Palifermin reduced the incidence and duration of mucositis in patients with hematologic malignancies
2/10/2005 Rebekah Cin Hem/Onc Today Avoiding a painful complication of chemotherapy and radiotherapy be-fore bone marrow transplantation may be easier with an FDA approval of palifermin (Kepivance, Amgen). The approval followed a placebo-controlled, double-blind, phase-3 study that found the IV drug reduced the risk of mucositis during pre-transplant regimens. The study, which appeared in The New England Journal of Medicine, also found that palifermin shortened the duration of mucositis in patients who developed the adverse effect. Mucositis development High-dose chemotherapy and radiotherapy followed by hematopoietic stem-cell support is a well-established treatment for hematologic cancers, said Ricardo Spielberger, MD, of the City of Hope National Medical Center in Duarte, Calif. and lead researcher of the study. Unfortunately, oral mucositis commonly develops. About 70% to 80% of patients undergoing high-dose chemotherapy, radiotherapy and hematopoietic stem-cell support experience the adverse effect. Spielberger and his colleagues predicted that palifermin would mimic naturally occurring keratinocyte growth factor by stimulating cells on the surface layer of the mouth to grow. This would lead to fast replacement of the cells killed by the cancer treatments as well as accelerating the healing process of mouth ulcers. Mucositis alleviated Researchers enrolled 212 eligible patients with leukemia or lymphoma who received high doses of chemotherapy and radiation treatments associated with bone marrow transplantation. The patients were randomized to two treatment arms. In one group, 106 patients received IV palifermin for three days before treatment. In the other group, 106 patients received a placebo in place of palifermin. Ninety-eight percent of [...]