A prospective, three-arm, randomized trial of EGCG for preventing radiation-induced esophagitis in lung cancer patients receiving radiotherapy

Zhao, Hanxi; Li, Jia; Chen, Guanxuan; Li, Xin; Meng, Xiangjiao; Zhao, Xianguang; Xing, Ligang; Zhu, Wei

doi:10.1016/j.radonc.2019.02.022

Cited by 29 publications

(20 citation statements)

References 33 publications

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“…It has been proved to have a strong protective effect against radiation-induced damages in the normal tissue on the cellular and animal level ( 7 – 9 ). Recently, the anti-irradiation damage activity of EGCG has been preliminarily proved in clinical trials, with our data confirming that the application of plant-derived polyphenol can ameliorate ARIE, radiation mucositis, and radiation dermatitis ( 10 – 16 ). The safety and effectiveness of EGCG make it one of the promising candidates for radioprotection.…”

Section: Introductionsupporting

confidence: 65%

“…A subsequent single-arm study was launched to ensure its efficacy in the treatment of ARIE (15). Our prospective controlled trial NCT02577393 confirmed that EGCG had significantly reduced esophagitis than conventional treatment (mLDG) during chemoradiotherapy for lung cancer, especially when used for prophylaxis (10). The above studies preliminarily proved that EGCG could meet the first three of the mentioned four key requirements.…”

Section: Discussionmentioning

confidence: 78%

“…NCT02577393 study as a three-arm, controlled, randomized, prospective study was conducted to explore the preventive and therapeutic action of EGCG against ARIE in patients with the combination of chemoradiotherapy. The protocol was available at Oncology and Radiotherapy online ( 10 ). EGCG was purchased from NINGBO HEP Biotech Co., Ltd and dissolved in 0.9% saline solution to make the concentration up to 440 umol/L with reference to the results of phase I study ( 16 ).…”

Section: Methodsmentioning

confidence: 99%

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Evaluation of Epigallocatechin-3-Gallate as a Radioprotective Agent During Radiotherapy of Lung Cancer Patients: A 5-Year Survival Analysis of a Phase 2 Study

et al. 2021

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BackgroundPrevious analysis of the study (NCT02577393) had demonstrated the application of epigallocatechin-3-gallate (EGCG) could be safe and effective in the prevention and treatment of acute radiation esophagitis in patients with advanced lung cancer. EGCG seemed to improve the response rate of small cell lung cancer (SCLC) to radiotherapy in a subgroup analysis. This research continued to analyze the impact of EGCG application on cancer-radiation efficacy and patient survival.MethodsAll patients with SCLC in the NCT02577393 study were included. Patients were randomized into EGCG group or conventional therapy group as protocol. The primary endpoints of the study were radiation response rate and progression-free survival (PFS). Overall survival (OS) and the efficacy of EGCG in the treatment of esophagitis were assessed as secondary endpoints.ResultsA total of 83 patients with lung cancer in the NCT02577393 study were screened, and all 38 patients with SCLC were eligible for analysis. No significant differences with regard to baseline demographic and clinical characteristics were observed between the two groups. The objective response rate (ORR) was higher than that of conventionally treated patients (84.6 vs 50%, P = 0.045), while the median PFS and OS were not significantly prolonged. At data cut-off (1 January 2021), 5-year PFS was 33% with EGCG versus 9.3% with conventional treatment, and 5-year OS was 30.3% versus 33.3%, respectively. The mean adjusted esophagitis index and pain index of patients with EGCG application were lower than conventional treatment (5.15 ± 2.75 vs 7.17 ± 1.99, P = 0.030; 8.62 ± 5.04 vs 15.42 ± 5.04, P < 0.001).ConclusionThe study indicates EGCG may alleviate some esophagitis-related indexes in SCLC patients exposed to ionizing radiation without reducing survival. However, this conclusion should be confirmed by further studies with large sample size.

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Section: Introductionsupporting

confidence: 65%

Section: Discussionmentioning

confidence: 78%

Section: Methodsmentioning

confidence: 99%

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Evaluation of Epigallocatechin-3-Gallate as a Radioprotective Agent During Radiotherapy of Lung Cancer Patients: A 5-Year Survival Analysis of a Phase 2 Study

et al. 2021

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“…First, the majority of reports concerning flavonoids in NSCLC were based on results obtained in laboratory animals and data from studies in human subjects are currently lacking. Although a relevant study was recently carried out and proposed that EGCG could alleviate the side effect of acute radiation in lung cancer patients (Zhao, Jia, et al, 2019), this report was restricted to the alleviation of radiotherapy syndrome. More attention should be given to the effects of flavonoids in NSCLC with chemoresistance, especially regarding in vivo tumour proliferation and invasion.…”

Section: Challenges and Perspectivesmentioning

confidence: 99%

Molecular mechanism and pharmacokinetics of flavonoids in the treatment of resistant EGF receptor‐mutated non‐small‐cell lung cancer: A narrative review

Wang

Chen

et al. 2021

British J Pharmacology

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Here, we review the molecular mechanism and pharmacokinetics of flavonoids in the treatment of resistant EGF receptor (EGFR)‐mutated non‐small‐cell lung cancer (NSCLC) and particularly the possible mechanism(s) of delicaflavone, a biflavonoid extracted from Selaginella doederleinii Hieron. EGFR TK inhibitors (EGFR‐TKI) are ubiquitously used in the treatment of NSCLC bearing EGFR mutations. However, patients treated with EGFR‐TKI inevitably and continuously develop resistance. In laboratory studies, flavonoids, as potential adjuvants for cancer chemotherapy, exhibited anti‐cancer properties such as inhibition of chemoresistance by interference with ABC transporters‐induced drug efflux, curbing of c‐MET amplification, or reversal of T790M mutation‐mediated resistance. The current review aims at summarizing the association between the anti‐cancer potentials of flavonoids and their possible regulatory roles in certain types of mutation that could trigger EGFR‐TKI resistance in NSCLC. Potential practical applications of these phytochemicals, as well as the relevant pharmacokinetics, are also discussed.

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“…Es existieren bislang lediglich kleinere Studien zur Prophylaxe einer Strahlenösophagitis mit Radioprotektoren [11] oder anderen zytoprotektiven Präparaten wie Amifostine [2] oder Wachstumsfaktoren wie GMCFS (granulocyte-macrophage colony-stimulating factor) [12].…”

Section: Diskussionunclassified

Therapie einer akuten Strahlenösophagitis mit orodispersiblem Budesonid

Reinshagen

Hoffmann

2020

Z Gastroenterol

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A prospective, three-arm, randomized trial of EGCG for preventing radiation-induced esophagitis in lung cancer patients receiving radiotherapy

Cited by 29 publications

References 33 publications

Evaluation of Epigallocatechin-3-Gallate as a Radioprotective Agent During Radiotherapy of Lung Cancer Patients: A 5-Year Survival Analysis of a Phase 2 Study

Evaluation of Epigallocatechin-3-Gallate as a Radioprotective Agent During Radiotherapy of Lung Cancer Patients: A 5-Year Survival Analysis of a Phase 2 Study

Molecular mechanism and pharmacokinetics of flavonoids in the treatment of resistant EGF receptor‐mutated non‐small‐cell lung cancer: A narrative review

Therapie einer akuten Strahlenösophagitis mit orodispersiblem Budesonid

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