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Similar Efficacy for Ovarian Ablation Compared With Cyclophosphamide, Methotrexate, and Fluorouracil: From a Randomized Comparison of Premenopausal Patients With Node-Positive, Hormone Receptor–Positive Breast Cancer

Bent Ejlertsen, Henning T. Mouridsen, Maj-Britt Jensen, Nils-Olof Bengtsson, Jonas Bergh, Soren Cold, Per Edlund, Marianne Ewertz, Peter W. de Graaf, Claus Kamby, Dorte L. Nielsen

From the Department of Oncology, Rigshospitalet, Copenhagen University Hospital; Danish Breast Cancer Cooperative Group Registry, Copenhagen; Department of Oncology, Odense University Hospital, Odense; Department of Oncology, Aalborg Hospital, Aarhus University, Aarhus; Department of Oncology, Herlev University Hospital, Herlev, Denmark; Department of Oncology, Umeaa County Hospital, Umeaa; Radiumhemmet, Stockholm Oncology, Karolinska Institute and University Hospital, Stockholm; Department of Oncology, Gaavle County Hospital, Gaavle, Sweden; and the Department of Surgery and Traumatology, Reinier de Graaf Groep, Delft, the Netherlands

Address reprint requests to Bent Ejlertsen, MD, PhD, Department of Oncology, Bldg 5012 Rigshospitalet, 9. Blegdamsvej, DK-2100 Copenhagen, Denmark; e-mail: ejlertsen{at}rh.dk

Purpose: To compare the efficacy of ovarian ablation versus chemotherapy in early breast cancer patients with hormone receptor–positive disease.

Patients and Methods: We conducted an open, randomized, multicenter trial including premenopausal breast cancer patients with hormone receptor–positive tumors and either axillary lymph node metastases or tumors with a size of 5 cm or more. Patients were randomly assigned to ovarian ablation by irradiation or to nine courses of chemotherapy with intravenous cyclophosphamide, methotrexate, and fluorouracil (CMF) administered every 3 weeks.

Results: Between 1990 and May 1998, 762 patients were randomly assigned, and the present analysis is based on 358 first events. After a median follow-up time of 8.5 years, the unadjusted hazard ratio for disease-free survival in the ovarian ablation group compared with the CMF group was 0.99 (95% CI, 0.81 to 1.22). After a median follow-up time of 10.5 years, overall survival (OS) was similar in the two groups, with a hazard ratio of 1.11 (95% CI, 0.88 to 1.42) for the ovarian ablation group compared with the CMF group.

Conclusion: In this study, ablation of ovarian function in premenopausal women with hormone receptor–positive breast cancer had a similar effect to CMF on disease-free and OS. No significant interactions were demonstrated between treatment modality and hormone receptor content, age, or any of the well-known prognostic factors.

Presented in part at the 35th Annual Meeting of the American Society of Clinical Oncology, May 15-18, 1999, Atlanta, GA.

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

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