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Drug Evaluation

Palifermin: a keratinocyte growth factor that reduces oral mucositis after stem cell transplant for haematological malignancies

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Pages 2287-2299 | Published online: 24 Oct 2006

Bibliography

  • SONIS ST: A biological approach to mucositis. J. Support. Oncol. (2004) 2:21-36.
  • GABRIEL DA, SHEA T, OLAJIDE O, SERODY JS, COMEAU T: The effect of oral mucositis on morbidity and mortality in bone marrow transplant. Semin. Oncol. (2003) 30(Suppl. 18):76-83.
  • SPIELBERGER R, STIFF P, BENSINGER W et al.: Palifermin for oral mucositis after intensive therapy for hematologic cancers. N. Engl. J. Med. (2004) 351:2590-2598.
  • SCHMITZ N, PFISTNER B, SEXTRO M et al.: Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin’s disease: a randomized trial. Lancet (2002) 359:2065-2071.
  • SONIS ST, OSTER G, FUCHS H et al.: Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J. Clin. Oncol. (2001) 19:2201-2205.
  • RAPOPORT AP, MILLER WATELET LF, LINDER T et al.: Analysis of factors that correlate with mucositis in recipients of autologous and allogeneic stem-cell transplants. J. Clin. Oncol. (1999) 17:2446-2453.
  • FILICKO J, LAZARUS HM, FLOMENBERG N: Mucosal injury in patients undergoing hematopoietic progenitor cell transplantation: new approaches to prophylaxis and treatment. Bone Marrow Transplant. (2003) 31:1-10.
  • NIKOLETTI S, HYDE S, SHAW T, MYERS H, KRISTJANSON LJ: Comparison of plain ice and flavoured ice for preventing oral mucositis associated with the use of 5-fluorouracil. J. Clin. Nurs. (2005) 14:750-753.
  • NOTTAGE M, MCLACHLAN SA, BRITTAIN MA et al.: Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-incuded mucositis: a randomized, placebo-controlled trial. Support. Care Cancer (2003) 11:41-47.
  • OKUNO SH, WOODHOUSE CO, LOPRINZI CL et al.: Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. Am. J. Clin. Oncol. (1999) 22:258-261.
  • GABRIEL DA, SHEA TC, SERODY JS et al.: Cytoprotection by amifostine during autologous stem cell transplantation for advanced refractory hematologic malignancies. Biol. Blood Marrow Transplant (2005) 11:1022-1030.
  • BENSADOUN RJ, FRANQUIN JC, CIAIS G et al.: Low-energy He/Ne laser in the prevention of radiation-induced mucositis. A multicenter Phase III randomized study in patients with head and neck cancer. Support. Care Cancer (1999) 7:244-252.
  • VALCARCEL D, SANZ MA, SUREDA A et al.: 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. (2002) 29:783-787.
  • CRAWFORD J, TOMITA DK, MAZANET R, GLASPY J, OZER H: Reduction of oral mucositis by filgrastim (r-metHuG-CSF) in patients receiving chemotherapy. Cytokines Cell Mol. Ther. (1999) 5:187-193.
  • MASUCCI G, BROMAN P, KELLY C et al.: 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. (2005) 22:247-256.
  • WORTHINGTON H, CLARKSON J, EDEN O: Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst. Rev. (2006) 19:CD000978.
  • FREYTES CO, RATANATHARATHORN V, TAYLOR C et al.: 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. (2004) 10:8318-8324.
  • CLARKE SJ, ABDI E, DAVIS ID et al.: Recombinant human keratinocyte growth factor (rHuKGF) prevents chemotherapy-induced mucositis in patients with advanced colorectal cancer: a randomized Phase II trial. Proceedings of the 37th American Society of Clinical Oncology (ASCO). Baltimore (MD) USA (12 – 15 May 2001) Abstract 1529.
  • STIFF PJ, ERDER H, BENSINGER WI et al.: Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant (2006) 37:393-401.
