PO.ET02.07 · 实验与分子治疗
电化学疗法治疗非黑色素瘤皮肤癌：临床结局与耐受性
Non-melanoma skin cancer treated with electrochemotherapy: Clinical outcomes and tolerability
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摘要 Abstract
中文摘要
背景：电化学疗法(ECT)将电穿孔与化疗相结合，以增强细胞毒性药物在肿瘤细胞中的摄取。本研究评估在非黑色素瘤皮肤癌(NMSC)患者中使用静脉博来霉素的ECT的疗效和安全性。
方法：16例经组织学确诊的NMSC患者在门诊环境下于神经安定镇痛下接受治疗。静脉博来霉素以15,000 IU/m²体表面积的剂量给药。电脉冲使用OncoPore设备(BIOTEX SRL，布宜诺斯艾利斯，阿根廷)递送。每次治疗持续不到一小时，除1例患者外，所有患者均只需单次治疗。肿瘤反应根据RECIST标准评估，不良事件按照CTCAE指南分级。
结果：在16例接受治疗的患者中，11例为鳞状细胞癌，5例为基底细胞癌。12例患者(75%)达到完全缓解，3例(19%)达到部分缓解，1例(6%)表现为疾病稳定(SD)，客观缓解率为94%。值得注意的是，1例隐性营养不良性大疱性表皮松解症患者达到了完全缓解且无并发症。不良事件为轻至中度且短暂。最常见的是疼痛(2级)，可用非甾体抗炎药有效控制。红斑(1级)和肿胀(1-2级)在一周内自行消退。4例患者(25%)发生感染(2级)，经口服抗生素成功治疗。未观察到严重或全身性不良事件。所有病例的美学结局均极佳，周围健康组织得以保留，瘢痕极小。
结论：使用静脉博来霉素的ECT是一种针对非黑色素瘤皮肤癌患者的安全、有效且耐受性良好的治疗选择。较高的客观缓解率、极低的毒性以及良好的美容效果支持其在门诊环境中的应用。此外，其在一例大疱性表皮松解症患者中的疗效提示了在特定脆弱皮肤状况中的潜在适用性。这些结果进一步确立了ECT作为NMSC管理治疗手段中一项有价值的补充。
查看英文原文 English abstract
Background: Electrochemotherapy (ECT) combines electroporation and chemotherapy to enhance cytotoxic drug uptake in tumor cells. This study evaluates the efficacy and safety of ECT using intravenous bleomycin in patients with non-melanoma skin cancer (NMSC).
Methods: Sixteen patients with histologically confirmed NMSC were treated under neuroleptoanalgesia in an outpatient setting. Intravenous bleomycin was administered at a dose of 15,000 IU/m² of body surface area. Electric pulses were delivered using the OncoPore device (BIOTEX SRL, Buenos Aires, Argentina). Each session lasted less than one hour, and all but one patient required a single treatment. Tumor response was assessed according to RECIST criteria, and adverse events were graded following CTCAE guidelines.
Results: Among the 16 treated patients, 11 had squamous cell carcinoma and 5 had basal cell carcinoma. Twelve patients (75%) achieved Complete Response, three (19%) had Partial Response, and one (6%) exhibited Stable Disease (SD), yielding an Objective Response rate of 94%. Notably, one patient with recessive dystrophic epidermolysis bullosa achieved a complete response without complications. Adverse events were mild to moderate and transient. The most frequent was pain (grade 2), effectively managed with nonsteroidal anti-inflammatory drugs. Erythema (grade 1) and swelling (grade 1-2) resolved spontaneously within one week. Infection (grade 2) occurred in four patients (25%) and was successfully treated with oral antibiotics. No severe or systemic adverse events were observed. Esthetic outcomes were excellent in all cases, with preservation of surrounding healthy tissue and minimal scarring.
Conclusions: ECT with intravenous bleomycin represents a safe, effective, and well-tolerated therapeutic option for patients with non-melanoma skin cancer. The high objective response rate, minimal toxicity, and favorable cosmetic results support its implementation in outpatient settings. Furthermore, its efficacy in a patient with epidermolysis bullosa suggests potential applicability in selected fragile-skin conditions. These results reinforce ECT as a valuable addition to the therapeutic armamentarium for NMSC management.
利益披露 Disclosure
F. H. Maglietti, None..
R. Lertora, None..
N. S. Martinez, None..
A. Da Rosa Silva, None..
S. D. Michinski, None.