Prophylactic use of epigallocatechin-3-gallate (EGCG) was associated with a reduced risk of radiation-induced dermatitis (RID) in patients with breast cancer undergoing postoperative radiotherapy. These results of a phase 2 study were reported in JAMA Dermatology.
The trial (ClinicalTrials.gov Identifier: NCT02580279) enrolled patients who were being treated with postoperative radiotherapy for breast cancer at the Shandong Cancer Hospital and Institute in Shandong, China. Patients were randomly assigned 2:1 to EGCG solution (660 mmol/L) or a 0.9% saline-based placebo. Solutions used in both trial arms were sprayed onto the whole radiation field beginning on day 1 of radiation therapy and continuing until 2 weeks after completion of treatments. Incidence of grade 2 or worse RID was the primary study endpoint, and several secondary endpoints were also evaluated.
The study enrolled 180 patients, with 165 included in efficacy analyses (111 from the EGCG arm and 54 from the placebo arm). The efficacy population had a median age of 46 years (range, 26 to 67).
Incidence of grade 2 or worse RID was 50.5% (95% CI, 41.2%-59.8%) in the EGCG arm, whereas incidence was 72.2% (95% CI, 60.3%-84.1%) in the placebo arm (P =.008).
Patients in the EGCG arm also had a lower mean RID index (5.22 [SD, 1.60]) compared with patients in the placebo arm (6.21 [SD, 1.56]; P <.001). In general, time to appearance of RID after radiotherapy was 2 to 3 weeks. However, in the EGCG arm, mean time to appearance of RID was 3.27 weeks (SD, 0.86), which was significantly longer than in the placebo group (2.89 weeks [SD, 0.60]; P =.001).
Patients in the EGCG arm also demonstrated significantly lower symptom index scores compared with patients in the placebo arm. Overall, symptom scores were significantly better in the EGCG arm than in the placebo arm for itching (P <.001), burning feeling (P =.001), tenderness (P =.002), and pain (P =.03).
Adverse events deemed to be related to EGCG were reported in 4 patients (3.6%): grade 1 pricking skin sensation in 3 patients (2.7%) and pruritis in 1 patient (0.9%). In the control group, 2 patients (3.7%) experienced grade 1 or 2 pricking skin sensation. No reported severe adverse events were considered related to the use of either EGCG or the placebo.
“In this randomized clinical trial, prophylactic use of EGCG solution significantly reduced the incidence and severity of RID in patients with breast cancer receiving adjuvant radiotherapy,” the study investigators concluded in their report. They also suggested the possibility that EGCG may become a standard of skin care with radiotherapy.
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 1, 2022. doi:10.1001/jamadermatol.2022.1736