Efficacy of Capecitabine Versus 5-fluorouracil in Colorectal and Gastric Cancers: a Meta-analysis of Individual Data from 6171 Patients

Background: To compare the effects of oral capecitabine-containing chemotherapy regimens with i.v. 5-fluorouracil (5-FU)-containing chemotherapy regimens on overall survival in patients with gastrointestinal cancers.

Methods: A meta-analysis, based on individual patient data from six randomised non-inferiority trials, was carried out at the request of regulatory authorities to compare the effects of single-agent capecitabine or capecitabine-containing chemotherapy versus matched 5-FU-based regimens in terms of overall survival in patients with stage III colon, metastatic colorectal or advanced gastric cancer.

Results: Data from a total of 6171 patients with stage III colon cancer (n = 1987), metastatic colorectal cancer (n = 3868) or advanced gastric cancer (n = 316) were included. A total of 3097 patients were treated with capecitabine-containing chemotherapy and 3074 patients with 5-FU-containing chemotherapy. The unadjusted hazard ratio for overall survival for capecitabine-containing chemotherapy versus 5-FU-containing chemotherapy was 0.94 (95% confidence interval 0.89-1.00; P = 0.0489).

Conclusions: Oral capecitabine is at least equivalent to i.v. 5-FU in terms of overall survival in patients with gastrointestinal cancers. Capecitabine and 5-FU can be used interchangeably in these patient populations.