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Mepitel film -- a transparent, breathable, adhesive soft silicone film dressing -- is more effective than standard of care in preventing acute radiation dermatitis in at-risk breast cancer patients, a phase III randomized trial showed.

Among patients with large breasts or those who had undergone mastectomy and were undergoing radiotherapy, the incidence of grade 2 or 3 radiation dermatitis was 15.5% with use of Mepitel film versus 45.6% with standard of care, such as topical antibiotics or corticosteroids (OR 0.20, 95% CI 0.12-0.34, P<0.0001), reported Edward Chow, MBBS, of Sunnybrook Health Sciences Centre in Toronto, during an .

Improvements with Mepitel film over standard of care remained significant when looking at the development of grade 3 radiation dermatitis (2.79% vs 13.6%, OR 0.19, 95% CI 0.07-0.45, P<0.0002) and moist desquamation (7.97% vs 19.2%, OR 0.36, 95% CI 0.19-0.68, P=0.002).

According to Chow, more than 95% of patients undergoing radiotherapy develop acute radiation dermatitis, with symptoms that include erythema, pain, pruritus, edema, pigmentation, moist desquamation, and ulceration.

Risk factors for moderate-to-severe radiation dermatitis include mastectomy, large breasts, and radiation dose fractionation.

"Patients who develop moderate-to-severe radiation dermatitis may experience treatment interruption, and an increased risk of long-term toxicities," explained Chow. These late skin effects can include fibrosis, telangiectasia, and hyperpigmentation.

Supportive regimens are highly variable across institutions, Chow pointed out, with the standard of care including aqueous cream, saline compresses, topical corticosteroids and antibiotics, oral analgesics, and home care dressings.

In the study, Chow noted that patient Radiation-Induced Skin Reaction Assessment Scale (RISRAS) scores indicated that Mepitel film significantly reduced tenderness, discomfort or pain, and burning sensation, while healthcare professional RISRAS scores showed it significantly reduced erythema and moist desquamation.

Furthermore, patient- and healthcare professional-assessed Skin Symptom Assessment (SSA) scores were significantly lower for blistering/peeling, erythema, and pigmentation in the Mepitel film arm. Patient-assessed SSA scores were also significantly reduced for edema, while healthcare professional-assessed scores were lower for pain/soreness.

In addition, fewer patients in the Mepitel film arm were prescribed topical antibiotics (23.1% vs 43.2%) compared with patients in the standard-of-care arm.

ASCO discussant Jean Wright, MD, of Johns Hopkins University in Baltimore, said the results of the study represented "the most improvement in skin toxicity that I have seen in many years."

"The reduction in moist desquamation is very important in that moist desquamation is associated with pain and treatment interruption," she pointed out. "And we also saw improvements in all of the various scales that were used -- both patient and provider reported."

The modified intention-to-treat analysis included 376 patients with a diagnosis of breast cancer (invasive or in situ carcinoma) or phyllodes tumors treated at three centers; 251 were randomized to Mepitel film (median age 58) and 125 were randomized to standard of care (median age 60).

Of the two groups, 41-42% underwent mastectomy, and 58-59% underwent lumpectomy.

The primary endpoint was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during radiotherapy and within 3 months of completion of radiotherapy.

In her discussion, Wright noted that while the results of the study are clinically meaningful, "the fact that the authors reported on so many different metrics really highlights the limitations of the current CTCAE scale, and the lack of consensus on alternative measurement scales."

For example, she pointed out that the CTCAE relies on the subjective measurement of erythema, but doesn't report on pigmentation, and combines moist desquamation into multiple categories. In addition, she noted that many reporting systems are healthcare provider assessed, with few incorporating patient reporting.

Thus, a strength of the study "is that it does attempt to address the limitations of the current skin toxicity grading scales by including multiple healthcare provider- and patient-reported assessments," she said, adding that the findings "highlight the urgency of developing a simple, user-friendly tool that is applicable across skin tones and correlates with patient experience."

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