A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer.
<h4>Introduction</h4>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 a...
Guardado en:
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | article |
Lenguaje: | EN |
Publicado: |
Public Library of Science (PLoS)
2021
|
Materias: | |
Acceso en línea: | https://doaj.org/article/fee0788613ee46fca6169836edf043ce |
Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
id |
oai:doaj.org-article:fee0788613ee46fca6169836edf043ce |
---|---|
record_format |
dspace |
spelling |
oai:doaj.org-article:fee0788613ee46fca6169836edf043ce2021-12-02T20:15:48ZA real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer.1932-620310.1371/journal.pone.0253021https://doaj.org/article/fee0788613ee46fca6169836edf043ce2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0253021https://doaj.org/toc/1932-6203<h4>Introduction</h4>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.<h4>Patients and methods</h4>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.<h4>Results</h4>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).<h4>Conclusion</h4>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.Stephanie I KimAndy H SzetoKatherine P MorganBlaine BrowerMary W DunnAmir H KhandaniPaul A GodleyTracy L RoseEthan M BaschMatthew I MilowskyYoung E WhangDaniel J CronaPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0253021 (2021) |
institution |
DOAJ |
collection |
DOAJ |
language |
EN |
topic |
Medicine R Science Q |
spellingShingle |
Medicine R Science Q Stephanie I Kim Andy H Szeto Katherine P Morgan Blaine Brower Mary W Dunn Amir H Khandani Paul A Godley Tracy L Rose Ethan M Basch Matthew I Milowsky Young E Whang Daniel J Crona A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. |
description |
<h4>Introduction</h4>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.<h4>Patients and methods</h4>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.<h4>Results</h4>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).<h4>Conclusion</h4>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. |
format |
article |
author |
Stephanie I Kim Andy H Szeto Katherine P Morgan Blaine Brower Mary W Dunn Amir H Khandani Paul A Godley Tracy L Rose Ethan M Basch Matthew I Milowsky Young E Whang Daniel J Crona |
author_facet |
Stephanie I Kim Andy H Szeto Katherine P Morgan Blaine Brower Mary W Dunn Amir H Khandani Paul A Godley Tracy L Rose Ethan M Basch Matthew I Milowsky Young E Whang Daniel J Crona |
author_sort |
Stephanie I Kim |
title |
A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. |
title_short |
A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. |
title_full |
A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. |
title_fullStr |
A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. |
title_full_unstemmed |
A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. |
title_sort |
real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2021 |
url |
https://doaj.org/article/fee0788613ee46fca6169836edf043ce |
work_keys_str_mv |
AT stephanieikim arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT andyhszeto arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT katherinepmorgan arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT blainebrower arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT marywdunn arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT amirhkhandani arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT paulagodley arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT tracylrose arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT ethanmbasch arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT matthewimilowsky arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT youngewhang arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT danieljcrona arealworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT stephanieikim realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT andyhszeto realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT katherinepmorgan realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT blainebrower realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT marywdunn realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT amirhkhandani realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT paulagodley realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT tracylrose realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT ethanmbasch realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT matthewimilowsky realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT youngewhang realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer AT danieljcrona realworldevaluationofradium223incombinationwithabirateroneorenzalutamideforthetreatmentofmetastaticcastrationresistantprostatecancer |
_version_ |
1718374564261527552 |