• J. Clin. Oncol. · Sep 2005

    Randomized Controlled Trial Multicenter Study Clinical Trial

    Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: results from INT 0101 (E5188).

    • Nancy E Davidson, Anne M O'Neill, Allen M Vukov, C Kent Osborne, Silvana Martino, Douglas R White, and Martin D Abeloff.
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Room 409, Baltimore, MD 21231, USA. davidna@jhmi.edu
    • J. Clin. Oncol. 2005 Sep 1; 23 (25): 5973-82.

    PurposeChemotherapy, 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 MethodsPremenopausal 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.ResultsWith 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.ConclusionAddition 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.

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