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外文.pdf
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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, and Ralf Wong
Purpose: To compare the response rate, efficacy pa- produced a significantly lower incidence (P .0002) of
rameters, and toxicity profile of oral capecitabine with diarrhea, stomatitis, nausea, and alopecia. Patients
bolus intravenous (IV) fluorouracil plus leucovorin (5- treated with capecitabine also displayed lower inci-
FU/LV) as first-line treatment in patients with metastatic dences of grade 3/4 stomatitis and grade 3/4 neutro-
colorectal cancer. penia (P .0001) leading to significantly less neutro-
Patients and Methods: We prospectively randomized penic fever/sepsis. Grade 3 hand-foot syndrome (P
605 patients to treatment with oral capecitabine for 14 .00001) and grade 3/4 hyperbilirubinemia were the
days every 3 weeks or 5-FU/LV by rapid IV injection daily only toxicities more frequently associated with capecit-
for 5 days in 4-week cycles. abine than with 5-FU/LV treatment.
Results: The overall objective tumor response rate Conclusion: Oral capecitabine was more active than
among
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