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Etoposide, dexamethasone, and pegaspargase with sandwiched radiotherapy in early-stage natural killer/T-cell lymphoma: A randomized phase III study

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作者：
Zhong Huijuan[1] * ; Cheng Shu[1] * ; Zhang Xi[2] * ; Xu Bing[3] * ; Chen Jiayi[4] ; Jiang Xufeng[5] ; Xiong Jie[1] ; Hu Yu[6] ; Cui Guohui[6] ; Wei Juying[7] ; Qian Wenbin[8] ; Huang Xiaobing[9] ; Hou Ming[10] ; Yan Feng[11] ; Wang Xin[12] ; Song Yongping[13] ; Hu Jianda[14] ; Liu Yuanhua[15] ; Ma Xuejun[16] ; Li Fei[17] ; Wu Chongyang[18] ; Chen Junmin[19] ; Yu Li[20] ; Bai Ou[21] ; Xu Jingyan[22] ; Zhu Zunmin[23] ; Liu Li[24] ; Zhou Xin[25] ; Huang Li[26] ; Tong Yin[27] ; Niu Ting[28] ; Wu Depei[29] ; Zhang Hao[30] ; Wang Chaofu[31] ; Ouyang Binshen[31] ; Yi Hongmei[31] ; Song Qi[32] ; Cai Gang[4] ; Li Biao[5] ; Liu Jia[2] ; Li Zhifeng[3] ; Xiao Rong[9] ; Wang Luqun[10] ; Jiang Yujie[12] ; Liu Yanyan[13] ; Zheng Xiaoyun[14] ; Xu Pengpeng[1] ; Huang Hengye[33] ; Wang Li[1] ; Chen Saijuan[1,34] ; Zhao Weili[1,34] ;
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 200025, China [2]Department of Hematology, Xinqiao Hospital, Chongqing 400037, China [3]Department of Hematology, First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361009, China [4]Department of Radiation Oncology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China [5]Department of Nuclear Medicine, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China [6]Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430022, China [7]Department of Hematology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China [8]Department of Hematology, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China [9]Institute of Hematology, Department of Hematology, Sichuan Provincial People’s Hospital, Chengdu, Sichuan 610072, China [10]Department of Hematology, Shandong Provincial Key Laboratory of Immunohematology, Qilu Hospital, Shandong University, Jinan, Shandong 250012, China [11]Department of Hematology, Third Affiliated Hospital of Suzhou University, First People’s Hospital of Changzhou, Changzhou, Jiangsu 213004, China [12]Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China [13]Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan 450003, China [14]Fujian Institute of Hematology, Fujian Medical University Union Hospital, Fuzhou, Fujian 350401, China [15]Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, Jiangsu 210009, China [16]Department of Medical Oncology, Shanghai Cancer Center, Fudan University, Shanghai 200032, China [17]Department of Hematology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, China [18]Department of Hematology, Second Hospital of Lanzhou University, Lanzhou, Gansu 730030, China [19]Department of Hematology and Rheumatology, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian 350004, China [20]Department of Hematology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330008, China [21]Department of Hematology, First Hospital of Jilin University, Changchun, Jilin 130061, China [22]Department of Hematology, Nanjing Drum Tower Hospital, Nanjing, Jiangsu 210008, China [23]Department of Hematology, Henan Province People’s Hospital, Zhengzhou, Henan 450003, China [24]Department of Hematology, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shanxi 710032, China [25]Department of Hematology, Wuxi People’s Hospital Affiliated to Nanjing Medical University, Wuxi, Jiangsu 214023, China [26]Department of Oncology and Hematology, Hospital Affiliated to Southwest Medical University, Luzhou, Sichuan 646000, China [27]Department of Hematology, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200080, China [28]Department of Hematology, Hematology Research Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [29]First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, China [30]Department of Otolaryngology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China [31]Department of Pathology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China [32]Department of Radiology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China [33]School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China [34]Pôle de Recherches Sino-Français en Science du Vivant et Génomique, Laboratory of Molecular Pathology, Shanghai 200025, China
出处：
DOI： 10.1016/j.xinn.2023.100426
ISSN：

