The rate of severe radiation dermatitis was reduced with the use of Mepital Film in patients with breast cancer undergoing mastectomy.
Patients with breast cancer undergoing mastectomy experienced a significant reduction in severe radiation dermatitis (RD) following treatment with Mepitel Film, an adhesive silicone dressing that reduces friction, according to findings from a phase 3 trial.1 The data were presented during an ASCO plenary session.
Specifically, Mepitel Film reduced the incidence of grade 2 and 3 RD (OR, 0.20; 95% CI, 0.12-0.34; P < .0001) compared with standard of care. Thirty-nine out of 251 (15.54%) patients receiving the novel intervention experienced grade 2 or 3 RD (95% CI, 11.29%-20.62%) whereas 57 out of 127 patients (45.6%) receiving standard of care experienced severe RD (95% CI, 36.67%-54.75%).
Moreover, in a secondary analysis assessing the intervention’s effect on the rate of grade 3 RD, Mepitel Film also elicited encouraging results (OR, 0.19; 95% CI, 0.07-0.45; P <.0002). In the experimental arm, 2.79% of patients (n = 7) developed grade 3 RD whereas 13.60% (n = 17) of patients receiving standard of care experienced RD of grade 3 severity.
In addition, the percentage of patients who developed moist desquamation with Mepitel Film was 7.97% (n = 20) vs 19.20% with standard of care treatment (n = 24). The odds ratio was 0.36 (95% CI, 0.19-0.68; P = .002). These patients were also less likely to be prescribed topical antibiotics (23.1% vs 43.2%; P < .001).
Patients enrolled in the trial who received Mepitel Film also reported reduced tenderness, discomfort, or pain, as well as decreased blistering, erythema, pigmentation, and edema compared with those who received standard care. Health care professionals reported reductions in erythema and moist desquamation, as well as reduced pain or soreness, erythema, and pigmentation, among those who received Mepitel Film.
“The study confirmed the film is beneficial in patients with a higher risk of RD,” said Edward Chow, MBBS, MSc, PhD, FRCPC, senior scientist at Sunnybrook Research Institute, in a presentation of the findings. “We therefore recommend consideration of Mepitel Film to prevent moderate to severe RD in these patients who are high risk.”
Many patients with breast cancer will receive radiotherapy to prevent locoregional recurrence of their disease. However, this treatment approach is linked to skin toxicities, or RD, and it is common for patients who experience moderate to severe RD to require treatment interruption. Acute RD is observed in more than 95% of patients who undergo radiotherapy, and 32.7% of patients who undergo post-mastectomy radiotherapy will develop grade 3 RD, with extensive moist desquamation. Patients with larger breasts (bra band greater than 40 inches or larger than a size D cup) are at an increased risk of developing severe RD.
Acute RD typically develops within the first few weeks of treatment and manifests with erythema, pain, pruritis, edema, pigmentation, moist desquamation, and ulceration. The late skin effects develop within months to years following radiotherapy and manifest as fibrosis, telangiectasia, and hyperpigmentation.
Despite this, there is little uniformity in skin care regimens across institutions. Many institutions use aqueous creams and washing with as soap and water as RD prophylaxis, but this can be quite variable. Other strategies including saline compresses, topical corticosteroids (eg, hydrocortisone), topical antibiotics, oral analgesics, and home care dressings are also common. Previous studies have suggested that Mepitel Film, a silicone-based polyurethane film with Safetac technology, may be useful in this setting, but the evidence is insufficient.
RD is graded according to symptomatic presentation with varying severities. Grade 0 is no changes in the skin. Grade 1 is considered mild if faint erythema or dry desquamation is present. Grade 2 is considered moderate if moderate to brisk erythema, patchy moist desquamation—mostly confined to skin folds and creases, or moderate edema is present. Finally, severe RD, or grade 3 RD, is characterized by moist desquamation in areas other than skin folds and creases, bleeding induced by minor trauma or abrasion.
This single-center study enrolled and randomly assigned 403 patients in a 2:1 allocation ration to receive either Mepitel Film or standard care (which in this institution, included strategies such as saline compress, corticosteroids, at home dressings, etc). During the study, 8 patients switched from Mepitel Film to standard care treatment, 2 because of an allergic rash, 1 because of excessive pruritus’, and 5 because of other reasons.
The median age in the Mepitel Film arm was 58 years and 60 years in the standard arm. For surgery, 147 and 72 patients received lumpectomies in the Mepitel Film and standard arms, respectively, and 105 and 53 patients had undergone a mastectomy. Conventional RT was used on 15 and 10 patients, respectively, whereas hypofractionated radiotherapy was used in 236 and 115 patients, respectively.
For patients receiving Mepitel Film, the product was applied to the entire breast or chest wall on the first day of treatment by a trained clinical research assistant, and the integrity of the film was assessed everyday during radiotherapy. Standard care was applied to the supraclavicular and axillary region, as Mepitel Film does not adhere well to these areas. On the final day of therapy, a new layer of Mepitel Film was applied to provide protection for the 2-week period following RT completion.
Patients completed self-reported skin-symptom assessments at baseline, during each week of therapy, each week for the first 6 weeks following radiotherapy, and every 3 months post therapy. They also completed radiation-induced skin reaction assessment scale at baseline, on the last day of treatment, 2 to 4 weeks after treatment, and 3 months after treatment. Finally, they were assessed via the CTCAEv 5o by their treatment team at baseline, each week during treatment, on the last day of treatment, and 2 to 4 weeks post therapy.
According to Jean L .Wright, MD, an associate professor radiation oncology, at Johns Hopkins University, who discussed the research in a post-presentation session during the plenary, this research represents the “most significant improvement in clinically meaningful skin toxicity intervention in many years.”2
This was an “extremely well-done study with findings that are applicable to patients today,” she said, noting that eliminating barriers to use represents the next key step forward in this area of research. Overall, the results are “clinically meaningful” and “address a critical clinical issue,” she concluded.