Large study shows bicalutamide improves overall survival in men with locally advanced PCa.


NEW YORK CITY—Results of the largest clinical trial ever conducted in non-metastatic prostate cancer suggest that bicalutamide (Casodex) added to standard care may improve overall survival in men with locally advanced disease undergoing radiotherapy.

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The drug did not improve overall survival or progression-free survival (PFS) in patients with localized prostate cancer, however, according to William See, MD, professor and chair of urology at the Medical College of Wisconsin, Milwaukee. He presented the findings here at the 2006 Chemotherapy Foundation Symposium.


In a series of three large, identical trials in North America, Europe, and Scandinavia that enrolled a total of 8,113 patients, men with prostate cancer were randomly assigned to receive bicalutamide 150 mg in addition to standard care or to receive standard care alone. Median follow-up was 7.4 years.


At baseline, most patients had localized disease, and virtually all were node negative. Gleason scores were well or moderately differentiated in more than 60% of patients. The primary treatment was radiotherapy in 17%, radical prostatectomy in 55%, and watchful waiting in 28%.


“In patients with localized disease there is absolutely no difference between treatment groups in overall survival,” Dr. See told listeners. “However, there was and continues to be a reduction in PFS favoring bicalutamide, with a 33% reduction in risk of bone-scan confirmed disease progression.” Bone-scan disease progression was confirmed in 6.8% of the bicalutamide-treated group versus 9.8% of the standard care group.


The majority of patients with improved PFS in the bicalutamide arm were in the European and Scandinavian trials, which may be related to more advanced tumors in patients enrolled in those countries, Dr. See said. The patients with locally advanced disease undergoing radiotherapy and who received bicalutamide had a 35% reduction in mortality driven by a decrease in the number of disease-specific deaths.


The study revealed a nonsignificant trend in survival benefit for bicalutamide in the watchful waiting group; no benefit was observed for bicalutamide in the radical prostatectomy group.