Originally published as JCO Early Release 10.1200/JCO.2008.21.4577 on November 2 2009

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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.

Corresponding author: Heikki Joensuu, MD, Department of Oncology, Helsinki University Central Hospital, Haartmaninkatu 4, P.O.B. 180, FIN-00029 Helsinki, Finland; 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.

See accompanying editorial on page 5671 and articles on pages 5693, 5700 and 5838

Written on behalf of the Finnish Breast Cancer Group.

Supported by sanofi-aventis, Pierre Fabre, Pharmacia, Roche, and the state of Finland.

Presented in part at the 28th Annual San Antonio Breast Cancer Symposium, December 8-11, 2005, San Antonio, TX.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: ISRCTN76560285 [controlled-trials.com] .

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