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

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    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.

    Original languageEnglish (US)
    Pages (from-to)536-544
    Number of pages9
    JournalJapanese Journal of Clinical Oncology
    Volume35
    Issue number9
    DOIs
    StatePublished - Sep 1 2005

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    Keywords

    • 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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