, Kyprianou K, Kolitsi G, Dardoufas K (1998) A pilot study of the effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients during X-radiation therapy: a preliminary report. Int J Radiat Oncol Biol Phys 42(3):551–556PubMedCrossRef Nicolatou O, Sotiropoulou-Lontou A, Skarlatos J, Kyprianou K, Kolitsi G, Dardoufas K (1998) A pilot study of the effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients during X-radiation therapy: a preliminary report. Int J Radiat Oncol Biol Phys 42(3):551–556PubMedCrossRef
58.
go back to reference Nicolatou-Galitis O, Dardoufas K, Markoulatos P, Sotiropoulou-Lontou A, Kyprianou K, Kolitsi G, Pissakas G, Skarleas C, Kouloulias V, Papanicolaou V, Legakis NJ, Velegraki A (2001) Oral pseudomembranous candidiasis, herpes simplex virus-1 infection, and oral mucositis in head and neck cancer patients receiving radiotherapy and granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwash. J Oral Pathol Med 8:471–480CrossRef Nicolatou-Galitis O, Dardoufas K, Markoulatos P, Sotiropoulou-Lontou A, Kyprianou K, Kolitsi G, Pissakas G, Skarleas C, Kouloulias V, Papanicolaou V, Legakis NJ, Velegraki A (2001) Oral pseudomembranous candidiasis, herpes simplex virus-1 infection, and oral mucositis in head and neck cancer patients receiving radiotherapy and granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwash. J Oral Pathol Med 8:471–480CrossRef
59.
go back to reference Saarilahti K, Kajanti M, Joensuu T, Kouri M, Joensuu H (2002) Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study. Int J Radiat Oncol Biol Phys 54(2):479–485PubMedCrossRef Saarilahti K, Kajanti M, Joensuu T, Kouri M, Joensuu H (2002) Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study. Int J Radiat Oncol Biol Phys 54(2):479–485PubMedCrossRef
60.
go back to reference Mantovani G, Massa E, Astara G, Murgia V, Gramignano G, Lusso MR, Camboni P, Ferreli L, Mocci M, Perboni S, Mura L, Madeddu C, Maccio A (2003) Phase II clinical trial of local use of GM-CSF for prevention and treatment of chemotherapy- and concomitant chemoradiotherapy-induced severe oral mucositis in advanced head and neck cancer patients: an evaluation of effectiveness, safety and costs. Oncol Rep 10(1):197–206PubMed Mantovani G, Massa E, Astara G, Murgia V, Gramignano G, Lusso MR, Camboni P, Ferreli L, Mocci M, Perboni S, Mura L, Madeddu C, Maccio A (2003) Phase II clinical trial of local use of GM-CSF for prevention and treatment of chemotherapy- and concomitant chemoradiotherapy-induced severe oral mucositis in advanced head and neck cancer patients: an evaluation of effectiveness, safety and costs. Oncol Rep 10(1):197–206PubMed
61.
go back to reference Sprinzl GM, Galvan O, de Vries A, Ulmer H, Gunkel AR, Lukas P, Thumfart WF (2001) Local application of granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of oral mucositis. Eur J Cancer 37(16):2003–2009PubMedCrossRef Sprinzl GM, Galvan O, de Vries A, Ulmer H, Gunkel AR, Lukas P, Thumfart WF (2001) Local application of granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of oral mucositis. Eur J Cancer 37(16):2003–2009PubMedCrossRef
62.
go back to reference Chi KH, Chen CH, Chan WK, Chow KC, Chen SY, Yen SH, Chao JY, Chang CY, Chen KY (1995) Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leucovorin chemotherapy. Journal of clinical oncology: official journal of the Am Soc Clin Oncol 13(10):2620–2628 Chi KH, Chen CH, Chan WK, Chow KC, Chen SY, Yen SH, Chao JY, Chang CY, Chen KY (1995) Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leucovorin chemotherapy. Journal of clinical oncology: official journal of the Am Soc Clin Oncol 13(10):2620–2628
63.
go back to reference Kannan V, Bapsy PP, Anantha N, Doval DC, Vaithianathan H, Banumathy G, Reddy KB, Kumaraswamy SV, Shenoy AM (1997) Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma. Int J Radiat Oncol Biol Phys 37(5):1005–1010PubMedCrossRef Kannan V, Bapsy PP, Anantha N, Doval DC, Vaithianathan H, Banumathy G, Reddy KB, Kumaraswamy SV, Shenoy AM (1997) Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma. Int J Radiat Oncol Biol Phys 37(5):1005–1010PubMedCrossRef
64.
