Guidance
4 Efficacy
4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A non-randomised comparative study of 113 patients (85 basal cell carcinoma [BCC] and 28 squamous cell carcinoma [SCC]) compared 2 different electric pulse sequences for electrochemotherapy of stage I (T1N0M0) BCC and SCC tumours. The complete response rate was 83% at 12 months.
4.2 A non-randomised comparative study of 34 patients comparing electrochemotherapy against either intratumoural bleomycin alone or electric pulse therapy included 21 patients with BCC or SCC (66 tumours). The study reported an objective response rate of 100% and a complete response of 94% (51/54) in BCC primary tumours treated with electrochemotherapy at 12 weeks. The 1 SCC tumour treated with electrochemotherapy had a partial response. There were no complete responses in the 11 BCC tumours treated with either intratumoural bleomycin alone (8 tumours) or electric pulse therapy alone (3 tumours).
4.3 The study of 113 patients (85 BCC and 28 SCC tumours) with an initial 100% complete response reported that 14% (16/113) of tumours recurred between 2 and 6 months after treatment (no further details reported).
4.4 A case series of 6 patients (3 BCC and 3 SCC tumours) reported no damage to nerve or ocular function after electrochemotherapy in 4 patients with tumours close to the facial nerve or eye muscles.
4.5 The case series of 6 patients (3 BCC and 3 SCC tumours) reported a 'very satisfactory' cosmetic outcome at between 6 and 12 months after electrochemotherapy (no further details reported).
4.6 The specialist advisers listed additional key efficacy outcomes as quality of life, control of bleeding and reduction of odour from fungating tumours.