Antibacterial regimen reduces severity of radiation therapy-induced dermatitis
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Key findings:
- Staphylococcus aureus colonization is an independent risk factor for severe acute radiation dermatitis.
- Bacterial decolonization mitigated the risk for developing grade 2 or higher acute radiation dermatitis.
A bacterial decolonization-based regimen safely and effectively prevented development of severe acute radiation dermatitis among adults receiving radiation therapy, results of a randomized phase 2/phase 3 trial showed.
The findings — published in JAMA Oncology — may establish bacterial colonization as a new standard approach to prevent severe acute radiation dermatitis, especially among those undergoing radiation therapy for breast cancer, investors noted.
“We need to address the bacterial component of radiation dermatitis,” Beth N. McLellan, MD, director of supportive oncodermatology at Montefiore Einstein Cancer Center, told Healio. “Using a bacterial decolonization regimen is a safe, effective and readily available way to significantly decrease radiation dermatitis severity.”
Background
The risk for developing acute radiation dermatitis is highest among individuals with breast, head and neck, and anogenital cancers, according to McLellan, who also serves as chief of the division of dermatology at Albert Einstein College of Medicine and Montefiore Health System.
“Among patients with breast cancer, the risk is highest in women who receive radiation after a mastectomy,” she said. “This work — as is all of our research — is motivated by a desire to help people with cancer receive the best possible treatment with the least impact on their quality of life.”
In the first of two reports published simultaneously in JAMA Oncology, McLellan and colleagues established Staphylococcus aureus colonization as an independent risk factor for developing severe acute radiation dermatitis among adults with breast or head and neck cancer.
The prospective cohort analysis included 76 adults (mean age, 58.5 ± 12.6 years; 73.7% women) who had severe acute radiation dermatitis. Results showed significantly higher prevalence of baseline nasal S. aureus colonization among those who developed severe (grade 2 or higher) symptoms compared with those who experienced grade 1 dermatitis (34.5% vs. 12.8%; P = .02).
An additional regression analysis showed significantly higher odds of developing grade 2 or higher acute radiation dermatitis among those who had baseline S. aureus nasal colonization (OR = 4.24; 95% CI, 1.24-14.51).
The results suggest that cutaneous bacteria play a role in causing and worsening acute radiation dermatitis, McLellan said.
“This is similar to what has been shown in other skin diseases — such as eczema — but is a new finding in the area of radiation dermatitis,” she added.
Methodology
Next, McLellan and colleagues conducted a randomized phase 2/phase 3 trial to evaluate the efficacy of bacterial decolonization to reduce the severity of acute radiation dermatitis compared with standard-of-care treatment.
The study included 77 patients (mean age, 59.9 ± 11.9 years; 97.4% women; 33.7% Black; 32.5% Hispanic) with breast (n = 75) or head and neck (n = 2) cancer who underwent proton beam radiotherapy with curative intent between June 2019 and August 2021.
Investigators randomly assigned participants in a 1:1 ratio to receive either standard of care or a bacterial decolonization approach that included intranasal mupirocin ointment and chlorhexidine body cleanser to be used before and during the period of active radiation therapy treatment.
Development of grade 2 or higher acute radiation dermatitis with moist desquamation served as the study’s primary outcome measurement.
Key findings
Thirty-nine study participants underwent bacterial decolonization, none of whom developed grade 2 or higher acute radiation dermatitis. Conversely, nine patients (23.7%) who received standard-of-care treatment experienced grade 2 or higher acute radiation dermatitis with moist desquamation (P = .001).
None of the patients with breast cancer treated with bacterial colonization developed grade 2 or higher symptoms, whereas eight patients (21.6%) receiving standard-of-care treatment developed grade 2 acute radiation dermatitis with moist desquamation (P = .002).
Investigators reported a significantly lower mean acute radiation dermatitis grade among participants who underwent bacterial decolonization compared with those who received standard-of-care treatment (1.2 ± 0.7 vs. 1.6 ± 0.8; P = .02).
One patient (2.5%) discontinued bacterial decolonization treatment due to related itching.
Clinical implications
“Bacterial decolonization is now an additional option for patients planning for radiation therapy,” McLellan told Healio. “Because this treatment is very safe and we don’t have a good way of predicting who will get severe disease, I recommend bacterial decolonization for all patients with breast cancer, until we have more data.”
A variety of bacterial decolonization methods are beneficial to help accommodate patient preferences and promote treatment adherence, according to McLellan. These options include creams, cleansers or nasal sprays, such as those used in her group’s study.
“The more options we have, the more we can provide individualized treatment for all of our patients,” she said.
References:
- Kost Y, et al. JAMA Oncol. 2023;doi:10.1001/jamaoncol.2023.0444.
- Kost Y, et al. JAMA Oncol. 2023;doi:10.1001/jamaoncol.2023.0454.
For more information:
Beth N. McLellan, MD, can be reached at Division of Dermatology, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, 3411 Wayne Ave., 2nd Floor, Bronx, NY 10467; email: bmclella@montefiore.org.
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