S299
Clinical - Breast
ESTRO 2026
in all patients. For the comparative analysis, 48 patients in the trial cohort were matched 1:1 with 48 patients in the standard-of-care cohort using PSM. The cumulative incidence of Grade 2 ARD was significantly lower in the trial group (stratified log-rank test, p = 0.03) (Figure 1). According to the stratified Cox proportional hazards model, the hazard of Grade 1 skin pain (HR, 0.37; 95% CI, 0.15–0.88; p = 0.02) and topical corticosteroid use (HR, 0.31; 95% CI, 0.15–0.66; p < 0.01) were significantly lower in the trial group, whereas other ARD-related adverse events did not differ significantly between the groups (Table 1).
radiotherapy in early-stage non-small cell lung cancer. Radiotherapy and Oncology. 2020 Apr 1;145:209– 14. Pisani C, et al. Correlation of [18F] FDG-PET/CT with dosimetry data: recurrence pattern after radiotherapy for head and neck carcinoma. Radiat Oncol. 2021 Mar 21;16:57. Funding French national cancer institute: INCa grant PHRC-K 15-146 Keywords: breast cancer, hypofractionation, Radiotherapy Poster Discussion 3336 Safety and efficacy of StrataXRT for radiation dermatitis in patients with breast cancer: a phase II pilot study (jRCT1032230451) Takuya Hayashi, Mami Ogita, Masanari Minamitani, Hideomi Yamashita Department of Radiology, The University of Tokyo Hospital, Tokyo, Japan Purpose/Objective: StrataXRT, a silicone-based topical gel, has been reported to reduce acute radiation dermatitis (ARD), although existing results are inconsistent [1-3]. This study aimed to evaluate its safety and efficacy in patients with breast cancer who underwent postoperative radiotherapy. Material/Methods: A single-arm phase II pilot study was conducted at our institution. Patients with breast cancer scheduled to undergo postoperative radiotherapy were eligible for inclusion. StrataXRT was applied from the first day of radiotherapy until at least 14 days after completion of radiotherapy or until recovery from ARD-related symptoms. The study had two primary endpoints: the incidence of Grade ≥ 2 ARD within 90 days after completion of radiotherapy, and completion of StrataXRT use, defined as adherence ≥ 70%. Adverse events were assessed according to CTCAE version 5.0. For the pre-planned comparative analysis, a standard- of-care cohort corresponding to the trial cohort was selected from a historical cohort of 176 patients (January 2022–December 2023) using propensity score matching (PSM). The time to onset of ARD-related adverse events was compared using stratified log-rank and stratified Cox proportional hazards models. Results: Fifty patients were enrolled between January 2024 and January 2025. The mean age and BMI were 53 years and 22.9 kg/m2, respectively. Regional nodal and boost irradiation were performed in 10 and 22 patients. Among the 50 patients, Grade 2 and Grade 1 ARD occurred in 3 and 44 patients, respectively. Grade 1 skin pain and pruritus were observed in 8 and 19 patients. No adverse events related to StrataXRT were observed. Completion of StrataXRT use was achieved
Conclusion: StrataXRT was safe, continuously applicable, and reduced the incidence of Grade 2 ARD and the hazard of Grade 1 skin pain and topical corticosteroid use, supporting its efficacy in reducing ARD-related symptoms and serving as a possible alternative to topical corticosteroids. References: [1] Lee SF, Shariati S, Caini S, Wong H, Chan AW, Gojsevic M, et al. StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2023;31:515.[2] Kennedy SKF, Gojsevic M, Rajeswaran T, Zhang L, Kuszaj O, Day M, et al. StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a pilot study. Supportive Care in Cancer. 2024;32:670.[3] Wong CL,
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