[In Process Citation]
In a European, randomised Phase III trial, we studied ovarian ablation using a GnRH-agonist (leuprorelin acetate 3M depot, Takeda Pharma GmbH, Aachen) with CMF combination chemotherapy in pre- and peri-menopausal, hormone receptor-positive patients with involvement of 1-9 axillary lymph nodes. All planned 600 patients were recruited. We carried out an interim analysis of the hormonal effects and tolerability in 133 patients. The "castration effect" of the chemotherapy has previously been suspected but not systematically investigated. The hormonal effect should be an important aspect of adjuvant chemotherapy for node-positive breast cancer. For the first time we were able to demonstrate a pronounced estradiol-lowering effect of a "standard" chemotherapy regimen at least for the duration of the treatment. The side-effect profile of the two treatments in the interim analysis revealed marked advantages in favour of the GnRHa therapy. Currently no differences in efficacy are noted. However, sound conclusions can only be drawn after a far longer observation period, particularly after stratification according to the extent of node involvement and hormone receptor status.
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