Prospective Randomised Control Trial comparing Electrochemotherapy and Surgery for the Primary Treatment of Basal Cell Carcinoma
Ruth Tevlin, MB BAO BCh, MRCSI1, S Salwa, MD1, J. Mc Kiernan, MD1, Christina Buckley, MB BAO BCh, MRCSI1, M. Bourke, MD1, E.J. Kelly, MB BCh BAO, MD, FRCSI, FRCS (Plast)1, S. T. O'Sullivan, MD, FRCSI, FRCS(Plast)1, D. Soden, PhD2, A.J. P. Clover, B Med Sci (Hons), BM BS, MRCS, MD, FRCS (Plast1.
1Department of Plastic and Reconstructive Surgery, Cork University Hospital,, Cork, Ireland, 2Cork Cancer Research Centre, Cork University Hospital,, Cork, Ireland.
Basal Cell Carcinoma (BCC) is the commonest cutaneous malignancy. Surgery remains the gold standard treatment modality. Electrochemotherapy (ECT), combining electroporation and the administration of normally impermeant chemotherapeutic agents, has demonstrated efficiency for BCC management but has not been assessed in a prospective randomized setting. This study hypothesized that there would be no difference in response rates between the two groups to initial treatment or in treatment durability over time
A prospective randomised control trial was established to determine the efficiency of ECT as a primary treatment modality for BCC with current gold standard surgery acting as control. Initial response rates to treatment and recurrence rate over a three year period were assessed
86 patients with 105 lesions were enrolled and completed minimum follow-up of 1 year (ECT: 45 patients, 60 lesions; surgery: 41 patients, 45 lesions). All patients responded to their primary treatment modality, however 5 patients in the ECT group required a second ECT treatment and 2 patients in the surgical group required further excision.
After three years of follow-up there had been 4 recurrences in the ECT group and 1 recurrence in the surgical group. With loss to follow-up there is a disease free progression of 92% (46/50) in those lesions treated with ECT and 97% (32/33) in those treated with surgery (p=0.37).
Electrochemotherapy is an effective treatment for primary BCC and has a durable effect that is comparable with surgery at three years of follow-up.
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