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Originally published as JCO Early Release 10.1200/JCO.2002.09.112 on July 9 2002

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Journal of Clinical Oncology, Vol 20, Issue 24 (December), 2002: 4621-4627
© 2002 American Society for Clinical Oncology

Randomized Adjuvant Trial of Tamoxifen and Goserelin Versus Cyclophosphamide, Methotrexate, and Fluorouracil: Evidence for the Superiority of Treatment With Endocrine Blockade in Premenopausal Patients With Hormone-Responsive Breast Cancer—Austrian Breast and Colorectal Cancer Study Group Trial 5

By Raimund Jakesz, Hubert Hausmaninger, Ernst Kubista, Michael Gnant, Christian Menzel, Thomas Bauernhofer, Michael Seifert, Karin Haider, Brigitte Mlineritsch, Peter Steindorfer, Werner Kwasny, Michael Fridrik, Guenther Steger, Viktor Wette, Hellmut Samonigg

From the Departments of Surgery, Internal Medicine, and Gynecology, Vienna University, Vienna; Third Medical Department and Department of Special Gynecology, Salzburg Hospital, Salzburg; Medical Department, Graz University, and Second Department of Surgery, Graz Hospital, Graz; Department of Surgery, Wiener Neustadt Hospital, Wiener Neustadt; First Medical Department, Linz Hospital, Linz; and Department of Surgery, Sankt Veit Hospital, Sankt Veit, Austria.

This article was published ahead of print at www.jco.org.Address reprint requests to Raimund Jakesz, MD, Department of Surgery, University of Vienna, Vienna General Hospital, Waehringer Guertel 18-20, Vienna A-1090, Austria; email: raimund.jakesz{at}akh-wien.ac.at

PURPOSE: Effective adjuvant treatment modalities in premenopausal breast cancer patients today include chemotherapy, ovariectomy, and tamoxifen administration. The purpose of Austrian Breast and Colorectal Cancer Study Group Trial 5 was to compare the efficacy of a combination endocrine treatment with standard chemotherapy.

PATIENTS AND METHODS: Assessable trial subjects (N = 1,034) presenting with hormone-responsive disease were randomized to receive either 3 years of goserelin plus 5 years of tamoxifen or six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Stratification criteria included tumor stage and grade, number of involved nodes, type of surgery, and steroid hormone receptor content. Relapse-free survival (RFS) was defined as time from randomization to first relapse, local recurrence, or contralateral incidence, and overall survival (OS) as time to date of death.

RESULTS: With a 60-month median follow-up, 17.2% of patients in the endocrine group and 20.8% undergoing chemotherapy developed relapses. Local recurrences emerged in 4.7% and 8.0%, respectively. RFS and local recurrence-free survival differed significantly in favor of endocrine therapy (P = .037 and P = .015), with a similar trend observed in OS (P = .195).

CONCLUSION: Overall, our data suggest that the goserelin-tamoxifen combination is significantly more effective than CMF in the adjuvant treatment of premenopausal patients with stage I and II breast cancer.

Other members of the Austrian Breast and Colorectal Cancer Study Group are listed in the Appendix, available online at www.jco.org.


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