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Dynamic change in Epstein-Barr virus DNA predicts prognosis in early stage natural killer/T-cell lymphoma with pegaspargase-based treatment: long-term follow-up and biomarker analysis from the NHL-004 multicenter randomized study

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机构： [1]Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [2]Department of Radiation Oncology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [3]Clinical Research Institute, Shanghai Jiao Tong University School of Medicine,Shanghai, China [4]Department of Pathology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [5]Department of Radiology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [6]Department of Otolaryngology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [7]Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China [8]Department of Hematology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China [9]Department of Hematology, Xinqiao Hospital, Chongqing, China [10]Department of Hematology, First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China [11]Department of Hematology, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China [12]Institute of Hematology, Department of Hematology, Sichuan Provincial People’s Hospital, Chengdu, Sichuan, China [13]Department of Hematology, Shandong Provincial Key Laboratory of Immunohematology, Qilu Hospital, Shandong University, Jinan, Shandong, China [14]Department of Hematology, Third Affiliated Hospital of Suzhou University, First People’s Hospital of Changzhou, Changzhou, Jiangsu, China [15]Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong, China [16]Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan, China [17]Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, Jiangsu, China [18]Department of Medical Oncology, Shanghai Cancer Center, Fudan University, Shanghai, China [19]Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China [20]Department of Hematology, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, China [21]Department of Hematology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China [22]Department of Hematology, Second Hospital of Lanzhou University, Lanzhou, Gansu, China [23]Department of Hematology and Rheumatology, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China [24]Department of Hematology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China [25]Department of Hematology, First Hospital of Jilin University, Changchun, Jilin, China [26]Department of Hematology, Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China [27]Department of Hematology, Henan Province People’s Hospital, Zhengzhou, Henan, China [28]Department of Hematology, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shanxi, China [29]Department of Hematology, Wuxi People’s Hospital Affiliated to Nanjing Medical University, Wuxi, Jiangsu, China [30]Department of Hematology, Hematology Research Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan, China [31]Department of Hematology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China [32]Department of Hematology, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China [33]First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China [34]Department of Nuclear Medicine, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [35]Department of Hematology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, Fujian, China [36]Pôle de Recherches Sino-Français en Science du Vivant et Génomique, Laboratory of Molecular Pathology, Shanghai, China

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The multi-center randomized phase 3 NHL-004 study compared etoposide, dexamethasone and pegaspargase (ESA) versus methotrexate, etoposide, dexamethasone and pegaspargase (MESA) regimen, combined with sandwiched radiotherapy, in newly diagnosed early-stage nasal natural killer/T-cell lymphoma (NKTCL). Here we report the long-term outcomes (median follow-up, 64 months) and biomarker analysis. 256 eligible patients aged 14-70 years were randomly assigned (1:1) to ESA or MESA arm. The 5-year progression-free survival (PFS) rates were 80.3% and 74.9% in ESA and MESA arms (hazard ratio [HR] = 0.78 [95%CI, 0.46-1.33], p = 0.371), and the 5-year overall survival (OS) rates were 85.1% and 80.9% (HR = 0.74 [95%CI, 0.40-1.37], p = 0.332), respectively. No new safety signals related to treatments were observed. Interim plasma Epstein-Barr virus (EBV) DNA positivity and stable disease/progression disease response were independent predictors of inferior PFS and OS. No prognostic significance was observed according to molecular subtypes. Interim EBV DNA positivity correlated with upregulated chromatin remodeling alterations, immune escape related genes, and decreased infiltrating monocytes/M1 macrophages. With low toxicity, non-intravenous and outpatient design, ESA with sandwiched radiotherapy achieved long-term durable response in patients with newly diagnosed early-stage NKTCL. Dynamic monitoring of plasma EBV DNA provided clinical rationale in future mechanism-based therapy of NKTCL.

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出版当年[2025]版：

大类 | 1 区

医学

小类 | 2 区血液学

最新[2025]版：

大类 | 1 区

医学

小类 | 2 区血液学

第一作者：

第一作者机构： [1]Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

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通讯机构： [1]Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [36]Pôle de Recherches Sino-Français en Science du Vivant et Génomique, Laboratory of Molecular Pathology, Shanghai, China

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