go back to reference Rosso M, Blasi G, Gherlone E, Rosso R (1997) Effect of granulocyte-macrophage colony-stimulating factor on prevention of mucositis in head and neck cancer patients treated with chemo-radiotherapy. J Chemother 9(5):382–385PubMed Rosso M, Blasi G, Gherlone E, Rosso R (1997) Effect of granulocyte-macrophage colony-stimulating factor on prevention of mucositis in head and neck cancer patients treated with chemo-radiotherapy. J Chemother 9(5):382–385PubMed
65.
go back to reference Wagner W, Alfrink M, Haus U, Matt J (1999) Treatment of irradiation-induced mucositis with growth factors (rhGM-CSF) in patients with head and neck cancer. Anticancer Res 19(1B):799–803PubMed Wagner W, Alfrink M, Haus U, Matt J (1999) Treatment of irradiation-induced mucositis with growth factors (rhGM-CSF) in patients with head and neck cancer. Anticancer Res 19(1B):799–803PubMed
66.
go back to reference McAleese JJ, Bishop KM, A'Hern R, Henk JM (2006) Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. Br J Radiol 79(943):608–613PubMedCrossRef McAleese JJ, Bishop KM, A'Hern R, Henk JM (2006) Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. Br J Radiol 79(943):608–613PubMedCrossRef
67.
go back to reference Ryu JK, Swann S, LeVeque F, Scarantino CW, Johnson D, Chen A, Fortin A, Pollock J, Kim H, Ang KK (2007) The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: a double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. Int J Radiat Oncol Biol Phys 67(3):643–650PubMedCrossRef Ryu JK, Swann S, LeVeque F, Scarantino CW, Johnson D, Chen A, Fortin A, Pollock J, Kim H, Ang KK (2007) The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: a double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. Int J Radiat Oncol Biol Phys 67(3):643–650PubMedCrossRef
68.
go back to reference Makkonen TA, Minn H, Jekunen A, Vilja P, Tuominen J, Joensuu H (2000) Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study. Int J Radiat Oncol Biol Phys 46(3):525–534PubMedCrossRef Makkonen TA, Minn H, Jekunen A, Vilja P, Tuominen J, Joensuu H (2000) Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study. Int J Radiat Oncol Biol Phys 46(3):525–534PubMedCrossRef
69.
go back to reference Ifrah N, Witz F, Jouet JP, Francois S, Lamy T, Linassier C, Pignon B, Berthou C, Guyotat D, Cahn JY, Harousseau JL (1999) Intensive short term therapy with granulocyte-macrophage-colony stimulating factor support, similar to therapy for acute myeloblastic leukemia, does not improve overall results for adults with acute lymphoblastic leukemia. GOELAMS Group. Cancer 86(8):1496–1505PubMedCrossRef Ifrah N, Witz F, Jouet JP, Francois S, Lamy T, Linassier C, Pignon B, Berthou C, Guyotat D, Cahn JY, Harousseau JL (1999) Intensive short term therapy with granulocyte-macrophage-colony stimulating factor support, similar to therapy for acute myeloblastic leukemia, does not improve overall results for adults with acute lymphoblastic leukemia. GOELAMS Group. Cancer 86(8):1496–1505PubMedCrossRef
70.
go back to reference Nemunaitis J, Rosenfeld CS, Ash R, Freedman MH, Deeg HJ, Appelbaum F, Singer JW, Flomenberg N, Dalton W, Elfenbein GJ et al (1995) Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation. Bone Marrow Transplant 15(6):949–954PubMed Nemunaitis J, Rosenfeld CS, Ash R, Freedman MH, Deeg HJ, Appelbaum F, Singer JW, Flomenberg N, Dalton W, Elfenbein GJ et al (1995) Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation. Bone Marrow Transplant 15(6):949–954PubMed
71.
go back to reference Gordon B, Spadinger A, Hodges E, Ruby E, Stanley R, Coccia P (1994) Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis after hematopoietic stem-cell transplantation. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 12(9):1917–1922 Gordon B, Spadinger A, Hodges E, Ruby E, Stanley R, Coccia P (1994) Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis after hematopoietic stem-cell transplantation. Journal of Clinical Oncology: Official Journal of the Am Soc Clin Oncol 12(9):1917–1922
72.
