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Addition of abiraterone acetate to prednisone improved fatigue in patients with prostate cancer
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The addition of abiraterone acetate to prednisone improved patient-reported fatigue among a cohort of patients with metastatic castration-resistant prostate cancer that progressed after docetaxel chemotherapy, according to results of a randomized, placebo-controlled phase 3 trial.
Fatigue is a common and debilitating side effect of prostate cancer treatment.
In this study, researchers evaluated patient-reported fatigue in 1,195 patients, 797 of whom were randomly assigned patients to prednisone plus abiraterone acetate (Zytiga, Janssen Biotech). The other 398 patients received prednisone plus placebo.
Cora N. Sternberg, MD, chief of the department of medical oncology at San Camillo-Forlanini Hospital in Rome, and colleagues provided patients with a Brief Fatigue Inventory (BFI) questionnaire to measure patient-reported intensity and fatigue interference with daily life activities.
This was the first phase 3 trial to use a validated fatigue-specific instrument to evaluate fatigue in patients with advanced prostate cancer, according to researchers.
Among patients with clinically significant fatigue at baseline, 58.1% of those assigned to prednisone plus abiraterone acetate reported improvement in fatigue intensity compared with 40.3% of patients assigned to prednisone alone (P=.0001).
Patients assigned to the combination regimen also reported improved fatigue interference (55% vs. 38%; P=.0075) and accelerated improvement in fatigue intensity (median 59 days vs. 194 days; P=.0155) compared with prednisone alone, study results showed.
“In patients with metastatic castration-resistant prostate cancer progressing after docetaxel chemotherapy, abiraterone acetate and prednisone yielded clinically meaningful improvements in patient reported fatigue compared with prednisone alone,” Sternberg and colleagues concluded.
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