| Etoposide, dexamethasone, and pegaspargase with sandwiched radiotherapy in early-stage natural killer/T-cell lymphoma: A randomized phase III study | |
| 2023-05-15 | |
| Source Publication | Innovation
 |
| ISSN | 2666-6758 |
| Volume | 4Issue:3 |
| Abstract | 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 |
| Keyword | Oncology Sensitivity analysis Adverse events Confidence interval Dexamethasones Etoposide Four cycles Natural killer T cell Non-inferiority Randomisation Response rate T-cell lymphomas |
| Publisher | Cell Press |
| DOI | 10.1016/j.xinn.2023.100426 |
| Indexed By | EI |
| Language | 英语 |
| WOS Research Area | Science & Technology - Other Topics |
| WOS Subject | Multidisciplinary Sciences |
| WOS ID | WOS:001000134800001 |
| EI Accession Number | 20231714024445 |
| EI Keywords | Radiotherapy |
| EI Classification Number | 461.6 Medicine and Pharmacology ; 622.3 Radioactive Material Applications ; 921 Mathematics |
| Original Document Type | Journal article (JA) |
| Citation statistics | |
| Document Type | 期刊论文 |
| Identifier | https://ir.lzu.edu.cn/handle/262010/500782 |
| Collection | 兰州大学 |
| Corresponding Author | Zhao, Weili |
| Affiliation | 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, Fujian, Xiamen; 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, Hubei, Wuhan; 430022, China; 7.Department of Hematology, First Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, Hangzhou; 310003, China; 8.Department of Hematology, Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, Hangzhou; 310009, China; 9.Institute of Hematology, Department of Hematology, Sichuan Provincial People's Hospital, Sichuan, Chengdu; 610072, China; 10.Department of Hematology, Shandong Provincial Key Laboratory of Immunohematology, Qilu Hospital, Shandong University, Shandong, Jinan; 250012, China; 11.Department of Hematology, Third Affiliated Hospital of Suzhou University, First People's Hospital of Changzhou, Jiangsu, Changzhou; 213004, China; 12.Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong, Jinan; 250021, China; 13.Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Henan, Zhengzhou; 450003, China; 14.Fujian Institute of Hematology, Fujian Medical University Union Hospital, Fujian, Fuzhou; 350401, China; 15.Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu, Nanjing; 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, Jiangxi, Nanchang; 330006, China; 18.Department of Hematology, Second Hospital of Lanzhou University, Gansu, Lanzhou; 730030, China; 19.Department of Hematology and Rheumatology, First Affiliated Hospital of Fujian Medical University, Fujian, Fuzhou; 350004, China; 20.Department of Hematology, The Second Affiliated Hospital of Nanchang University, Jiangxi, Nanchang; 330008, China; 21.Department of Hematology, First Hospital of Jilin University, Jilin, Changchun; 130061, China; 22.Department of Hematology, Nanjing Drum Tower Hospital, Jiangsu, Nanjing; 210008, China; 23.Department of Hematology, Henan Province People's Hospital, Henan, Zhengzhou; 450003, China; 24.Department of Hematology, Tangdu Hospital, Fourth Military Medical University, Shanxi, Xi'an; 710032, China; 25.Department of Hematology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Jiangsu, Wuxi; 214023, China; 26.Department of Oncology and Hematology, Hospital Affiliated to Southwest Medical University, Sichuan, Luzhou; 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, Sichuan, Chengdu; 610041, China; 29.First Affiliated Hospital of Soochow University, Jiangsu, Suzhou; 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 |
| Recommended Citation 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). |
| 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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