Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed: A Southwest Oncology Group Study (SWOG 9235)

Objectives. To determine the efficacy and tolerability of bicalutamide in p atients with advanced prostate cancer with progression after conventional h ormonal therapy. Methods. Fifty-two patients received bicalutamide, 150 mg once daily, as se cond-line therapy after progressing following treatment with orchiectomy or luteinizing hormone-releasing hormone analogue or diethylstilbestrol, alon e or in combination. Patients had measurable (n = 8) or assessable (n = 44) disease, a Southwest Oncology Group performance status of 0 to 2, and no p rior antiandrogen therapy or chemotherapy. The objective response to treatm ent was assessed every 12 weeks; symptoms and pain were assessed monthly wi th questionnaires for 6 months. Results. There was evidence of palliation with three measures of pain and, to a lesser extent, with a measure of overall symptom status after 3 months of taking bicalutamide. No complete or partial responses occurred. However , 9 (20%) of 44 subjects with adequate prostate-specific antigen data had a 50% or higher decrease in their prostate-specific antigen levels, which di d not correlate with symptom improvement. The median survival time was 15 m onths. The most common side effects were hot flashes (23%) and nausea (21%) . Conclusions. These data suggest that bicalutamide decreases pain and improv es symptom status in patients with prostate cancer in whom first-line hormo nal therapy failed. UROLOGY 58: 53-58, 2001. ( C) 2001, Elsevier Science In c.