摘要：
Methotrexate, etoposide, dexamethasone, and pegaspargase (MESA) with sandwiched radiotherapy is known to be effective for early-stage extranodal natural killer/T-cell lymphoma, nasal type (NKTCL). We explored the efficacy and safety of reduced-intensity, non-intravenous etoposide, dexamethasone, and pegaspargase (ESA) with sandwiched radiotherapy. This multicenter, randomized, phase III trial enrolled patients aged between 14 and 70 years with newly diagnosed early-stage nasal NKTCL from 27 centers in China. Patients were randomly assigned (1:1) to receive ESA (pegaspargase 2,500 IU/m2 intramuscularly on day 1, etoposide 200 mg orally, and dexamethasone 40 mg orally on days 2-4) or MESA (methotrexate 1 g/m2 intravenously on day 1, etoposide 200 mg orally, and dexamethasone 40 mg orally on days 2-4, and pegaspargase 2,500 IU/m2 intramuscularly on day 5) regimen (four cycles), combined with sandwiched radiotherapy. The primary endpoint was overall response rate (ORR). The non-inferiority margin was -10.0%. From March 16, 2016, to July 17, 2020, 256 patients underwent randomization, and 248 (ESA [n = 125] or MESA [n = 123]) made up the modified intention-to-treat population. The ORR was 88.8% (95% confidence interval [CI], 81.9-93.7) for ESA with sandwiched radiotherapy and 86.2% (95% CI, 78.8-91.7) for MESA with sandwiched radiotherapy, with an absolute rate difference of 2.6% (95% CI, -5.6-10.9), meeting the non-inferiority criteria. Per-protocol and sensitivity analysis supported this result. Adverse events of grade 3 or higher occurred in 42 (33.6%) patients in the ESA arm and 81 (65.9%) in the MESA arm. ESA with sandwiched radiotherapy is an effective, low toxicity, non-intravenous regimen with an outpatient design, and can be considered as a first-line treatment option in newly diagnosed early-stage nasal NKTCL.© 2023 The Authors.

基金：
Multicenter Clinical Research Project by Shanghai Jiao Tong University School of Medicine (DLY201601), the National Key R&D Program of China (2022YFC 2502600), the National Natural Science Foundation of China (82130004, 81830007, 82070204, and 81670176), Chang Jiang Scholars Program, Shanghai Municipal Education Commission Gaofeng Clinical Medicine Grant Support (20152206 and 20152208), the Clinical Research Plan of Shanghai Hospital Development Center (SHDC2020CR1032B), the Collaborative Innovation Center of Systems Biomedicine, and the Samuel Waxman Cancer Research Foundation.
语种：
外文
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中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
最新[2023]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
JCR分区：
出版当年[2023]版：
Q1 MULTIDISCIPLINARY SCIENCES
最新[2023]版：
Q1 MULTIDISCIPLINARY SCIENCES

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

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 200025, China
共同第一作者：
通讯作者：
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 200025, China [34]Pôle de Recherches Sino-Français en Science du Vivant et Génomique, Laboratory of Molecular Pathology, Shanghai 200025, China
推荐引用方式(GB/T 7714)：
Zhong Huijuan,Cheng Shu,Zhang Xi,et al.Etoposide, dexamethasone, and pegaspargase with sandwiched radiotherapy in early-stage natural killer/T-cell lymphoma: A randomized phase III study[J].INNOVATION.2023,4(3):doi:10.1016/j.xinn.2023.100426.
APA：
Zhong Huijuan,Cheng Shu,Zhang Xi,Xu Bing,Chen Jiayi...&Zhao Weili.(2023).Etoposide, dexamethasone, and pegaspargase with sandwiched radiotherapy in early-stage natural killer/T-cell lymphoma: A randomized phase III study.INNOVATION,4,(3)
MLA：
Zhong Huijuan,et al."Etoposide, dexamethasone, and pegaspargase with sandwiched radiotherapy in early-stage natural killer/T-cell lymphoma: A randomized phase III study".INNOVATION 4..3(2023)

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