Health-related Quality of Life for Abiraterone Plus Prednisone Versus Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer: Results from a Phase II Randomized Trial.

Autor: Khalaf DJ; Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada., Sunderland K; Department of Biostatistics, BC Cancer Vancouver Centre, Vancouver, BC, Canada., Eigl BJ; Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada., Kollmannsberger CK; Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada., Ivanov N; Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada., Finch DL; Department of Medical Oncology, BC Cancer Southern Interior, Kelowna, BC, Canada., Oja C; Department of Medical Oncology, BC Cancer Fraser Valley, Surrey, BC, Canada., Vergidis J; Department of Medical Oncology, BC Cancer Island Centre, Victoria, BC, Canada., Zulfiqar M; Department of Medical Oncology, BC Cancer Abbotsford Centre, Abbotsford, BC, Canada., Gleave ME; Department of Urological Sciences, The Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada., Chi KN; Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada; Department of Urological Sciences, The Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada. Electronic address: kchi@bccancer.bc.ca.
Jazyk: angličtina
Zdroj: European urology [Eur Urol] 2019 Jun; Vol. 75 (6), pp. 940-947. Date of Electronic Publication: 2018 Dec 24.
DOI: 10.1016/j.eururo.2018.12.015
Abstrakt: Background: Abiraterone and enzalutamide are associated with side effects that may impair health-related quality of life (HRQoL).
Objective: To assess patient-reported HRQoL, depression symptoms, and cognitive function for abiraterone versus enzalutamide.
Design, Setting, and Participants: We randomized 202 patients in a phase II study of abiraterone versus enzalutamide for first-line treatment of metastatic castration-resistant prostate cancer (ClinicalTrials.gov: NCT02125357).
Intervention: Patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Patient Health Questionnaire-9 (PHQ-9) questionnaires, and Montreal Cognitive Assessment (MoCA) cognitive assessments at baseline and on treatment.
Outcome Measurements and Statistical Analysis: To compare the change in FACT-P scores over time between treatment arms, we used a mixed model for repeated measures (MMRM). For FACT-P domains where there was an interaction between the treatment arm and age, we constructed separate models for patients aged <75 and ≥75yr. We compared the proportion of patients with clinically meaningful change from baseline for FACT-P, and the proportion of patients with an abnormal score and median change from baseline for PHQ-9 and MoCA using Fisher's exact test and Mann-Whitney U test.
Results and Limitations: In the MMRM analysis, there was a positive test for interaction in the treatment arm by age for total FACT-P (p=0.048). FACT-P change from baseline over time was better for abiraterone than for enzalutamide in the ≥75-yr model (p=0.003), with no difference in the <75-yr model (p>0.9). A higher proportion of patients experienced clinically meaningful worsening with enzalutamide for the physical and functional well-being domains (37% vs 21%, p=0.013; 39% vs 23%, p=0.015). The distribution of change in PHQ-9 scores from baseline favored abiraterone at weeks 4, 8, and 12. These analyses were not prespecified, and results should be considered to be hypothesis generating.
Conclusions: Patient-reported outcomes favored abiraterone compared with enzalutamide with differences in FACT-P HRQoL and PHQ-9 depression scores. Differences in the total FACT-P scores were seen only in the elderly patient subgroup.
Patient Summary: In this report, we examined the change in patient-reported quality-of-life scores from the start of treatment over time for patients treated with abiraterone versus enzalutamide for metastatic castration-resistant prostate cancer. We found that elderly patients treated with abiraterone had better quality of life over time, with no difference between treatments for the younger subgroup of patients.
(Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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