Treatment of patients with newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) in Belgium: a real world data analysis

ABSTRACT

INTRODUCTION

Abiraterone acetate + prednisone (AAP) and docetaxel have proven their efficacy in the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) in clinical trials. However, real-world data are scarce. The goal of this study is to evaluate real-world data on the efficacy and safety of these therapies in mHSPC patients.

PATIENTS AND METHODS

Records of 93 patients from 21 different centres were retrospectively reviewed. Primary and secondary endpoints were radiographic and PSA progression-free survival (RPFS – PSA-PFS) and cancer specific and overall survival (CSS – OS), respectively. Adverse events (AEs) were evaluated according to the Common Terminology Criteria for Adverse Events version 5.0. Differences in oncological outcome and AEs were evaluated between three treatment groups: ADT only (N=26) – ADT + AAP (N=48) – ADT + docetaxel (N=19). Survival analysis was performed using Kaplan–Meier statistics.

RESULTS

Median RPFS was 13 months (95% confidence interval [CI]: 9–17) for ADT only, 21 months (95% CI: 19–23) for ADT + AAP and 12 months (95% CI: 11–14) for ADT + docetaxel (p = 0.004). The 1-year PSA-PFS, CSS and OS were 73.5%, 90.7% and 88.7%, respectively, with no significant differences between the three groups. Adverse events of grade 3 or higher were not observed more frequently.

CONCLUSION

Retrospective real-world data show a significantly longer RPFS for mHSPC patients treated with ADT + AAP compared to ADT only or ADT + docetaxel at short-term follow-up. This can aid in counselling of mHSPC patients in daily clinical practice.

KEYWORDS:

• Abiraterone acetate
• androgen deprivation therapy
• docetaxel
• metastatic hormone sensitive prostate cancer

Acknowledgments

Data collection was performed by all authors. Data analysis was performed by Edward Lambert and Charles Van Praet. The article was written by Edward Lambert. Proofreading was performed by all authors. All authors had the final responsibility for the decision to submit for publication.

Disclosure statement

Edward Lambert has received financial support for travel and/or accommodation from Ipsen. CharlesVan Praet is a consultant for Astellas and has received financial support for travel and/oraccommodation from Ipsen and Intuitive Surgical. Siska Van Bruwaene is a consultant for Janssen,Astellas and Bayer. Simon Van Wambeke has an advisory role in Janssen and has received financialsupport for travel and/or accommodation from Ipsen, Roche and Janssen. Brieuc Sautois has servedin a consulting or advisory role for Clovis Oncology, Astellas, Janssen and Sanofi and received financialsupport for travel and/or accommodation from Janssen. Karen Fransis is a consultant for Astellas,Ipsen, BD, Bayer, Intuitive Surgical, Janssen and Ferring. Steven Joniau is a consultant for Astellas,Ipsen, Bayer, Sanofi and Janssen. He has received grants from Astellas, Amgen, Bayer, Sanofi, Janssenand Ipsen and participates in trials for Astellas, Bayer and Janssen. Nicolaas Lumen is a consultant forJanssen, Bayer and Astellas and has received grants from Janssen, Bayer, Astellas, Ipsen and AstraZeneca.The other authors have stated that they have no conflicts of interest.

Data availability statemenT

All data generated or analyzed during this study are included in this article [. Further enquiries can be directed to the corresponding author. https://authoragreement.taylorandfrancisgroup.com/LicenseSummary/Index/1e027452-ec07-4838-8e8d-b990393b95a4

Additional information

Funding

Janssen provided financial support for the conduct of this research. Janssen did not have an active part in study design; in data collection; in data analysis or interpretation of data; in the writing of the report; or in the decision to submit the article for publication.