Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in "real-life" patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.
European urology open science. 2024 Mar 25*** epublish ***
Pawel Rajwa, Angelika Borkowetz, Thomas Abbott, Andrea Alberti, Anders Bjartell, James T Brash, Riccardo Campi, Andrew Chilelli, Mitchell Conover, Niculae Constantinovici, Eleanor Davies, Bertrand De Meulder, Sherrine Eid, Mauro Gacci, Asieh Golozar, Haroon Hafeez, Samiul Haque, Ayman Hijazy, Tim Hulsen, Andreas Josefsson, Sara Khalid, Raivo Kolde, Daniel Kotik, Samu Kurki, Mark Lambrecht, Chi-Ho Leung, Julia Moreno, Rossella Nicoletti, Daan Nieboer, Marek Oja, Soundarya Palanisamy, Peter Prinsen, Christian Reich, Giulio Raffaele Resta, Maria J Ribal, Juan Gómez Rivas, Emma Smith, Robert Snijder, Carl Steinbeisser, Frederik Vandenberghe, Philip Cornford, Susan Evans-Axelsson, James N'Dow, Peter-Paul M Willemse
Department of Urology, Medical University of Silesia, Zabrze, Poland., Department of Urology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany., European Association of Urology, Nijmegen, The Netherlands., Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy., Department of Translational Medicine, Lund University, Lund, Sweden., IQVIA, Real World Solutions, Brighton, UK., Astellas Pharma Europe Ltd, Surrey, UK., Janssen Research & Development, Titusville, NJ, USA., Bayer AG, Berlin, Germany., Association EISBM, Vourles, France., SAS Institute, Cary, NC, USA., Odysseus Data Services, New York, NY, USA., Shaukat Khanum Memorial Cancer Hospital & Research Centre, Peshawar, Pakistan., Department of Hospital Services & Informatics, Philips Research, Eindhoven, The Netherlands., Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden., University of Oxford, Oxford, UK., Institute of Computer Science, University of Tartu, Tartu, Estonia., Center for Advanced Systems Understanding, Görlitz, Germany., Bayer OY, Turku, Finland., S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China., Erasmus MC University Medical Center, Rotterdam, The Netherlands., Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands., Uro-Oncology Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain., Department of Urology, Hospital Clinico San Carlos, Madrid, Spain., Guidelines Office, European Association of Urology, Arnhem, The Netherlands., Collaborate Project Management, Munich, Germany., Liverpool University Hospitals NHS Trust, Liverpool, UK., Academic Urology Unit, University of Aberdeen, Aberdeen, UK., Department of Urology, Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands.