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.
Alpha DaRT的初步疗效和安全性已得到证实（NCT04377360），但该治疗的长期安全性和持久性尚不明确。本项对四项前瞻性试验的汇总分析评估了Alpha DaRT治疗头颈部或皮肤肿瘤的长期安全性与疗效。研究在六家国际机构共治疗71例患者的81处病灶，中位随访时间14.1个月（范围：2-51个月）。通过经皮间质植入技术置入Alpha DaRT放射源，使其辐射范围覆盖肿瘤体积及边缘区域。植入后2-3周移除放射源。结果显示89%的病灶（n=72）达到完全缓解，10%（n=8）达到部分缓解。两年精算局部无复发生存率为77%[95% CI 63-87]。复发与非复发灶、基线肿瘤大小或组织学类型等变量均未影响长期结局。27%的患者出现2级及以上急性毒性反应，经保守治疗后均缓解。未观察到2级及以上远期毒性反应。这些数据支持Alpha DaRT良好的安全性特征，目前该疗法正在美国开展关键性临床试验。
肿瘤(癌症)患者之家