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Goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with breast cancer. GABG trial IV-B-93.

588 Background: The role of medical ablation after adjuvant chemotherapy in endocrine sensitive or non-sensitive tumors is not yet clearly defined.


METHODS
We initiated a prospective, randomized multicenter study comparing goserelin (3.6 mg every 28 days for 2 years) and control after adjuvant chemotherapy consisting of three cycles of CMF (500/40/600 mg/m2, i.v. on days 1, 8 q 29) in patients with 0-3+ lymph nodes (LN) and four cycles of EC (90/600 mg/m2, i.v. day 1 q 22) followed by 3 x CMF in patients with 4-9+ LN. At first only patients with hormone receptor (HR)-negative breast cancer were included. However, the study was extended to patients with HR-positive breast cancer and 1-9+ LN, when the ZEBRA study was closed.


RESULTS
776 patients were included (goserelin: n=384; control: n=392), 60% had negative HR, 40% were LN-, 23% had 4-9+ LN; 30% of the patients were 40 years or younger, and 60% received breast conserving surgery. 215 events were observed after a median follow-up of 4.7 years. The first event of failure (goserelin vs control) was an isolated locoregional recurrence (43 vs 29), a distant failure (59 vs 82) and death without previous recurrence (0 vs 2). Five-year event-free survival rates were 71.3% (95% confidence interval (CI), 66.3% to 76.3%) and 67.6% (95% CI, 62.2% to 73.0%) in the goserelin and in the control group, respectively. The estimated hazard ratio of goserelin vs control was 0.92 (95% CI 0.70 to 1.21; P > 0.5) indicating no long-term benefit of goserelin in these patients. In an analysis restricted to LN+ patients, there was no indication of a differential treatment effect in HR+ as compared to HR- patients.


CONCLUSIONS
The results of this study do not support the use of a GnRH analogue after adjuvant chemotherapy in premenopausal patients with breast cancer. [Table: see text].