In the phase 3 PROfound trial, patients were asked to completed health-related quality of life assessments (Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire plus subscales) at baseline and every 8 weeks until disease progression. The five subscales included: physical wellbeing, functional wellbeing, emotional wellbeing, social wellbeing, and prostate cancer subscale. The Trial Outcome Index (TOI: physical wellbeing + functional wellbeing + prostate cancer subscale) and FACT Advanced Prostate Symptom Index (FAPSI-6: derived from 6 FACT-P items) were also calculated. Adjusted mean change and time to deterioration in scores were statistically analyzed.
The overall questionnaire compliance rate was 64% of patients receiving olaparib and 57% for patients receiving physician’s choice of enzalutamide or abiraterone. Baseline FACT-P total score was similar for both treatment arms. FACT-P total and subscale scores during treatment were all higher for olaparib compared to physician’s choice of enzalutamide or abiraterone.
Furthermore, there were clinically meaningful differences between treatment arms in the adjusted least square mean changes from baseline:
The time to deterioration in FACT-P total and TOI, FAPSI-6, physical well-being, and prostate cancer subscale scores favored olaparib but were not statistically significant, with hazard ratios ranging from 0.68 to 0.94.
Dr. Thiery-Vuillemin concluded this presentation of additional health-related quality of life outcomes from PROfound with the following take-home messages:
- Olaparib delayed deterioration in health-related quality of life scores vs physician’s choice of new hormonal agent and was associated with better health-related quality of life functioning over time
- These results support the clinical benefit of improved radiographic progression-free survival
Presented by: Antoine Thiery-Vuillemin, MD, PhD, Centre Hospitalier de Besancon, Besancon, France
Co-Authors: Johann S. De Bono, Fred Saad, Giuseppe Procopio, Neal D. Shore, Karim Fizazi, Guilhem Roubaud, Gabriel dos Anjos, Gwenaelle Gravis, Jae Young Joung, Nobuaki Matsubara, Daniel Castellano, Arnold Degboe, Christopher Gresty, Jinyu Kang, Allison Allen, Joseph E Burgents, Maha H. A. Hussain; The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom; Centre Hospitalier de l’Université de Montréal/CRCHUM, Montreal, QC, Canada; Medical Oncology Dept, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Carolina Urologic Research Center, Myrtle Beach, SC; Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Dept of Medical Oncology, Institute Bergonié, Bordeaux, France; Hospital Ernesto Dornelles, Porto Alegre, Brazil; Centre de Recherche en Cancerologie de Marseille (CRCM), Institut Paoli-Calmettes, Aix-Marseille University, Marseille, France; Center for Prostate Cancer, National Cancer Center, Goyang, South Korea; Dept of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan; Hospital Universitario, Madrid, Spain; AstraZeneca, Gaithersburg, MD; AstraZeneca, Cambridge, United Kingdom; Merck & Co., Inc., Kenilworth, NJ; Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL
Written By: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, Twitter: @zklaassen_md at the 2020 ASCO Annual Meeting, Virtual Scientific Program #ASCO20, May 29- 31, 2020
1. de Bono J, Mateo J, Fizazi K, et al. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020.
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