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. Export

@article{citeulike:6074046, abstract = {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.}, author = {Joensuu, Heikki and Bono, Petri and Kataja, Vesa and Alanko, Tuomo and Kokko, Riitta and Asola, Raija and Utriainen, Tapio and Turpeenniemi-Hujanen, Taina and Jyrkki\"{o}, Sirkku and M\"{o}ykkynen, Kari and Helle, Leena and Ingalsuo, Seija and Pajunen, Marjo and Huusko, Mauri and Salminen, Tapio and Auvinen, P\"{a}ivi and Leinonen, Hannu and Leinonen, Mika and Isola, Jorma and Kellokumpu-Lehtinen, Pirkko-Liisa L.}, citeulike-article-id = {6074046}, citeulike-linkout-0 = {http://dx.doi.org/10.1200/JCO.2008.21.4577}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19884557}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19884557}, day = {2}, doi = {10.1200/JCO.2008.21.4577}, issn = {1527-7755}, journal = {Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, month = {November}, posted-at = {2009-11-05 11:59:34}, priority = {2}, title = {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.}, url = {http://dx.doi.org/10.1200/JCO.2008.21.4577}, year = {2009} }

TY - JOUR ID - citeulike:6074046 L3 - citeulike-article-id:6074046 N2 - 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. JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology SN - 1527-7755 TI - 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. AU - Joensuu, Heikki AU - Bono, Petri AU - Kataja, Vesa AU - Alanko, Tuomo AU - Kokko, Riitta AU - Asola, Raija AU - Utriainen, Tapio AU - Turpeenniemi-Hujanen, Taina AU - Jyrkkiö, Sirkku AU - Möykkynen, Kari AU - Helle, Leena AU - Ingalsuo, Seija AU - Pajunen, Marjo AU - Huusko, Mauri AU - Salminen, Tapio AU - Auvinen, Päivi AU - Leinonen, Hannu AU - Leinonen, Mika AU - Isola, Jorma AU - Kellokumpu-Lehtinen, Pirkko-Liisa PY - 2009/11/02/ UR - http://dx.doi.org/10.1200/JCO.2008.21.4577 ER -