  • STIFF PJ, EMMANOUILIDES C, BENSINGER WI et al.: Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting. J. Clin. Oncol. (2006). In press.
  • SPIELBERGER R, EMMANOUILIDES C, BENSINGER W, RONG A, CESANO A, STIFF P: Long-term survival is comparable between palifermin-treated and placebo-treated patients with hematologic malignancies undergoing high-dose chemotherapy and total body irradiation followed by autologous hematopoietic stem cell transplantation. The American Society of Hematology 46th Annual Meeting and Exposition. Atlanta (GA) USA (10 – 13 December 2005) Abstract 2925.
  • SCHUSTER MW, ANAISSIE E, HURD D et al.: Final analysis of the Phase II, randomized, double-blind, placebo-controlled trial of single dose velafermin (CG53135-05) for the prevention of oral mucositis. Proceedings of the 42nd American Society of Clinical Oncology (ASCO). Atlanta (GA) USA (2 – 6 June 2006) Abstract 6537.
  • SCHUSTER MW, SHORE TB, GREENBERG J et al.: Phase I trial of CG53135-05 to prevent mucositis in patients undergoing high-dose chemotherapy (HDCT) and autologous peripheral blood stem cell transplantation (PBSCT). Proceedings of the 42nd American Society of Clinical Oncology (ASCO). Atlanta (GA) USA (2 – 6 June 2006) Abstract 6656.
  • GIBSON RJ, BOWEN JM, KEEFE DMK: Palifermin reduces diarrhea and increases survival following irinotecan treatment in tumor-bearing DA rats. Int. J. Cancer (2005) 116:464-470.
  • MEROPOL NJ, SOMER RA, GUTHEIL J et al.: Randomized Phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. J. Clin. Oncol. (2003) 21:1452-1458.
  • REYNOLDS CM, LEVINE JE, UBERTI JP et al.: Keratinocyte growth factor (palifermin) in combination with tacrolimus and methotrexate for the prevention of acute graft-versus-host-disease in patients at high risk of aGVHD. The American Society of Hematology 46th Annual Meeting and Exposition. San Diego (CA) USA (4 – 7 December 2004) Abstract 1228.
  • KRIJANOVSKI OI, HILL GR, COOKE KR et al.: Keratinocyte growth factor separates graft-versus-leukemia effects from graft-versus-host disease. Blood (1999) 94:825-831.
  • VANCLEE A, LUTGENS LCHW, OVING EBH et al.: Keratinocyte growth factor ameliorates acute graft-versus-host disease in a novel non-myeloablative haploidentical transplantation model. Bone Marrow Trans. (2005) 36:907-915.
  • ROSSI S, BLAZAR BR, FARRELL CL et al.: Keratinocyte growth factor preserves normal thymopoiesis and thymic microenvironment during experimental graft-versus-host disease. Blood (2002) 100:682-691.
  • SEGGEWISS R, LORE K, GUENAGA FJ et al.: Keratinocyte growth factor increases thymic output of naive T cells after total body irradiation and autologous peripheral blood progenitor cell transplantation in rhesus macaques. The American Society of Hematology 46th Annual Meeting and Exposition. Atlanta (GA) USA (10 – 13 December 2005) Abstract 187.
  • MIN D, TAYLOR PA, PANOSKALTSIS-MORTARI A et al.: Protection from thymic epithelial cell injury by keratinocyte growth factor: a new approach to improve thymic and peripheral T cell reconstitution after bone marrow transplantation. Blood (2002) 99:4592-4600.
  • WELSH DA, SUMMER WR, DOBARD EP, NELSON S, MASON CM: Keratinocyte growth factor prevents ventilator-induced lung injury in an ex vivo rat model. Am. J. Respir. Crit. Care Med. (2000) 162:1081-1086.
