Cabula C, Campana L G, Grilz G, Galuppo S, Bussone R, De Meo L, Bonadies A, Curatolo P, De Laurentiis M, Renne M, Valpione S, Fabrizio T, Solari N, Guida M, Santoriello A, D'Aiuto M, Agresti R
Oncologic Surgery, Ospedale Oncologico A. Businco, Cagliari, Italy.
Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
Ann Surg Oncol. 2015 Dec;22 Suppl 3:S442-50. doi: 10.1245/s10434-015-4779-6. Epub 2015 Aug 5.
The management of breast cancer (BC) skin metastases represents a therapeutic challenge. Electrochemotherapy (ECT) combines the administration of bleomycin with temporary permeabilization induced by locally administered electric pulses. Preliminary experience with ECT in BC patients is encouraging.
A total of 125 patients with BC skin metastases who underwent ECT between 2010 and 2013 were enrolled onto a multicenter retrospective cohort study. The treatment was administered following the European Standard Operative Procedures of Electrochemotherapy. Tumor response was clinically assessed adapting the Response Evaluation Criteria in Solid Tumors, and toxicity was evaluated according to Common Terminology Criteria for Adverse Events 4.0. Cox regression analysis was used to identify predictive factors.
Response was evaluable in 113 patients for 214 tumors (median 1 per patient, range 1-3). The overall response rate after 2 months was 90.2 %, while the complete response (CR) rate was 58.4 %. In multivariate analysis, small tumor size (P < 0.001), absence of visceral metastases (P = 0.001), estrogen receptor positivity (P = 0.016), and low Ki-67 index (P = 0.024) were significantly associated with CR. In the first 48 h, 10.4 % of patients reported severe skin pain. Dermatologic toxicity included grade 3 skin ulceration (8.0 %) and grade 2 skin hyperpigmentation (8.8 %). Tumor 1-year local progression-free survival was 86.2 % (95 % confidence interval 79.3-93.8) and 96.4 % (95 % confidence interval 91.6-100) in the subgroup of those with CR.
In this study, small tumor size, absence of visceral metastases, estrogen receptor positivity, and low Ki-67 index were predictors of CR after ECT. Patients who experienced CR had durable local control. ECT represents a valuable skin-directed therapy for selected patients with BC.
乳腺癌皮肤转移的治疗是一项具有挑战性的任务。电化学疗法(ECT)将博来霉素的给药与局部施加电脉冲诱导的暂时性通透性增加相结合。ECT在乳腺癌患者中的初步经验令人鼓舞。
共有125例在2010年至2013年间接受ECT治疗的乳腺癌皮肤转移患者纳入一项多中心回顾性队列研究。治疗按照欧洲电化学疗法标准操作程序进行。采用实体瘤疗效评价标准对肿瘤反应进行临床评估,并根据不良事件通用术语标准4.0评估毒性。使用Cox回归分析确定预测因素。
113例患者的214个肿瘤(中位每人1个,范围1 - 3个)的反应可评估。2个月后的总体反应率为90.2%,而完全缓解(CR)率为58.4%。在多变量分析中,肿瘤体积小(P < 0.001)、无内脏转移(P = 0.001)、雌激素受体阳性(P = 0.016)和低Ki-67指数(P = 0.024)与CR显著相关。在最初48小时内,10.4%的患者报告有严重的皮肤疼痛。皮肤毒性包括3级皮肤溃疡(8.0%)和2级皮肤色素沉着(8.8%)。在CR亚组中,肿瘤1年局部无进展生存率为86.2%(95%置信区间79.3 - 93.8)和96.4%(95%置信区间91.6 - 100)。
在本研究中,肿瘤体积小、无内脏转移、雌激素受体阳性和低Ki-67指数是ECT后CR的预测因素。经历CR的患者具有持久的局部控制。ECT是针对特定乳腺癌患者的一种有价值的皮肤定向治疗方法。