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

摘要: 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 metastatic colorectal cancer. PATIENTS AND METHODS: We prospectively randomized 605 to for 14 days every 3 weeks or 5-FU/LV by rapid IV injection daily 5 4-week cycles. RESULTS: The overall objective tumor rate among all was significantly higher group (24.8%) than (15.5%; P = .005). In groups, median times disease progression were 4.3 4.7 months (log-rank .72), failure 4.1 3.1 (P .19), survival 12.5 13.3 .974), respectively. Capecitabine, compared treatment, produced a lower incidence < .0002) diarrhea, stomatit...