Department of Otolaryngology-Head and Neck Surgery, IRCCS Policlinico San Matteo Foundation, 27100 Pavia, Italy.
South Tees NHS Foundation Trust, Middlesbrough TS4 3BW, UK.
Curr Oncol. 2022 Jul 28;29(8):5324-5337. doi: 10.3390/curroncol29080423.
This prospective registry-based study aims to describe electrochemotherapy (ECT) modalities in basal cell carcinoma (BCC) patients and evaluate its efficacy, safety, and predictive factors. The International Network for Sharing Practices of Electrochemotherapy (InspECT) multicentre database was queried for BCC cases treated with bleomycin-ECT between 2008 and 2019 (n = 330 patients from seven countries, with 623 BCCs [median number: 1/patient; range: 1-7; size: 13 mm, range: 5-350; 85% were primary, and 80% located in the head and neck]). The procedure was carried out under local anaesthesia in 68% of cases, with the adjunct of mild sedation in the remaining 32%. Of 300 evaluable patients, 242 (81%) achieved a complete response (CR) after a single ECT course. Treatment naïvety (odds ratio [OR] 0.35, 95% confidence interval [C.I.] 0.19-0.67, = 0.001) and coverage of deep tumour margin with electric pulses (O.R. 5.55, 95% C.I. 1.37-21.69, = 0.016) predicted CR, whereas previous radiation was inversely correlated (O.R. 0.25, = 0.0051). Toxicity included skin ulceration (overall, 16%; G3, 1%) and hyperpigmentation (overall, 8.1%; G3, 2.5%). At a 17-month follow-up, 28 (9.3%) patients experienced local recurrence/progression. Despite no convincing evidence that ECT confers improved outcomes compared with standard surgical excision, it can still be considered an opportunity to avoid major resection in patients unsuitable for more demanding treatment. Treatment naïvety and coverage of the deep margin predict tumour clearance and may inform current patient selection and management.
本前瞻性基于注册的研究旨在描述电化学疗法(ECT)在基底细胞癌(BCC)患者中的应用模式,并评估其疗效、安全性和预测因素。国际电化学疗法实践共享网络(InspECT)多中心数据库对 2008 年至 2019 年间接受博来霉素-ECT 治疗的 BCC 病例进行了查询(来自 7 个国家的 330 例患者,共 623 个 BCC[中位数:1/例;范围:1-7;大小:13mm,范围:5-350;85%为原发性,80%位于头颈部])。68%的病例在局部麻醉下进行手术,其余 32%的病例在轻度镇静下进行手术。在 300 例可评估的患者中,242 例(81%)在单次 ECT 疗程后达到完全缓解(CR)。治疗初治(比值比[OR]0.35,95%置信区间[CI]0.19-0.67, = 0.001)和肿瘤深部边界用电脉冲覆盖(OR5.55,95%CI1.37-21.69, = 0.016)可预测 CR,而先前的放疗呈负相关(OR0.25, = 0.0051)。毒性包括皮肤溃疡(总体 16%;G3 级 1%)和色素沉着过度(总体 8.1%;G3 级 2.5%)。在 17 个月的随访中,28 例(9.3%)患者出现局部复发/进展。尽管没有确凿的证据表明 ECT 比标准手术切除能带来更好的结果,但在不适合更具挑战性治疗的患者中,它仍然可以被视为避免广泛切除的机会。治疗初治和肿瘤深部边界的覆盖可预测肿瘤清除率,并可能为当前的患者选择和管理提供信息。