go back to reference Rovirosa A, Ferre J, Biete A (1998) Granulocyte macrophage-colony-stimulating factor mouthwashes heal oral ulcers during head and neck radiotherapy. Int J Radiat Oncol Biol Phys 41(4):747–754PubMedCrossRef Rovirosa A, Ferre J, Biete A (1998) Granulocyte macrophage-colony-stimulating factor mouthwashes heal oral ulcers during head and neck radiotherapy. Int J Radiat Oncol Biol Phys 41(4):747–754PubMedCrossRef
73.
go back to reference Bez C, Demarosi F, Sardella A, Lodi G, Bertolli VG, Annaloro C, Rimondini L, Porter SR, Carrassi A (1999) GM-CSF mouthrinses in the treatment of severe oral mucositis: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 88(3):311–315PubMedCrossRef Bez C, Demarosi F, Sardella A, Lodi G, Bertolli VG, Annaloro C, Rimondini L, Porter SR, Carrassi A (1999) GM-CSF mouthrinses in the treatment of severe oral mucositis: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 88(3):311–315PubMedCrossRef
74.
go back to reference Valcarcel D, Sanz MA Jr, Sureda A, Sala M, Munoz L, Subira M, Laborda R, Clopes A, Sierra J (2002) Mouth-washings with recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) do not improve grade III–IV oropharyngeal mucositis (OM) in patients with hematological malignancies undergoing stem cell transplantation. Results of a randomized double-blind placebo-controlled study. Bone Marrow Transplant 29(9):783–787PubMedCrossRef Valcarcel D, Sanz MA Jr, Sureda A, Sala M, Munoz L, Subira M, Laborda R, Clopes A, Sierra J (2002) Mouth-washings with recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) do not improve grade III–IV oropharyngeal mucositis (OM) in patients with hematological malignancies undergoing stem cell transplantation. Results of a randomized double-blind placebo-controlled study. Bone Marrow Transplant 29(9):783–787PubMedCrossRef
75.
go back to reference Ibrahim EM, al-Mulhim FA (1997) Effect of granulocyte-macrophage colony-stimulating factor on chemotherapy-induced oral mucositis in non-neutropenic cancer patients. Med Oncol 14(1):47–51PubMedCrossRef Ibrahim EM, al-Mulhim FA (1997) Effect of granulocyte-macrophage colony-stimulating factor on chemotherapy-induced oral mucositis in non-neutropenic cancer patients. Med Oncol 14(1):47–51PubMedCrossRef
76.
go back to reference Hejna M, Kostler WJ, Raderer M, Steger GG, Brodowicz T, Scheithauer W, Wiltschke C, Zielinski CC (2001) Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: results of a prospective randomised trial. Eur J Cancer 37(16):1994–2002PubMedCrossRef Hejna M, Kostler WJ, Raderer M, Steger GG, Brodowicz T, Scheithauer W, Wiltschke C, Zielinski CC (2001) Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: results of a prospective randomised trial. Eur J Cancer 37(16):1994–2002PubMedCrossRef
77.
go back to reference Rossi A, Rosati G, Colarusso D, Manzione L (2003) Subcutaneous granulocyte-macrophage colony-stimulating factor in mucositis induced by an adjuvant 5-fluorouracil plus leucovorin regimen. A phase II study and review of the literature. Oncology 64(4):353–360PubMedCrossRef Rossi A, Rosati G, Colarusso D, Manzione L (2003) Subcutaneous granulocyte-macrophage colony-stimulating factor in mucositis induced by an adjuvant 5-fluorouracil plus leucovorin regimen. A phase II study and review of the literature. Oncology 64(4):353–360PubMedCrossRef
78.
go back to reference Masucci G, Broman P, Kelly C, Lindahl S, Malmberg L, Reizenstein J, Alenius M, Lewensohn R (2005) Therapeutic efficacy by recombinant human granulocyte/monocyte-colony stimulating factor on mucositis occurring in patients with oral and oropharynx tumors treated with curative radiotherapy: a multicenter open randomized phase III study. Med Oncol 22(3):247–256PubMedCrossRef Masucci G, Broman P, Kelly C, Lindahl S, Malmberg L, Reizenstein J, Alenius M, Lewensohn R (2005) Therapeutic efficacy by recombinant human granulocyte/monocyte-colony stimulating factor on mucositis occurring in patients with oral and oropharynx tumors treated with curative radiotherapy: a multicenter open randomized phase III study. Med Oncol 22(3):247–256PubMedCrossRef
79.
