Abstract | BACKGROUND: METHODS: All analyses were conducted using prespecified criteria for clinically meaningful improvement and deterioration in FACT-P total score as well as subscale scores; all respective thresholds were defined using an accepted methodology. Improvement was assessed only in patients with clinically significant functional status impairment at baseline. RESULTS: Significant improvements in the FACT-P total score were observed in 48% of patients receiving abiraterone versus 32% of patients receiving prednisone (p < 0.0001). Also, the median time to deterioration in FACT-P total score was longer (p < 0.0001) in patients receiving abiraterone (59.9 weeks versus 36.1 weeks). Similar differences were observed in all FACT-P subscales, with the exception of the social/family well-being domain. Median time to improvement in the physical well-being domain and the trial outcome index was significantly shorter (p < 0.01) with abiraterone when compared with the prednisone arm. CONCLUSIONS: The previously demonstrated survival benefit for abiraterone is accompanied by improvements in patient-reported HRQoL and a significant delay in HRQoL deterioration when compared with prednisone.
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Authors | Stephen Harland, John Staffurth, Arturo Molina, Yanni Hao, Dennis D Gagnon, Cora N Sternberg, David Cella, Karim Fizazi, Christopher J Logothetis, Thian Kheoh, Christopher M Haqq, Johann S de Bono, Howard I Scher, COU-AA-301 Investigators |
Journal | European journal of cancer (Oxford, England : 1990)
(Eur J Cancer)
Vol. 49
Issue 17
Pg. 3648-57
(Nov 2013)
ISSN: 1879-0852 [Electronic] England |
PMID | 23973186
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 Elsevier Ltd. All rights reserved. |
Chemical References |
- Androstadienes
- Antineoplastic Agents
- Placebos
- Taxoids
- Docetaxel
- Abiraterone Acetate
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Topics |
- Abiraterone Acetate
- Adenocarcinoma
(drug therapy, epidemiology, pathology)
- Androstadienes
(therapeutic use)
- Antineoplastic Agents
(therapeutic use)
- Chemotherapy, Adjuvant
- Docetaxel
- Humans
- Male
- Neoplasm Metastasis
- Orchiectomy
- Placebos
- Prostatic Neoplasms
(drug therapy, epidemiology, pathology)
- Quality of Life
- Surveys and Questionnaires
- Taxoids
(therapeutic use)
- Treatment Failure
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