Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy Journal Article


Authors: Sternberg, C. N.; Molina, A.; North, S.; Mainwaring, P.; Fizazi, K.; Hao, Y.; Rothman, M.; Gagnon, D. D.; Kheoh, T.; Haqq, C. M.; Cleeland, C.; de Bono, J. S.; Scher, H. I.
Article Title: Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy
Abstract: Background: 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. Patients and methods: 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. Results: 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). Conclusions: In patients with mCRPC progressing after docetaxel chemotherapy, abiraterone acetate and prednisone yielded clinically meaningful improvements in patient-reported fatigue compared with prednisone alone. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Keywords: palliation; patient-reported outcome; advanced prostate cancer
Journal Title: Annals of Oncology
Volume: 24
Issue: 4
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2013-04-01
Start Page: 1017
End Page: 1025
Language: English
PROVIDER: scopus
PUBMED: 23152362
DOI: 10.1093/annonc/mds585
DOI/URL:
Notes: --- - "Export Date: 1 May 2013" - "Art. No.: mds585" - "CODEN: ANONE" - ":doi 10.1093/annonc/mds585" - "Source: Scopus"
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  1. Howard Scher
    862 Scher