1. Fuerst, Mark L.

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Mepitel film (MF), a silicone-based polyurethane film dressing, may prevent acute radiation dermatitis in breast cancer patients. Radiation dermatitis is common among those undergoing breast radiation treatment (RT), in particular patients with large breasts and after mastectomy. Patients who develop moderate-to-severe radiation dermatitis may experience treatment interruption and an increased risk of long-term toxicities. Supportive skin care regimens are highly variable across institutions, noted Edward Chow, MBBS, MSc, PhD, FRCPC, senior scientist at Odette Cancer Centre in the Sunnybrook Health Sciences Centre in Toronto, during the 2022 American Society of Clinical Oncology (ASCO) Plenary Series (Abstract 390226).

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A randomized, multi-center, open-label Phase III trial showed MF was more effective than standard skin care in preventing Grade 2 or 3 radiation dermatitis in patients with breast cancer undergoing radiation treatment. Patients reported reduced symptoms, including tenderness, discomfort or pain, and burning sensations, as well as blistering/peeling, erythema, pigmentation, and edema.


"Based on the results of the study, we recommend consideration of MF to prevent moderate-to-severe radiation dermatitis in patients at high risk," Chow noted.


Study Details

Researchers randomly assigned 376 patients to receive MF (266 patients) or standard skin care (137 patients). Standard care at Odette Cancer Centre is aqueous cream, saline compresses, topical corticosteroids, topical antibiotics, oral analgesics, and home care/dressings, Chow said.


The study included patients with large breasts after lumpectomy (bra size >=36 inches or cup size >=C) or after mastectomy, regardless of previous bra size, to receive treatment with the film or standard skin care. Patients were stratified by surgery type (lumpectomy vs. mastectomy), dose fractionation (conventional vs. hypofractionated), and administration of boost/bolus.


The primary endpoint was Grade 2 or 3 radiation dermatitis using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during RT and within 3 months of completion of RT. Secondary endpoints included the incidence of moist desquamation, use of topical antibiotic cream, and patient-reported and clinician-reported outcomes using the modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Skin Symptom Assessment (SSA).


Chow reported the incidence of Grade 2 or 3 radiation dermatitis was significantly lower in patients who received the film (15.5%) as compared to standard care (45.6%), and across three stratification factors. Benefits of the film over standard care remained significant in patients who developed Grade 3 radiation dermatitis (2.8% vs. 13.6%) and moist desquamation (8% vs. 19.2%).


When evaluating the combined patient and health care professional score using the RISRAS, the MF arm had significantly lower scores than standard care, Chow noted. Individual items on the RISRAS also favored the film for tenderness, discomfort of pain, and burning sensation in patient-reported scores, and erythema and moist desquamation in clinician-reported scores.


Similarly, when assessed by the SSA, blistering/peeling, erythema, pigmentation, and edema in patient-reported scores, and pain/soreness, blistering/peeling, erythema, and pigmentation in clinician-reported scores were significantly reduced by the film. In addition, patients treated with the film were prescribed significantly fewer topical antibiotics (23.1% vs. 43.2%).


"This study confirms Mepitel film is beneficial in patients with a higher risk of radiation dermatitis," Chow noted.


ASCO Discussant Jean L. Wright, MD, Director of Breast Cancer Program in the Department of Radiation Oncology and Molecular Radiation Sciences at Johns Hopkins Medicine, commented: "There is a wide range of toxicity varying with target, dose, technique, and patient factors, including race, obesity, breast size, smoking, and more. Higher-grade skin toxicity is a clear problem for higher-risk patients. This shows the importance of robust methods to mitigate this risk, which is very high."


She said the current study addresses a critical clinical issue and appropriately focuses on a high-risk patient cohort. "The reported improvements are clinically meaningful," Wright said. "They highlight the limitations of CTCAE and lack of consensus on alternative measurement scales." She noted the results must be replicated in datasets that include a full spectrum of skin tones.


Mark L. Fuerst is a contributing writer.