Palifermin. In myelotoxic therapy-induced oral mucositis

Drugs

Volumn 65, Issue 15, 2005, Pages 2139-2146

  Asif, M Asif A ^a   Wellington, Keri ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

AMYLASE; ANTINEOPLASTIC AGENT; PALIFERMIN; PLACEBO; TRIACYLGLYCEROL LIPASE;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; AMYLASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTHRALGIA; AUTOLOGOUS STEM CELL TRANSPLANTATION; BONE MARROW TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CANCER PAIN; CANCER PATIENT; CANCER RADIOTHERAPY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG TOLERABILITY; DYSESTHESIA; EDEMA; ERYTHEMA; HEMATOLOGIC MALIGNANCY; HUMAN; HYPERTENSION; MUCOSA INFLAMMATION; PRURITUS; REDUCED INTENSITY CONDITIONING; REVIEW; SKIN TOXICITY; STEADY STATE; TASTE DISORDER; TONGUE DISEASE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; WORLD HEALTH ORGANIZATION;

ANIMALS; CLINICAL TRIALS; DOUBLE-BLIND METHOD; FIBROBLAST GROWTH FACTOR 7; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; KERATINOCYTES; RANDOMIZED CONTROLLED TRIALS; STOMATITIS; TRANSPLANTATION CONDITIONING; TREATMENT OUTCOME;

EID: 26944437739     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200565150-00008     Document Type: Review

References (20)

1. Sonis ST, Elting LS, Keefe D, et al. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer 2004; 100 (9 Suppl.): 1995-2025
2. Elting LS, Cooksley C, Chambers M. The burdens of cancer therapy: clinical and economic outcomes of chemotherapyinduced mucositis. Cancer 2003; 98 (7): 1531-9
3. 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 (8): 2201-5
4. Bellm LA, Epstein JB, Rose-Ped A, et al. Patient reports of complications of bone marrow transplantation. Support Care Cancer 2000; 8 (1): 33-9
5. Ruescher TJ, Sodeifi A, Scrivani SJ, et al. The impact of mucositis on a-hemolytic streptococcal infection in patients undergoing autologous bone marrow transplantation for hema tologic malignancies. Cancer 1998; 82 (11): 2275-81
6. Rubenstein EB, Peterson DE, Schubert M, et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer 2004; 100 (9 Suppl.): 2026-46
7. auf dem Keller U, Krampert M, Kümin A, et al. Keratinocyte growth factor: effects on keratinocytes and mechanisms of action. Eur J Cell Biol 2004; 83 (11-12): 607-12
8. Amgen Inc. Product information (US): Kepivance™ (palifermin 6.25mg) lyophilized powder for IV injection [online]. Available from URL: http://www.kepivance.com [Accessed 2005 Aug 16]
9. Spielberger R, Stiff P, Bensinger W, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med 2004; 351 (25): 2590-8
10. 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 Apr 15; 21 (8): 1452-8
11. 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 [abstract no. 1529]. Proc Am Soc Clin Oncol 2001; 20 (Pt 1): 383a
12. Dörr W, Spekl K, Farrell CL. Amelioration of acute oral mucositis by keratinocyte growth factor: fractionated irradiation. Int J Radiat Oncol Biol Phys 2002; 54 (1): 245-51
13. Dörr W, Bässler S, Reichel S, et al. 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 (3): 881-7
14. Zia-Amirhosseini P, Salfi M, Leese P, et al. Pharmacokinetics and pharmacodynamics of palifermin (a r-huKGF molecule) in healthy volunteers after intravenous administration of single escalating doses up to 250 mcg/kg [abstract no. 5036]. Blood 2004; 104 (11 Pt 2): 341-2
15. 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 (1): 177-87
16. Serdar CM, Heard R, Prathikanti R, et al. Safety, pharmacokinetics and biologic activity of rHuKGF in normal volunteers: results of a placebo-controlled randomized double-blind phase 1 study [abstract no. 761]. Blood 1997; 90 (Suppl. 1. Pt 1): 172
17. Durrant S, Pico JL, Schmitz N, et al. A phase I study of recombinant human keratinocyte growth factor (rHuKGF) in lymphoma patients receiving high-dose chemotherapy (HDC) with autologous peripheral blood progenitor cell transplantable tion (AUTOPBPCT) [abstract no. 3130]. Blood 1999; 94 (10 Suppl. 1 Pt 1): 708
18. 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 trans plantation (auto-PBPCT) after radiation-based conditioning: results of a phase 2 trial [abstract no. 25]. Proc Am Soc Clin Oncol 2001; 20 (Pt 1): 7a
19. Emmanouilides C, Spielberger R, Stiff P, et al. Palifermin treatment of mucositis in transplant patients reduces health resource use: phase 3 results [abstract no. 883]. Blood 2003; 102 (11 Pt 1): 251-2
20. Elting LS, Shih YCT, Stiff PJ, et al. Palifermin reduces estimated downstream costs of autologous stem cell transplant (SCT): analysis of phase 3 trial results [abstract no. 2191]. Blood 2004; 104 (11 Pt 1): 602