Originally published as JCO Early Release 10.1200/JCO.2005.04.1152 on October 30 2006

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Palifermin Reduces the Incidence of Oral Mucositis in Patients With Metastatic Colorectal Cancer Treated With Fluorouracil-Based Chemotherapy

Lee S. Rosen, Ehtesham Abdi, Ian D. Davis, John Gutheil, Frederick M. Schnell, John Zalcberg, Alessandra Cesano, Urte Gayko, Mon-Gy Chen, Stephen Clarke

From Premiere Oncology, John Wayne Cancer Institute, St John's Health Center, Santa Monica; Sharp HealthCare, Sidney Kimmel Cancer Center, San Diego; Amgen Inc, Thousand Oaks, CA; Bendigo Health Care Group, Bendigo; Department of Medical Oncology, Austin Health, Heidelberg; Peter MacCallum Cancer Institute, Melbourne, Victoria; Medical Oncology Department, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; and Central Georgia Hematology Oncology, Macon, GA

Address reprint requests to Lee S. Rosen, MD, Premiere Oncology, John Wayne Cancer Institute, 2020 Santa Monica Blvd, Ste 510, Santa Monica, CA 90404; e-mail: lrosen{at}premiereoncology.com

Purpose To characterize the efficacy and safety of palifermin in reducing the incidence of oral mucositis (OM) and diarrhea when administered to patients with metastatic colorectal cancer (CRC) receiving fluorouracil/leucovorin (FU/LV) chemotherapy.

Patients and Methods Patients (N = 64) were randomly assigned to receive either placebo or palifermin (40 µg/kg for 3 consecutive days) before each of two consecutive cycles of chemotherapy with FU/LV. The incidence of OM and diarrhea, safety, disease progression, and survival were evaluated.

Results Thirty-six patients received placebo and 28 patients received palifermin. The incidence of WHO grade 2 or higher OM was lower in patients who received palifermin compared with placebo (29% v 61% in cycle 1; 11% v 47% in cycle 2). FU dose reductions in the second chemotherapy cycle were more frequent in the placebo group (31%) than in the palifermin group (14%). Investigators reported lower mucositis scores and patients reported less severe symptoms with palifermin. There were no statistically significant differences in the incidence or severity of diarrhea or in overall survival between the groups. Overall, palifermin was safe and well tolerated.

Conclusion Palifermin administered at the indicated dosing regimen (40 µg/kg for 3 consecutive days) before chemotherapy was well tolerated and resulted in a statistically significant and clinically meaningful reduction in the incidence of WHO grade 2 or higher OM in patients with metastatic CRC.

published online ahead of print at www.jco.org on October 30, 2006.

Supported by Amgen Inc, Thousand Oaks, CA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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