Mepitel Film—a silicone-based polyurethane film dressing—may be beneficial in reducing skin toxicities caused by radiation treatment, according to data presented during the October 2022 session of the ASCO Plenary Series by Chow et al (Abstract 390226).

Results of the phase III trial showed the film is more effective than standard skin care in preventing grade 2 or 3 radiation dermatitis in patients with breast cancer undergoing radiation treatment. Patients reported reductions in tenderness, discomfort or pain, and burning sensations, as well as blistering/peeling, erythema, pigmentation, and edema.

“Based on these findings, we recommend considering Mepitel Film to prevent moderate-to-severe radiation dermatitis in patients at high risk for the condition,” said lead study author Edward Chow, MBBS, MSc, PhD, senior scientist at Odette Cancer Centre, Sunnybrook Health Sciences Centre, in Toronto.

As Dr. Chow explained, radiotherapy is important to prevent locoregional recurrence in breast cancer, but radiotherapy-induced skin toxicities are common. Moreover, patients who develop moderate-to-severe radiation dermatitis may experience treatment interruption and an increased risk of long-term toxicities.

According to Dr. Chow, supportive care regimens for radiation dermatitis are highly variable across institutions. Standard care at the Odette Cancer Center involves aqueous creams, saline compress, topical corticosteroids, topical antibiotics, oral analgesics, and home care/dressings.

Study Methods

For this study Dr. Chow and colleagues randomly assigned 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 study’s primary endpoint was grade 2 or 3 radiation dermatitis using the Common Terminology Criteria for Adverse Events version 5.0 during radiotherapy and within 3 months of completion of radiation. Secondary endpoints included the incidence of moist desquamation, use of topical antibiotic cream, and patient- and clinician-reported outcomes using the modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Skin Symptom Assessment (SSA).

Improved Clinical and Patient Outcomes

Between January 2020 and May 2022, the investigators randomly assigned patients to receive treatment with the film (n = 266) or a standard skin-care regimen (n = 137). A total of 376 patients were included in the modified intention-to-treat analysis.

As Dr. Chow reported, the film significantly reduced grade 2 or 3 radiation dermatitis compared to standard skin care (15.5% vs 45.6%, P < .0001), and the effects were similar across three stratification factors. Only 2.8% of patients randomly assigned to the experimental dressing experienced grade 3 radiation dermatitis vs 13.6% of patients who received standard care (P < .0002). The benefits of the film over standard care also remained significant in patients who developed moist desquamation (8.0% vs 19.2%).

In addition, RISRAS scores favored the film arm with respect to tenderness, discomfort or pain, and burning sensation compared to standard care. The experimental dressing arm also had significantly lower scores for clinician-reported erythema and moist desquamation.

Similarly, patient-reported SSA scores showed significantly reduced rates of blistering/peeling, erythema, pigmentation, and edema among patients who received the film. When assessed by clinicians, SSA scores for pain/soreness, blistering/peeling, erythema, and pigmentation were significantly lower in the film arm.

Patients treated with film vs standard skin care were also prescribed topical antibiotics significantly less frequently (23.1% vs 43.2%, P < .0001).

In their abstract, researchers concluded, “[The film] significantly reduces radiation dermatitis in [patients with] breast cancer undergoing radiotherapy when compared to the standard care. We recommend changes to the clinical practice for radiation dermatitis prevention and inclusion of [the film] in high-risk patients in future guideline recommendations.”

Disclosure: For full disclosures of the study authors, visit coi.asco.org.