Valcarenghi Dario, Tolotti Angela, Vees Hansjoerg, Torri Valter, Liptrott Sarah Jayne, Presta Giovanni, Puliatti Andrea, Moser Laura, Sari Davide, Valli Mariacarla
Nursing Development and Research Unit, Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale (EOC), Via Gallino, 12, 6500 Bellinzona, Switzerland.
Unità di Radio-Oncologia, Clinica Hirslanden, Witellikerstrasse 40, 8032 Zürich, Switzerland.
Clin Transl Radiat Oncol. 2025 Feb 18;52:100936. doi: 10.1016/j.ctro.2025.100936. eCollection 2025 May.
BACKGROUND & PURPOSE: Radiotherapy plays a key role in breast cancer treatment however, radiation-induced dermatitis can impact on treatment delivery and patient quality of life.The primary outcome was to compare Mepitel® Film versus standard treatment in preventing radiotherapy skin toxicity onset.
A multicentre randomised controlled phase III study compared standard treatment (aqueous-urea cream - Excipial U hydrolotion applied at the beginning of radiotherapy and antiseptic cream - Flammazine or Ialugen Plus applied at the onset of moist desquamation) versus Mepitel® Film in patients with breast cancer undergoing post-operative radiotherapy. The primary outcome was the proportion of moist desquamation (RTOG score ≥ 2) in the experimental and control groups.
During the study (2016-2020), 161 patients were randomized, 154 (95.7 %) were evaluable. Skin toxicity Radiation Therapy Oncology Group (RTOG) score ≥ 2 was observed in 9.5 % and 13.9 % of experimental and control groups respectively (Relative Risk = 0.68, 95 %CI 0.28-1.66; p = 0.393). RTOG scores > 0 were 90.5 % and 94.9 % in experimental and control groups respectively (Relative Risk = 0.95, 95 %CI 0.87-1.04; p = 0.294).Multivariable analysis, controlled for age, diabetes, BMI and smoking exposure, showed a risk reduction of RTOG > 0 of 38 % (HR = 0.62 95 %CI 0.49-0.96, p = 0.028), and a risk reduction of RTOG > 1 of 33 % (HR = 0.67 95 %CI 0.26-1.76, p = 0.420) in the experimental group.The median time to recovery from RTOG grade > 0 toxicity was 17 and 32 days for experimental and control groups, respectively (p = 0.027). At multivariable analysis, time to recovery was 38 % faster in the experimental group (HR = 1.38 95 %CI (0.99-1.93) p = 0.059).
Although the study did not demonstrate a statistically significant reduction in RTOG > 2 skin toxicity, there was evidence of a reduction in the rate of skin toxicity and an improvement in time to recovery. The device was well tolerated by patients.
放射治疗在乳腺癌治疗中起着关键作用，然而，放射性皮炎会影响治疗的实施和患者的生活质量。主要结局是比较美皮贴薄膜与标准治疗在预防放疗皮肤毒性发作方面的效果。
一项多中心随机对照III期研究，将标准治疗（放疗开始时应用水合尿素乳膏——优色林U水包油乳剂，湿性脱皮开始时应用抗菌乳膏——磺胺嘧啶银乳膏或加卢金）与美皮贴薄膜在接受术后放疗的乳腺癌患者中进行比较。主要结局是试验组和对照组中湿性脱皮（放射肿瘤学组（RTOG）评分≥2）的比例。
在研究期间（2016 - 2020年），161例患者被随机分组，154例（95.7%）可进行评估。试验组和对照组中分别有9.5%和13.9%的患者观察到皮肤毒性放射肿瘤学组（RTOG）评分≥2（相对危险度 = 0.68，95%置信区间0.28 - 1.66；p = 0.393）。试验组和对照组中RTOG评分>0的分别为90.5%和94.9%（相对危险度 = 0.95，95%置信区间0.87 - 1.04；p = 0.294）。多变量分析，对年龄、糖尿病、体重指数和吸烟暴露进行校正后，试验组中RTOG>0的风险降低了38%（风险比 = 0.62，95%置信区间0.49 - 0.96，p = 0.028），RTOG>1的风险降低了33%（风险比 = 0.67，95%置信区间0.26 - 1.76，p = 0.420）。试验组和对照组从RTOG>0毒性恢复的中位时间分别为17天和32天（p = 0.027）。在多变量分析中，试验组的恢复时间快38%（风险比 = 1.38，95%置信区间(0.99 - 1.93) p = 0.059）。
尽管该研究未显示RTOG>2皮肤毒性有统计学意义的降低，但有证据表明皮肤毒性发生率降低且恢复时间有所改善。该装置患者耐受性良好。
