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    2019-11-11


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    Contents lists available at ScienceDirect
    Radiotherapy and Oncology
    Original Article
    A prospective, three-arm, randomized trial of EGCG for preventing radiation-induced esophagitis in lung cancer patients receiving radiotherapy
    Hanxi Zhao a, Li Jia b, Guanxuan Chen c, Xiaolin Li a, Xiangjiao Meng a, Xianguang Zhao a, Ligang Xing a,⇑, Wanqi Zhu a,⇑
    a Department of Radiation Oncology, Shandong Cancer Hospital Affiliated to Shandong University; b Department of Radiation Oncology, Jinan Fourth People’s Hospital; and c Shandong Key Laboratory of Radiation Oncology, Jinan, China
    Article history:
    Keywords:
    EGCG
    Lung cancer
    Acute radiation-induced esophagitis 
    Background and purpose: This trial investigated whether epigallocatechin-3-gallate (EGCG), a radiopro-tector, could be effective in the prevention and treatment of acute radiation-induced esophagitis (ARIE). Methods and materials: This is a phase II study of EGCG combined with chemoradiation in unresectable stage III non-small-cell lung cancer or limited stage small cell lung cancer. Patients were randomized into a prophylactic EGCG group (arm A), a therapeutic EGCG group after the occurrence of esophagitis (arm B) or conventional therapy group (arm C). Esophagitis grades, pain and dysphagia scores were recorded weekly. Adjusted esophagitis index (AEI), pain index (API) and dysphagia index (ADI) were calculated to reflect changes in esophagitis grade, pain score and dysphagia score throughout treatment.
    Results: A total of 83 patients were eligible for toxicity analysis (arm A vs arm B vs arm C: N = 28:27:28). There was no significant difference in the baseline characteristics among three arms of the patients. The difference in the maximum esophagitis grade among three groups was statistically significant (P = 0.004). The maximum ARIE for patients with EGCG was significantly lower than for those with conventional ther-apy. The mean AEI of arm A was lower than that of arm B, while the mean AEI of arm C was the highest (arm A vs arm B, P = 0.028; arm B vs arm C, P = 0.002). Furthermore, API and ADI were significantly lower in patients receiving EGCG than in conventionally treated patients.
    Conclusion: The application of EGCG could effectively alleviate acute radiation esophagitis in advanced lung cancer without obvious side effects. Prophylactic application of EGCG had a slight advantage over therapeutic use in treatment of acute esophagitis.
    Lung cancer (LC), as one of the most common malignant tumors, is the leading cause of cancer-related deaths worldwide [1]. Most patients are diagnosed with locally advanced disease and require sequential or concurrent chemoradiotherapy (CRT) [2]. However, a combination therapy often causes severe adverse events leading to prolonged treatment, unplanned treatment interruptions or ineffective doses. Acute radiation-induced esophagitis (ARIE) is a major non-hematologic toxicity of chemoradiotherapy in patients with stage III non-small cell lung cancer (NSCLC) or limited stage small cell lung cancer (LD-SCLC). ARIE compromises the quality of life of patients and affects the efficacy of anticancer treatment [3]. Indeed, severe ARIE is closely associated with the radiation dose received by a certain volume of esophagus [4]. Novel radia-