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Poster display session

3170 - Initial Results from AQUARiUS, a Prospective, Observational, Multi-Centre Phase IV Study Assessing Patient-Reported Outcomes (PROs) in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients (pts) Treated with Abiraterone Acetate plus prednisone (AAP) or Enzalutamide (ENZ)

Date

10 Sep 2017

Session

Poster display session

Presenters

Antoine Thiery-Vuillemin

Citation

Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370

Authors

A. Thiery-Vuillemin1, M.H. Poulsen2, A. Reid3, E. Lagneau4, G. Ploussard5, A. Birtle6, L.M. Dourthe7, D. Beal-Ardisson8, E. Pintus9, R. Trepiakas10, M. Lukac11, S. Van Sanden12, L. Dearden13

Author affiliations

  • 1 Service D'oncologie Médicale, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 2 Department Of Urology, Odense Hospital, Odense/DK
  • 3 Oncology, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 4 Oncology, Institut de Cancérologie de Bourgogne, Dijon/FR
  • 5 Chirurgien Urologue, Clinique Saint Jean Languedoc, Toulouse/FR
  • 6 Medical Oncology, Rosemere Cancer Centre, Royal Preston Hospital, Preston/GB
  • 7 Radiotherapie, Clinique Sainte Anne, Strasbourg/FR
  • 8 Oncologue Medical, Hôpital prive Jean Mermoz, Lyon/FR
  • 9 Oncology, Frimley Health NHS Foundation Trust, Slough/GB
  • 10 Oncology, Zealand University Hospital, Naestved/DK
  • 11 Medical Sciences, PAREXEL International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica NV, Beerse/BE
  • 12 Janssen Health Economics & Market Access Emea, Janssen Pharmaceutica NV, Beerse/BE
  • 13 Janssen Emea Hemar, Janssen EMEA, High Wycombe/GB
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Resources

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.

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