A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer Public Deposited

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  • Kim, S.I.
    • Affiliation: Eshelman School of Pharmacy, Division of Pharmacotherapy and Experimental Therapeutics
  • Szeto, A.H.
    • Affiliation: Eshelman School of Pharmacy, Division of Pharmacotherapy and Experimental Therapeutics
  • Morgan, K.P.
    • Affiliation: Eshelman School of Pharmacy
  • Brower, B.
    • Affiliation: School of Medicine, Department of Medicine
  • Dunn, M.W.
    • Affiliation: School of Medicine, Department of Medicine
  • Khandani, A.H.
    • Affiliation: School of Medicine, Department of Radiology
  • Godley, P.A.
    • Affiliation: School of Medicine, Department of Medicine
  • Rose, T.L.
    • Affiliation: School of Medicine, Department of Medicine
  • Basch, E.M.
    • Affiliation: School of Medicine, Department of Medicine
  • Milowsky, M.I.
    • Affiliation: School of Medicine, Department of Medicine
  • Whang, Y.E.
    • Affiliation: School of Medicine, Department of Medicine
  • Crona, D.J.
    • Affiliation: Eshelman School of Pharmacy, Division of Pharmacotherapy and Experimental Therapeutics
Abstract
  • Introduction Radium-223, abiraterone, and enzalutamide have each been shown to significantly improve survival as monotherapy in patients with metastatic castration-resistant prostate cancer. However, effects of combination radium-223 plus abiraterone or enzalutamide on survival and safety remain unclear. Patients and methods This single-center retrospective cohort study used electronic health record data of patients with metastatic castration-resistant prostate cancer and bone metastases who were treated with radium-223 between April 1, 2014 and February 19, 2019. Patients who received radium-223 monotherapy were compared to patients who received a combination of radium-223 plus either abiraterone or enzalutamide. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, time to symptomatic skeletal event, symptomatic skeletal event-free survival, and incidence of drug-related adverse events. Time-to-event analyses were estimated by log rank tests using Kaplan-Meier curves. Hazard ratios and 95% confidence intervals were derived from Cox proportional hazards models. Chi-square tests evaluated difference in serious adverse events between the two arms. Results A total of 60 patients met inclusion criteria (n = 41 in the monotherapy arm, n = 19 in the combination arm). Differences in median overall survival were not observed (12.7 vs. 12.8 months; HR 1.15, 95% CI 0.59-2.23; P = 0.68), but median progression-free survival was significantly longer in the combination arm (7.6 vs. 4.9 months; HR 1.94, 95% CI 1.11-3.40; P = 0.02). Significant differences were not observed in time to first SSE (P = 0.97), SSE-free survival (P = 0.16), or in the overall incidence of serious adverse events (P = 0.45). Conclusion Combination radium-223 plus abiraterone or enzalutamide did not improve overall survival, but prolonged progression-free survival without increasing the incidence of serious adverse events in metastatic castration-resistant prostate cancer patients with bone metastases. However, these results are limited by small numbers and patient selection inherent in retrospective analysis.
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  • Article
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  • In Copyright
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  • Attribution 4.0 International
Journal title
  • PLoS ONE
Journal volume
  • 16
Journal issue
  • 6-Jun
Language
  • English
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  • 1932-6203
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  • Public Library of Science
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