Radiation dermatitis is one of the most common side effects of radiotherapy for women with breast cancer. Results from a phase 3 trial add to previous evidence from smaller trials that show that a silicone-based film can protect skin from this side effect.
But it is not being used much in clinical practice.
Instead, radiation dermatitis is usually treated after the fact, most often with aqueous creams. Medscape Medical News set out to investigate why.
The product is Mepitel film, from Swedish medical device company Mölnlycke Health Care Ltd.
It should be used for women who are at high risk for developing radiation dermatitis, said Edward Chow, MBBS, PhD, of the Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada, who was the senior author of the phase 3 study published recently in the Journal of Clinical Oncology.
"Other doctors think that because radiation dermatitis isn't life-threatening it isn't as important, but the condition does affect the quality of life for patients," Chow said. "If we can lessen the pain and discomfort, why wouldn't we as physicians?"
Chow's open-label, multicenter trial was conducted in 376 women with large breasts (bra cup size C or larger) who were undergoing radiotherapy after lumpectomy or mastectomy. The primary endpoint was grade 2 or 3 radiation dermatitis using the Common Terminology Criteria for Adverse Events. (Grade 2 is described as moderate, whereas grade 3 is severe.)
The film significantly reduced the incidence of grade 2 or 3 radiation dermatitis, down to 15.5% compared with 45.6% in patients receiving standard care (odds ratio [OR], 0.20, 95% CI, 0.12 - 0.34, P < .0001).
There was also a significant reduction in grade 3 radiation dermatitis (2.8% vs 13.6%; OR, 0.19, P < .0002) and moist desquamation (8% vs 19.2%; OR, 0.36; P = .002).
"The film was remarkably effective and helped protect patients from potentially debilitating side effects," commented Corey Speers, MD, PhD, a radiation oncologist with University Hospitals in Cleveland, Ohio who saw the study data presented during an American Society of Clinical Oncology virtual plenary session in October.
He believes that preventing radiation dermatitis before it develops is the best way to care for patients.
"[Radiation dermatitis] is usually associated with pain and discomfort and can lead to more serious issues like infection or delayed wound healing, and unfortunately, there aren't effective treatments for it once it's developed, so preventing it is our most effective strategy," Speers said.
Takes Time to Apply
One reason for the film not being used much could be that it takes time apply the film, suggested Patries Herst, PhD, Department of Radiation Therapy, University of Otago in Wellington, New Zealand. She was the lead author of a study published in 2014 that also analyzed the effectiveness of the film in preventing radiation dermatitis.
In their trial, a research radiation therapist applied the film to women when they were starting their radiotherapy. The film is applied to a portion of the breast or chest wall, and Herst emphasized the importance of applying the film correctly, making sure the film is not stretched during application and not overlapping other pieces of the film, while also making sure that it conforms to the breast shape. The film was replaced when it would curl too much around the sides, approximately every 1 or 2 weeks.
"Radiation therapy itself is very short. And so you have about 10 minutes for every patient,” she explained.
“But applying the film adds 20 to 30 minutes and it's really awkward to apply properly," Herst said. "You have to tap it in and then have to maybe cut it so that it fits better. And hospitals say, 'We don't have the time' and that is still the biggest issue that we're seeing right now.”
In Chow's study, the average time spent applying the film on lumpectomy patients was 55 minutes and was slightly shorter at 45 minutes for mastectomy patients. He acknowledges that it does take time that staff at most hospitals and clinics simply don't have.
Chow suggested that maybe a family member or other caregiver could apply the film, and he referenced an educational video from the manufacturer that provides in-depth instructions on the correct way to apply the film for radiotherapy patients. However, this could lead to errors and a waste of product if not the film was not applied properly, he acknowledged.
The cost of Mepitel film may also be a deterrent. Chow's study noted that during the entire course of radiotherapy, the cost for the film was about $80-$100 per patient. However, he believes the benefits outweigh the cost.
In addition, there have been issues with supplies, and it has been difficult for people to get their hands on the actual product.
Currently, the Mayo Clinic is also conducting a study testing Mepitel Film for radiation dermatitis in breast cancer patients following mastectomy. Mayo Clinic principal investigator Kimberly Corbin, MD, could not go into great detail about the ongoing trial, but she said it has been difficult to get the product.
"We have been using the film at Mayo for a number of years," Corbin said, but we have "have found that it is challenging to get supplies."
"While we have generally been able to have some supply established through our store here, we know that is not typical and it is difficult for patients to access," she said. In addition, "there are not a ton of centers with experience in application."
Medscape Medical News reached out to the film manufacturer Mölnlycke Health Care. A representative with the company, Allyson Bower-Willner, could not comment on the distribution of Mepitel film in the United States or if the company plans to increase the amount of product shipped. The film is available "to a limited set of customers," she said.
J Clin Oncol. Published in the February 2023 edition. Abstract
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Images: Dr. Edward Chow, Odette Cancer Centre
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Cite this: Mepitel Film for Radiation Dermatitis: It Works, so Why Isn't It Used? - Medscape - Mar 09, 2023.