This study included 1199 mCNPC patients who were randomized 1:1 to ADT + abiraterone and prednisone vs ADT alone. Utilities used included the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EQ-5D-5L questionnaires. These were assessed at baseline, day 1 of cycles 2-13, then every 2 months until treatment discontinuation. EQ-5D-5L were performed every 4 months until 12 months after treatment discontinuation. Time to event and repeated measures analyses on changes from baseline were conducted to assess the impact of adding abiraterone and prednisone on HRQoL. The questionnaire compliance rate for this study was excellent (≥90%). Compared to patients receiving ADT alone, the ADT + abiraterone and prednisone arm had significant delayed time to pain and fatigue intensity and interference progression. Furthermore, FACT-P assessments demonstrated significant delay in degradation for the total score and symptom subscales for the ADT + abiraterone and prednisone arm. Repeated measures analyses showed maintenance or improvement from baseline for the ADT + abiraterone and prednisone arm compared to the ADT alone arm, with significant differences emerging as early as the second cycle. Significant improvement from baseline in EQ-5D visual analogue scale assessment for general health status and health utility scores occurred as early as cycle 5 and was maintained throughout the study.
The authors concluded that compared with patients receiving ADT alone, treatment with ADT + abiraterone and prednisone consistently demonstrated improvement across multiple PRO measures. This included a statistically significant improvement in HRQoL and delays in progression of pain fatigue intensity and interference, and functional decline. These impressive results for PROs are comparable to the significantly improved clinical outcomes initially reported in LATITUDE , providing further evidence for adding abiraterone and prednisone to ADT for men presenting with mCNPC.
Speaker: Kim Chi, British Columbia Cancer Agency, Vancouver, Canada
Co-Authors: A. Protheroe (Oxford, United Kingdom) A. Rodriguez Antolin (Madrid, Spain)
G. Facchini (Naples, Italy) H. Suttmann (Hamburg, Germany) N. Matsubara (Chiba, Japan) Z. Ye (Wuhan, China) B. Keam (Seoul, Korea, Republic of) T. Li (Raritan, United States of America) K. McQuarrie (Horsham, United States of America) B. Jia (Shanghai, China) P. De Porre (Beerse, Belgium) J. Martin (Buckinghamshire, United Kingdom) M. B. Todd (Raritan, United States of America) K. Fizazi (Villejuif, France)
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, Twitter: @zklaassen_md at the European Society for Medical Oncology Annual Congress - September 8 - 12, 2017 - Madrid, Spain
1. Fizazi K, Tran N, Fein L, et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017;377(4):352-360.