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Initial Safety and Tumor Control Results From a "First-in-Human" Multicenter Prospective Trial Evaluating a Novel Alpha-Emitting Radionuclide for the Treatment of Locally Advanced Recurrent Squamous Cell Carcinomas of the Skin and Head and Neck.

一项 “首例” 多中心前瞻性试验的初步安全性和肿瘤控制结果,该试验评估了一种新型 α-发射放射性核素治疗局部晚期复发性皮肤和头部鳞状细胞癌还有脖子。

  • 影响因子:3.70
  • DOI:10.1016/j.ijrobp.2019.10.048
  • 作者列表:"Popovtzer A","Rosenfeld E","Mizrachi A","Bellia SR","Ben-Hur R","Feliciani G","Sarnelli A","Arazi L","Deutsch L","Kelson I","Keisari Y
  • 发表时间:2020-03-01
Abstract

PURPOSE:Our purpose was to report the feasibility and safety of diffusing alpha-emitter radiation therapy (DaRT), which entails the interstitial implantation of a novel alpha-emitting brachytherapy source, for the treatment of locally advanced and recurrent squamous cancers of the skin and head and neck. METHODS AND MATERIALS:This prospective first-in-human, multicenter clinical study evaluated 31 lesions in 28 patients. The primary objective was to determine the feasibility and safety of this approach, and the secondary objectives were to evaluate the initial tumor response and local progression-free survival. Eligibility criteria included all patients with biopsy-proven squamous cancers of the skin and head and neck with either primary tumors or recurrent/previously treated disease by either surgery or prior external beam radiation therapy; 13 of 31 lesions (42%) had received prior radiation therapy. Toxicity was evaluated according to the Common Terminology Criteria for Adverse Events version 4.03. Tumor response was assessed at 30 to 45 days at a follow-up visit using the Response Evaluation Criteria in Solid Tumors, version 1.1. Median follow-up time was 6.7 months. RESULTS:Acute toxicity included mostly local pain and erythema at the implantation site followed by swelling and mild skin ulceration. For pain and grade 2 skin ulcerations, 90% of patients had resolution within 3 to 5 weeks. Complete response to the Ra-224 DaRT treatment was observed in 22 lesions (22/28; 78.6%); 6 lesions (6/28, 21.4%) manifested a partial response (>30% tumor reduction). Among the 22 lesions with a complete response, 5 (22%) developed a subsequent local relapse at the site of DaRT implantation at a median time of 4.9 months (range, 2.43-5.52 months). The 1-year local progression-free survival probability at the implanted site was 44% overall (confidence interval [CI], 20.3%-64.3%) and 60% (95% CI, 28.61%-81.35%) for complete responders. Overall survival rates at 12 months post-DaRT implantation were 75% (95% CI, 46.14%-89.99%) among all patients and 93% (95% CI, 59.08%-98.96%) among complete responders. CONCLUSIONS:Alpha-emitter brachytherapy using DaRT achieved significant tumor responses without grade 3 or higher toxicities observed. Longer follow-up observations and larger studies are underway to validate these findings.

摘要

目的: 我们的目的是报道扩散 α 发射体放射治疗 (DaRT) 的可行性和安全性,这需要组织间植入一种新型的 α 发射体近距离治疗源,用于治疗局部晚期和复发性皮肤和头颈部鳞癌。 方法和材料: 这项前瞻性首诊人体多中心临床研究评估了 28 例患者的 31 个病灶。主要目的是确定这种方法的可行性和安全性,次要目标是评估初始肿瘤反应和局部无进展生存期。合格标准包括所有经活检证实的皮肤和头颈部鳞状细胞癌患者,原发肿瘤或复发/既往通过手术或既往外照射治疗的疾病; 31 个病灶中有 13 个 (42%) 既往接受过放射治疗。毒性根据不良事件通用术语标准 4.03 版进行评价。在随访访视时,使用实体瘤反应评价标准 1.1 版,在 30 ~ 45 天评估肿瘤反应。中位随访时间为 6.7 个月。 结果: 急性毒性反应多为植入部位局部疼痛和红斑,其次为肿胀和轻度皮肤溃疡。对于疼痛和 2 级皮肤溃疡,90% 的患者在 3 ~ 5 周内消退。在 22 个病灶 (22/28; 78.6%) 中观察到Ra-224 DaRT治疗的完全缓解; 6 个病灶 (6/28,21.4%) 表现为部分缓解 (肿瘤缩小> 30%)。在 22 个完全缓解的病灶中,5 个 (22%) 在DaRT植入部位出现随后的局部复发,中位时间为 4.9 个月 (范围,2.43-5.52 个月)。植入部位的 1 年局部无进展生存概率总体为 44% (置信区间 [CI],20.3%-64.3%) 和 60% (95% CI,28.61%-81.35%) 对于完整的响应者。所有患者植入DaRT后 12 个月时的总生存率为 75% (95% CI,46.14%-89.99%),完全应答者为 93% (95% CI,59.08%-98.96%)。 结论: 使用DaRT的 α-发射体近距离放射治疗获得了显著的肿瘤反应,未观察到 3 级或更高的毒性。更长的随访观察和更大的研究正在进行,以验证这些发现。

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影响因子:2.93
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影响因子:0.96
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DOI:10.1097/DAD.0000000000001459
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皮肤肿瘤方向

皮肤肿瘤是发生在皮肤的细胞增生性疾病,是一种常见病。发生于皮内或皮下组织的新生物,种类很多,临床上分良性肿瘤和恶性肿瘤。恶性肿瘤可以不断增殖,引起转移,威胁生命,称为皮肤癌。

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