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, Masayuki Yasutomi

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)536-544
Number of pages9
JournalJapanese Journal of Clinical Oncology
Issue number9
StatePublished - Sep 2005
Externally publishedYes


  • Carmofur
  • Chemotherapy
  • Colorectal cancer
  • Disease-free survival
  • Overall survival
  • Randomized clinical trials

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research


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