A multicenter phase-II study of 5-FU, leucovorin and oxaliplatin (FOLFOX6) in patients with pretreated metastatic colorectal cancer

Ken Kato, Yoshitaka Inaba, Yasushi Tsuji, Taito Esaki, Akira Yoshioka, Nobuyuki Mizunuma, Toshiro Mizuno, Hitoshi Kusaba, Hirohumi Fujii, Kei Muro, Yasuhiro Shimada, Kuniaki Shirao

    Research output: Contribution to journalArticlepeer-review

    5 Citations (Scopus)


    Objective: Infusional 5-fluorouracil and leucovorin with oxaliplatin is one of the standard regimens for patients with pretreated metastatic colorectal cancer, as well as for first-line chemotherapy. FOLFOX4 has shown its efficacy in pivotal trials, but patients must make twiceweekly hospital visits. FOLFOX6 is a more convenient regimen, requiring a visit once every two weeks. The objective of this study was to evaluate the efficacy and safety profile of FOLFOX6 in Japanese patients with pretreated colorectal cancer. Method: Fifty-one metastatic colorectal cancer patients who failed to respond to first-line chemotherapy were enrolled in the study from April to July 2005. Oxaliplatin, 5-fluorouracil and l-leucovorin were administered every two weeks. Oxaliplatin (100 mg/m2) and l-leucovorin (200 mg/m2) were given intravenously over 2 h followed by 5-fluorouracil bolus 400 mg/m2 i.v. and 46-h infusion of 2400 mg/m2. The primary endpoint was the response rate. Results: Two patients had no measurable lesions and were excluded from the efficacy analysis. Of the 49 eligible patients, one complete response and 6 partial responses were observed, resulting in a response rate (RR) of 14.3% (95% confidence interval: 5.9-27.2%). Median time to treatment failure and progression-free survival was 4.4 and 5.3 months, respectively. Overall survival was 11.4 months. The incidence of grade 2/3 (Debiopharm neurotoxicity criteria) peripheral neuropathy was 41.2%, whereas the overall incidence of grade 3/4 neutropenia was 43.2%. Conclusion: The results of our study suggest that FOLFOX6 had an acceptable profile in terms of both efficacy and safety in previously treated colorectal cancer patients.

    Original languageEnglish
    Article numberhyq158
    Pages (from-to)63-68
    Number of pages6
    JournalJapanese journal of clinical oncology
    Issue number1
    Publication statusPublished - Jan 2011

    All Science Journal Classification (ASJC) codes

    • Oncology
    • Radiology Nuclear Medicine and imaging
    • Cancer Research


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