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


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.

SUBMITTER: Zhong H 

PROVIDER: S-EPMC10173773 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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

Zhong Huijuan H   Cheng Shu S   Zhang Xi X   Xu Bing B   Chen Jiayi J   Jiang Xufeng X   Xiong Jie J   Hu Yu Y   Cui Guohui G   Wei Juying J   Qian Wenbin W   Huang Xiaobing X   Hou Ming M   Yan Feng F   Wang Xin X   Song Yongping Y   Hu Jianda J   Liu Yuanhua Y   Ma Xuejun X   Li Fei F   Wu Chongyang C   Chen Junmin J   Yu Li L   Bai Ou O   Xu Jingyan J   Zhu Zunmin Z   Liu Li L   Zhou Xin X   Huang Li L   Tong Yin Y   Niu Ting T   Wu Depei D   Zhang Hao H   Wang Chaofu C   Ouyang Binshen B   Yi Hongmei H   Song Qi Q   Cai Gang G   Li Biao B   Liu Jia J   Li Zhifeng Z   Xiao Rong R   Wang Luqun L   Jiang Yujie Y   Liu Yanyan Y   Zheng Xiaoyun X   Xu Pengpeng P   Huang Hengye H   Wang Li L   Chen Saijuan S   Zhao Weili W  

Innovation (Cambridge (Mass.)) 20230413 3


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 cent  ...[more]

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