PURPOSE:Chemotherapy, tamoxifen, and ovarian ablation/suppression (OA/OS) are effective adjuvant approaches for premenopausal, steroid hormone receptor-positive breast cancer. The value of combined therapy has not been clearly established. PATIENTS AND METHODS: Premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer (1,503 eligible patients) were randomly assigned to six cycles of cyclophosphamide, doxorubicin, and fluorouracil (CAF), CAF followed by 5 years of monthly goserelin (CAF-Z), or CAF followed by 5 years of monthly goserelin and daily tamoxifen (CAF-ZT). The primary end points were time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS) for CAF-Z versus CAF, and CAF-ZT versus CAF-Z. RESULTS: With a median follow-up of 9.6 years, the addition of tamoxifen to CAF-Z improved TTR and DFS but not OS. There was no overall advantage for addition of goserelin to CAF. CONCLUSION: Addition of tamoxifen to CAF-Z improves outcome for premenopausal node-positive, receptor-positive breast cancer. The role of OA/OS alone or with other endocrine agents should be studied more intensely.
RCT Entities:
PURPOSE: Chemotherapy, tamoxifen, and ovarian ablation/suppression (OA/OS) are effective adjuvant approaches for premenopausal, steroid hormone receptor-positive breast cancer. The value of combined therapy has not been clearly established. PATIENTS AND METHODS: Premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer (1,503 eligible patients) were randomly assigned to six cycles of cyclophosphamide, doxorubicin, and fluorouracil (CAF), CAF followed by 5 years of monthly goserelin (CAF-Z), or CAF followed by 5 years of monthly goserelin and daily tamoxifen (CAF-ZT). The primary end points were time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS) for CAF-Z versus CAF, and CAF-ZT versus CAF-Z. RESULTS: With a median follow-up of 9.6 years, the addition of tamoxifen to CAF-Z improved TTR and DFS but not OS. There was no overall advantage for addition of goserelin to CAF. CONCLUSION: Addition of tamoxifen to CAF-Z improves outcome for premenopausal node-positive, receptor-positive breast cancer. The role of OA/OS alone or with other endocrine agents should be studied more intensely.
Authors: Prudence A Francis; Meredith M Regan; Gini F Fleming; István Láng; Eva Ciruelos; Meritxell Bellet; Hervé R Bonnefoi; Miguel A Climent; Gian Antonio Da Prada; Harold J Burstein; Silvana Martino; Nancy E Davidson; Charles E Geyer; Barbara A Walley; Robert Coleman; Pierre Kerbrat; Stefan Buchholz; James N Ingle; Eric P Winer; Manuela Rabaglio-Poretti; Rudolf Maibach; Barbara Ruepp; Anita Giobbie-Hurder; Karen N Price; Marco Colleoni; Giuseppe Viale; Alan S Coates; Aron Goldhirsch; Richard D Gelber Journal: N Engl J Med Date: 2014-12-11 Impact factor: 91.245
Authors: Meredith M Regan; Olivia Pagani; Gini F Fleming; Barbara A Walley; Karen N Price; Manuela Rabaglio; Rudolf Maibach; Barbara Ruepp; Alan S Coates; Aron Goldhirsch; Marco Colleoni; Richard D Gelber; Prudence A Francis Journal: Breast Date: 2013-10-02 Impact factor: 4.380
Authors: Amye J Tevaarwerk; Robert J Gray; Bryan P Schneider; Mary Lou Smith; Lynne I Wagner; John H Fetting; Nancy Davidson; Lori J Goldstein; Kathy D Miller; Joseph A Sparano Journal: Cancer Date: 2012-10-12 Impact factor: 6.860