Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada.
Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada.
Pract Radiat Oncol. 2021 Jan-Feb;11(1):e36-e45. doi: 10.1016/j.prro.2020.09.004. Epub 2020 Sep 17.
Severe radiation dermatitis (RD) is distressing and may have adverse long-term effects including fibrosis and telangiectasia. Treatment interruptions due to severe RD may increase the risk of recurrence. Two randomized trials of Mepitel film demonstrated efficacy in preventing severe RD in breast cancer, but this product has not been widely adopted in North America. We aimed to assess the feasibility and efficacy of Mepitel film for prevention of breast RD at a Canadian center.
Patients were stratified based on breast size and receipt of postmastectomy radiation therapy. The primary outcome was RD grade using the Common Terminology Criteria for Adverse Events. Secondary outcomes included moist desquamation, patient- and clinician-reported symptoms of skin toxicity, and cosmetic outcomes.
Thirty patients receiving external beam radiation therapy to the breast or chest wall were enrolled. Two patients (6.7%) discontinued use of the Mepitel film before completing radiation therapy. No patients developed grade 3 RD or higher. Five patients (17.9%) developed grade 2 RD: 3 (10.7%) had moist desquamation, and 2 (7.1%) had brisk erythema without moist desquamation.
Mepitel film completely prevented grade 3 RD. Rates of moist desquamation and grade 2 RD were lower with Mepitel film than in studies using aqueous cream, but unlike previous trials of Mepitel film we did not achieve complete prevention of moist desquamation. Further research is needed to confirm the efficacy of Mepitel film versus standard prophylaxis for RD and identify the patients who will benefit the most from the film.
严重放射性皮炎（RD）令人痛苦，并且可能会产生长期不良影响，包括纤维化和毛细血管扩张。由于严重 RD 而导致的治疗中断可能会增加复发的风险。两项关于 Mepitel 膜的随机试验已证实其在预防乳腺癌中重度 RD 方面的疗效，但该产品尚未在北美广泛应用。我们旨在评估加拿大中心使用 Mepitel 膜预防乳房 RD 的可行性和疗效。
根据乳房大小和接受乳房切除术后放疗的情况对患者进行分层。主要结局是采用常见不良事件术语标准评估 RD 分级。次要结局包括湿性脱皮、患者和临床医生报告的皮肤毒性症状以及美容结局。
共有 30 名接受乳房或胸壁外照射放疗的患者入组。有 2 名患者（6.7%）在完成放疗前停止使用 Mepitel 膜。没有患者发生 3 级或更高级别的 RD。有 5 名患者（17.9%）发生 2 级 RD：3 名（10.7%）出现湿性脱皮，2 名（7.1%）出现红斑但无湿性脱皮。
Mepitel 膜完全预防了 3 级 RD。使用 Mepitel 膜的湿性脱皮和 2 级 RD 发生率低于使用水性乳膏的研究，但与之前使用 Mepitel 膜的试验不同，我们并未完全预防湿性脱皮。需要进一步的研究来证实 Mepitel 膜在预防 RD 标准预防方面的疗效，并确定最受益于该膜的患者。
