Addition of bicalutamide 80 mg to LHRH-agonist monotherapy in patients with advanced prostate cancer: Impact on quality of life

Abstract

4703 Background: Bicalutamide (‘Casodex’) 80 mg (licensed dose in Japan) is being evaluated as part of combination therapy in patients (pts) with previously untreated advanced prostate cancer in an ongoing Japanese double-blind Phase III trial. Interim analysis after all pts had completed at least 6 months' follow-up (median follow-up 15 months) showed that first-line treatment with bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist significantly improved the prostate-specific antigen normalization rate at 12 weeks and reduced the risk of treatment failure and disease progression compared with LHRH-agonist monotherapy, without compromising tolerability (Proc Am Soc Clin Oncol 2003; 22: 422 [abs 1695]). We now report quality-of-life (QoL) findings during the first 24 weeks of treatment. Methods: Pts with previously untreated advanced (stage C/D) prostate cancer were randomized to receive bicalutamide 80 mg od (n=102) or placebo (n=101), in addition to an LHRH agonist. QoL was assessed using the Japanese version of the Functional Assessment of Cancer Therapy (FACT), a general questionnaire (FACT-G) assessing physical, social/family, emotional and functional wellbeing, plus a disease-specific subscale for prostate cancer symptoms (FACT-P); this was completed at baseline and at Weeks 1, 5 and 24. Results: The questionnaire collection rate at Week 24 was 93.1% in the bicalutamide 80 mg group and 89.1% with placebo. Total FACT scores showed no clear improvement in QoL in either treatment group at each time point. Mean FACT-P scores (specific to prostate cancer symptoms) increased by 4.64 and 3.10 from baseline to Week 24 in the bicalutamide 80 mg and placebo groups, respectively (difference 1.54;95%CI-1.03,4.11). Analyses of FACT-P scores using generalized estimating equations revealed a greater overall improvement with bicalutamide 80 mg compared with placebo (p=0.051). Conclusions: Compared with LHRH-agonist monotherapy, bicalutamide 80 mg in combination with an LHRH agonist improves symptom-related QoL in pts with previously untreated advanced prostate cancer. ‘Casodex’ is a trademark of the AstraZeneca group of companies. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Around 30 pharma companies including AstraZeneca Around 30 pharma companies including AstraZeneca AstraZeneca