INTERMITTENT ANDROGEN SUPPRESSION WITH LEUPROLIDE AND FLUTAMIDE FOR PROSTATE-CANCER - A PILOT-STUDY

Objectives. To affirm the feasibility of using intermittent androgen s uppression in patients with hormone-naive prostate cancer. Methods. Le uprolide and flutamide were administered for 9 to 12 months and then d iscontinued until prostate-specific antigen (PSA) levels reached a thr eshold value determined by the baseline PSA value. This constituted on e cycle of treatment. Androgen suppression was then administered inter mittently as described until there was evidence of androgen independen ce. Results. Twenty-two patients with PSA failure after primary therap y with surgery and/or radiation and untreated early or Stage D2 diseas e were treated. Twenty-one patients completed androgen suppression dur ing cycle 1, with a median time to PSA nadir of 3.5 months (range, 2 t o 12). Fifteen patients completed cycle 1 with a median time off treat ment of 6 months (range, 2 to 19) or 38% (range, 17% to 64%) of a trea tment cycle. Six patients continued off treatment during cycle I for I + to 31 + months. During cycle 2, 1 2 patients achieved a PSA nadir i n a median time of 3.5 months. Two patients completed cycle 2 with a m edian time off treatment of 10 months (51%), Median follow-up for all patients is 26 months (range, 10 to 51). While off treatment, all pati ents reported a reduction of symptoms associated with androgen suppres sion. Conclusions. Intermittent androgen suppression is a feasible alt ernative to continuous androgen suppression for treatment of prostate cancer, and duality of life is improved while off treatment. Copyright 1996 by Elsevier Science Inc.