Phase I study of topical epigallocatechin-3-gallate (EGCG) in patients with breast cancer receiving adjuvant radiotherapy

Zhao, Hanxi; Zhu, Wei; Li, Jia; Sun, Xuejun; Chen, Guanxuan; Zhao, Xianguang; Li, Xin; Meng, Xiangjiao; Kong, Lingling; Xing, Ligang; Yu, Jinming

doi:10.1259/bjr.20150665

Cited by 72 publications

(54 citation statements)

References 41 publications

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“…In our study, no Grade 3-4 dermatitis was found in patients who received the EGCG therapy, and most patients only suffered Grade 1 toxicity, even though they received the same radiation dose. Moreover, EGCG was well tolerated by patients, as we have previously demonstrated in phase I study [8]. The current study provides the clinical evidence for topical EGCG treatment to minimize radiation dermatitis.…”

Section: Discussionsupporting

confidence: 71%

“…Our previous phase I trial also demonstrated that symptoms of radiation-induced dermatitis were alleviated in most patients receiving EGCG (24 patients, 40-660 μmol/L), even during continued RT treatment [8]. Therefore, the efficacy of EGCG for treating radiation dermatitis warranted systematic studies.…”

Section: Discussionmentioning

confidence: 99%

“…The EGCG dose of 660 μmol/L (purity≥95% by HPLC; from NINGBO HEP Biotech Co., Ltd) was chosen based on our previous study [8]. The solution was sprayed by the same investigator three times a day at 0.05 ml/cm 2 to the whole radiation field for two weeks after radiation completion.…”

Section: Methodsmentioning

confidence: 99%

“…Our recent phase I study has demonstrated that the topical administration of EGCG is safe, and that the recommended concentration is 660 μmol/L during skin radiation [8]. In this prospective study, we carried out a single-institution phase II trial to assess the effectiveness of EGCG as a topical agent for ARST, and to evaluate the radiation-induced dermatitis outcomes in women who underwent adjuvant radiotherapy (RT) for breast cancer.…”

Section: Introductionmentioning

confidence: 99%

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Epigallocatechin-3-gallate ameliorates radiation-induced acute skin damage in breast cancer patients undergoing adjuvant radiotherapy

Zhu

Chen³

et al. 2016

Oncotarget

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There are few effective treatment options for radiation-induced dermatitis in breast cancer patients. We conducted a single-arm trial to tested the hypothesis that topical epigallocatechin-3-gallate (EGCG) is effective against radiation-induced dermatitis in breast cancer patients undergoing radiotherapy. Forty-nine patients participated in this study. The patients underwent mastectomy followed by adjuvant radiotherapy. Topical EGCG was applied daily, starting when grade I dermatitis appeared and ending two weeks after radiotherapy. The maximum dermatitis observed during the EGCG treatment was as follows: Grade 1 toxicity, 71.4% (35 patients); grade 2 toxicity, 28.6% (14 patients); there were no patients with grade 3 or 4 toxicity. The majority of the radiation-induced dermatitis was observed 1 week after the end of radiotherapy. EGCG reduced the pain in 85.7% of patients, burning-feeling in 89.8%, itching in 87.8%, pulling in 71.4%, and tenderness in 79.6%. These findings suggest topical EGCG may be an effective treatment for radiation-induced dermatitis and has acceptable toxicity.

