MP14-08 REAL-WORD CLINICAL CHARACTERIZATION OF METASTATIC HORMONE SENSITIVE PROSTATE CANCER: DATA FROM THE EUROPEAN NETWORK OF EXCELLENCE FOR BIG DATA IN PROSTATE CANCER (PIONEER)

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) II (MP14)1 May 2024MP14-08 REAL-WORD CLINICAL CHARACTERIZATION OF METASTATIC HORMONE SENSITIVE PROSTATE CANCER: DATA FROM THE EUROPEAN NETWORK OF EXCELLENCE FOR BIG DATA IN PROSTATE CANCER (PIONEER) Rossella Nicoletti, Juan Gomez Rivas, Laura Ibáñez, Carl Steinbeisserc, Bertrand de Meulder, Lyon France, Asieh Golozar, Susan Evans Axelsson, Robert Snijder, Anders Bjartell, Philip Cornford, Mieke Van Hemelrijck, Katharina Beyer, Peter-Paul Willemse, Teemu Murtola, Monique J. Robool, Jesus Moreno Sierra, Riccardo Campi, Mauro Gacci, Nicolas Mottet, Axel Merseburger, and James Ndow Rossella NicolettiRossella Nicoletti , Juan Gomez RivasJuan Gomez Rivas , Laura IbáñezLaura Ibáñez , Carl SteinbeissercCarl Steinbeisserc , Bertrand de MeulderBertrand de Meulder , Lyon FranceLyon France , Asieh GolozarAsieh Golozar , Susan Evans AxelssonSusan Evans Axelsson , Robert SnijderRobert Snijder , Anders BjartellAnders Bjartell , Philip CornfordPhilip Cornford , Mieke Van HemelrijckMieke Van Hemelrijck , Katharina BeyerKatharina Beyer , Peter-Paul WillemsePeter-Paul Willemse , Teemu MurtolaTeemu Murtola , Monique J. RoboolMonique J. Robool , Jesus Moreno SierraJesus Moreno Sierra , Riccardo CampiRiccardo Campi , Mauro GacciMauro Gacci , Nicolas MottetNicolas Mottet , Axel MerseburgerAxel Merseburger , and James NdowJames Ndow View All Author Informationhttps://doi.org/10.1097/01.JU.0001009428.69695.82.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Androgen deprivation therapy (ADT) was the standard of care (SOC) for patients with metastatic Hormone Sensitive Prostate Cancer (mHSPC) for decades; recently, emerging therapies (ARTA, Taxane-based Chemotherapy and their combinations) plus ADT have proven to be more effective than ADT alone, however there is an unmet need of standardization of RCT comparing the various combinations of available drugs. Real Word Data (RWD) may be used to identify relevant outcomes and clinical cohorts with unmet clinical needs with a greater likelihood of benefiting from new therapies. We aim to describe demographics, clinical characteristics, treatment patterns and clinical outcomes of a large multicenter cohort of patients with mHSPC in RWD under the PIONEER project. METHODS: Data of patients with mHSPC across a distributed network of observational databases were collected. Male patients without prior ADT with mHSPC were enrolled in Cohort 1, while Cohort 2 was defined as the start of ADT as a proxy definition of mHSPC disease. Patients were further stratified in metachronous (cohort 1.1 and 2.1) and synchronous (cohort 1.2 and 2.2) disease. RESULTS: Overall, 94,261 mHSPC patients were includedin cohort 1 and 77,123 in cohort 2. More than half of the patients were over 70 years old (54%). In cohort 2, 2,819 patients were metachronous (cohort 2.1) and 55,502 patients were synchronous (cohort 2.2). Most of the patients are treated with ADT only; 28% of mHSPC received combination therapies. After a Median follow-up of 500days (ranged from 398-699 days) in the metachronous setting 22% of patienrs discontinued the treatment. Regarding the clinical outcomes, time to admission to hospital or emergency department, adverse events and death increase with time, but noticeably events are more common in synchronous disease. CONCLUSIONS: This is the largest study in Europe with RWD in the mHSPC setting. Landscape of prostate cancer treatment is constantly evolving, so it is important to understand the behavior of the disease in real-world setting, so we are able to fill gaps or create new questions to create evidence. In RWD that patients are older, with more co-mobilities and 1/3 of them do not undergo a SOC treatment when compared to RCT. Source of Funding: PIONEER is funded through the IMI2 Joint Undertaking and is listed under grant agreement No. 777492. IMI2 receives support from the European Union`s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The views communicated within are those of PIONEER. Neither the IMI nor the European Union, EFPIA or any associated partners are responsible for any use that may be made of the information contained herein © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e222 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Rossella Nicoletti More articles by this author Juan Gomez Rivas More articles by this author Laura Ibáñez More articles by this author Carl Steinbeisserc More articles by this author Bertrand de Meulder More articles by this author Lyon France More articles by this author Asieh Golozar More articles by this author Susan Evans Axelsson More articles by this author Robert Snijder More articles by this author Anders Bjartell More articles by this author Philip Cornford More articles by this author Mieke Van Hemelrijck More articles by this author Katharina Beyer More articles by this author Peter-Paul Willemse More articles by this author Teemu Murtola More articles by this author Monique J. Robool More articles by this author Jesus Moreno Sierra More articles by this author Riccardo Campi More articles by this author Mauro Gacci More articles by this author Nicolas Mottet More articles by this author Axel Merseburger More articles by this author James Ndow More articles by this author Expand All Advertisement PDF downloadLoading ...