Journal of Clinical Oncology, Vol 17, Issue 6
(June), 1999: 1701
© 1999 American Society for Clinical Oncology
Randomized Trial of Low-Dose Chemotherapy Added to Tamoxifen in Patients With Receptor-Positive and Lymph NodePositive Breast Cancer
R. Jakesz,
H. Hausmaninger,
K. Haider,
E. Kubista,
H. Samonigg,
M. Gnant,
D. Manfreda,
G. Tschurtschenthaler,
R. Kolb,
M. Stierer,
M. Fridrik,
B. Mlineritsch,
P. Steindorfer,
M. Mittlböck,
G. Steger,
,
Austrian Breast Cancer Study Group
Address reprint requests to Raimund Jakesz, MD, Department of Surgery, University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria; email raimund.jakesz{at}akh-wien.ac.at
PURPOSE: To evaluate the outcome in patients with stage II hormone receptorpositive breast cancer treated or not treated with low-dose, short-term chemotherapy in addition to tamoxifen in terms of disease-free and overall survival.
PATIENTS AND METHODS: A total of 613 patients were randomized to receive either low-dose chemotherapy (doxorubicin 20 mg/m2 and vincristine 1 mg/m2 on day 1; cyclophosphamide 300 mg/m2; methotrexate 25 mg/m2; and fluorouracil 600 mg/m2 on days 29 and 36 intravenously) or no chemotherapy in addition to 20 mg of tamoxifen orally for 2 years. A third group without any treatment (postmenopausal patients only) was terminated after the accrual of 79 patients due to ethical reasons.
RESULTS: After a median follow-up period of 7.5 years, the addition of chemotherapy did not improve the outcome in patients as compared with those treated with tamoxifen alone, neither with respect to disease-free nor overall survival. Multivariate analysis of prognostic factors for disease-free survival revealed menopausal status, in addition to nodal status, progesterone receptor, and histologic grade as significant. Both untreated postmenopausal and tamoxifen-treated premenopausal patients showed identical prognoses significantly inferior to the tamoxifen-treated postmenopausal cohort. Prognostic factors for overall survival in the multivariate analysis showed nodal and tumor stage, tumor grade, and hormone receptor level as significant.
CONCLUSION: Low-dose chemotherapy in addition to tamoxifen does not improve the prognosis of stage II breast cancer patients with hormone-responsive tumors. Tamoxifen-treated postmenopausal patients show a significantly better prognosis than premenopausal patients, favoring the hypothesis of a more pronounced effect of tamoxifen in the older age groups.
Department of Surgery, Internal Medicine, and Gynecology and Obstetrics, University of Vienna, and Department of Surgery, Hanusch-Krankenhaus Vienna, Vienna; Department of Oncology, Salzburg; Department of Surgery, Wr. Neustadt; Department of Surgery and Medical Oncology, University of Graz, Graz; Department of Surgery, Klagenfurt; and Department of Internal Medicine, Linz, Austria.

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