Center for Experimental Drug and Gene Electrotransfer, Department of Oncology, Copenhagen University Hospital Herlev, Denmark.
Acta Oncol. 2012 Jul;51(6):713-21. doi: 10.3109/0284186X.2012.685524. Epub 2012 Jun 26.
Cutaneous recurrences of breast cancer may cause considerable discomfort due to ulceration, oozing, and pain and can also be difficult to treat. Electrochemotherapy is a localised anticancer treatment using electric pulses to make cell membranes permeable, augmenting uptake of chemotherapeutic drugs, and thus enabling highly efficient tumour cell kill. This is the first systematic investigation of electrochemotherapy for larger cutaneous recurrences of breast cancer.
We conducted a phase II trial for patients with cutaneous recurrences where no further treatment options were available. Primary endpoint was objective response evaluated by clinical examination. Secondary endpoints included response evaluated by PET/CT, change in lung diffusion capacity, patient reported symptoms, and distress related to bodily appearance. Treatment consisted of bleomycin injection followed by application of electric pulses.
Seventeen heavily pre-treated patients received electrochemotherapy. Twelve patients were evaluable (follow-up > 8 weeks). CT showed four (33%) patients achieving over 50% tumour volume reduction, clinical examination showed one CR and one PR (OR 17%). Symptomatic relief included decreasing exudates, odour, and bleeding. Treatment was well tolerated; the main side effect was post-treatment pain.
This first phase II study indicates that electrochemotherapy is a promising treatment alternative for cutaneous recurrences of breast cancer.
乳腺癌皮肤复发可导致溃疡、渗出和疼痛，给患者带来极大不适，且治疗较为困难。电化疗是一种局部抗癌治疗方法，利用电脉冲使细胞膜通透性增加，增强化疗药物的摄取，从而实现高效的肿瘤细胞杀伤。这是首次对较大面积乳腺癌皮肤复发进行电化疗的系统研究。
我们对没有其他治疗选择的乳腺癌皮肤复发患者进行了 II 期临床试验。主要终点是通过临床检查评估的客观缓解。次要终点包括通过 PET/CT 评估的缓解、肺扩散能力的变化、患者报告的症状以及与身体外观相关的不适。治疗包括博来霉素注射后应用电脉冲。
17 名经大量预处理的患者接受了电化疗。12 名患者可评估（随访>8 周）。CT 显示 4 名（33%）患者肿瘤体积减少超过 50%，临床检查显示 1 名完全缓解和 1 名部分缓解（OR 17%）。症状缓解包括渗出物、气味和出血减少。治疗耐受性良好，主要副作用为治疗后疼痛。
这项首次 II 期研究表明，电化疗是治疗乳腺癌皮肤复发的一种有前途的替代方法。
