A silicone-based polyurethane film dressing (known as Mepitel® Film) appears to be beneficial in reducing skin toxicities caused by radiation treatment, according to data presented during the October 2022 ASCO Plenary Series.1
The results of a phase III trial showed that this film dressing may be more effective than standard 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, and clinicians observed reductions in 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, a senior scientist at Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto. As Dr. Chow explained, radiotherapy is important to prevent locoregional recurrence in breast cancer, but radiotherapy-induced skin toxicities are common. Approximately 95% of patients exposed to radiotherapy develop acute radiation dermatitis, which typically occurs within the first few weeks of treatment.
“Patients who develop moderate-to-severe radiation dermatitis may experience treatment interruption and an increased risk of long-term toxicities,” said Dr. Chow. “[Radiation dermatitis] has a negative impact on quality of life, treatment, and long-term cosmesis.”
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 mastectomy, regardless of previous bra size, to receive Mepitel 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 v5.0 during radiotherapy and within 3 months of completion of radiation therapy. 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 and Skin Symptom Assessment (SSA).
KEY POINTS
- Mepitel® Film significantly reduced radiation dermatitis in patients with breast cancer undergoing radiation treatment when compared with standard care.
- These findings support the inclusion of this experimental dressing in clinical practice guidelines for the prevention of radiation dermatitis in high-risk patients.
A trained clinical research assistant applied the experimental film dressing to the entire breast or chest wall on the first day of treatment, and film integrity was assessed every day during radiotherapy. In patients receiving locoregional radiotherapy, said Dr. Chow, the breast/chest wall alone was covered with the experimental film dressing, and patients were asked to follow standard care on the supraclavicular and axillary regions due to poor adherence of the dressing in these areas. On the last day of radiotherapy, the entire film was replaced for all patients randomly assigned to the experimental arm to provide protection over the 2 weeks after completion of radiotherapy.
Improved Clinical and Patient Outcomes
Between January 2020 and May 2022, the investigators randomly assigned patients to the experimental film dressing (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, Mepitel Film significantly reduced grade 2 or 3 radiation dermatitis when compared with standard skin care (15.5% vs 45.6%; P < .0001), and the effects were similar across three stratification factors. A total of 2.8% of patients randomly assigned to receive the experimental dressing experienced grade 3 radiation dermatitis vs 13.6% of patients who received standard care (P < .0002). The benefits of the experimental dressing over standard care also remained significant in patients who developed moist desquamation (8.0% vs 19.2%).
Patient response scores favored the experimental dressing with respect to tenderness, discomfort or pain, and burning sensation when compared with standard care. The experimental dressing also yielded significantly lower scores for clinician-reported erythema and moist desquamation. Similarly, patient-reported SSA scores showed significantly reduced blistering/peeling, erythema, pigmentation, and edema among patients who received the experimental dressing. When patients were assessed by clinicians, SSA scores for pain/soreness, blistering/peeling, erythema, and pigmentation were significantly lower with the experimental dressing. Patients treated with the experimental dressing vs standard skin care were also prescribed topical antibiotics significantly less often (23.1% vs 43.2%; P < .0001).
The cost of the Mepitel Film was $80 for patients who underwent mastectomy and $99 for those who underwent lumpectomy. Application of the dressing required an average of 46 minutes and 55 minutes, respectively.
DISCLOSURE: Dr. Chow reported no conflicts of interest.
REFERENCE
1. Chow E, et al: Mepitel Film for the prevention of acute radiation dermatitis in breast cancer. ASCO Plenary Series. Abstract 390226. Presented on October 18, 2022.
