Mepitel®膜与标准护理预防辅助放疗乳腺癌患者皮肤毒性：一项随机对照试验

IF 2.7 3区医学 Q3 ONCOLOGY

Clinical and Translational Radiation Oncology Pub Date : 2025-02-18 DOI:10.1016/j.ctro.2025.100936

Dario Valcarenghi , Angela Tolotti , Hansjoerg Vees , Valter Torri , Sarah Jayne Liptrott , Giovanni Presta , Andrea Puliatti , Laura Moser , Davide Sari , Mariacarla Valli

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引用次数: 0

摘要

背景,目的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效果和患者的生活质量。主要结局是比较Mepitel®Film与标准治疗在预防放射治疗皮肤毒性发作方面的效果。方法一项多中心随机对照III期研究比较了标准治疗（在放疗开始时使用水尿素乳膏-表皮U水洗液和在湿性脱屑开始时使用抗菌乳膏- Flammazine或Ialugen Plus）与Mepitel®Film对乳腺癌术后放疗患者的影响。主要观察指标为实验组和对照组湿性脱屑比例（RTOG评分≥2）。结果在研究期间（2016-2020年），随机抽取161例患者，154例（95.7%）可评估。试验组和对照组皮肤毒性放射治疗肿瘤组（RTOG）评分≥2分的分别为9.5%和13.9%(相对危险度= 0.68,95% CI 0.28-1.66；p = 0.393)。RTOG分数>；实验组和对照组的相对危险度分别为90.5%和94.9%(相对危险度= 0.95,95% CI 0.87-1.04；p = 0.294)。多变量分析，控制年龄，糖尿病，BMI和吸烟暴露，显示RTOG的风险降低；0 = 38% (HR = 0.62 95% CI 0.49-0.96, p = 0.028)， RTOG和gt的风险降低；1 / 33 （HR = 0.67 95% CI 0.26-1.76, p = 0.420）。从RTOG等级恢复的中位时间>；实验组和对照组毒性分别为17和32 d （p = 0.027）。在多变量分析中，实验组恢复时间快38% （HR = 1.38, 95% CI (0.99-1.93) p = 0.059）。结论：虽然该研究没有显示RTOG和gt的统计学显著降低；2 .皮肤毒性，有证据表明皮肤毒性发生率降低，恢复时间缩短。患者对该装置的耐受性良好。

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Mepitel® film versus standard care for the prevention of skin toxicity in breast cancer patients treated with adjuvant radiotherapy: A randomized controlled trial

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.

Methods

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.

Results

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).

Conclusions

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.

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