AQUARiUS is a phase IV, multi-center ongoing study evaluating PROs and medical resource use in two cohorts of chemotherapy naïve mCRPC patients newly initiated on abiraterone + prednisone or enzalutamide in the real-world setting. The study prospectively collects PROs on quality of life, cognition, fatigue and pain using EORTC QLQ-C30, FACT-Cog, BFI-SF and BPI-SF questionnaires, respectively, for 12 months in 211 patients. This analysis describes PRO data for 105 patients with 3-month follow-up (abiraterone + prednisone, n=46; enzalutamide, n=59). Multivariate repeated measures linear and logistic regression models were used to analyze change from baseline scores and risk for clinically meaningful worsening, respectively, adjusting for baseline characteristics.
Baseline characteristics were well balanced between the cohorts. Change from baseline comparisons favor abiraterone + prednisone over enzalutamide for months 1, 2 and 3 for perceived cognitive impairments (e.g., 1.1 vs -5.9 at month 3, p=0.02) and cognitive functioning (e.g., -0.6 vs -14.9 at month 3, p=0.04) and for month 2 and 3 for usual level and interference of fatigue (e.g., -0.7 vs 1.0 and -0.2 vs 0.7 at month 3, p=0.02). Within the first 3 months enzalutamide-treated patients had a significantly higher risk of experiencing clinically meaningful worsening in perceived cognitive impairments vs abiraterone + prednisone-treated patients.
In conclusion, initial results from the AQUARiUS study suggest favorable outcomes for perceived cognitive impairments, cognitive functioning, usual level of fatigue, and fatigue interference for abiraterone + prednisone vs enzalutamide within the first 3 months after treatment initiation. These results are based on initial data and await confirmation with further analyses, which will include more patients with longer follow-up.
Speaker: Antoine Thiery-Vuillemin, Universite de Franche-Comte, Besançon, France
Co-Authors: M. Poulsen (Odense, Denmark) A. Reid (Sutton, United Kingdom) E. Lagneau (Dijon, France) G. Ploussard (Toulouse, France) A. Birtle (Preston, United Kingdom) L. Dourthe (Strasbourg, France) D. Beal-Ardisson (Lyon, France) E. Pintus (Slough, United Kingdom) R. Trepiakas (Naestved, Denmark) M. Lukac (Beerse, Belgium) S. Van Sanden (Beerse, Belgium) L. Dearden (High Wycombe, United Kingdom)
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
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