go back to reference Clarkson JE, Worthington HV, Furness S, McCabe M, Khalid T, Meyer S (2010) Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev (8):CD001973. doi:10.1002/14651858.CD001973.pub4 Clarkson JE, Worthington HV, Furness S, McCabe M, Khalid T, Meyer S (2010) Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev (8):CD001973. doi:10.​1002/​14651858.​CD001973.​pub4
80.
go back to reference Foncuberta MC, Cagnoni PJ, Brandts CH, Mandanas R, Fields K, Derigs HG, Reed E, Sonis ST, Fay J, LeVeque F, Pouillart P, Schrezenmeier H, Emmons R, Thiel E (2001) Topical transforming growth factor-beta3 in the prevention or alleviation of chemotherapy-induced oral mucositis in patients with lymphomas or solid tumors. J Immunother 24(4):384–388PubMedCrossRef Foncuberta MC, Cagnoni PJ, Brandts CH, Mandanas R, Fields K, Derigs HG, Reed E, Sonis ST, Fay J, LeVeque F, Pouillart P, Schrezenmeier H, Emmons R, Thiel E (2001) Topical transforming growth factor-beta3 in the prevention or alleviation of chemotherapy-induced oral mucositis in patients with lymphomas or solid tumors. J Immunother 24(4):384–388PubMedCrossRef
81.
go back to reference Wymenga AN, van der Graaf WT, Hofstra LS, Spijkervet FK, Timens W, Timmer-Bosscha H, Sluiter WJ, van Buuren AH, Mulder NH, de Vries EG (1999) Phase I study of transforming growth factor-beta3 mouthwashes for prevention of chemotherapy-induced mucositis. Clin Cancer Res 6:1363–1380 Wymenga AN, van der Graaf WT, Hofstra LS, Spijkervet FK, Timens W, Timmer-Bosscha H, Sluiter WJ, van Buuren AH, Mulder NH, de Vries EG (1999) Phase I study of transforming growth factor-beta3 mouthwashes for prevention of chemotherapy-induced mucositis. Clin Cancer Res 6:1363–1380
82.
go back to reference de Koning BA, Philipsen-Geerling B, Hoijer M, Hählen K, Büller HA, Pieters R (2007) Protection against chemotherapy induced mucositis by TGF-beta(2) in childhood cancer patients: results from a randomized cross-over study. Pediatr Blood Cancer 48(5):532–539PubMedCrossRef de Koning BA, Philipsen-Geerling B, Hoijer M, Hählen K, Büller HA, Pieters R (2007) Protection against chemotherapy induced mucositis by TGF-beta(2) in childhood cancer patients: results from a randomized cross-over study. Pediatr Blood Cancer 48(5):532–539PubMedCrossRef
83.
go back to reference Prince HM, Regester G, Gates P, Jablonskis L, Seymour JF, Lillie K, West R, Wolf M, Januszewicz H, Belford D (2005) A phase Ib clinical trial of PV701, a milk-derived protein extract, for the prevention and treatment of oral mucositis in patients undergoing high-dose BEAM chemotherapy. Biol Blood Marrow Transplant 11(7):512–520PubMedCrossRef Prince HM, Regester G, Gates P, Jablonskis L, Seymour JF, Lillie K, West R, Wolf M, Januszewicz H, Belford D (2005) A phase Ib clinical trial of PV701, a milk-derived protein extract, for the prevention and treatment of oral mucositis in patients undergoing high-dose BEAM chemotherapy. Biol Blood Marrow Transplant 11(7):512–520PubMedCrossRef
84.
go back to reference Girdler NM, McGurk M, Aqual S, Prince M (1995) The effect of epidermal growth factor mouthwash on cytotoxic-induced oral ulceration. A phase I clinical trial. Am J Clin Oncol 18(5):403–406PubMedCrossRef Girdler NM, McGurk M, Aqual S, Prince M (1995) The effect of epidermal growth factor mouthwash on cytotoxic-induced oral ulceration. A phase I clinical trial. Am J Clin Oncol 18(5):403–406PubMedCrossRef
85.
