Purpose: Primary aim of this study was to investigate whether an adjuvant two year GnRHa treatment (leuprorelinacetate 3 month depot [LAD- 3M], Trenantone ) shows "non- inferiority" with respect to progression- free survival in comparison to CMF chemotherapy in hormone receptor- and nodal- positive, pre- perimenopausal patients with breast cancer. Further criteria were suppression of oestradiol serum levels and induction of amenorrhoea.Patients and Methods: Pre- perimenopausal, hormone receptor positive patients with breast cancer and up to nine positive lymph nodes were randomized into two study arms. Group 1 received adjuvant 11.25 mg LAD- 3M s.c. every three months for two years and group 2 six i.v. double cycles of CMF (Cyclophosphamide 500 mg, Methotrexate 40 mg, 5- Fluorouracil 600 mg each per m2)ondays 1 and 8 every 28 days. The progression- free survival after 2 years, was statistically analyzed for the per protocol (PP) treated patients in a confirmatory one- sided equivalence test according to Farrington- Manning. A difference of ≤ 10% was defined as equivalent. Results: In the (n = 526) PP population 83% (224/270) of the LAD- 3M and 80.9% (207/256) in the CMF group remained progression free after two years (p = 0.0002). Therefore the hypothesis that the treatment with LAD- 3M is clinically relevant inferior to CMF with respect to progression- free survival could be rejected. The side effect profile showed the expected symptoms with typical postmenopausal complaints and chemotherapy induced symptoms with LAD- 3M and CMF respectively. Suppression of oestradiol serum levels was more pronounced in the LAD- 3M treatment group and higher rates of amenorrhoea resulted with the CMF treatment. Conclusion: The 3 month depot of leuprorelinacetate in receptor positive, pre- perimenopausal patients as an adjuvant treatment is as effective as CMF and therefore is a real alternative to chemotherapy with a better side effect profile.
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