Originally published as JCO Early Release 10.1200/JCO.2005.05.551 on August 8 2005

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Chemoendocrine Therapy for Premenopausal Women With Axillary Lymph Node–Positive, Steroid Hormone Receptor–Positive Breast Cancer: Results From INT 0101 (E5188)

From the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Dana-Farber Cancer Institute, Boston, MA; Oncology/Hematology Associates of Central Illinois, Peoria, IL; Breast Center at Baylor College of Medicine and the Methodist Hospital, Houston, TX; John Wayne Cancer Institute, Santa Monica, CA; Wake Forest Medical Center, Winston-Salem, NC

Address reprint requests to Nancy E. Davidson, MD, Sidney Kimmel Cancer Center at Johns Hopkins, 1650 Orleans St, Room 409, Baltimore, MD 21231; e-mail: davidna{at}jhmi.edu

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.

Supported by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA16116, CA13650, CA32102, CA38926, and CA03927 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Presented at the 35th Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15-18, 1999, and the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

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

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