Campana Luca G, Marconato Roberto, Valpione Sara, Galuppo Sara, Alaibac Mauro, Rossi Carlo R, Mocellin Simone
Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padova, Padua, Italy.
Surgical Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Via Gattamelata, 64, 35128, Padua, Italy.
J Transl Med. 2017 May 31;15(1):122. doi: 10.1186/s12967-017-1225-5.
Electrochemotherapy (ECT), by combining manageable cytotoxic agents with short electric pulses, represents an effective palliative skin-directed therapy. The accumulated evidence indicates that ECT stands out as a safe and well-tolerated alternative treatment for patients with multiple or large basal cell carcinoma (BCC), who are not suitable for conventional treatments. However, long-term data and shared indications are lacking.
In this observational study, we retrospectively analyzed 84 prospectively collected patients with multiple, recurrent or locally advanced BCC who were not candidate for standard therapies and received bleomycin-based ECT according to the European Standard Operative Procedures of ECT, from 2006 to 2016.
Disease extent was local, locally advanced and metastatic in 40 (48%), 41 (49%) and 3 (3%), respectively. Forty-four (52%) individuals had multiple BCCs. Grade 3 skin toxicity after ECT was observed in 6% of cases. Clearance rate was 50% (95% CI 39-61%). Primary presentation (p = 0.004), tumor size <3 cm (p < 0.001), well-defined borders (p = 0.021), absence of tumor ulceration (p = 0.001), non-aggressive BCC histology (p = 0.046) and age ≤69 years were associated with higher complete response rate. In patients with local BCC, the clearance rate was 72.5 and 85% after one or two ECT cycles, respectively. In the laBCC group, 32 patients (78%) achieved an objective response. Five-year recurrence rate for local and laBCC was 20 and 38%, respectively (p ≤ 0.001).
One or two ECT cycles with bleomycin may be a valuable palliative treatment in well-selected patients with multiple BCCs and favorable tumor features. Validation of predictive factors will be imperative to match patients with optimal ECT treatment modalities. Management of laBCC with ECT warrants further investigation. Trial registration ISRCTN14633165 Registered 24 March 2017 (retrospectively registered).
电化学疗法(ECT)通过将可控的细胞毒性药物与短电脉冲相结合,是一种有效的姑息性皮肤定向治疗方法。越来越多的证据表明,对于不适合传统治疗的多发性或大型基底细胞癌(BCC)患者,ECT是一种安全且耐受性良好的替代治疗方法。然而,目前缺乏长期数据和统一的适应症。
在这项观察性研究中,我们回顾性分析了2006年至2016年间84例前瞻性收集的多发性、复发性或局部晚期BCC患者,这些患者不适合标准治疗,并根据欧洲ECT标准手术程序接受了以博来霉素为基础的ECT治疗。
疾病范围为局部、局部晚期和转移性的分别有40例(48%)、41例(49%)和3例(3%)。44例(52%)患者有多发性BCC。ECT后3级皮肤毒性发生率为6%。清除率为50%(95%CI 39-61%)。初次表现(p = 0.004)、肿瘤大小<3 cm(p < 0.001)、边界清晰(p = 0.021)、无肿瘤溃疡(p = 0.001)、非侵袭性BCC组织学(p = 0.046)和年龄≤69岁与更高的完全缓解率相关。在局部BCC患者中,一或两个ECT周期后的清除率分别为72.5%和85%。在局部晚期BCC组中,32例患者(78%)获得了客观缓解。局部和局部晚期BCC的五年复发率分别为20%和38%(p≤0.001)。
对于精心挑选的具有多发性BCC且肿瘤特征良好的患者,一或两个含博来霉素的ECT周期可能是一种有价值的姑息治疗方法。验证预测因素对于为患者匹配最佳ECT治疗方式至关重要。ECT治疗局部晚期BCC值得进一步研究。试验注册ISRCTN14633165 于2017年3月24日注册(回顾性注册)。