Palifermin: in myelotoxic therapy-induced oral mucositis.
Palifermin, a recombinant human keratinocyte growth factor (KGF), mimics the actions of endogenous KGF and has shown efficacy in the management of myelotoxic therapy-induced oral mucositis in cancer patients. In a randomised, double-blind trial in patients with haemtaological malignancies receiving conditioning radiochemotherapy before undergoing autologous stem cell transplant, intravenous palifermin 60 microg/kg/day (two 3-day cycles, administered before myelotoxic therapy and after transplant) significantly reduced the median duration (primary endpoint) [3 vs 9 days] and incidence (63% vs 98%) of WHO grade 3 or 4 oral mucositis, compared with placebo. Patient-reported outcomes also showed significant improvement with palifermin treatment, which was associated with significant reductions in healthcare resource utilisation, compared with placebo. The drug was generally well tolerated, with skin/oral toxicities, pain/arthralgias and dysaesthesia being the most common palifermin-related adverse reactions.
Siddiqui
M Asif A
MA
Adis International Limited, Auckland, New Zealand.
Wellington
Keri
K
D000818:Animals; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D051523:Fibroblast Growth Factor 7 / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015603:Keratinocytes / Q000187:drug effects / Q000378:metabolism; D016032:Randomized Controlled Trials as Topic; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D019172:Transplantation Conditioning / Q000009:adverse effects*; D016896:Treatment Outcome
D051523:Fibroblast Growth Factor 7