October 14, 2013
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Abiraterone acetate improved patient-reported quality of life

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The addition of abiraterone acetate to prednisone significantly improved patient-reported quality of life compared with prednisone alone in a cohort of patients with advanced prostate cancer.

Researchers conducted a randomized, double blind, phase 3 trial that included 1,195 patients with metastatic castration-resistant prostate cancer who failed docetaxel chemotherapy. Patients were enrolled at 147 sites in 13 countries.

Karim Fizazi, MD 

Karim Fizazi

Karim Fizazi, MD, PhD, a medical oncologist in the department of cancer medicine at Institut Gustave Roussy at the University of Paris, and colleagues randomly assigned 797 patients to receive 5 mg prednisone twice daily plus 1000 mg daily abiraterone acetate (Zytiga, Janssen Biotech). The other 398 patients received prednisone plus placebo.

OS served as the primary endpoint. Previously reported results showed abiraterone acetate significantly improved OS compared with prednisone (15.8 months vs. 11.2 months; HR=0.74; 95% CI, 0.64-0.86). The addition of abiraterone also improved other efficacy endpoints, including median time to PSA progression and radiographic PFS.

In the current analysis, researchers used the validated Functional Assessment of Cancer Therapy — Prostate (FACT-P) questionnaire to determine the effect of abiraterone therapy on patients’ health-related quality of life.

Fizazi and colleagues reported a higher percentage of patients assigned to abiraterone plus prednisone experienced significant improvements in FACT-P total score (48% vs. 32%, P<.0001). The median time to deterioration in FACT-P total score also was longer among those treated with abiraterone (59.9 weeks vs. 36.1 weeks; P<.0001).

“Similar differences were observed in all FACT-P subscales, with the exception of the social/family well-being domain,” researchers wrote. “Median time to improvement in the physical well-being domain and the trial outcome index was significantly shorter (P<.01) with abiraterone when compared with the prednisone arm.”