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JCO Early Release, published online ahead of print Nov 2 2009
Received December 6, 2008 Fluorouracil, Epirubicin, and Cyclophosphamide With Either Docetaxel or Vinorelbine, With or Without Trastuzumab, As Adjuvant Treatments of Breast Cancer: Final Results of the FinHer Trial
From the Departments of Oncology and Cardiology, Helsinki University Central Hospital, Helsinki; Laboratory of Cancer Biology, Institute of Medical Technology, University of Tampere; Tampere University Hospital, Tampere; Kuopio University Hospital, Kuopio; Kanta-Häme Central Hospital, Hämeenlinna; Satakunta Central Hospital, Pori; Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu; Department of Oncology, Turku University Central Hospital; 4Pharma Ltd, Turku; South Karelia Central Hospital, Lappeenranta; Kymenlaakso Central Hospital, Kotka; Vaasa Central Hospital, Vaasa; Jyväskylä Central Hospital, Jyväskylä; and Kajaani Central Hospital, Kajaani, Finland. * To whom correspondence should be addressed. E-mail: heikki.joensuu{at}hus.fi
Purpose: Docetaxel has not been compared with vinorelbine as adjuvant treatment of early breast cancer. Efficacy and long-term safety of a short course of adjuvant trastuzumab administered concomitantly with chemotherapy for human epidermal growth factor receptor 2 (HER2) –positive cancer are unknown. Patients and Methods: One thousand ten women with axillary node–positive or high-risk node-negative breast cancer were randomly assigned to receive three cycles of docetaxel or vinorelbine, followed in both groups by three cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC). Women with HER2-positive cancer (n = 232) were further assigned to either receive or not receive trastuzumab for 9 weeks with docetaxel or vinorelbine. The median follow-up time was 62 months after random assignment. Results: Women assigned to docetaxel had better distant disease–free survival (DDFS) than those assigned to vinorelbine (hazard ratio [HR] = 0.66; 95% CI, 0.49 to 0.91; P = .010). In the subgroup of HER2-positive disease, patients treated with trastuzumab tended to have better DDFS than those treated with chemotherapy only (HR = 0.65; 95% CI, 0.38 to 1.12; P = .12; with adjustment for presence of axillary nodal metastases, HR = 0.57; P = .047). In exploratory analyses, docetaxel, trastuzumab, and FEC improved DDFS compared with docetaxel plus FEC (HR = 0.32; P = .029) and vinorelbine, trastuzumab, and FEC (HR = 0.31; P = .020). The median left ventricular ejection fraction of trastuzumab-treated patients remained unaltered during the 5-year follow-up; only one woman treated with trastuzumab was diagnosed with a heart failure. Conclusion: Adjuvant treatment with docetaxel improves DDFS compared with vinorelbine. A brief course of trastuzumab administered concomitantly with docetaxel is safe and effective and warrants further evaluation.
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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