StrataXRT® - 一种硅基成膜凝胶敷贴剂预防和治疗头颈部癌症患者放射性皮炎的单盲、随机对照试验。

A single-blind, randomised controlled trial of StrataXRT® - A silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer.

机构信息

Princess Alexandra Hospital, Metro South Health and Hospital Services, Woolloongabba, Q4102, Queensland, Australia; School of Nursing, Queensland University of Technology, Kelvin Grove, Q4059, Queensland, Australia.

School of Nursing, Queensland University of Technology, Kelvin Grove, Q4059, Queensland, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Q4029, Queensland, Australia.

出版信息

Radiother Oncol. 2019 Oct;139:72-78. doi: 10.1016/j.radonc.2019.07.014. Epub 2019 Aug 21.

DOI:10.1016/j.radonc.2019.07.014

PMID:31445838

Abstract

AIM

Investigate the effects of StrataXRT® versus 10% Glycerine (Sorbolene cream) for preventing and managing radiation dermatitis in patients with head and neck cancer receiving radical radiotherapy (≥50 Gy) with or without chemotherapy or biotherapy.

METHODS

A single-blind, randomised controlled, superiority trial was conducted. Patients either received StrataXRT® or Sorbolene (usual care). Skin toxicity, pain, itching and skin-related quality of life scores were collected from baseline, and up to four weeks post-treatment.

RESULTS

A total of 197 patients were randomised into the study. Skin toxicity was dependent on the treatment group with StrataXRT® patients experiencing lower mean skin toxicity at the end of the radiation treatment (P = 0.002). At the end of treatment, the StrataXRT® arm had a lower percentage of grade 2 (80%) and grade 3 (28%) skin toxicity compared to the sorbolene arm (91% and 45% respectively). After adjustment for Cetuximab, the StrataXRT® arm had a 12% lower risk of experiencing grade 2 skin toxicity (RRR = 0.876, 95% CI: 0.778-0.987, P = 0.031); and a 36% lower risk of experiencing grade 3 skin toxicity (RRR = 0.648, 95% CI: 0.442-0.947, P = 0.025). Cox regression analysis showed that patients receiving StrataXRT® had a 41.0% and 49.4% reduced risks of developing grade 2 and 3 skin toxicity respectively throughout treatment compared to the Sorbolene arm. There were no differences between groups in patient-reported outcomes. No treatment interruptions and study product related adverse events were reported in either arm.

CONCLUSION

StrataXRT® is effective for preventing, and delaying the development of grade 2 and 3 skin toxicity.

TRIAL REGISTRATION

ACTRN12616000511437.

摘要

目的

研究 StrataXRT® 与 10%甘油（Sorbolene 乳膏）预防和治疗头颈部接受根治性放疗（≥50Gy）联合或不联合化疗或生物治疗的癌症患者放射性皮炎的效果。

方法

采用单盲、随机对照、优效性试验。患者分别接受 StrataXRT®或 Sorbolene（常规护理）治疗。从基线和治疗后 4 周收集皮肤毒性、疼痛、瘙痒和皮肤相关生活质量评分。

结果

共 197 例患者被随机分配到研究中。皮肤毒性与治疗组有关，StrataXRT®组在放疗结束时皮肤毒性的平均评分较低（P=0.002）。治疗结束时，StrataXRT®组 2 级（80%）和 3 级（28%）皮肤毒性的比例低于 Sorbolene 组（分别为 91%和 45%）。调整 Cetuximab 后，StrataXRT®组发生 2 级皮肤毒性的风险降低了 12%（RRR=0.876，95%CI：0.778-0.987，P=0.031）；发生 3 级皮肤毒性的风险降低了 36%（RRR=0.648，95%CI：0.442-0.947，P=0.025）。Cox 回归分析显示，与 Sorbolene 组相比，接受 StrataXRT®治疗的患者在整个治疗过程中发生 2 级和 3 级皮肤毒性的风险分别降低了 41.0%和 49.4%。两组患者报告的结局无差异。两组均未报告治疗中断和与研究产品相关的不良事件。