Artikel
CMF versus goserelin as adjuvant therapy for node-negative, hormone-receptor–positive breast cancer in premenopausal patients: a randomised, trial (GABG trial IV-A-93)
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Veröffentlicht: | 20. März 2006 |
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We investigated gonadotropin-releasing hormone analogues as adjuvant treatment for patients with node-negative, hormone-sensitive, premenopausal breast cancer. Patients were randomised to either three cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) chemotherapy (n = 378) or goserelin every 28 days for 2 years (n = 393). During a median follow up of 4.9 years, 123 events were observed. The first-failure event of CMF vs. goserelin, respectively, was ipsilateral locoregional recurrence (18 vs. 20), contralateral breast cancer (7 vs. 6), distant failure (35 vs. 24), and death without recurrence (2 vs. 2). Forty-two (23 vs. 19) deaths of any cause occurred. The estimated adjusted hazard ratio for goserelin versus CMF (intention-to-treat analysis) was 0.79 (95% CI = 0.54–1.14; P = 0.19). Treatment effect favoured goserelin in grade 1 or 2 tumours and tumours of ≤ 20 mm in size. We conclude that medical ovarian ablation with goserelin represents a valid option for premenopausal patients with node-negative breast cancer.