电化学疗法的治疗效果：一项针对376例浅表肿瘤患者的多机构前瞻性观察研究。

Treatment efficacy with electrochemotherapy: A multi-institutional prospective observational study on 376 patients with superficial tumors.

作者信息

Campana L G, Testori A, Curatolo P, Quaglino P, Mocellin S, Framarini M, Borgognoni L, Ascierto P A, Mozzillo N, Guida M, Bucher S, Rotunno R, Marenco F, De Salvo G L, De Paoli A, Rossi C R, Bonadies A

机构信息

Surgical Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy; Department of Surgery, Oncology and Gastroenterology, University of Padova, Italy.

European Institute of Oncology (IEO), Milano, Italy.

出版信息

Eur J Surg Oncol. 2016 Dec;42(12):1914-1923. doi: 10.1016/j.ejso.2016.06.399. Epub 2016 Jun 29.

DOI:10.1016/j.ejso.2016.06.399

PMID:27424789

Abstract

BACKGROUND

Cutaneous metastases represent a therapeutic challenge. An increasing body of experience suggests that electrochemotherapy (ECT) provides effective tumor control, although its evidence basis should be strengthened.

METHODS

This prospective, multicenter, observational study enrolled patients with superficial metastases, who underwent ECT at 10 centers between 2008 and 2013. Outcomes included adherence to European Standard Operating Procedures of ECT (ESOPE), tumor response, local progression-free survival (LPFS), toxicity and patient-reported outcomes (PROs, EORTC QLQ-C30 plus an 8-item questionnaire).

RESULTS

We enrolled 376 eligible patients. Tumor histotype distribution was as follows: melanoma, 56%; squamous cell carcinoma, 11%; Kaposi sarcoma, 11%; breast carcinoma, 8%; basal cell carcinoma, 6%; soft tissue sarcomas, 3%; others, 5%. We registered 1304 target tumors (median size 1 cm). Treatment adhered to ESOPE in 88% of patients as to the route of drug administration, and in 70% as to electrode application. The procedure was mainly performed under sedation (64.6%) and by using intravenous chemotherapy (93.4%). Tumor response rate at 60 days was 88% (complete, 50%). Small tumor size predicted complete response achievement (OR 2.24, p = 0.003), higher LPFS (HR 0.68, p = 0.004) and improved PROs (Global Health Status, p < 0.001; wound bleeding, p < 0.001; healing, p = 0.002; and aesthetics, p < 0.001). Skin toxicity (grade ≥3, 7.8%) was lower in patients with tumors <2 cm (p≤0.001). One-year LPFS was 73.7% (95%CI 68.4-78.3).

CONCLUSIONS

ECT represents a valuable skin-directed therapy across a range of malignancies. The most frequently applied treatment modality is intravenous chemotherapy under sedation. Small tumor size predicts durable tumor control, fewer side-effects and better PROs.

摘要

背景

皮肤转移瘤是一个治疗难题。越来越多的经验表明，电化学疗法（ECT）能有效控制肿瘤，尽管其证据基础有待加强。

方法

这项前瞻性、多中心、观察性研究纳入了患有浅表转移瘤的患者，这些患者于2008年至2013年间在10个中心接受了ECT治疗。观察指标包括对ECT欧洲标准操作程序（ESOPE）的依从性、肿瘤反应、局部无进展生存期（LPFS）、毒性以及患者报告的结局（PROs，欧洲癌症研究与治疗组织QLQ-C30加上一份8项问卷）。

结果

我们纳入了376例符合条件的患者。肿瘤组织学类型分布如下：黑色素瘤，56%；鳞状细胞癌，11%；卡波西肉瘤，11%；乳腺癌，8%；基底细胞癌，6%；软组织肉瘤，3%；其他，5%。我们记录了1304个靶肿瘤（中位大小1厘米）。88%的患者在药物给药途径方面以及70%的患者在电极应用方面遵循了ESOPE。该操作主要在镇静状态下进行（64.6%），并使用静脉化疗（93.4%）。60天时的肿瘤反应率为88%（完全缓解，50%）。小肿瘤大小预示着完全缓解的实现（OR 2.24，p = 0.003）、更高的LPFS（HR 0.68，p = 0.004）以及更好的PROs（总体健康状况，p < 0.001；伤口出血，p < 0.001；愈合，p = 0.002；以及美观，p < 0.001）。肿瘤<2厘米的患者皮肤毒性（≥3级，7.8%）较低（p≤0.001）。一年的LPFS为73.7%（95%CI 68.4 - 78.3）。