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Section: Discussionsupporting

confidence: 71%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Epigallocatechin-3-gallate ameliorates radiation-induced acute skin damage in breast cancer patients undergoing adjuvant radiotherapy

Zhu

Chen³

et al. 2016

Oncotarget

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“…One reason might be due to their obvious antioxidant activities, which might contribute to decreasing the level of oxidative stress before or during treatment . Also, the potential antioxidant activities might assist them to have better biological and radioprotective effects for normal cells . Another reason might be their abilities to inhibit EBV lytic reactivation and enhance the efficiency of radiation .…”

Section: Preventive and Therapeutic Implicationsmentioning

confidence: 99%

The role of oxidative stress in EBV lytic reactivation, radioresistance and the potential preventive and therapeutic implications

Luo

et al. 2017

Intl Journal of Cancer

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Epstein-Barr virus (EBV) is an important cancer causing virus. Cancer associated with EBV account for approximately 1.5% of all cancers, and represent 1.8% of all cancer deaths worldwide. EBV reactivation plays an important role in the development of EBV-related diseases and is closely related with patients' survival and clinical stages of EBV-related cancers. The therapy regarding to EBV-related cancers is very urgent, especially in endemic areas. Generating oxidative stress is a critical mechanism by which host cells defend against infection by virus. In addition, ROS-mediated oxidative stress plays a significant but paradoxical role acting as a "double-edged sword" to regulate cellular response to radiation, which is the main therapy strategy for EBV-related cancers, especially nasopharyngeal carcinoma. Therefore, in this review we primarily discuss the possible interplay among the oxidative stress, EBV lytic reactivation and radioresistance. Understanding the role of oxidative stress in EBV lytic reactivation and radioresistance will assist in the development of effective strategies for prevention and treatment of EBV-related cancers.

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Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy

et al. 2022

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IMPORTANCE Safe and effective prophylactic therapies for radiation-induced dermatitis (RID) remain an unmet need.OBJECTIVE To determine if epigallocatechin-3-gallate (EGCG) solution reduces the incidence of RID in patients undergoing radiotherapy after breast cancer surgery. DESIGN, SETTING, AND PARTICIPANTSThis phase 2 double-blind, placebo-controlled randomized clinical trial enrolled 180 patients with breast cancer receiving postoperative radiotherapy at Shandong Cancer Hospital and Institute in Shandong, China, between November 2014 and June 2019. Data analysis was performed from September 2019 to January 2020.INTERVENTIONS Participants were randomly assigned (2:1) to receive either EGCG solution (660 μmol/L) or placebo (0.9% NaCl saline) sprayed to the whole radiation field from day 1 of the radiation until 2 weeks after radiation completion. MAIN OUTCOMES AND MEASURESThe primary end point was incidence of grade 2 or worse RID, defined by the Radiation Therapy Oncology Group scale. The secondary end points included RID index (RIDI), symptom index, changes in the skin temperature measured by infrared thermal images, and safety.RESULTS A total of 180 eligible patients were enrolled, of whom 165 (EGCG, n = 111; placebo, n = 54) were evaluable for efficacy (median [range] age, 46 [26-67] years). The occurrence of grade 2 or worse RID was significantly lower (50.5%; 95% CI, 41.2%-59.8%) in the EGCG group than in the placebo group (72.2%; 95% CI, 60.3%-84.1%) (P = .008). The mean RIDI in the EGCG group was significantly lower than that in the placebo group. Furthermore, symptom indexes were significantly lower in patients receiving EGCG. Four patients (3.6%) had adverse events related to the EGCG treatment, including grade 1 pricking skin sensation (3 [2.7%]) and pruritus (1 [0.9%]). CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, prophylactic use of EGCG solution significantly reduced the incidence and severity of RID in patients receiving adjuvant radiotherapy for breast cancer. It has the potential to become a new choice of skin care for patients receiving radiotherapy.

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Phase I study of topical epigallocatechin-3-gallate (EGCG) in patients with breast cancer receiving adjuvant radiotherapy

Cited by 72 publications

References 41 publications

Epigallocatechin-3-gallate ameliorates radiation-induced acute skin damage in breast cancer patients undergoing adjuvant radiotherapy

Epigallocatechin-3-gallate ameliorates radiation-induced acute skin damage in breast cancer patients undergoing adjuvant radiotherapy

The role of oxidative stress in EBV lytic reactivation, radioresistance and the potential preventive and therapeutic implications

Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy

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