Palliative Electrochemotherapy in Vulvar Carcinoma: Preliminary Results of the ELECHTRA (Electrochemotherapy Vulvar Cancer) Multicenter Study

Abstract

Vulvar cancer (VC) is a rare disease of which recurrence poses management problems due to patients’ advanced age and comorbidities, and to the localization of the disease. Palliative treatments, allowing local disease control in patients previously treated with multimodal therapies or with comorbidities, are lacking. In this study we tested electrochemotherapy (ECT) on recurrent VC refractory to standard therapies to assess the tumor response and to define the selection criteria for patient’s candidate to ECT. This is a multicenter observational study carried out in five Italian centers. Data about patients and tumor characteristics, treatment, toxicity, and clinical response were recorded. In all procedures, intravenous bleomycin was administered according to European Standard Operative Procedure ECT (ESOPE) guidelines. Sixty-one patients, with a median age 79 years (range: 39–85) and mainly affected by squamous cellular carcinoma (91.8%), were treated with ECT. No serious adverse events were reported. Patients were discharged after three days (median, range: 0–8 days). Two months after ECT, the clinical response rate was 83.6% and was not related to age, body mass index, International Federation of Gynecology and Obstetrics (FIGO) stage, number of treated nodules, or previous treatments. ECT is a safe procedure with a favorable cost-effectiveness ratio and should be considered as a treatment option for local disease control in patients unsuitable for standard therapies.

Use of electrochemotherapy in women with vulvar cancer to improve quality-of-life in the palliative setting: a meta-analysis

“…Four studies encompassing 104 women with vulvar cancer were included in the review22–25 (Figure 1). The studies were published between 2013 and 2019.…”

“…The studies were published between 2013 and 2019. Three studies were prospective,23–25 while one study was partly prospective and retrospective 22. The methodological index for non-randomized studies was nine for all studies; hence, the included studies were of moderate quality (online supplementary table 1).…”

“…Pooling of results from four studies22–25 encompassing 98 women rendered a summary proportion of 78.8% (95% CI 70.4% to 86.2%; Figure 2A) for overall response with no significant inter-study heterogeneity ( I 2 =0%, P=0.40; Figure 3). Pooling of results from four studies22–25 rendered a summary proportion of 48.7% (95% CI 30.7% to 61.50%; Figure 2B) for complete response with moderate inter-study heterogeneity ( I 2 =31.3%, P=0.22; Figure 3). Pooling of results from four studies22–25 rendered a summary proportion of 30.2% (95% CI 21.7% to 39.4%; Figure 2C) for partial response with no significant inter-study heterogeneity ( I 2 =0%, P=0.66; Figure 3).…”

“…Conversely, the reported overall response rate was 19.9% for the tumors treated with cisplatin or bleomycin alone 13. In light of the aforementioned promising evidence, a fair number of studies aimed to ascertain its efficacy in new settings including vulvar cancer 22–25…”

“…The present meta-analysis determined that the first cycle of electrochemotherapy afforded complete response in nearly half of women, while the overall response rate accounted for approximately 80%. Only two studies evaluated the efficacy of a second electrochemotherapy cycle amongst women with partial response or recurrence after initial complete response 22 24. The reported complete response rate was 40% 22 24.…”