J Cassidy1, L Saltz2, C Twelves3, E Van Cutsem4, P Hoff5, Y Kang6, J P Saini7, F Gilberg7, D Cunningham8. 1. Glasgow University, Glasgow, UK. Electronic address: j.cassidy@beatson.gla.ac.uk. 2. Memorial Sloan Kettering Cancer Center, New York, USA. 3. University of Leeds, Leeds, UK. 4. University Hospital Gasthuisberg, Leuven, Belgium. 5. Centro De Oncologia/Hospital Sirio Libanes, São Paulo, Brazil. 6. Asan Medical Center, Seoul, Republic of Korea. 7. F. Hoffmann-La Roche, Basel, Switzerland. 8. The Royal Marsden Hospital, Sutton, UK.
Abstract
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.
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.