A pilot phase II study of capecitabine in advanced or recurrent breast cancer.

Toshiaki Saeki, Tsunehito Kimura, Masakazu Toi, Tetsuo Taguchi

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    Abstract

    BACKGROUND: A pilot phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent regimen of capecitabine (Xeloda) in patients with advanced or recurrent breast cancer. METHODS: A total of 23 patients who had received no more than one prior chemotherapy regimen received oral 828 mg/m2 capecitabine twice daily for 3 weeks followed by a 1-week rest period. The response to capecitabine was evaluated in 22 patients (one patient ineligible). RESULTS: The overall response rate was 45.5% (95% CI, 24.4-67.8%), including 1 complete response (4.5%) and 9 patients with partial response (40.9%). A further 7 patients (31.8%) had stable disease. The median duration of response was 7.2 months (range, 3.0-15.8 months) and the median time to progression was 6.4 months (95% CI, 4.1-15.1 months). Treatment-related adverse events >or= grade 3 were observed in 7 patients (30.1%). CONCLUSION: Intermittent capecitabine therapy (828 mg/m(2) twice daily for 3 weeks followed by a 1-week rest period) was shown to be effective and well tolerated as second-line treatment for advanced or recurrent breast cancer. The Japanese regimen is worthy of further study in larger numbers of patients in phase II / III clinical trials.

    Original languageEnglish (US)
    Pages (from-to)49-57
    Number of pages9
    JournalBreast cancer (Tokyo, Japan)
    Volume13
    Issue number1
    DOIs
    StatePublished - 2006

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    ASJC Scopus subject areas

    • Oncology
    • Radiology Nuclear Medicine and imaging
    • Pharmacology (medical)

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