Mepitel Film vs standard treatment for preventing radiotherapy skin toxicity: phase III study

Purpose or Objective Evidence supporting use of Mepitel Film for prophylaxis of radiation‐induced skin toxicity is limited. This study aims to compare efficacy and patient comfort with the use of the Mepitel® Film dressing vs standard treatment (dressing with aqueous cream and antiseptic ointments) in women treated with adjuvant radiotherapy after breast surgery. The results of the study, if positive, may lead to a possible re‐evaluation of treatment protocols currently in use. Primary Objective To compare the efficacy of Mepitel® Film and standard treatment with aqueous creams and antiseptic ointments in preventing the onset of radiotherapy skin toxicity (>/= grade 2, according to the Radiation Therapy Oncology Group (RTOG) score. Secondary objectives Comparison of the two treatment arms in terms of: 1. time to onset of skin toxicity; 2. time to healing; 3. severity of acute and late skin toxicity; 4. patient satisfaction and comfort; Materials and Methods The study, an open randomised controlled phase III trial, planned enrolment of 164 patients with breast cancer undergoing post‐operative radiotherapy, assigned in a 1:1 ratio to one of two treatment arms. One group of patients received the Mepitel® Film dressing (experimental group) and one group (control group) received standard treatment currently in use at the Switzerland radiotherapy departments, as per Scientific Association of Swiss Radiation Oncologist (SASRO) guidelines. (https://www.sasro.ch) The study was registered in Clinicaltrials.gov, number NCT02741258. The first patient was enrolled on 26/01/2016, and the last on 30/12/2020. Results 161 patients were recruited between 2016 and 2020. Demographic characteristics of the two groups of patients were well balanced. 83.1% of patients were treated according to study protocol. RTOG 1 score was 90.7% vs 94.9% and RTOG2 was 9.3% vs 13.9% (in Mepitel arm vs ST respectively). RTOG toxicity1 was observed after median 26 days in Mepitel arm vs 21 days in ST arm (p=0.0052), with a reduction in median recovery times (19 vs 32 days) (p=0.0068). Multivariate analysis, controlled for age, diabetes, BMI and smoking exposure, showed a 41% reduction in the risk of RTOG 1 (HR=0.59 95% CI (0.42‐0.84), p=0.0036. In the Mepitel arm, the median time to evidence of RTOG2 was 51 days vs 57 (p=0.0569) and multivariate analysis showed a reduction in the risk of RTOG 2 of 71% (HR=0.29 95% CI (0.09‐0.92), p=0.0357. Conclusion The study showed overall improved toxicity control for the experimental arm, a reduction in the risk of toxicity and a reduction in recovery times. The device was well tolerated by patients, as reported by questionnaires.