go back to reference Hong JP, Lee SW, Song SY, Ahn SD, Shin SS, Choi EK, Kim JH (2009) Recombinant human epidermal growth factor treatment of radiation-induced severe oral mucositis in patients with head and neck malignancies. Eur J Cancer Care (Engl) 18(6):636–641CrossRef Hong JP, Lee SW, Song SY, Ahn SD, Shin SS, Choi EK, Kim JH (2009) Recombinant human epidermal growth factor treatment of radiation-induced severe oral mucositis in patients with head and neck malignancies. Eur J Cancer Care (Engl) 18(6):636–641CrossRef
86.
go back to reference Wu HG, Song SY, Kim YS, Oh YT, Lee CG, Keum KC, Ahn YC, Lee SW (2009) Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial. Cancer 115(16) Wu HG, Song SY, Kim YS, Oh YT, Lee CG, Keum KC, Ahn YC, Lee SW (2009) Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial. Cancer 115(16)
87.
go back to reference Antin JH, Lee SJ, Neuberg D, Alyea E, Soiffer RJ, Sonis S, Ferrara JL (2002) A phase I/II double-blind, placebo-controlled study of recombinant human interleukin-11 for mucositis and acute GVHD prevention in allogeneic stem cell transplantation. Bone Marrow Transplant 29(5):373–377PubMedCrossRef Antin JH, Lee SJ, Neuberg D, Alyea E, Soiffer RJ, Sonis S, Ferrara JL (2002) A phase I/II double-blind, placebo-controlled study of recombinant human interleukin-11 for mucositis and acute GVHD prevention in allogeneic stem cell transplantation. Bone Marrow Transplant 29(5):373–377PubMedCrossRef
88.
go back to reference Hunter A, Mahendra P, Wilson K, Fields P, Cook G, Peniket A, Crawley C, Hickling R, Marcus R (2009) Treatment of oral mucositis after peripheral blood SCT with ATL-104 mouthwash: results from a randomized, double-blind, placebo-controlled trial. Bone Marrow Transplant 43(7):563–569PubMedCrossRef Hunter A, Mahendra P, Wilson K, Fields P, Cook G, Peniket A, Crawley C, Hickling R, Marcus R (2009) Treatment of oral mucositis after peripheral blood SCT with ATL-104 mouthwash: results from a randomized, double-blind, placebo-controlled trial. Bone Marrow Transplant 43(7):563–569PubMedCrossRef
89.
go back to reference Peterson DE, Barker NP, Akhmadullina LI, Rodionova I, Sherman NZ, Davidenko IS, Rakovskaya GN, Gotovkin EA, Shinkarev SA, Kopp MV, Kulikov EP, Moiseyenko VM, Gertner JM, Firsov I, Tuleneva T, Yarosh A, Woon CW (2009) Phase II, randomized, double-blind, placebo-controlled study of recombinant human intestinal trefoil factor oral spray for prevention of oral mucositis in patients with colorectal cancer who are receiving fluorouracil-based chemotherapy. J Clin Oncol 27(26):4333–4338PubMedCrossRef Peterson DE, Barker NP, Akhmadullina LI, Rodionova I, Sherman NZ, Davidenko IS, Rakovskaya GN, Gotovkin EA, Shinkarev SA, Kopp MV, Kulikov EP, Moiseyenko VM, Gertner JM, Firsov I, Tuleneva T, Yarosh A, Woon CW (2009) Phase II, randomized, double-blind, placebo-controlled study of recombinant human intestinal trefoil factor oral spray for prevention of oral mucositis in patients with colorectal cancer who are receiving fluorouracil-based chemotherapy. J Clin Oncol 27(26):4333–4338PubMedCrossRef
90.
go back to reference Levine JE, Blazar BR, DeFor T, Ferrara JL, Weisdorf DJ (2008) Long-term follow-up of a phase I/II randomized, placebo-controlled trial of palifermin to prevent graft-versus-host disease (GVHD) after related donor allogeneic hematopoietic cell transplantation (HCT). Biol Blood Marrow Transplant 14(9):1017–1021PubMedCrossRef Levine JE, Blazar BR, DeFor T, Ferrara JL, Weisdorf DJ (2008) Long-term follow-up of a phase I/II randomized, placebo-controlled trial of palifermin to prevent graft-versus-host disease (GVHD) after related donor allogeneic hematopoietic cell transplantation (HCT). Biol Blood Marrow Transplant 14(9):1017–1021PubMedCrossRef
91.
