The ALSYMPCA study established a 3.6 month Overall Survival (OS) benefit in metastatic Castration Resistant Prostate Cancer (mCRPC) patients treated with Radium‐223 dichloride (Ra‐223) over placebo. Here we report clinical outcomes of Ra‐223 treatment in a nonstudy population. In this prospective registry, patients from 20 Dutch hospitals were included prior to Ra‐223 treatment. Clinical parameters collected included previous treatments and Adverse Events. Primary outcome was 6 months Symptomatic Skeletal Event (SSE)‐free survival, while secondary outcomes included Progression‐Free Survival (PFS) and Overall Survival (OS). Of the 305 patients included, 300 were evaluable. The mean age was 73.6 years, 90% had ≥6 bone metastases and 74.1% were pretreated with Docetaxel, 19.5% with Cabazitaxel and 80.5% with Abiraterone and/or Enzalutamide. Of all patients, 96.7% were treated with Ra‐223 and received a median of 5 cycles. After a median follow‐up of 13.2 months, 6 months SSE‐free survival rate was 83%, median PFS was 5.1 months and median OS was 15.2 months. Six months SSE‐free survival rate and OS were comparable with those reported in ALSYMPCA. “Previous Cabazitaxel treatment” and “bone‐only metastases” were independent predictors of a shorter and longer PFS, respectively, while above‐median LDH and “bone‐only metastases” were independent predictors of shorter and longer OS, respectively. Toxicity was similar as reported in the ALSYMPCA trial. These results suggest that in a nonstudy population, Ra‐223 treatment is well‐tolerated, equally effective as in the ALSYMPCA population and that patients not previously treated with Cabazitaxel benefit most from Ra‐223.

中文翻译：

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前瞻性观察性注册表评估了非研究人群中Radium-223治疗的临床结果。

ALSYMPCA研究在安慰剂治疗下，用二氯化Rad223（Ra-223）治疗的转移性去势抵抗性前列腺癌（mCRPC）患者建立了3.6个月的总生存期（OS）。在这里，我们报告了在非研究人群中进行Ra-223治疗的临床结果。在此前瞻性注册表中，在Ra‐223治疗之前纳入了来自20家荷兰医院的患者。收集的临床参数包括既往治疗和不良事件。主要结局为6个月无症状骨骼事件（SSE）生存，而次要结局包括无进展生存（PFS）和总体生存（OS）。在305名患者中，有300名是可评估的。平均年龄为73.6岁，其中90％≥6发生骨转移，多西紫杉醇预处理组占74.1％，卡巴他赛预处理组占19.5％，阿比特龙和/或恩扎鲁胺组占80.5％。在所有患者中，有96.7％的患者接受了Ra‐223的治疗，平均接受5个周期的治疗。中位随访13.2个月后，6个月无SSE生存率为83％，中位无进展生存期为5.1个月，中位生存期为15.2个月。六个月的无SSE生存率和OS与ALSYMPCA中报告的相当。“先前的卡巴他赛治疗”和“仅骨转移”分别是较短和较长PFS的独立预测因子，而中位数LDH和“仅骨转移”分别是较短和较长OS的独立预测因子。毒性与ALSYMPCA试验中报道的相似。这些结果表明，在非研究人群中，对Ra‐223的治疗耐受性良好，与ALSYMPCA人群同样有效，并且以前未接受卡巴他赛治疗的患者受益于Ra‐223。7％的患者接受Ra‐223治疗，中位值为5个周期。中位随访13.2个月后，6个月无SSE生存率为83％，中位无进展生存期为5.1个月，中位生存期为15.2个月。六个月的无SSE生存率和OS与ALSYMPCA中报告的相当。“先前的卡巴他赛治疗”和“仅骨转移”分别是较短和较长PFS的独立预测因子，而中位数LDH和“仅骨转移”分别是较短和较长OS的独立预测因子。毒性与ALSYMPCA试验中报道的相似。这些结果表明，在非研究人群中，对Ra‐223的治疗耐受性良好，与ALSYMPCA人群中的治疗效果相同，并且以前未接受卡巴他赛治疗的患者受益于Ra‐223。7％的患者接受Ra‐223治疗，中位值为5个周期。中位随访13.2个月后，6个月无SSE生存率为83％，中位无进展生存期为5.1个月，中位生存期为15.2个月。六个月的无SSE生存率和OS与ALSYMPCA中报告的相当。“先前的卡巴他赛治疗”和“仅骨转移”分别是较短和较长PFS的独立预测因子，而中位数LDH和“仅骨转移”分别是较短和较长OS的独立预测因子。毒性与ALSYMPCA试验中报道的相似。这些结果表明，在非研究人群中，对Ra‐223的治疗耐受性良好，与ALSYMPCA人群中的治疗效果相同，并且以前未接受卡巴他赛治疗的患者受益于Ra‐223。