Palifermin

Abstract

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.