Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials

摘要: This study evaluates the efficacy of capecitabine using data from a large, well-characterised population patients with metastatic colorectal cancer (mCRC) treated in two identically designed phase III studies. A total 1207 previously untreated mCRC were randomised to either oral (1250 mg m(-2) twice daily, days 1-14 every 21 days; n=603) or intravenous (i.v.) bolus 5-fluorouracil/leucovorin (5-FU/LV; Mayo Clinic regimen; n=604). Capecitabine demonstrated statistically significant superior response rate compared 5-FU/LV (26 vs 17%; P<0.0002). Subgroup analysis that consistently resulted rates (P<0.05), even patient subgroups poor prognostic indicators. The median time and duration similar progression (TTP) was equivalent arms (hazard ratio (HR) 0.997, 95% confidence interval (CI) 0.885-1.123, P=0.95; 4.6 4.7 months 5-FU/LV, respectively). Multivariate Cox regression identified younger age, liver metastases, multiple metastases Karnofsky Performance Status as independent indicators for TTP. Overall survival (HR 0.95, CI 0.84-1.06, P=0.48; 12.9 12.8 months, results rate, TTP overall survival, an improved safety profile convenience i.v. first-line treatment MCRC. For whom fluoropyrimidine monotherapy is indicated, should be strongly considered. Following encouraging I II trials, trials are evaluating combination irinotecan, oxaliplatin radiotherapy. suitable replacement 5-FU backbone therapy.