Lower Fracture Rates in Patients Treated with Radium-223, Abiraterone or Enzalutamide,When Given Concurrently with Bone Health Agents: A Real-World Analysis |
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| Institution: | 1. University of Nevada Las Vegas, Las Vegas, NV;2. University of California Irvine, Orange, CA;3. Comprehensive Cancer Centers of Nevada, Las Vegas, NV;1. Division of Urology/Urooncology, Department of Surgery, School of Medicine, Universidad del Valle, Cali, Colombia;2. Urooncology Unit. Hospital Clinic, Universitat de Barcelona, Barcelona, Spain;1. Department of Surgical Oncology, Division of Urologic Oncology, Fox Chase Cancer Center, Philadelphia PA;2. Wayne State University Department of Urology, Detroit, MI;3. Biostatistics and Bioinformatics Facility, Fox Chase Cancer Center, Philadelphia PA;1. Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;2. Department of Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet, Copenhagen Denmark;3. International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health (EDMaRC) University of Copenhagen, Copenhagen, Denmark;4. Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;5. Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark;6. Centre of Physical Activity Research, Centre of Inflammation and Metabolism, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;7. Statistics and Data analysis, Danish Cancer Society Research Center, Danish Cancer Society, Copenhagen, Denmark;1. Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Center, New York, NY;2. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY;3. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY;4. SUNY Downstate Health Sciences University, Brooklyn, NY;5. Department of Urology, SUNY Downstate Health Sciences University, Brooklyn, NY;1. Struttura Semplice Dipartimentale di Oncologia Medica per la Presa in Carico Globale del Paziente Oncologico \"Don Tonino Bello,\" I.R.C.C.S. Istituto Tumori \"Giovanni Paolo II,\" Bari, Italy;2. Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy;3. Oncology Unit, Macerata Hospital, Macerata, Italy;4. Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy;1. Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, NC;2. Lineberger Comprehensive Cancer Center (LCCC), UNC-CH, Chapel Hill, NC, USA;3. Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, CT, USA;4. Department of Chronic Disease Epidemiology, Yale School of Medicine, Yale School of Public Health, New Haven, CT, USA;5. Department of Epidemiology, Gillings School of Global Public Health, UNC-CH, Chapel Hill, NC, USA;6. Department of Population Health Sciences, Duke University School of Medicine (DUSM), Durham, NC, USA;7. Duke Cancer Institute (DCI) Center for Prostate and Urologic Cancers, Durham, NC, USA;8. Department of Medicine, DUSM, Durham, NC, USA;9. Department of Surgery (Urology), DUSM, Durham, NC, USA;10. Duke Cancer Institute (DCI), DUSM, Durham, NC, USA;11. Department of Urology, Yale School of Medicine, New Haven, CT, USA;12. Department of Medicine, Yale School of Medicine, New Haven, CT, USA |
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| Abstract: | BackgroundThe phase 3 trial ERA223 demonstrated an increased fracture rate and no survival advantage for metastatic castration resistant prostate cancer (mCRPC) patients on Radium-223 (Ra-223) with abiraterone, leading to regulatory restrictions on combination therapy. However, less than half of trial patients received bone health agents (BHA). We reviewed electronic health record (EHR) data evaluating fracture rates for patients on BHA receiving Ra-223, androgen deprivation therapy and either abiraterone or enzalutamide.Patients and MethodsWe conducted a retrospective, cohort analysis of EHR data of mCRPC patients on Ra-223 treated at a single community center by a single provider between 2010 and 2018. The primary objective was evaluating fracture rates for patients on BHA receiving Ra-223 and abiraterone. We conducted a secondary analysis for enzalutamide.ResultsOne hundred seventy-seven patients received Ra-223 concurrently with abiraterone or enzalutamide between November 2010 and August 2018. The median age was 73 at first Ra-223 dose (range 40-93). The median follow-up time from last Ra-223 dose was 30 months (range 2-106). One hundred sixty-four patients (93%) received BHAs. One hundred fifty-nine patients (89%) were on a BHA before and/or during Ra-223. Sixty-seven patients received denosumab (38%), 63 received zoledronic acid (36%), and 29 received both nonconcurrently (16%). Eleven patients (6.2%) experienced a fracture after starting Ra-223, 9 of which occurred while on prior and/or concurrent BHA. We observed a 5.7% fracture rate for mCRPC patients who received combination therapy and denosumab or zoledronic acid.ConclusionThis real-world analysis demonstrating a low fracture rate in patients with mCRPC receiving a BHA while on Ra-223 and abiraterone or enzalutamide may inform current clinical practice. |
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