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Japanese Journal of Clinical Oncology Advance Access published online on September 9, 2005

Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi147
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© 2005 Foundation for Promotion of Cancer Research
Received April 4, 2005
Accepted July 26, 2005

Original Article

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

Junichi Sakamoto 1*, Chikuma Hamada 1, Mahbubur Rahman 1, Susumu Kodaira 1, Katsuki Ito 1, Hiroaki Nakazato 1, Yasuo Ohashi 1, and Masayuki Yasutomi 1

1 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

* To whom correspondence should be addressed.
Junichi Sakamoto, E-mail: sakamoto{at}pbh.med.kyoto-u.ac.jp


   Abstract

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.

Keywords: colorectal cancer; carmofur; chemotherapy; disease-free survival; overall survival; randomized clinical trials.
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