MP11-13 CLINICAL FRACTURE INCIDENCE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (mHSPC) AND RISK-REDUCTION FOLLOWING ADDITION OF ZOLEDRONIC ACID TO ANDROGEN DEPRIVATION THERAPY (ADT) WITH OR WITHOUT DOCETAXEL (DOC): LONG-TERM RESULTS FROM 2 PHASE 3 TRIALS FROM THE STAMPEDE PLATFORM PROTOCOL

You have accessJournal of UrologyCME1 Apr 2023MP11-13 CLINICAL FRACTURE INCIDENCE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (mHSPC) AND RISK-REDUCTION FOLLOWING ADDITION OF ZOLEDRONIC ACID TO ANDROGEN DEPRIVATION THERAPY (ADT) WITH OR WITHOUT DOCETAXEL (DOC): LONG-TERM RESULTS FROM 2 PHASE 3 TRIALS FROM THE STAMPEDE PLATFORM PROTOCOL Craig Jones, Ashwin Sachdeva, Laura Murphy, Macey Murray, Louise Brown, Eugene McCloskey, Janet Brown, Gerhardt Attard, Mahesh Parmar, Nicholas James, Matthew Sydes, and Noel Clarke Craig JonesCraig Jones , Ashwin SachdevaAshwin Sachdeva , Laura MurphyLaura Murphy , Macey MurrayMacey Murray , Louise BrownLouise Brown , Eugene McCloskeyEugene McCloskey , Janet BrownJanet Brown , Gerhardt AttardGerhardt Attard , Mahesh ParmarMahesh Parmar , Nicholas JamesNicholas James , Matthew SydesMatthew Sydes , and Noel ClarkeNoel Clarke View All Author Informationhttps://doi.org/10.1097/JU.0000000000003226.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Long-term ADT is recommended for men with mHSPC: bone loss and increased fracture risk are known complications. The STAMPEDE trial compared ADT±docetaxel (Doc)±zoledronic acid (ZA): adding ZA did not improve overall survival (OS) but long-term effects of bisphosphonate treatment on skeletal health was not formally collected as part of the trial. Accessible, high quality, routinely-collected healthcare data (RCHD) enables analysis of outcome data beyond standard trial follow-up to evaluate long-term treatment toxicity and clinical efficacy of ZA as a bone protective agent in mHSPC. The Hospital Episode Statistics (HES) database provides RCHD for patients in England and Wales. METHODS: HES data up to 2018 were obtained for patients (pts) randomised 2:1 between ADT (Arm A) and ADT+ZA (Arm B), or ADT+Doc (Arm C) or ADT+Doc+ZA (Arm E). ZA (4 mg) was six 3-weekly cycles, then 4-weekly for 2 years. Clinical fracture events were identified using a bespoke pre-specified coding framework of International Classification of Diseases (ICD 10) diagnosis and Classification of Interventions and Procedures (OPCS 4) procedure codes. Multivariate Cox regression models were developed to adjust for age, N stage, WHO performance status, Gleason score and NSAID use to determine impact of ZA on fracture risk. RESULTS: Connected datasets were available for 2,145 eligible pts (796 M0, 1,349 M1) of 2,962 (72%). Overall, 5-year fracture incidence was 6.4%; higher in M1 pts (9.6% in M1 vs 2.1% in M0, p<0.0001), and lower amongst M1 pts allocated ZA (4.55% with ZA vs 12.9% without ZA, p<0.0001) (Figure 1). ZA significantly reduced fracture risk in M1 pts (HR 0.36, 95% CI 0.22-0.57, p<0.0005) but not in M0 pts (HR 0.67, 95% CI 0.32-1.39, p=0.28). CONCLUSIONS: By accessing RCHD, we evaluated long-term fracture events amongst patients in STAMPEDE. Fracture rates were clinically notable in M1 and reduced significantly in pts allocated ZA with ADT±Doc. These data support using bone protective agents to reduce clinically significant fractures in mHSPC. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e129 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Craig Jones More articles by this author Ashwin Sachdeva More articles by this author Laura Murphy More articles by this author Macey Murray More articles by this author Louise Brown More articles by this author Eugene McCloskey More articles by this author Janet Brown More articles by this author Gerhardt Attard More articles by this author Mahesh Parmar More articles by this author Nicholas James More articles by this author Matthew Sydes More articles by this author Noel Clarke More articles by this author Expand All Advertisement PDF downloadLoading ...