  • KAZA AK, KRON IL, LEUWERKE SM, TRIBBLE CG, LAUBACH VE: Keratinocyte growth factor enhances post-pneumonectomy lung growth by alveolar proliferation. Circulation (2002) 106:I120-I124.
  • TERRY NH, BRINKLEY J, DOIG AJ et al.: Cellular kinetics of murine lung: model system to determine basis for radioprotection with keratinocyte growth factor. Int. J. Radiat. Oncol. Biol. Phys. (2004) 58:435-444.
  • HOHLFELD JM, HOYMANN HG, TSCHERNIG T et al.: Keratinocyte growth factor transiently alters pulmonary function in rats. J. Appl. Physiol. (2004) 96:704-710.
  • GEER DJ, SWARTZ DD, ANDREADIS ST: Biomimetic delivery of keratinocyte growth factor upon cellular demand for accelerated wound healing in vitro and in vivo. Am. J. Pathol. (2005) 167:1575-1586.
  • ESCÁMEZ MJ, GARCÍA M, LARCHER F et al.: An in vivo model of wound healing in genetically modified skin-humanized mice. J. Invest. Dermatol. (2004) 123:1182-1191.
  • ROBSON MC, PHILLIPS TJ, FALANGA V et al.: Randomized trial of topically applied repifermin (recombinant human keratinocyte growth factor-2) to accelerate wound healing in venous ulcers. Wound Repair Regen. (2001) 9:347-352.
  • RUBIN JS, OSADA H, FINCH PW TAYLOR WG, RUDIKOFF S, AARONSON SA: Purification and characterization of a newly identified growth factor specific for epithelial cells. Proc. Natl. Acad. Sci. USA (1989) 86:802-806.
  • FINCH PW, RUBIN JS, MIKI T, RON D, AARONSON SA: Human KGF is FGF-related with properties of a paracrine effector of epithelial cell growth. Science (1989) 245:752-755.
  • PTITSYN LR, AL’TMAN IB, GUROV MV, VASIL’EV AV, VOROTELIAK EA, TERSKIKH VV: Production of recombinant human keratinocyte growth factor in Escherichia Coli cells. Bioorg. Khim. (1998) 24:523-529.
  • CHANG Y, WANG J, LU X, THEWKE DP, MASON RJ: KGF induces lipogenic genes through a PI3K and JNK/SREBP-1 pathway in H292 cells. J. Lipid Res. (2005) 46:2624-2635.
  • BAO S, WANG Y, SWEENEY P et al.: Keratinocyte growth factor induces Akt kinase activity and inhibits Fas-mediated apoptosis in A549 lung epithelial cells. Am. J. Physiol. Lung Cell Mol. Physiol. (2005) 288:L36-L42.
  • RAY P, DEVAUX Y, STOLZ DB et al.: Inducible expression of keratinocyte growth factor (KGF) in mice inhibits lung epithelial cell death induced by hyperoxia. Proc. Natl. Acad. Sci. USA (2003) 100:6098-103.
  • DORR W, SPEKL K, FARRELL CL: Amelioration of acute oral mucositis by keratinocyte growth factor: fractionated irradiation. Int. J. Rad. Oncol. Biol. Phys. (2002) 54:245-251.
  • GIBSON RJ, KEEFE DMK, CLARKE JM et al.: The effect of keratinocyte growth factor on tumour growth and small intestinal mucositis after chemotherapy in the rat with breast cancer. Cancer Chemother. Pharmacol. (2002) 50:53-58.
  • GOODLAD RA, MANDIR N, MEERAN K, GHATEI MA, BLOOM SR, PLAYFORD RJ: Does the response of the intestinal epithelium to keratinocyte growth factor vary according to the method of administration? Regul. Pept. (2000) 87:83-90.
  • SLONINA D, HOINKIS C, DORR W: Effect of keratinocyte growth factor on radiation survival and colony size of human epidermal keratinocytes in vitro. Radiat. Res. (2001) 156:761-766.
