Spugnini E P, Porrello A
Molecular Oncogenesis Laboratory, S.A.F.U. Department, Regina Elena Cancer Institute, Center for Experimental Research, Rome, Italy.
J Exp Clin Cancer Res. 2003 Dec;22(4):571-80.
The objectives of this phase I/II study were: i) to determine whether electrochemotherapy (intralesional bleomycin + electric pulses) could be effective in companion animals with different, large neoplasms compared to chemotherapy (conventional intralesional bleomycin); ii) to identify potential toxicities; iii) to preliminarily assess the electric field requirements. Twenty-two patients received intralesional bleomycin + administration of permeabilizing electric pulses. Specifically, after the injection of the drug, sequences of 8 biphasic electric pulses lasting 50 + 50 micros each, with 1 ms interpulse intervals, were delivered in bursts of 1300 V/cm for cutaneous and soft tissue lesions, and of 800 V/cm for oral mucosal and exposed soft tissue neoplasms, using caliper electrodes. The treatment was well tolerated and side effects were infrequent. Nevertheless, two previously unreported toxicities (drug-induced vasculitis and pulmonary thromboembolism) have been identified. A high response rate (complete remission + partial remission: > 80%), often long lasting (> 40%) was obtained. Furthermore, results of this trial were compared to a subset of veterinary cancer patients treated with bleomycin single agent, observing a remarkable superiority of the combined treatment (p < 0.01). Altogether, results suggest that electrochemotherapy is a potentially advantageous rescue protocol for bulky, even relapsing neoplasms of companion animals. Further investigations in this field might allow developing improved protocols for the treatment of down-staged relapsing cancer in pets as well as in humans.
本I/II期研究的目的是：i）确定与化疗（传统的瘤内注射博来霉素）相比，电化学疗法（瘤内注射博来霉素+电脉冲）对患有不同类型大肿瘤的伴侣动物是否有效；ii）识别潜在毒性；iii）初步评估电场要求。22例患者接受了瘤内注射博来霉素并给予透化电脉冲。具体而言，在注射药物后，使用卡尺电极，以1300V/cm的强度对皮肤和软组织病变进行13次每次持续50 + 50微秒、脉冲间隔为1毫秒的8个双相电脉冲序列，对口腔黏膜和暴露的软组织肿瘤以800V/cm的强度进行同样的电脉冲序列。该治疗耐受性良好，副作用罕见。然而，已识别出两种以前未报告的毒性（药物性血管炎和肺血栓栓塞）。获得了较高的缓解率（完全缓解+部分缓解：> 80%），且通常持续时间较长（> 40%）。此外，将该试验结果与接受博来霉素单药治疗的一部分兽医癌症患者的结果进行比较，发现联合治疗具有显著优势（p < 0.01）。总体而言，结果表明电化学疗法对于伴侣动物的大块肿瘤甚至复发性肿瘤可能是一种潜在的有利挽救方案。该领域的进一步研究可能会开发出改进的方案，用于治疗宠物以及人类分期降低的复发性癌症。
