3-MONTH DEPOT OF GOSERELIN ACETATE - CLINICAL EFFICACY AND ENDOCRINE PROFILE

Objectives. To compare the pharmacodynamics and tolerability of the ne w goserelin acetate 10.8-mg depot with the 3.6-mg depot in patients wi th advanced prostate cancer during the first 3 months of therapy. Meth ods. One hundred sixty patients were randomized in two comparative stu dies to receive either the 10.8-mg goserelin acetate depot every 12 we eks or the 3.6-mg goserelin acetate depot every 4 weeks for 12 weeks a nd then the 10.8-mg depot every 12 weeks thereafter. Data for pharmaco dynamic assessments were collected prospectively, whereas clinical res ponse data were collected retrospectively. Results. Serum testosterone profiles of the 10.8-mg goserelin acetate depot and the 3.6-mg gosere lin acetate depot were similar; testosterone levels in both groups fel l below castrate levels by day 21 after administration. Decreases in s erum prostate-specific antigen level after 3 months of therapy were al so similar in both groups: 94% with the 10.8-mg depot and 92.5% with t he 3.6-mg depot, For all patients, the median time to progression was 152.7 weeks and the median time to death was 213.6 weeks, The safety p rofile of the 10.8-mg goserelin acetate depot was similar to that of t he 3.6-mg depot; hot flashes was the most common adverse event. The in cidence of injection site reactions was very low (2 [0.3%] of 614 admi nistrations). Conclusions, The new 10.8-mg depot was pharmacodynamical ly equivalent to the current 3.6-mg depot and was well tolerated, both locally and systemically. The observed times to progression and survi val were as expected in this patient population. The 10.8-mg goserelin -acetate depot provided a dosing schedule that was convenient for the patient and the physician, and it has the potential to reduce health c are costs while maintaining the quality of life in patients being trea ted for advanced prostate cancer. Copyright 1996 by Elsevier Science I nc.