Journal
ANNALS OF ONCOLOGY
Volume 24, Issue 4, Pages 1017-1025Publisher
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mds585
Keywords
advanced prostate cancer; palliation; patient-reported outcome
Categories
Funding
- Janssen Biotech, Inc.
- Janssen Global Services, LLC.
- Janssen Biotech
- Amgen
- Astellas-Medivation
- AstraZeneca
- Bayer
- BMS
- Celgene
- Cougar Biotechnology/Janssen Biotech
- Dendreon
- Exelixis
- Keocyt
- Millenium-Takeda
- Novartis
- Sanofi-Aventis
- Johnson Johnson
- Cancer Research UK
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Fatigue is a common, debilitating side-effect of prostate cancer and its treatment. Patient-reported fatigue was evaluated as part of COU-AA-301, a randomized, placebo-controlled, phase III trial of abiraterone acetate and prednisone versus placebo and prednisone in metastatic castration-resistant prostate cancer (mCRPC) patients after docetaxel chemotherapy. This is the first phase III study in advanced prostate cancer to evaluate fatigue outcomes using a validated fatigue-specific instrument. The Brief Fatigue Inventory (BFI) questionnaire was used to measure patient-reported fatigue intensity and fatigue interference with activities of daily life. All analyses were conducted using prespecified responder definitions of clinically meaningful changes. A total of 797 patients were randomized to abiraterone acetate and prednisone, and 398 were randomized to placebo and prednisone. Compared with prednisone alone, in patients with clinically significant fatigue at baseline, abiraterone acetate and prednisone significantly increased the proportion of patients reporting improvement in fatigue intensity (58.1% versus 40.3%, P = 0.0001), improved fatigue interference (55.0% versus 38.0%, P = 0.0075), and accelerated improvement in fatigue intensity (median 59 days versus 194 days, P = 0.0155). In patients with mCRPC progressing after docetaxel chemotherapy, abiraterone acetate and prednisone yielded clinically meaningful improvements in patient-reported fatigue compared with prednisone alone.
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