SAN FRANCISCO—In men with localized or locally advanced prostate cancer, immediate treatment with the nonsteroidal antiandrogen bicalutamide(Drug information on bicalutamide) (Casodex), alone or in addition to standard therapy, significantly reduces disease progression.
The finding comes from an early analysis of data from the largest trial (8,113 patients) of its kind ever carried out, said investigator William A. See, MD, professor and chief of urology, Medical College of Wisconsin, Milwaukee.
The trial was designed to determine whether the benefit of adjuvant hormonal therapy seen in breast cancer with tamoxifen(Drug information on tamoxifen) (Nolvadex) can be found in prostate cancer, Dr. See said in an interview after the 37th Annual Meeting of the American Society of Clinical Oncology where he presented the results (ASCO abstracts 705 and 2366).
"The rationale for such a hope," he explained, "lies in the clear similarities between breast and prostate tumors: They both occur in secondary sex organs, are hormonally sensitive, occur late in life, have long lag periods, and are associated with multifocal disease."
The international trial was carried out in three major geographical areas—North America (3,292 patients), Scandinavia (1,218), and Europe, South Africa, Australia, and Mexico (3,603)—and had to take into account cultural differences in prostate cancer treatment patterns. For example, watchful waiting was a frequent treatment modality in Europe and Scandinavia, but was not allowed in North America, Dr. See said.
Patients were randomized to bicalutamide 150 mg/d or placebo, in addition to standard therapy composed of radical prostatectomy, radiotherapy, or watchful waiting. Included patients had prostate cancer with negative bone scans.
At a median follow-up of 3-years, bicalutamide reduced the risk of disease progression by a highly significant 42%, compared with placebo (P < .0001). Of 4,052 patients in the bicalutamide group, 363 progressed, compared with 559 of 4,061 placebo patients.
