Sarcoma and Melanoma Unit, Veneto Region Oncology Research Institute (IOV-IRCCS), Department of Oncological and Surgical Sciences, University of Padova, Padova, Italy.
Br J Surg. 2012 Jun;99(6):821-30. doi: 10.1002/bjs.8749. Epub 2012 Apr 17.
The aim of the study was to determine predictive factors for effectiveness, toxicity and local disease control in patients with malignant melanoma treated with bleomycin-based electrochemotherapy (ECT).
Electrochemotherapy was offered to patients with superficially disseminated melanoma metastases unsuitable for resection and unresponsive to chemotherapy.
Eighty-five patients were treated with up to six ECT cycles with minimal, mainly dermatological, toxicity. One month after the first ECT, an objective response was observed in 80 patients (94 per cent). After retreatment because of a partial response in 39 patients, a complete response was achieved in 19 patients. Among the 41 (48 per cent) complete responders at first ECT, 19 patients received a second cycle because of new lesions after a median of 6 (range 2-14) months. After a median follow-up of 26 months, six patients experienced local recurrence with a 2-year local progression-free survival rate of 87 per cent. In multivariable analysis, significant predictive factors for response were tumour size (odds ratio (OR) 0·23, 95 per cent confidence interval (c.i.) 0·19 to 0·86; P = 0·003) and number of lesions (OR 0·38, 0·28 to 0·88; P = 0·002). An increasing number of electrode applications (hazard ratio (HR) 2·18, 95 per cent c.i. 1·22 to 3·44; P = 0·041) and ECT cycles (HR 0·46, 0·22 to 0·95; P = 0·005) were predictors of local control. There were no predictors of toxicity. Melanoma thickness and lower limb location of metastases were prognostic for survival.
The most suitable candidates for ECT were patients with few and small metastases on the lower limb treated with multiple electrode applications and ECT cycles.
本研究旨在确定采用博来霉素电化学疗法(ECT)治疗恶性黑色素瘤患者的有效性、毒性和局部疾病控制的预测因素。
对不适合切除和对化疗无反应的浅表播散性黑色素瘤转移患者提供电化学疗法。
85 例患者接受了多达 6 个 ECT 周期的治疗,仅有轻微的、主要是皮肤毒性。在首次 ECT 治疗后 1 个月,80 例患者(94%)观察到客观反应。在 39 例因部分缓解而进行再次治疗后,19 例患者达到完全缓解。在首次 ECT 时的 41 例(48%)完全缓解者中,19 例因中位数为 6 个月(范围 2-14 个月)后新病灶而接受第二次周期治疗。在中位随访 26 个月后,6 例患者出现局部复发,2 年局部无进展生存率为 87%。在多变量分析中,肿瘤大小(比值比(OR)0.23,95%置信区间(CI)0.19 至 0.86;P=0.003)和病变数量(OR 0.38,0.28 至 0.88;P=0.002)是反应的显著预测因素。电极应用数量的增加(风险比(HR)2.18,95%CI 1.22 至 3.44;P=0.041)和 ECT 周期(HR 0.46,0.22 至 0.95;P=0.005)是局部控制的预测因素。毒性无预测因素。黑色素瘤厚度和下肢转移部位是生存的预后因素。
最适合 ECT 的患者是下肢有少量小转移灶、接受多次电极应用和 ECT 周期治疗的患者。