¹Meta-Analysis Group of the Japanese Society for Cancer of the Colon and Rectum; Secretariat, Department of Epidemiological & Clinical Research Information Management, Kyoto University, Graduate School of Medicine, Kyoto, Japan

Correspondence: Dr J Sakamoto, Young Leaders Program, Department of Social Life Science, Nagoya University Graduate School of Medicine, 65 Tsurumaicho, Showaku, Nagoya 466-8550, Japan. E-mail: sakamjun@med.nagoya-u.ac.jp

Received 1 December 2006; Revised 19 February 2007; Accepted 19 February 2007; Published online 20 March 2007.

Abstract

Uracil–Tegafur (UFT), an oral fluorinated pyrimidine chemotherapeutic agent, has been used for adjuvant chemotherapy in curatively resected colorectal cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with rectal cancer. The objective of this study was to perform a reappraisal of randomised clinical trials conducted in this field. We designed an individual patient-based meta-analysis of relevant clinical trials to examine the benefit of UFT for curatively resected rectal cancer in terms of overall survival (OS), disease-free survival (DFS), and local relapse-free survival (LRFS). We analysed individual patient data of five adjuvant therapy randomised clinical trials for rectal cancer, which met the predetermined inclusion criteria. These five trials had a combined total of 2091 patients, UFT as adjuvant chemotherapy compared to surgery-alone, 5-year follow-up, intention-to-treat-based analytic strategy, and similar endpoints (OS and DFS). In a pooled analysis, UFT had significant advantage over surgery-alone in terms of both OS (hazard ratio, 0.82; 95% confidence interval (CI), 0.70–0.97; P=0.02) and DFS (hazard ratio, 0.73; 95%CI, 0.63–0.84; P<0.0001). This individual patient-based meta-analysis demonstrated that oral UFT significantly improves both OS and DFS in patients with curatively resected rectal cancer.