  • POTTEN CS, BOOTH D, CRAGG NJ O’SHEA JA, TUDOR GL, BOOTH C: Cell kinetic studies in the murine ventral tongue epithelium: the effects of repeated exposure to keratinocyte growth factor. Cell Prolif. (2002) 35(Suppl. 1):22-31.
  • DORR W: Oral mucosa: response modification by keratinocyte growth factor. In: Modification of Radiation Response: Cytokines, Growth Factors, and Other Biological Targets. Nieder C, Milas L, Ang KK (Eds). Springer, Berlin-New York (2003):113-122.
  • ZIA-AMIRHOSSEINI P, SALFI M, LEESE P, SULLIVAN JT: Pharmacokinetics (PK) and pharmacodynamics (PD) of palifermin (a r-huKGF molecule) in healthy volunteers after intravenous administration of single escalating doses up to 250 mcg/kg. The American Society of Hematology 46th Annual Meeting and Exposition. San Diego (CA) USA (4 – 7 December 2004) Abstract 5036.
  • MATSUI H, TAGA M, KUROGI K et al.: Biological action of keratinocyte growth factor in BeWo cells, a human choriocarcinoma cell line. J. Endocrinol. Invest. (2000) 23:19-22.
  • MUNZ B, FRANK S, HUBNER G, OLSEN E, WERNER S: A novel type of glutathione peroxidase: expression and regulation during wound repair. Biochem. J. (1997) 326:579-585.
  • TAKEOKA M, WARD WF, POLLACK H, KAMP DW, PANOS RJ: KGF facilitates repair of radiation-induced DNA damage in alveolar epithelial cells. Am. J. Physiol. (1997) 272:L1174-80.
  • ZIA-AMIRHOSSEINI P, SALFI M, ELHARDT D et al.: Pharmacokinetics (PK) of 2 dosing regimens of palifermin in patients with hematologic malignancies undergoing high-dose chemoradiotherapy and hematopoietic stem cell transplantation. The American Society of Hematology 46th Annual Meeting and Exposition. San Diego (CA) USA (4 – 7 December 2004) Abstract 5294.
  • DORR W, BASSLER S, REICHEL S, SPEKL K: Reduction of radiochemotherapy-induced early oral mucositis by recombinant human keratinocyte growth factor (palifermin): experimental studies in mice. Int. J. Radiat. Oncol. Biol. Phys. (2005) 62:881-887.
  • DORR W, REICHEL S, SPEKL K: Effects of keratinocyte growth factor (palifermin) administration protocols on oral mucositis (mouse) induced by fractionated irradiation. Radiother. Oncol. (2005) 75:99-105.
  • DORR W, HEIDER K, SPEKL K: Reduction of oral mucositis by palifermin (rHuKGF): dose-effect of rHuKGF. Int. J. Radiat. Biol. (2005) 81:557-565.
  • FARRELL CL, BREADY JV, REX KL et al.: Keratinocyte growth factor protects mice from chemotherapy and radiation-induced gastrointestinal injury and mortality. Cancer Res. (1998) 58:933-939.
  • OELMANN E, HAGHGU S, KULIMOVA E et al.: Influence of keratinocyte growth factor on clonal growth of epithelial tumor cells, lymphoma and leukemia cells and on sensitivity of tumor cells towards 5-fluorouracil in vitro. Int. J. Oncol. (2004) 25:1001-1012.
  • NING S, SHUI C, KHAN WB et al.: Effects of keratinocyte growth factor on the proliferation and radiation survival of human squamous cell carcinoma cell lines in vitro and in vivo. Int. J. Radiat. Oncol. Biol. Phys. (1998) 40:177-187.
  • HILLE A, RAVE-FRANK M, PRADIER O et al.: Effect of keratinocyte growth factor on the proliferation, clonogenic capacity and colony size of human epithelial tumour cells in vitro. Int. J. Radiat. Biol. (2003) 79:119-128.
