Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy

Abstract Background In a recent randomised, double-blind, phase III clinical trial among 1195 patients with metastatic castration-resistant prostate cancer (mCRPC) who had failed docetaxel chemotherapy, abiraterone acetate was shown to significantly prolong overall survival compared with prednisone...

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Bibliographic Details
Published in:European journal of cancer (1990) 2013-11, Vol.49 (17), p.3648-3657
Main Authors: Harland, Stephen, Staffurth, John, Molina, Arturo, Hao, Yanni, Gagnon, Dennis D, Sternberg, Cora N, Cella, David, Fizazi, Karim, Logothetis, Christopher J, Kheoh, Thian, Haqq, Christopher M, de Bono, Johann S, Scher, Howard I
Format: Article
Language:English
Subjects:
Abiraterone
Abiraterone Acetate
Adenocarcinoma - drug therapy
Adenocarcinoma - epidemiology
Adenocarcinoma - pathology
Androstadienes - therapeutic use
Antineoplastic Agents - therapeutic use
Biological and medical sciences
Chemotherapy, Adjuvant
Health
Hematology, Oncology and Palliative Medicine
Humans
Male
Medical sciences
Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
Neoplasm Metastasis
Orchiectomy
Outcome assessment
Pharmacology. Drug treatments
Placebos
Prostate
Prostatic Neoplasms - drug therapy
Prostatic Neoplasms - epidemiology
Prostatic Neoplasms - pathology
Quality of Life
Surveys and Questionnaires
Taxoids - therapeutic use
Treatment Failure
Tumors
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Summary:Abstract Background In a recent randomised, double-blind, phase III clinical trial among 1195 patients with metastatic castration-resistant prostate cancer (mCRPC) who had failed docetaxel chemotherapy, abiraterone acetate was shown to significantly prolong overall survival compared with prednisone alone. Here we report on the impact of abiraterone therapy on the health-related quality of life (HRQoL) observed during this trial, assessed using the validated Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. 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.
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2013.07.144