Diana Viray, Baholova Prundeterp, Edwin ten Winkel
BBP615 is a potent and selective aromatase inhibitor for treatment of advanced breast cancer. In an open-label study, 40 postmenopausal women failing tamoxifen therapy received 1mg BBP615 once daily until disease progression.
BBP615 produced clinical benefit (partial response or no change) in 27 of 40 evaluable patients (67.5%). Fifteen patients (37.5%) had a partial response (UICC criteria) which lasted for a median of 20 months (range 17–45 months), 12 patients (30%) had disease stabilization for a median of 18 months (12–26 months), and 13 patients (32,5%) had disease progression.
Median time to first response was 3.1 months (2.5–7.5 months): estimated median survival time for all patients was 30.8 months (12–60.7 months) and estimated median time to disease progression was 12.2 months (5.6–42.4 months).
Estradiol levels decreased to below limits of detection from 1st month of treatment until study end. Androstenedione, 17α-hydroxyprogesterone, dehydroepiandrosterone, and free-testosterone levels were unaffected by BBP615.
ACTH stimulation tests demonstrated that BBP615 does not interfere with adrenal mineralocorticoid and glucocorticoid steroid synthesis. Adverse events were mild-to-moderate.
BBP615 holds promis to be an effective and well-tolerated alternative treatment for postmenopausal advanced breast cancer patients following tamoxifen failure.
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