Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial

医学 随机对照试验 不良事件通用术语标准 乳腺癌 临床终点 肿块切除术 优势比 内科学 不利影响 外科 乳房切除术 放射治疗 癌症
作者
Tara Behroozian,Lauren Milton,Irene Karam,Liying Zhang,Keyue Ding,Julia Lou,François Gallant,Eileen Rakovitch,William T. Tran,Hany Soliman,Eric Leung,Danny Vesprini,Ewa Szumacher,Hanbo Chen,E. Donovan,Jacqueline Lam,Silvana Spadafora,Matt Wronski,Chris Lavoie,Natalie Walde
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:41 (6): 1250-1264 被引量:40
标识
DOI:10.1200/jco.22.01873
摘要

Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD.Patients were randomly assigned to receive MF or standard care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. The primary end point was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events v5.0. Secondary end points included patient- and clinician-reported outcomes.Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared with standard care (n = 39/251, 15.5%; 95% CI, 11.3 to 20.6% v n = 57/125, 45.6%; 95% CI, 36.7 to 54.8% respectively, odds ratio (OR): 0.20, P < .0001). Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). When evaluating the combined patient and health care provider score using Radiation-Induced Skin Reaction Assessment Scale, the MF arm had significantly lower scores (P < .0001). Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. Blistering/peeling, erythema, pigmentation, and edema were significantly reduced in the MF arm. Three patients removed the film prematurely because of rash (n = 2) and excessive pruritus (n = 1).MF significantly reduces RD in patients undergoing breast radiotherapy.
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