November 22, 2006 — Palifermin (Kepivance, Amgen) has been shown to reduce the incidence of painful mouth sores and ulcers in a new patient population — metastatic colorectal cancer patients receiving fluorouracil/leucovorin chemotherapy. The product resulted in a statistically significant and clinically meaningful reduction in oral mucositis, researchers conclude in the November 20 issue of the Journal of Clinical Oncology.
Palifermin, a recombinant keratinocyte growth factor, is already available in the United States, having received fast-track Food and Drug Administration approval in late 2004 for use in patients with hematological cancers undergoing intensive chemotherapy and radiation.
In this trial, conducted in 64 patients with colorectal cancer, palifermin was administered intravenously at a dose of 40 µg/kg for 3 consecutive days before each of 2 consecutive cycles of chemotherapy.
Oral mucositis of WHO grade 2 or higher was significantly reduced, occurring in 26% of the palifermin group and 61% of the placebo group in cycle 1, and in 11% of the palifermin group and 47% of the placebo group in cycle 2. However, there were no statistically significant differences between the 2 groups in the incidence and severity of diarrhea or in overall survival.
The researchers, headed by Lee Rosen, MD, from the John Wayne Cancer Institute in Santa Monica, California, comment that palifermin is "safe and well tolerated."
The study was funded by the manufacturer of palifermin, Amgen Inc.
Commenting on the study in a related editorial, Charles L. Loprinzi, MD, and colleagues from the Mayo Clinic, College of Medicine, in Rochester, Minnesota, conclude that the study "did demonstrate biologic activity of palifermin, with decreased mucositis in the treated group.
"Nonetheless, the results from this individual study are not likely to change clinical practice for several reasons," the editorial comments. These include the small size of the study, the decreasing clinical use of the chemotherapy regimen used in the trial (bolus fluorouracil plus leucovorin), the availability of oral cryotherapy (which was not tested in this study), and the cost of the therapy.
J Clin Oncol. 2006;24:5194-5200, 5183-5185.
Medscape Medical News © 2006
Cite this: Zosia Chustecka. Palifermin Reduces Mucositis From Chemotherapy in Colorectal Cancer - Medscape - Nov 22, 2006.