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Journal of Clinical Oncology, Vol 19, Issue 8 (April), 2001: 2282-2292
© 2001 American Society for Clinical Oncology

Comparison of Oral Capecitabine Versus Intravenous Fluorouracil Plus Leucovorin as First-Line Treatment in 605 Patients With Metastatic Colorectal Cancer: Results of a Randomized Phase III Study

By Paulo M. Hoff, Rafat Ansari, Gerald Batist, John Cox, Walter Kocha, Mario Kuperminc, Jean Maroun, David Walde, Charles Weaver, Evelyn Harrison, Hans U. Burger, Bruno Osterwalder, Alfred O. Wong, Ralf Wong

From The University of Texas M.D. Anderson Cancer Center, Houston; Physician Reliance Network, Inc, Dallas, TX; Michiana Hematology/Oncology, South Bend, IN; Hematology and Oncology Association of Virginia, Richmond, VA; Response Oncology, Memphis, TN; Hoffmann-La Roche Inc, Nutley, NJ; McGill University Department of Oncology, Montreal, Quebec; London Regional Cancer Centre, London; Ottawa Regional Cancer Centre, Ottawa; Group Health Center, Sault Ste Marie, Ontario; Tom Baker Cancer Center, Calgary, Alberta; H. Bliss Cancer Centre, St John’s, Newfoundland, Canada; and F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Address reprint requests to Paulo M. Hoff, MD, M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 426, Houston, TX 77030-4009; email: phoff{at}mdanderson.org

PURPOSE: To compare the response rate, efficacy parameters, and toxicity profile of oral capecitabine with bolus intravenous (IV) fluorouracil plus leucovorin (5-FU/LV) as first-line treatment in patients with metastatic colorectal cancer.

PATIENTS AND METHODS: We prospectively randomized 605 patients to treatment with oral capecitabine for 14 days every 3 weeks or 5-FU/LV by rapid IV injection daily for 5 days in 4-week cycles.

RESULTS: The overall objective tumor response rate among all randomized patients was significantly higher in the capecitabine group (24.8%) than in the 5-FU/LV group (15.5%; P = .005). In the capecitabine and 5-FU/LV groups, median times to disease progression were 4.3 and 4.7 months (log-rank P = .72), median times to treatment failure were 4.1 and 3.1 months (P = .19), and median overall survival times were 12.5 and 13.3 months (P = .974), respectively. Capecitabine, compared with bolus 5-FU/LV treatment, produced a significantly lower incidence (P < .0002) of diarrhea, stomatitis, nausea, and alopecia. Patients treated with capecitabine also displayed lower incidences of grade 3/4 stomatitis and grade 3/4 neutropenia (P < .0001) leading to significantly less neutropenic fever/sepsis. Grade 3 hand-foot syndrome (P < .00001) and grade 3/4 hyperbilirubinemia were the only toxicities more frequently associated with capecitabine than with 5-FU/LV treatment.

CONCLUSION: Oral capecitabine was more active than 5-FU/LV in the induction of objective tumor responses. Time to disease progression and survival were at least equivalent for capecitabine compared with the 5-FU/LV arm. Capecitabine also demonstrated clinically meaningful benefits over bolus 5-FU/LV in terms of tolerability.

Presented in part at the Thirty-Fifth Annual Meeting of the American Society of Clinical Oncology, Atlanta, Georgia, May 15-18, 1999.




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