5-Fluorouracil or capecitabine in the treatment of advanced colorectal cancer: a pooled-analysis of randomized trials.

The aim of this pooled-analysis is to evaluate the benefit of capecitabine (C) versus standard intravenous 5-Fluorouracil (5-FU) as monochemotherapy or combination therapy in advanced colorectal cancer (CRC) in terms of safety and efficacy. Eligible patients have been randomized to receive either C-based or 5-FU-based chemotherapy for the treatment of advanced CRC. Relative risks (RRs) with 95% confidence intervals (CIs) of selected side effects (diarrhea, nausea, vomiting, stomatitis, hand and foot syndrome, neutropoenia, febrile neutropoenia, and cardio toxicity) and overall response rate (ORR) were calculated and hazard ratios (HRs) of progression-free survival (PFS) and overall survival were obtained, respectively, from published data. The RRs of stomatitis and neutropoenia are 0.39 and 0.40, respectively with C (P < 0.00001). In particular high-grade mucositis and neutropoenia, they are reduced by 69 and 74%, respectively (RR: 0.31 and 0.26). Diarrhea, nausea, vomiting, febrile neutropoenia, and cardio toxicity with C are not worse than with 5-FU. The RR of hand and foot syndrome with C compared to 5-FU is 3.45, (P < 0.00001). Response rate, PFS, and OS are equivalent in both C- and 5-FU-based regimens. The use of C instead of 5-FU in advanced colorectal cancer regimens results in significantly less toxicity in terms of stomatitis and neutroponenia. Only hand and foot syndrome is worse with C than with 5-FU. Activity and efficacy are similar. Capecitabine could be therefore considered standard of care in advanced CRC.

RCT Entities:   Population Interventions Outcomes