Lee Shing Fung, Yip Pui Lam, Spencer Sandra, Ho Huong, Subramanian Brindha, Ding Wei, Lapuz Carminia, Foroudi Farshad, Kai Cynleen, Chao Michael
Department of Radiation Oncology, National University Cancer Institute, National University Hospital, Singapore; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Department of Radiation Oncology, National University Cancer Institute, National University Hospital, Singapore; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Int J Radiat Oncol Biol Phys. 2025 Apr 1;121(5):1145-1155. doi: 10.1016/j.ijrobp.2024.11.076. Epub 2024 Nov 26.
Acute radiation dermatitis (ARD) is a notable challenge for patients with breast cancer undergoing postmastectomy radiation therapy (RT). This study evaluates the efficacy, safety, and user experience of StrataXRT versus Mepitel Film for ARD prevention.
This multicenter, noninferiority trial involved intrapatient randomization of 44 patients with histologically confirmed breast carcinoma who had undergone postmastectomy RT across 4 Australian hospitals from January 1 to December 31, 2017. Patients were randomly assigned to receive Mepitel Film and StrataXRT on alternate halves of the irradiated chest wall. Mepitel Film was applied by nurses and replaced every 1 to 2 weeks or as necessary, ensuring continuous coverage throughout RT. Conversely, patients self-applied StrataXRT daily to the opposite half, with adherence details recorded in patient diaries. The primary outcome was the mean difference in the time-weighted average (TWA) grade of ARD within designated rectangles in each half over 10 weeks from the commencement of RT.
Forty patients were analyzed per-protocol. Measurements using thermoluminescent dosimeters showed no significant dose differences between medial and lateral rectangles. StrataXRT was inferior to Mepitel Film in the primary outcome, with a mean difference in TWA grade of 0.19 (95% confidence interval, 0.12-0.26; P < .001). Secondary outcomes-mean difference in TWA grade in chest wall halves, worst ARD grade, and incidence of moist desquamation-showed noninferiority between treatments. Patient preferences were closely matched, with 37.5% favoring StrataXRT and 40% Mepitel Film. StrataXRT caused itching in 1 patient and Mepitel Film in 3, leading to 1 removal.
Although StrataXRT did not meet the noninferiority threshold in the primary outcome and is considered inferior, its ease of application and patient acceptance suggest that it may still be offered for ARD prevention in postmastectomy RT when Mepitel Film is not a practical option. Open discussion with patients and caregivers is recommended to determine the most appropriate skin protection agent, considering both efficacy and practicality.
急性放射性皮炎（ARD）是接受乳房切除术后放疗（RT）的乳腺癌患者面临的一项重大挑战。本研究评估了StrataXRT与美皮康贴膜在预防ARD方面的疗效、安全性和用户体验。
这项多中心、非劣效性试验纳入了44例经组织学确诊的乳腺癌患者，这些患者于2017年1月1日至12月31日在澳大利亚的4家医院接受了乳房切除术后放疗。患者被随机分配在照射的胸壁的交替半侧接受美皮康贴膜和StrataXRT。美皮康贴膜由护士应用，每1至2周或根据需要更换，以确保在整个放疗期间持续覆盖。相反，患者每天在对侧半侧自行应用StrataXRT，并将依从性细节记录在患者日记中。主要结局是从放疗开始的10周内，每半侧指定矩形区域内ARD的时间加权平均（TWA）分级的平均差异。
按方案分析了40例患者。使用热释光剂量计的测量结果显示内侧和外侧矩形区域之间的剂量无显著差异。在主要结局方面，StrataXRT不如美皮康贴膜，TWA分级的平均差异为0.19（95%置信区间，0.12 - 0.26；P <.001）。次要结局——胸壁半侧TWA分级的平均差异、最差ARD分级和湿性脱屑发生率——显示治疗之间无劣效性。患者偏好相近，37.5%的患者青睐StrataXRT，40%的患者青睐美皮康贴膜。StrataXRT导致1例患者瘙痒，美皮康贴膜导致3例患者瘙痒，其中1例因此停用。
尽管StrataXRT在主要结局中未达到非劣效性阈值且被认为较差，但其易于应用和患者接受度表明，当美皮康贴膜不是实际选择时，在乳房切除术后放疗中预防ARD仍可提供StrataXRT。建议与患者和护理人员进行开放讨论，以确定最适合的皮肤保护剂，同时考虑疗效和实用性。
