Electrochemotherapy for basal cell carcinoma in the head and neck region: 5-year follow-up from the Insp-ECT registry

Abstract

Background: Basal cell carcinoma (BCC) is a cutaneous malignancy that typically appears in sun-exposed areas. We analyzed data from the Insp-ECT registry of all patients affected by BCC in the head and neck region. The aim of this study was to evaluate the safety and efficacy of electrochemotherapy (ECT) on a 5-year basis.

Patients and methods: A cohort of 132 patients was included. They were treated by ECT according to the current Standard Operating Procedures. The median age was 74 years (range 41-93). There was a median of 1 nodule per patient (range 1-7), and the median size of the lesions was 1.4 cm (range 0.5-5.0 cm).

Results: Patients tolerated ECT well, and 96% agreed to repeat it if needed. The side effects were mild and temporary. All patients achieved a complete clinical response after 1 to 3 ECT sessions. During the first year of follow-up, 4 (3%) patients experienced recurrence, which was treated (2 with ECT, 1 with surgery, and 1 with a combination of ECT and surgery), after which they remained free of disease until the end of follow-up at 5 years. Five patients reported recurrence thereafter and were treated according to their condition. At the 5-year follow-up, the disease-free survival (DFS) rate was 92% (95% confidence interval [CI]: 87%-96%). At that time, 3 patients were alive with disease (2%), and 124 patients were free of disease (98%).

Conclusions: This study shows the feasibility and efficacy of ECT treatment in elderly patients with BCC tumors in aesthetically and functionally sensitive areas, with negligible toxicity. Comparable efficacy to other treatment modalities was demonstrated at 1 year and 5 years of follow-up in terms of DFS.

Keywords: 5 years; basal cell carcinoma; electrochemotherapy; recurrence free survival.

FIGURE 1.

Types of electrodes used. (A) Type I: two plates with a 6 mm gap; (B) type IV: a wearable finger electrode with two parallel rows of needles; (C) type III: a hexagonal array with a 7.3 mm gap; or (D) type II: two parallel rows of needles with a 4 mm gap.

FIGURE 2.

Disease-free survival (DFS) of nodules treated with local (intratumoral, IT) or systemic (intravenous, IV) drug administration. YRS = years

FIGURE 3.

Treatment outcomes of patients treated with intravenous and intratumoral electrochemotherapy (ECT). The outcome is good in larger and smaller basal cell carcinoma (BCC) tumors. Patient No.1 (A) Recurrent BCC after multiple surgeries in a male, 82 years old patient. ECT performed under sedation and local anesthesia. Intravenous bleomycin 18200 IU. Needle row electrode; 11 pulses. Three cycles of ECT were performed (2 for the first treatment; 1 for recurrence after 2 years). (B) Result after 5 years of follow-up. Patient No. 2 (C) Primary BCC in a female, 86 years old patient with multiple severe comorbidities and non-suitable to standard treatments. One ECT session was performed under sedation and local anesthesia. Intralesional Bleomycin 1.5 ml (concentration 1 mg/ml). Needle row electrode; 7 pulses. (D) Result after 5 years of follow-up. Patient No. 3 (E) Primary BCC in a female, 69 years old patient. Patient refused standard treatments. One ECT session was performed in general anesthesia with laryngeal mask. Intravenous bleomycin 18200 IU; Hexagonal electrode; 9 pulses. (F) Result after 5 years of follow-up. Patient No.4 (G) Primary BCC in a female, 88 years old patient with severe comorbidities, Alzheimer’s disease and non-suitable to standard treatments. One ECT session was performed in general anesthesia with laryngeal mask. Intralesional bleomycin 1.5 ml (concentration 1 mg/ml); Finger electrode; 10 pulses. (H) Result after 5 years of follow-up.

FIGURE 4.

Pain intensity (visual numeric scale, VNS) preelectrochemotherapy (pre-ECT), immediately post-ECT and 1 month after ECT (mean and standard error).

FIGURE 5.

Kaplan-Meier survival curves for the whole population. DFS = disease free survival

FIGURE 6.

Kaplan-Meier survival (A) of patients with small (< 3 cm) vs large (> 3 cm) lesions (B), patients with primary vs recurrent lesions (C), patients with single vs multiple lesions (D), and patients with ulcerated vs nonulcerated lesions. The differences were not significant. DFS = disease free survival; YRS = years