  • NGUYEN TN, ZANG XP, PENTO JT: Keratinocyte growth factor stimulates the migration and proliferation of breast cancer cells in a culture wounding model. Pharmacol. Res. (2002) 46:179-183.
  • ZANG XP, PENTO JT: Keratinocyte growth factor-induced motility of breast cancer cells. Clin. Exp. Metastasis (2001) 18:573-580.
  • ROPIQUET F, HUGUENIN S, VILLETTE JM et al.: FGF7/KGF triggers cell transformation and invasion on immortalised human prostatic epithelial PNT1A cells. Int. J. Cancer (1999) 82:237-243.
  • OKUNIEFF P, FENTON BM, ZHANG L et al.: Fibroblast growth factors (FGFS) increase breast tumor growth rate, metastases, blood flow, and oxygenation without significant change in vascular density. Adv. Exp. Med. Biol. (2003) 530:593-601.
  • OKUNIEFF P, LI M, LIU W et al.: Keratinocyte growth factors radioprotect bowel and bone marrow but not KHT sarcoma. Am. J. Clin. Oncol. (2001) 24:491-495.
  • BRIZEL DM, HERMAN T, GOFFINET D et al.: A Phase I/II trial of escalating doses of recombinant human keratinocyte growth factor (rHuKGF) in head and neck cancer patients receiving radiotherapy with concurrent chemotherapy. Int. J. Radiat. Oncol. Biol. Phys. (2001) 51(Suppl. 1): Abstract 67.
  • BRIZEL DM, LE QT, ROSENTHAL D et al.: Phase II study of recombinant human keratinocyte growth factor in head and neck cancer treated with standard or hyperfractionated irradiation and concurrent chemotherapy. Proceedings of the 44th Annual meeting of the American Society For Therapeutic Radiology and Oncology (ASTRO). New Orleans (LA) USA (6 – 10 October 2002) Abstract 2128.
  • SPIELBERGER RT, STIFF P, EMMANOUILIDES C et al.: Efficacy of recombinant human keratinocyte growth factor (rHuKGF) in reducing mucositis in patients with hematologic malignancies undergoing autologous peripheral blood progenitor cell transplantation (auto-PBPCT) after radiation-based conditioning – results of a Phase II trial. Proceedings of the 37th American Society of Clinical Oncology (ASCO). Baltimore (MD) USA (12 – 15 May 2001) Abstract 25.
  • PANOSKALTSIS-MORTARI A, INGBAR DH, JUNG P et al.: KGF pretreatment decreases B7 and granzyme B expression and hastens repair in lungs of mice after allogeneic BMT. Am. J. Physiol. Lung Cell Mol. Physiol. (2000) 278:L988-L999.
  • CHEN L, BRIZEL DM, RABBANI ZN et al.: The protective effect of recombinant human keratinocyte growth factor on radiation-induced pulmonary toxicity in rats. Int. J. Radiat. Oncol. Biol. Phys. (2004) 60:1520-1529.
  • SUGAHARA K, IYAMA K, KURODA MJ, SANO K: Double intratracheal instillation of keratinocyte growth factor prevents bleomycin-induced lung fibrosis in rats. J. Pathol. (1998) 186:90-98.
  • PANOSKALTSIS-MORTARI A, TAYLOR PA, RUBIN JS et al.: Keratinocyte growth factor facilitates alloengraftment and ameliorates graft-versus-host disease in mice by a mechanism independent of repair of conditioning-induced tissue injury. Blood (2000) 96:4350-4356.
  • HILL GR, CRAWFORD JM, COOK KR, BRINSON YS, PAN L, FERRARA JL: Total body irradiation and acute graft-versus-host-disease: the role of gastrointestinal damage and inflammatory cytokines. Blood (1997) 90:3204-3213.
  • BLAZAR BR, WEISDORF DJ, DEFOR TE et al.: A Phase I/II randomized, placebo-control trial of palifermin to prevent graft-versus-host-disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood (2006) In press.

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