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Impact of abiraterone acetate plus prednisone or enzalutamide on fatigue and cognition in patients with metastatic castration-resistant prostate cancer: initial results from the observational AQUARiUS study
  1. Antoine Thiery-Vuillemin1,2,
  2. Mads Hvid Poulsen3,
  3. Edouard Lagneau4,
  4. Guillaume Ploussard5,
  5. Alison Birtle6,
  6. Louis-Marie Dourthe7,
  7. Dominique Beal-Ardisson8,
  8. Elias Pintus9,
  9. Redas Trepiakas10,
  10. Laurent Antoni11,
  11. Martin Lukac12,
  12. Suzy Van Sanden11,
  13. Geneviève Pissart11,
  14. Alison Reid13
  1. 1 Department of Medical Oncology, CHU Jean MINJOZ, Franche-Comté, France
  2. 2 UMR1098, INSERM, Besançon, France
  3. 3 Department for Urology, Odense Hospital, Odense, Denmark
  4. 4 Oncologie Medicale, Institut de Cancérologie de Bourgogne, Dijon, France
  5. 5 Urologie, Clinique Saint Jean Languedoc, Toulouse, France
  6. 6 Royal Lancaster Infirmary and Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK
  7. 7 cancerologie, Clinique Sainte Anne, Strasbourg, France
  8. 8 cancerologie, Hôpital prive Jean Mermoz, Lyon, France
  9. 9 oncology, Frimley Health NHS Foundation Trust, Slough, UK
  10. 10 oncology, Zealand University Hospital, Naestved, Denmark
  11. 11 EMEA oncology, Janssen Pharmaceutica N.V, Beerse, Belgium
  12. 12 CRO, PAREXEL International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica N.V, Beerse, Belgium
  13. 13 Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK
  1. Correspondence to Dr Antoine Thiery-Vuillemin; a.thieryvuillemin{at}mac.com

Abstract

Introduction Abiraterone acetate plus prednisone (AAP) and enzalutamide (ENZ) are commonly prescribed for metastatic castration-resistant prostate cancer (mCRPC). Data comparing their effects on patient-reported outcomes (PROs) from routine clinical practice are limited.

Methods AQUARiUS (NCT02813408) is an ongoing, two-cohort, prospective, observational, non-randomised, multicentre, phase IV European study assessing the effects of AAP and ENZ on PROs in 211 patients with mCRPC over 12 months. Patients receive AAP or ENZ per routine clinical practice. Data on cognition, fatigue, pain and health-related quality of life are measured using the Functional Assessment of Cancer Therapy-Cognitive Function, Brief Fatigue Inventory-Short Form, Brief Pain Inventory-Short Form and European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaires, respectively.

Results This 3-month analysis was conducted in 105 patients; 46 received AAP and 59 received ENZ. There were statistically significant differences in mean change from baseline favouring AAP over ENZ at months 1, 2 and 3 for perceived cognitive impairments and cognitive functioning. At each time-point, ENZ-treated patients had a significantly higher risk of experiencing clinically meaningful worsening in perceived cognitive impairments versus those receiving AAP.

Statistically significant differences in mean change from baseline favouring AAP over ENZ were seen for usual level of fatigue and fatigue interference at months 2 and 3 and for current fatigue and worse level of fatigue at month 3. Differences favouring AAP versus ENZ were seen for the fatigue scale of the QLQ-C30 questionnaire (months 1 and 3). There was a significantly higher risk of clinically meaningful worsening in usual level of fatigue with ENZ versus AAP at month 3.

No significant differences between cohorts were observed for pain (BPI-SF) at any time-point.

Conclusion This analysis suggests more favourable outcomes with AAP versus ENZ for cognition and fatigue in the first 3 months of treatment initiation for mCRPC. These findings require confirmation from future analyses of data from AQUARiUS from a larger number of patients with a longer follow-up period.

  • abiraterone acetate
  • enzalutamide
  • patient-reported outcomes
  • metastatic castration-resistant prostate cancer

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Footnotes

  • Contributors AT-V, MHP, AR, EL, GP, AB, L-MD, DB-A, EP and RT participated in the collection/generation of the study data and take responsibility for the integrity of the data collection. AT-V, AR, LA, SVS and GeP contributed to the study conception and design. ML took responsibility for the accuracy of the data. SVS performed the analysis, and AT-V, AR, LA, ML, GeP and SVS were involved in the interpretation of the data. All authors had access to all data analyses, critically reviewed drafts of the manuscript for important intellectual content and gave final approval to submit the manuscript for publication.

  • Funding This study is funded by Janssen Pharmaceutica N.V.

  • Competing interests AT-V reports grants and non-financial support from Janssen, personal fees from Astellas, grants from Janssen and Sanofi, grants and personal fees from Ipsen, Roche, BMS and Pfizer. GP serves on the advisory board and has received honoraria from Astellas and Janssen. AB has received personal fees from Janssen, Sanofi Aventis, Astellas and Roche. EP reports personal fees from Astellas, BMS and Clovis Oncology and non-financial support from Astellas, Clovis Oncology and Janssen. RT reports personal fees from Janssen-Cilag Astellas. LA, SVS and GeP are employees of Janssen Pharmaceutica N.V. and hold stock in Johnson & Johnson. ML is an employee of PAREXEL International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica N.V., Beerse, Belgium. AR has received personal fees from Janssen.

  • Patient consent Not required.

  • Ethics approval UK ethics committee was: East Midlands – Derby Research Ethics Committee, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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