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使用电化学疗法治疗皮肤和皮下肿瘤的I/II期试验。

Phase I/II trial for the treatment of cutaneous and subcutaneous tumors using electrochemotherapy.

作者信息

Heller R, Jaroszeski M J, Glass L F, Messina J L, Rapaport D P, DeConti R C, Fenske N A, Gilbert R A, Mir L M, Reintgen D S

机构信息

Department of Surgery, College of Medicine, University of South Florida, Tampa 33612-4799, USA.

出版信息

Cancer. 1996 Mar 1;77(5):964-71. doi: 10.1002/(sici)1097-0142(19960301)77:5<964::aid-cncr24>3.0.co;2-0.

DOI:10.1002/(sici)1097-0142(19960301)77:5<964::aid-cncr24>3.0.co;2-0
PMID:8608491
Abstract

BACKGROUND

Electroporation is a process that causes a transient increase in the permeability of cell membranes. It can be used to increase the intracellular concentration of chemotherapeutic agents in tumor cells (electrochemotherapy; ECT). A clinical study was initiated to determine if this mode of treatment would be effective against certain primary and metastatic cutaneous malignancies. A group of six patients, three with malignant melanoma, two with basal cell carcinoma, and one with metastatic adenocarcinoma, were enrolled in the study. the treatment was administered in a two-step process.

METHODS

Each patient received a 10 unit/m2 dose of bleomycin administered intravenously at 1 to 1.5 units/minute. This was followed by eight 99 microsecond pulses at an amplitude of 1.3 kV/cm administered directly to the tumors 5 to 15 minutes after the bleomycin was completely infused. Pulses were administered after the injection of 1% lidocaine solution around the treatment site.

RESULTS

Two of three melanoma patients had objective responses. In these two patients, five of six treated tumors decreased in size, and three completely responded. Untreated tumors displayed continued growth. Objective responses were observed in both basal cell carcinoma (BCC) patients. One patient had partial responses in both treated tumors. The other patient had one of four primary BCCs respond completely, and the remaining three respond partially. Patients with metastatic breast adenocarcinoma showed complete responses in both treated nodules after ECT. All patients tolerated the treatment well with no residual effects from the electric pulses.

CONCLUSIONS

ECT was an effective local treatment in the majority of nodules treated. The results thus far are very encouraging and the study is being continued.

摘要

背景

电穿孔是一种可使细胞膜通透性短暂增加的过程。它可用于提高肿瘤细胞内化疗药物的浓度(电化学疗法;ECT)。启动了一项临床研究以确定这种治疗方式对某些原发性和转移性皮肤恶性肿瘤是否有效。一组6名患者参与了该研究,其中3例为恶性黑色素瘤,2例为基底细胞癌,1例为转移性腺癌。治疗分两步进行。

方法

每位患者静脉注射博来霉素,剂量为10单位/平方米,注射速度为1至1.5单位/分钟。在博来霉素完全输注后5至15分钟,直接对肿瘤施加8个幅度为1.3 kV/cm、持续时间为99微秒的脉冲。在治疗部位周围注射1%利多卡因溶液后施加脉冲。

结果

3例黑色素瘤患者中有2例出现客观缓解。在这2例患者中,6个接受治疗的肿瘤中有5个体积缩小,3个完全缓解。未治疗的肿瘤持续生长。2例基底细胞癌(BCC)患者均观察到客观缓解。1例患者的2个接受治疗的肿瘤均出现部分缓解。另1例患者的4个原发性BCC中有1个完全缓解,其余3个部分缓解。转移性乳腺腺癌患者在ECT治疗后,2个接受治疗的结节均出现完全缓解。所有患者对治疗耐受性良好,电脉冲无残留影响。

结论

ECT对大多数接受治疗的结节是一种有效的局部治疗方法。迄今为止的结果非常令人鼓舞,该研究正在继续进行。

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