Purpose: Capecitabine is an active agent in the treatment of breast cancer. It is not known whether integration of capecitabine into an adjuvant regimen that contains a taxane, an anthracycline, and cyclophosphamide improves outcome in early breast cancer. Patients and Methods: Women with axillary node-positive or high-risk node-negative breast cancer were randomly assigned to receive either three cycles of docetaxel and capecitabine (TX) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX: n = 753) or three cycles of docetaxel (T) followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF: n = 747). The primary end point was recurrence-free survival (RFS). Results: During a median follow-up time of 59 months, 214 RFS events occurred (local or distant recurrences or deaths: TX/CEX, n = 96: T/CEF, n = 118). RFS was not significantly different between the groups (hazard ratio [HR], 0.79: 95% CI, 0.60 to 1.04: P = .087: 5-year RFS, 86.6% for TX/CEX v 84.1% for T/CEF). Fifty-six patients assigned to TX/CEX died during the follow-up compared with 75 of patients assigned to T/CEF (HR, 0.73: 95% CI, 0.52 to 1.04: P = .080). In exploratory analyses, TX/CEX improved breast cancer-specific survival (HR, 0.64: 95% CI, 0.44 to 0.95: P = .027) and RFS in women with triple-negative disease and in women who had more than three metastatic axillary lymph nodes at the time of diagnosis. We detected little severe late toxicity. Conclusion: Integration of capecitabine into a regimen that contains docetaxel, epirubicin, and cyclophosphamide did not improve RFS significantly compared with a similar regimen without capecitabine.
|Number of pages||8|
|Journal||JOURNAL OF CLINICAL ONCOLOGY|
|Publication status||Published - 2012|
|Publication type||A1 Journal article-refereed|
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