Electrochemotherapy for Recurrent Vulvar Cancer

Use of Electrochemotherapy in Women With Vulvar Cancer

This phase I/II interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells. The main goal is to assess tumor response and reduce the need for mutilating surgical procedures, thereby improving quality of life in women with recurrent vulvar cancer. Participants will be followed prospectively and treatment outcomes will be evaluated using RECIST criteria and adverse events using CTCAE v5.0.

This is a prospective phase I/II institutional interventional clinical study conducted at the Institute of Oncology Ljubljana. The study investigates electrochemotherapy (ECT) as neoadjuvant treatment for women with local recurrence of vulvar cancer. ECT is performed according to ESOPE standard operating procedures, using systemic administration of bleomycin followed by delivery of electric pulses to the tumor and surrounding safety margin. Tumor response will be assessed clinically according to RECIST criteria, and adverse events will be recorded according to CTCAE version 5.0. Quality of life will be evaluated using EQ-5D questionnaire, pain VAS diary, and patient willingness to undergo ECT again. The ECT-treated group will be compared with a matched control group of patients previously treated surgically for recurrent vulvar cancer at the same institution. The planned study duration is 5 years (September 2021-August 2026), with planned enrollment of 20 patients aged 18 years or older.

Inclusion Criteria:

• Local recurrence of vulvar cancer
• Age ≥ 18 years
• Expected life expectancy > 3 months
• Karnofsky performance status ≥ 70 or WHO performance status ≤ 2
• At least 2 weeks since last treatment
• Ability to understand the procedure and possible adverse effects
• Ability to provide written informed consent
• Patient discussed at multidisciplinary tumor board before enrollment
• Fit for anesthesia

Exclusion Criteria:

• Life-threatening infection and/or severe cardiac, hepatic, or other systemic disease
• Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)
• Age < 18 years
• Major coagulation disorders not responding to standard therapy
• Prior cumulative bleomycin dose ≥ 400 mg/m²
• Chronic renal impairment (creatinine > 150 µmol/L)
• Epilepsy
• Pregnancy
• Inability to understand the study or refusal to participate