Document Detail


Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy.
MedLine Citation:
PMID:  23152362     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
C N Sternberg; A Molina; S North; P Mainwaring; K Fizazi; Y Hao; M Rothman; D D Gagnon; T Kheoh; C M Haqq; C Cleeland; J S de Bono; H I Scher
Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-14
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  24     ISSN:  1569-8041     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-21     Completed Date:  2013-09-04     Revised Date:  2014-11-05    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1017-25     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Androstadienes / administration & dosage*
Castration
Fatigue / chemically induced,  drug therapy*,  epidemiology,  pathology
Humans
Male
Neoplasm Metastasis / drug therapy
Neoplasm Staging
Prednisone / administration & dosage
Prostatic Neoplasms / complications,  drug therapy*,  epidemiology,  pathology
Questionnaires
Taxoids / administration & dosage*,  adverse effects
Chemical
Reg. No./Substance:
0/Androstadienes; 0/Taxoids; 154229-18-2/17-(3-pyridyl)-5,16-androstadien-3beta-acetate; 15H5577CQD/docetaxel; VB0R961HZT/Prednisone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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