Article record

一项评估表没食子儿茶素没食子酸酯（EGCG）对缓解期鼻咽癌患者EBV再激活影响的随机试验——TCOG T2312研究

A randomized trial to evaluate the effect of epigallocatechin gallate (EGCG) on EBV reactivation in patients with nasopharyngeal carcinoma in remission -the TCOG T2312 study.

临床研究鼻咽癌IF 7.8Q1

文献信息

PMID	42833136
原文	在 PubMed 查看原文 ↗
发表日期	2026
作者	Hui-Jen Tsai 查看其他 19 位作者 Skye Hung-Chun Cheng；Shih-Neng Yang；Hsiao-Hui Tsou；Chin-Fu Hsiao；Yi-Fang Chang；Wen-Shan Liu；Jo-Ting Tsai；Ching-Yun Hsieh；Yu-Chen Tsai；Ming-Hsui Tsai；Jeng-Yuh Ko；Chun-Hung Hua；Lai-Lei Ting；Ming-Yu Lien；Yuan-Hua Wu；Sen-Tien Tsai；Jen-Yang Chen；Jin-Ching Lin；Tsang-Wu Liu
作者单位	National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan; Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Division of Hemato-Oncology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan. 查看其他 16 条单位信息 Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei City, Taiwan; Department of Radiation Oncology, Taitung Christian Hospital, Taitung City, Taitung County, Taiwan.；Department of Biomedical Imaging and Radiological Science, China Medical University, Taichung City, Taiwan.；Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.；Department of Hematology and Oncology, MacKay Memorial Hospital, Taipei, Taiwan.；Department of Radiation Oncology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Medical Education and Research, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.；Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Department of Radiation Oncology, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan.；Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan.；Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei City, Taiwan.；Department of Otorhinolaryngology, China Medical University Hospital, Taichung, Taiwan.；Department of Otolaryngology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.；Department of Radiation Oncology, Taipei Medical University Hospital, Taipei, Taiwan; Department of Radiation Oncology, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.；Department of Radiation Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.；Department of Otolaryngology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.；National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan. Electronic address: cjy@nhri.org.tw.；Institute of Clinical Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan; Department of Radiation Oncology, Changhua Christian Hospital, Changhua, Taiwan. Electronic address: jinchinglin@gmail.com.；National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan. Electronic address: walter@nhri.org.tw.
期刊	European journal of cancer (Oxford, England : 1990)
SCI 分区	Q1
IF	7.8
研究类型	临床研究 · 临床
所属专科	鼻咽癌

中文摘要

背景： 鼻咽癌（NPC）与EB病毒（EBV）感染相关。表没食子儿茶素没食子酸酯（EGCG）是绿茶提取物中的主要有效化合物，可抑制EBV再激活。我们开展了一项随机对照试验，以评估EGCG对治疗后处于缓解状态的NPC患者EBV再激活的影响。
方法： 接受以放疗为基础的治疗并获得完全缓解且血浆EBV DNA结果为阴性的NPC患者，被随机分配接受EGCG或安慰剂治疗3年。定期监测EBV相关抗体和EBV DNA。主要目标为EBV再激活率，次要目标为EGCG的安全性以及EBV再激活与临床结局之间的相关性。
结果： 本研究共纳入353例患者，其中327例可进行进一步分析。在这些患者中，161例和166例分别被随机分配接受EGCG和安慰剂。EGCG的毒性极小且耐受良好。两组之间在EBV DNA再激活或复发率方面未观察到显著差异。血浆EBV DNA阳性与高复发率以及较短的无复发生存期（RFS）和总生存期（OS）显著相关。
结论： 本研究未能证明EGCG能够降低缓解期NPC患者的EBV再激活和肿瘤复发。然而，结果表明EBV DNA是这些患者肿瘤复发、RFS和OS的预后因素。建议将血浆EBV DNA的持续随访作为NPC患者的监测标志物。（NCT01744587）。

英文摘要

BACKGROUND: Nasopharyngeal carcinoma (NPC) is associated with Epstein-Barr virus (EBV) infection. Epigallocatechin gallate (EGCG), a major effective compound in green tea extract, inhibits EBV reactivation. We conducted a randomized controlled trial to evaluate the effects of EGCG on EBV reactivation in posttreatment NPC patients in remission status.
METHODS: Patients with NPC who received radiation-based treatment and who achieved a complete response with negative plasma EBV DNA results were randomized to receive EGCG or placebo for 3 years. EBV-related antibodies and EBV DNA were monitored periodically. The primary objective was the EBV reactivation rate and the secondary objectives were safety of EGCG and correlation between EBV reactivation and clinical outcomes.
RESULTS: A total of 353 patients were included in this study, of whom 327 were evaluable for further analyses. Of these, 161 and 166 patients were randomized to receive EGCG and placebo, respectively. The toxicity of EGCG was minimal and well tolerated. No significant difference was observed in the EBV DNA reactivation or recurrence rate between the two groups. Positive plasma EBV DNA was significantly associated with a high recurrence rate and short recurrence-free survival (RFS) and overall survival (OS) times.
CONCLUSION: This study failed to demonstrate the ability of EGCG to reduce EBV reactivation and tumor recurrence in NPC patients in remission. However, the results showed that EBV DNA is a prognostic factor for tumor recurrence, RFS, and OS in these patients. Continuous follow-up of plasma EBV DNA is suggested as a surveillance marker for patients with NPC. (NCT01744587).