SAN FRANCISCOIn men with localized or locally advanced prostate
cancer, immediate treatment with the nonsteroidal antiandrogen bicalutamide
(Casodex), alone or in addition to standard therapy, significantly reduces
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,
The trial was designed to determine whether the benefit of adjuvant
hormonal therapy seen in breast cancer with 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 areasNorth
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
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.