COMBINATION TREATMENT VERSUS LHRH ALONE IN ADVANCED PROSTATIC-CANCER

Androgen deprivation based on hormone manipulation is the treatment of choice in advanced prostatic cancer. The unequivocal role of adrenal androgens in the growth of prostatic cancer after medical or surgical castration requires a new logical approach (complete androgen blockade ) in the treatment of advanced prostate cancer. One hundred and fifty patients with biopsy-proven advanced prostatic cancer were randomized into two groups. One group (74 patients) received leuprolide + flutami de (complete androgen blockade); the second group (76 patients) receiv ed only leuprolide and, during the first 3 weeks of treatment, cyprote rone acetate (150 mg/day) to prevent flare-up phenomena. The aim of th e study was to evaluate the differences between the two groups on over all survival and time to progression (log-rank test). One hundred and twenty-five patients were evaluable, 62 in the leuprolide-only group a nd 63 in the leuprolide + flutamide group. Median duration of follow-u p was 102 weeks. No statistical difference between the two groups was observed in overall survival, in time to disease progression, and in t ime to treatment failure. In the combination (leuprolide + flutamide) treatment group, a positive trend for overall survival and in time to progression was observed in a subgroup of patients with good performan ce status and no bone metastases. We observed mild gastrointestinal to xicity (diarrhea, nausea) in the group treated with leuprolide + fluta mide. The aim of this study was to compare the effectiveness of total androgen withdrawal with medical testicular suppression in advanced pr ostatic cancer. No significant statistical difference was observed bet ween the two groups in overall survival and in time to progression, bu t probably too few patients were enrolled in each treatment arm to giv e a statistical interpretation of our results. We conclude that there is a positive trend in the combination treatment arm in patients with good prognostic factors.