NEW ORLEANS--Progression-free survival rates after surgery for locally advanced prostate cancer were significantly improved by adjuvant therapy with the antiandrogen flutamide(Drug information on flutamide) (Eulexin) in a randomized European trial.
In this study, 356 radical prosta-tectomy patients with stage C (T3N0) prostate cancer were randomized to either continuous flutamide (250 mg tid) or no treatment, Manfred Wirth, MD, of the Dresden School of Medicine, said at the American Urological Association annual meeting.
Follow-up data collected every three months showed that tumor progression, defined as tumor recurrence and/or a rise in PSA levels, occurred in seven flutamide-treated patients and 25 controls. Mean follow-up was 102 weeks among patients receiving flutamide and 119 weeks in the control group.
Progression-free survival rates in the flutamide group were 97% at two years and 90% at four years (relative risk of tumor progression, 0.34). Control group rates--84% at two year and 69% at four years--were significantly lower.
The most common side effects of flutamide were gynecomastia (21%) and nausea (10%), with 21% of flutamide-treated patients discontinuing treatment because of side effects.
"Our preliminary results seem to indicate increased survival and delayed tumor progression for adjuvant antiandrogenic treatment in stage C prostate cancer patients after radical prostatectomy," Dr. Wirth said.
Long-term survival will continue to be monitored for 10 more years, he added. "While we are encouraged by these initial findings, we are cautious in our interpretation of the results," he said.