Perrone Anna Myriam, Corrado Giacomo, Coada Camelia Alexandra, Garganese Giorgia, Fragomeni Simona Maria, Tagliaferri Luca, Di Costanzo Stella, De Crescenzo Eugenia, Morganti Alessio Giuseppe, Ferioli Martina, De Terlizzi Francesca, Scambia Giovanni, De Iaco Pierandrea
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Bologna, Italy.
Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Int J Gynecol Cancer. 2023 Apr 3;33(4):473-481. doi: 10.1136/ijgc-2022-004127.
The management of vulvar cancer recurrences is complicated by patients' advanced age and comorbidities. Bleomycin-based electrochemotherapy is a potential treatment option in this setting. However, no data on long-term outcomes are available. Therefore, a multicenter observational study was designed to evaluate the 5-year results in these patients.
Data about patients and tumor characteristics, electrochemotherapy cycles, clinical response, and follow-up were recorded. Treatment procedures were performed according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE) guidelines. Response was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Fifty-one patients (mean age 82.31±7.28 years) with squamous cell vulvar cancer underwent electrochemotherapy (median number of sessions 1; range 1-4). 20 patients had complete response and 32% of these were disease-free after 2 years (median progression-free survival 16.8 months). In 13 patients with partial response the median progression-free survival was 15.36 months, while patients with stable or progressive disease showed tumor relapse after 6.95 and 3.26 months, respectively (p<0.001). Median overall survival was 18.77, 13.07, 6.73, and 11.13 months in patients with complete response, partial response, stable disease, and progressive disease, respectively (p=0.001).
Long-term follow-up of vulvar cancer patients showed reasonable tumor control after electrochemotherapy and improved progression-free survival and overall survival in responder subjects compared with non-responders. Further studies aimed at improving local response after electrochemotherapy are warranted. Thus, this approach represents a potential alternative for these patients.
外阴癌复发的管理因患者高龄和合并症而变得复杂。基于博来霉素的电化学疗法是这种情况下的一种潜在治疗选择。然而，目前尚无长期疗效数据。因此，设计了一项多中心观察性研究来评估这些患者的5年结果。
记录患者和肿瘤特征、电化学疗法周期、临床反应及随访数据。治疗程序按照欧洲电化学疗法标准操作程序（ESOPE）指南进行。根据实体瘤疗效评价标准（RECIST）评估反应。
51例（平均年龄82.31±7.28岁）外阴鳞状细胞癌患者接受了电化学疗法（疗程中位数为1；范围1 - 4）。20例患者完全缓解，其中32%在2年后无疾病（无进展生存期中位数为16.8个月）。13例部分缓解患者的无进展生存期中位数为15.36个月，而疾病稳定或进展的患者分别在6.95个月和3.26个月后出现肿瘤复发（p<0.001）。完全缓解、部分缓解、疾病稳定和疾病进展患者的总生存期中位数分别为18.77、13.07、6.73和11.13个月（p = 0.001）。
外阴癌患者的长期随访显示，电化学疗法后肿瘤得到合理控制，与无反应者相比，反应者的无进展生存期和总生存期有所改善。有必要开展进一步研究以改善电化学疗法后的局部反应。因此，这种方法是这些患者的一种潜在替代方案。