go back to reference Goldberg JD, Zheng J, Castro-Malaspina H, Jakubowski AA, Heller G, van den Brink MR, Perales MA (2012) Palifermin is efficacious in recipients of TBI-based but not chemotherapy-based allogeneic hematopoietic stem cell transplants. Bone Marrow Transplant. doi:10.1038/bmt.2012.115 [Epub ahead of print] Goldberg JD, Zheng J, Castro-Malaspina H, Jakubowski AA, Heller G, van den Brink MR, Perales MA (2012) Palifermin is efficacious in recipients of TBI-based but not chemotherapy-based allogeneic hematopoietic stem cell transplants. Bone Marrow Transplant. doi:10.​1038/​bmt.​2012.​115 [Epub ahead of print]
92.
go back to reference Henke M, Alfonsi M, Foa P, Giralt J, Bardet E, Cerezo L, Salzwimmer M, Lizambri R, Emmerson L, Chen MG, Berger D (2011) Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. Journal of clinical oncology: official journal of the Am Soc Clin Oncol 29(20):2815–2820CrossRef Henke M, Alfonsi M, Foa P, Giralt J, Bardet E, Cerezo L, Salzwimmer M, Lizambri R, Emmerson L, Chen MG, Berger D (2011) Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. Journal of clinical oncology: official journal of the Am Soc Clin Oncol 29(20):2815–2820CrossRef
93.
go back to reference Le QT, Kim HE, Schneider CJ, Murakozy G, Skladowski K, Reinisch S, Chen Y, Hickey M, Mo M, Chen MG, Berger D, Lizambri R, Henke M (2011) Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study. Journal of clinical oncology: official journal of the Am Soc Clin Oncol 29(20):2808–2814CrossRef Le QT, Kim HE, Schneider CJ, Murakozy G, Skladowski K, Reinisch S, Chen Y, Hickey M, Mo M, Chen MG, Berger D, Lizambri R, Henke M (2011) Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study. Journal of clinical oncology: official journal of the Am Soc Clin Oncol 29(20):2808–2814CrossRef
94.
go back to reference Caluwaerts S, Vandenbroucke K, Steidler L, Neirynck S, Vanhoenacker P, Corveleyn S, Watkins B, Sonis S, Coulie B, Rottiers P (2010) AG013, a mouth rinse formulation of Lactococcus lactis secreting human Trefoil Factor 1, provides a safe and efficacious therapeutic tool for treating oral mucositis. Oral Oncol 46(7):564–570PubMedCrossRef Caluwaerts S, Vandenbroucke K, Steidler L, Neirynck S, Vanhoenacker P, Corveleyn S, Watkins B, Sonis S, Coulie B, Rottiers P (2010) AG013, a mouth rinse formulation of Lactococcus lactis secreting human Trefoil Factor 1, provides a safe and efficacious therapeutic tool for treating oral mucositis. Oral Oncol 46(7):564–570PubMedCrossRef
95.
go back to reference Zheng C, Cotrim AP, Sunshine AN, Sugito T, Liu L, Sowers A, Mitchell JB, Baum BJ (2009) Prevention of radiation-induced oral mucositis after adenoviral vector-mediated transfer of the keratinocyte growth factor cDNA to mouse submandibular glands. Clin Cancer Res 15(14):4641–4648PubMedCrossRef Zheng C, Cotrim AP, Sunshine AN, Sugito T, Liu L, Sowers A, Mitchell JB, Baum BJ (2009) Prevention of radiation-induced oral mucositis after adenoviral vector-mediated transfer of the keratinocyte growth factor cDNA to mouse submandibular glands. Clin Cancer Res 15(14):4641–4648PubMedCrossRef
Metadata
Title
Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients
Authors
Judith E. Raber-Durlacher
Inger von Bültzingslöwen
Richard M. Logan
Joanne Bowen
Abdul Rahman Al-Azri
Hele Everaus
Erich Gerber
Jesùs Garcia Gomez
Bo G. Pettersson
Yoshihiko Soga
Fred K. L. Spijkervet
Wim J. E. Tissing
Joel B. Epstein
Sharon Elad
Rajesh V. Lalla
For the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO)
Publication date
01-01-2013
Publisher
Springer-Verlag
Published in
Supportive Care in Cancer / Issue 1/2013
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-012-1594-5

Other articles of this Issue 1/2013

Supportive Care in Cancer 1/2013 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine