The role of electrochemotherapy with intratumoral bleomycin for early tongue carcinoma.

BACKGROUND: The role of electrochemotherapy (ECT) using intratumoral bleomycin and electroporation as a first line treatment for oral tongue carcinoma has not been defined. AIMS/OBJECTIVES: To evaluate the method of ECT in oral tongue carcinoma. MATERIAL AND METHODS: Twenty-one successive patients with primary T1-T2 oral cancer predominantly of the oral tongue underwent either ECT (test; n = 9), or standard surgical resection and reconstruction (control; n = 12). Outcome variables were: local recurrence rates, 10-year-survival, adverse events, treatment cost, and quality of life. RESULTS: The 10-year local recurrence rate (44.4%) was higher and the tumour-specific survival rate (55.6%) was lower in the ECT group compared to the control group (17% and 91.6%, respectively). Postoperative haemorrhage, dysphagia, and pain were more frequent in ECT patients, treatment time was shorter, but treatment cost was higher. Quality of life was not improved by ECT. CONCLUSIONS AND SIGNIFICANCE: Our results indicate that ECT seems not as suitable for the treatment of early tongue cancer as it is for neoplastic and metastatic skin lesions and less favourable than standard surgical therapy.

Early Cost-effectiveness Analysis of Electrochemotherapy as a Prospect Treatment Modality for Skin Melanoma.

PURPOSE: Electrochemotherapy is increasingly entering into national and international guidelines, requiring formal evaluation of treatment costs and cost-effectiveness to ensure that its uptake provides value to budget-constrained health care systems. This study analyzed the early cost-effectiveness of electrochemotherapy in patients with Stage IIIc/IV skin melanoma in clinical practice in Slovenia. The costs of electrochemotherapy were compared to those of the standard of care, consisting of palliative treatment and therapy for symptoms. METHODS: wThe study enrolled 23 patients treated with electrochemotherapy at the Institute of Oncology (Ljubljana, Slovenia). The mean cost of electrochemotherapy was estimated using patient-specific cost data on electrochemotherapy procedures and subsequent follow-up. Quality-adjusted life-years (QALYs) were estimated by collecting EQ-5D-3L questionnaires at baseline, after complete or partial response following the treatment, and after a relapse of skin lesions. A discrete-time Markov model was built to estimate the lifetime costs and consequences of using electrochemotherapy compared to standard of care, from the perspective of the Slovenian health care system. The analysis was conducted separately in the whole patient sample and in the subset of patients with bleeding lesions. Deterministic and probabilistic sensitivity analyses were conducted to test model assumptions and to characterize the uncertainty around model parameters. FINDINGS: In the whole patient population, electrochemotherapy for skin melanoma Stage IIIc/IV was expected to increase QALYs by 0.29 (95% credible interval [CrI], 0.10-0.50), at the higher cost of 6568 EUR (95% CrI, 4593-8928) in comparison to the standard of care. At the cost-effectiveness threshold of 20,000 EUR/QALY, the estimated probabilities of electrochemotherapy being cost-effective compared to standard of care were 0.30 and 0.91 in the whole patient sample and in patients with bleeding lesions, respectively. In the whole sample population, a 50% reduction in the price of the electrodes was expected to increase the probability of electrochemotherapy being cost-effective from 0.30 to ~0.64. IMPLICATIONS: The findings from this cost-effectiveness analysis of data from clinical practice were based on a small sample size (ie, 23 patents), which made the subgroup of patients with bleeding lesions very small. Therefore, the findings in this patient population should be carefully interpreted.

Electrochemotherapy for the treatment of recurrent head and neck cancers: preliminary results.

AIMS AND BACKGROUND: Electrochemotherapy is a tumor ablation modality providing delivery into the cell interior of impermeant or poorly permeant chemotherapeutic drugs such as cisplatin and bleomycin. A locally applied electrical field enhances the membrane permeability allowing intracellular accumulation of the chemotherapeutic agent. The aim of the study was to evaluate the effectiveness of ECT for the treatment of a group of patients affected by recurrent of extended primary head and neck cancer and not suitable for standard therapeutic options. METHODS AND STUDY DESIGN: From April 2009 to January 2011, we treated with electrochemotherapy a total of 15 patients with head and neck cancers, 13 with squamous cell carcinoma, 1 with basaloid carcinoma and 1 with Merkel cell carcinoma. Electrical pulses were delivered to 33 lesions (3 primaries, 30 recurrences) after an intravenous bolus injection of a dose of 15,000 IU/m2 of bleomycin. In 3 cases, the lesion treated was a pathologic lymph node. RESULTS: Of the 31 lesions assessable for the study, 19 (61.5%) showed a complete response, 10 (32.5%) a partial response, 1 (3%) stable disease and 1 (3%) progression of the disease. The objective response 2 months after the procedure was 94%. All the lesions that underwent complete regression were less than 3 cm in their maximum diameter. The 2 assessable cases of pathologic lymph nodes showed a partial or no response. After a follow-up of 2 to 20 months, 29% of the patients were alive and free of disease, 50% were alive with disease, 14% died for disease and 7% died for other causes. CONCLUSIONS: Our study confirms the effectiveness of electrochemotherapy in the treatment or local control of recurrent or extended primary head and neck cancer in patients not suitable for standard therapeutic options.