Safety of concomitant therapy with radium-223 and abiraterone or enzalutamide in a real-world population.
Safety of concomitant therapy with radium-223 and abiraterone or enzalutamide in a real-world population.
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在现实世界人群中，镭 223 和阿比特龙或恩杂鲁胺联合治疗的安全性。
DOI：
10.1002/pros.24115
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Freedland,StephenJ
中科院分区：
文献类型：
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作者：
Zhao,Hanson;Howard,LaurenE;DeHoedt,AmandaM;Terris,MarthaK;Amling,ChristopherL;Kane,ChristopherJ;Cooperberg,MatthewR;Aronson,WilliamJ;Klaassen,Zachary;Polascik,ThomasJ;Vidal,AdrianaC;Freedland,StephenJ
背景转移性去势抵抗性前列腺癌（mCRPC）患者联合治疗的实际应用和结局在很大程度上尚不清楚。我们评估了在退伍军人事务部（VA）卫生系统中接受镭-223联合或不联合阿比特龙或恩杂鲁胺的男性的总生存期（OS）和骨骼相关事件（SRE）。方法我们回顾了2013年1月至2017年9月在VA接受镭-223的所有mCRPC患者的图表。我们使用考克斯模型来检验合并治疗与镭-223单独治疗对OS和SRE的影响。敏感性分析同时使用地舒单抗/bisphosphonates. ResultsThirhundred和18例患者治疗镭-223被确定; 116/318（37%）同时接受阿比特龙/Enzalutamide。277例（87%）患者在随访期间死亡。接受伴随治疗的患者在开始镭-223治疗时更年轻（中位年龄68 vs. 70，p= 0.027），随访时间更长（中位29.5 vs. 17.9个月，p= 0.030）。合并治疗的患者没有OS获益（风险比[HR]：0. 87，95%置信区间[CI]：0. 67 - 1. 12，p = 0. 28）。合并治疗患者的SRE风险有增加的趋势（HR：1.87，95% CI：0.96- 3.61，p = 0.066），但不显著。当分析仅限于使用骨保健剂的男性时，OS（HR：0.86，95%CI 0.64- 1.15，p = .30）和SRE（HR：2.36，95%CI：0.94- 5.94，p = .068）的结果相似。结论尽管在这项真实的世界研究中普遍使用伴随治疗，但mCRPC患者的OS无差异。观察到SRE风险无显著增加。进一步的工作需要评估联合治疗的最佳顺序、时机和安全性。
BackgroundReal‐world utilization and outcomes of combination therapy for men with metastatic castrate‐resistant prostate cancer (mCRPC) are largely unknown. We evaluated the overall survival (OS) and skeletal‐related events (SREs) among men who received radium‐223 with or without concomitant abiraterone or enzalutamide in the Veterans Affairs (VA) Health System.MethodsWe reviewed charts of all mCRPC patients who received radium‐223 in the VA from January 2013 to September 2017. We used Cox models to test the association between concomitant therapy versus radium‐223 alone on OS and SRE. Sensitivity analyses were performed for concomitant use of denosumab/bisphosphonates.ResultsThree hundred and eighteen patients treated with radium‐223 were identified; 116/318 (37%) received concomitant abiraterone/enzalutamide. Two hundred and seventy‐seven (87%) patients died during follow‐up. Patients who received concomitant therapy were younger at radium‐223 initiation (median age 68 vs. 70,p= .027) and had a longer follow‐up (median 29.5 vs. 17.9 months,p= .030). There was no OS benefit for those on concomitant therapy (hazard ratio [HR]: 0.87, 95% confidence interval [CI]: 0.67–1.12,p= .28). There was a trend for an increased SRE risk for patients on concomitant therapy (HR: 1.87, 95% CI: 0.96–3.61,p= .066), but this was not significant. When analyses were limited to men using bone heath agents, similar results were seen for OS (HR: 0.86, 95% CI 0.64–1.15,p= .30) and SRE (HR: 2.36, 95% CI: 0.94–5.94,p= .068).ConclusionsDespite the common use of concomitant therapy in this real‐world study, there was no difference in OS among mCRPC patients. A nonsignificant increased SRE risk was observed. Further work needs to evaluate the optimal sequence, timing, and safety of combination therapies.