外用戊酸倍他米松作为预防头颈部恶性肿瘤急性放射性皮炎的药物：一项随机、开放标签的3期试验。

Topical Betamethasone Valerate As a Prophylactic Agent to Prevent Acute Radiation Dermatitis in Head and Neck Malignancies: A Randomized, Open-Label, Phase 3 Trial.

作者信息

Menon Abhilash, Prem Shyama Sudha, Kumari Rashmi

机构信息

Department of Radiation Oncology, RCC, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.

出版信息

Int J Radiat Oncol Biol Phys. 2021 Jan 1;109(1):151-160. doi: 10.1016/j.ijrobp.2020.08.040. Epub 2020 Aug 24.

DOI:10.1016/j.ijrobp.2020.08.040

PMID:32853709

Abstract

PURPOSE

We assessed the role of topical betamethasone as a prophylactic agent in patients receiving radiation for head and neck malignancies.

METHODS AND MATERIALS

This randomized, open-label, phase 3 trial was completed at a single research institute. Patients receiving curative radiation for head and neck cancer were randomized into 2 groups of 75 patients each by computer-generated permuted block random assignment. Patients in the test arm applied 0.1% topical betamethasone valerate cream once a day, after radiation. Patients in the control arm received best supportive care. The Radiation Therapy Oncology Group acute toxicity grading scale was used to assess radiation dermatitis after every fifth fraction until completion and at 2 weeks after treatment. Primary outcome in both arms was the proportion of patients who developed grade 2 and 3 acute skin reaction. The trial is registered at the Central Trial Registry of India (CTRI/2017/04/008298).

RESULTS

Between April 15, 2017, and October 30, 2018,150 patients were randomized into the study, with 75 patients in each arm. Fourteen patients in the test arm and 15 patients in the control arm did not complete the intended treatment. Per the intention-to-treat analysis, 25 of 75 patients (33.3%) and 38 of 75 patients (50.7%) developed grade 2 or greater radiation dermatitis in the test and control arms, respectively (absolute difference, 17.4%; 95% confidence interval, 4%-30%; P = .032). Fifteen of 75 patients (20%) developed grade 3 reactions in the test arm compared with 18 of 75 patients (24%) in the control arm (absolute difference, 4%; 95% confidence interval, 7%-15%; P = .554).

CONCLUSION

Although prophylactic use of betamethasone significantly reduced the composite outcome of the proportion of patients developing grade 2 and grade 3 radiation dermatitis, it did not reduce the proportion of patients developing the clinically significant outcome of grade 3 radiation dermatitis.

摘要

目的

我们评估了局部使用倍他米松作为接受头颈部恶性肿瘤放疗患者的预防药物的作用。

方法和材料

这项随机、开放标签的3期试验在单一研究机构完成。接受头颈部癌根治性放疗的患者通过计算机生成的置换区组随机分配法被随机分为两组，每组75例。试验组患者在放疗后每天应用一次0.1%的戊酸倍他米松乳膏。对照组患者接受最佳支持治疗。使用放射治疗肿瘤学组急性毒性分级量表在每次放疗的第五次后直至放疗结束以及治疗后2周评估放射性皮炎。两组的主要结局是出现2级和3级急性皮肤反应的患者比例。该试验已在印度中央试验注册中心注册（CTRI/2017/04/008298）。

结果

2017年4月15日至2018年10月30日期间，150例患者被随机纳入研究，每组75例。试验组14例患者和对照组15例患者未完成预定治疗。根据意向性分析，试验组75例患者中有25例（33.3%）出现2级或更高级别的放射性皮炎，对照组75例患者中有38例（50.7%）出现，（绝对差异为17.4%；95%置信区间为4%-30%；P = 0.032）。试验组75例患者中有15例（20%）出现3级反应，对照组75例患者中有18例（24%）出现，（绝对差异为4%；95%置信区间为7%-15%；P = 0.554）。