PDF(Pubmed)
Abstract：
The initial favorable efficacy and safety profile for Alpha DaRT have been demonstrated (NCT04377360); however, the longer-term safety and durability of the treatment are unknown. This pooled analysis of four prospective trials evaluated the long-term safety and efficacy of Alpha DaRT for the treatment of head and neck or skin tumors. A total of 81 lesions in 71 patients were treated across six international institutions, with a median follow-up of 14.1 months (range: 2-51 months). Alpha DaRT sources were delivered via a percutaneous interstitial technique and placed to irradiate the tumor volume with the margin. The sources were removed two to three weeks following implantation. A complete response was observed in 89% of treated lesions (n = 72) and a partial response in 10% (n = 8). The two-year actuarial local recurrence-free survival was 77% [95% CI 63-87]. Variables, including recurrent versus non-recurrent lesions, baseline tumor size, or histology, did not impact long-term outcomes. Twenty-seven percent of patients developed related acute grade 2 or higher toxicities, which resolved with conservative measures. No grade 2 or higher late toxicities were observed. These data support the favorable safety profile of Alpha DaRT, which is currently being explored in a pivotal US trial.
摘要：
已证明AlphaDaRT的初始疗效和安全性良好（NCT04377360）；然而，治疗的长期安全性和耐久性尚不清楚.这项对四项前瞻性试验的汇总分析评估了AlphaDaRT治疗头颈部或皮肤肿瘤的长期安全性和有效性。在六个国际机构中，共有71例患者的81个病变接受了治疗，中位随访时间为14.1个月（范围：2-51个月）。AlphaDaRT源通过经皮间质技术递送，并放置以照射边缘的肿瘤体积。植入后两到三周去除来源。在89％的治疗病变（n=72）中观察到完全反应，在10％（n=8）中观察到部分反应。两年精算局部无复发生存率为77%[95%CI63-87]。变量,包括复发性和非复发性病变，基线肿瘤大小，或组织学，不影响长期结果。27％的患者出现相关的急性2级或更高的毒性，以保守的措施解决。没有观察到2级或更高的晚期毒性。这些数据支持AlphaDaRT的良好安全性，目前正在美国的一项关键试验中进行探索。
