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Japanese Journal of Clinical Oncology Advance Access originally published online on September 9, 2005
Japanese Journal of Clinical Oncology 2005 35(9):536-544; doi:10.1093/jjco/hyi147
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© 2005 Foundation for Promotion of Cancer Research

An Individual Patient Data Meta-analysis of Adjuvant Therapy with Carmofur in Patients with Curatively Resected Colon Cancer

Junichi Sakamoto, Chikuma Hamada, Mahbubur Rahman, Susumu Kodaira, Katsuki Ito, Hiroaki Nakazato, Yasuo Ohashi and Masayuki Yasutomi

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

For reprints and all correspondence: Junichi Sakamoto, Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. E-mail: sakamoto{at}pbh.med.kyoto-u.ac.jp

Received April 4, 2005; accepted July 26, 2005

Background: Oral carmofur, either as a single or in combination with other chemotherapeutic agents, has been used as adjuvant chemotherapy for curatively resected colon cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with this cancer. The objective of this study was to perform a reappraisal of randomized clinical trials conducted in this regard.

Methods: We designed an individual patient-based meta-analysis of relevant clinical trials to examine the benefit of oral carmofur for curatively resected colon cancer in terms of overall survival (OS) and disease-free survival (DFS).

Results: We analyzed individual patient data of three randomized clinical trials, which met the predetermined inclusion criteria. These three trials had a combined total of 2152 patients, carmofur as adjuvant chemotherapy compared with surgery-alone, 5 years follow-up, intention-to-treat-based analytic strategy and similar end points (OS and DFS). In a pooled analysis, 5 year OS rates were 80.4 and 76.4%, and 5 year DFS rates 76.9 and 71.0%, respectively, in carmofur and surgery-alone group. Oral carmofur had significant advantage over surgery-alone in terms of both OS [pooled hazard ratio, 0.82; 95% confidence interval (CI) = 0.68–0.99; P = 0.043] and DFS (pooled hazard ratio, 0.77; 95% CI = 0.65–0.91; P = 0.003).

Conclusions: This individual patient-based meta-analysis demonstrated that oral carmofur significantly improves both OS and DFS in patients with curatively resected colon cancers.

Key Words: colorectal cancer • carmofur • chemotherapy • disease-free survival • overall survival • randomized clinical trials


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