Epigallocatechin-3-gallate (EGCG) plus radiotherapy significantly reduced the incidence and severity of radiation-induced dermatitis in patients with breast cancer compared to radiotherapy alone, according to findings from a phase 2 trial.

“The most common adverse event associated with breast cancer radiotherapy is radiation-induced dermatitis,” explained Hanxi Zhao, MD, PhD, Shandong Cancer Hospital and Institute, Shandong, China, and colleagues, adding “There is no recognized standard approach to prevent [radiation-induced dermatitis].”

This double-blind, placebo-controlled, phase 2 randomized trial aimed to assess the clinical benefit of EGCG plus adjuvant radiotherapy compared to adjuvant radiotherapy alone in breast cancer.

The primary end point of the trial was incidence of grade 2 or worse radiation-induced dermatitis, defined by the Radiation Therapy Oncology Group scale. Secondary end points included radiation-induced dermatitis index, symptom index, changes in the skin temperature measured by infrared thermal images, and safety.

A total of 180 patients were enrolled in the trial between September 2019 and January 2020 and randomized in a 2:1 ratio to receive EGCG or placebo sprayed to the whole radiation field from day 1 of the radiation until 2 weeks after radiation completion.

Of the 180 patients enrolled in the study, 160 were evaluable for efficacy; 111 who received EGCG and 54 who received placebo. The occurrence of grade ≥2 radiation-induced dermatitis was 50.5% (95% confidence interval [CI], 41.2% to 59.8%) with EGCG plus radiotherapy vs 72.2% (95% CI, 60.3% to 84.1%) with radiotherapy alone (P = .008). The mean radiation-induced dermatitis index with EGCG plus radiotherapy was also significantly lower than with radiotherapy alone. Symptom indexes were significantly lower with EGCG plus radiotherapy vs radiotherapy alone.

“The safety profile and prophylactic effect of topical EGCG solution may offer a convenient, well-tolerated, and valid option for patients with breast cancer who are at risk for [radiation-induced dermatitis],” wrote Dr Zhao and colleagues.

The most common treatment-related adverse events with EGCG were grade 1 pricking skin sensation in 3 (2.7%) patients and pruritus in 1 (0.9%) patient.

“Use of EGCG the potential to become a new standard of skin care for patients receiving radiotherapy,” concluded Dr Zhao, et al.

Source:                                        

Zhao H, Zhu W, Zhao X, et al. Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy: A Double-Blind, Placebo-Controlled, Phase 2 Randomized Clinical Trial. JAMA Dermatol. Published online June 01, 2022. doi:10.1001/jamadermatol.2022.1736