PURPOSE: To assess quality of life (QOL) data from a double-blind Phase III study evaluating bicalutamide (Casodex) 80 mg as part of maximum androgen blockade (MAB) in patients with previously untreated advanced prostate cancer. METHODS:Patients with untreated stage C/D prostate cancer were randomized to MAB with bicalutamide plus a luteinizing hormone-releasing hormone agonist (LHRHa) or LHRHa monotherapy. QOL was evaluated at baseline and at weeks 1, 5, and 24 using the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. RESULTS: A total of 203 patients were assessed for QOL. The MAB group had more rapid and greater improvements in "emotional well-being" and "prostate cancer-specific issues" domain scores than the monotherapy group. Further analysis of "prostate cancer-specific issues" revealed that, compared with monotherapy, MAB provided a greater improvement in "micturition disorder"-related QOL. Complete improvement rates for items related to "pain and micturition disorder" were also higher with MAB. Item scores of "pain and micturition disorder" did not correlate strongly with prostate-specific antigen levels or tumor size. Fewer patients who had deterioration in their "pain and micturition disorder" item scores at week 1 in the MAB group than the monotherapy group. CONCLUSIONS: Maximum androgen blockade with bicalutamide plus LHRHa did not reduce the overall QOL of patients with previously untreated advanced prostate cancer. MAB was superior to monotherapy in achieving early improvement of QOL related to micturition disorder and pain.
RCT Entities:
PURPOSE: To assess quality of life (QOL) data from a double-blind Phase III study evaluating bicalutamide (Casodex) 80 mg as part of maximum androgen blockade (MAB) in patients with previously untreated advanced prostate cancer. METHODS:Patients with untreated stage C/D prostate cancer were randomized to MAB with bicalutamide plus a luteinizing hormone-releasing hormone agonist (LHRHa) or LHRHa monotherapy. QOL was evaluated at baseline and at weeks 1, 5, and 24 using the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. RESULTS: A total of 203 patients were assessed for QOL. The MAB group had more rapid and greater improvements in "emotional well-being" and "prostate cancer-specific issues" domain scores than the monotherapy group. Further analysis of "prostate cancer-specific issues" revealed that, compared with monotherapy, MAB provided a greater improvement in "micturition disorder"-related QOL. Complete improvement rates for items related to "pain and micturition disorder" were also higher with MAB. Item scores of "pain and micturition disorder" did not correlate strongly with prostate-specific antigen levels or tumor size. Fewer patients who had deterioration in their "pain and micturition disorder" item scores at week 1 in the MAB group than the monotherapy group. CONCLUSIONS: Maximum androgen blockade with bicalutamide plus LHRHa did not reduce the overall QOL of patients with previously untreated advanced prostate cancer. MAB was superior to monotherapy in achieving early improvement of QOL related to micturition disorder and pain.
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