Abstract 3170
Background
AQUARiUS is an ongoing study evaluating PROs and medical resource use in 2 cohorts of chemotherapy naïve mCRPC pts newly initiated on AAP or ENZ in the real-world setting.
Methods
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 (mo) in 211 pts. This analysis describes PRO data for pts with 3-mo follow-up (N = 105). Multivariate repeated measures linear and logistic regression models were used to analyse change from baseline scores and risk for clinically meaningful worsening, respectively, adjusting for baseline characteristics.
Results
Baseline characteristics were well balanced between the ENZ (N = 59) and AAP (N = 46) cohorts. PRO items with significant differences (p
Conclusions
Initial results suggest favourable outcomes for perceived cognitive impairments and functioning, and fatigue for AAP vs ENZ within the first 3 months after treatment initiation.
Clinical trial identification
NCT02813408
Legal entity responsible for the study
Janssen Pharmaceutica N.V.
Funding
Janssen Pharmaceutica N.V.
Disclosure
A. Thiery-Vuillemin: Grants and non-financial support from JNJ, personal fees from Astellas, grants from JNJ and Sanofi, grants and personal fees from Ipsen, Roche, BMS, and Pfizer. M.H. Poulsen: Sponsor of study from Janssen Pharmaceutica. A. Reid: Honoraria from Janssen, travel and grant support from Janssen and Astellas and awarded a place in Janssen's 'Key Opinion Leaders of the future' programme. G. Ploussard: Advisory board and honoraria from Astellas and Janssen. E. Pintus: Grants from Janssen, non-financial support from Astellas, personal fees from Astellas and non-financial support from Janssen. R. Trepiakas: Personal fees from Janssen-Cilag and Astellas. M. Lukac: Personal fees from Parexel International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica NV, Beerse, Belgium. S. Van Sanden: Employee of Janssen and hold stock in Johnson & Johnson. L. Dearden: Employee of Janssen. All other authors have declared no conflicts of interest.
Disclosure
A. Thiery-Vuillemin: Grants and non-financial support from JNJ, personal fees from Astellas, grants from JNJ and Sanofi, grants and personal fees from Ipsen, Roche, BMS, and Pfizer. M.H. Poulsen: Sponsor of study from Janssen Pharmaceutica. A. Reid: Honoraria from Janssen, travel and grant support from Janssen and Astellas and awarded a place in Janssen\'s \'Key Opinion Leaders of the future\' programme. G. Ploussard: Advisory board and honoraria from Astellas and Janssen. E. Pintus: Grants from Janssen, non-financial support from Astellas, personal fees from Astellas and non-financial support from Janssen. R. Trepiakas: Personal fees from Janssen-Cilag and Astellas. M. Lukac: Personal fees from Parexel International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica NV, Beerse, Belgium. S. Van Sanden: Employee of Janssen and hold stock in Johnson & Johnson. L. Dearden: Employee of Janssen. All other authors have declared no conflicts of interest.