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PEMD方案治疗新诊断的早期非上呼吸道消化道或晚期结外自然杀伤/T细胞淋巴瘤的疗效与安全性

[Efficacy and safety of PEMD regimen in newly diagnosed early-stage non-upper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma].

作者信息

Zhang X Y, Du K X, Shen H R, Wu J Z, Li Y, Yin H, Wang L, Liang J H, Li J Y, Xu W

机构信息

The First Affiliated Hospital of Nanjing Medical University (Department of Hematology, Jiangsu Province Hospital), Nanjing 210029, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2025 Feb 14;46(2):147-151. doi: 10.3760/cma.j.cn121090-20241120-00463.

Abstract

To evaluate the efficacy and safety of the pegaspargase, etoposide, methotrexate, and dexamethasone (PEMD) regimen in patients with early-stage nonupper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma (ENKTL) . This retrospective analysis included 38 patients with newly diagnosed early-stage non-upper respiratory digestive tract or advanced ENKTL who received PEMD regimen for induction chemotherapy at the First Affiliated Hospital of Nanjing Medical University from January 2016 to December 2022. Survival outcomes and prognostic factors were examined by Kaplan-Meier, and the Log-rank test was used to compare survival. The study population had a median age of 48 years (range, 26-72 years) and included 30 males (78.9%) and 8 females (21.1%). 7 patients' age >60 years (18.4%). The Eastern Cooperative Oncology Group (ECOG) performance score was >1 in 7 patients (18.4%) ; 20 patients (52.6%) had elevated lactate dehydrogenase levels; and 37 patients (97.4%) exhibited extranodal involvement. Using the Ann Arbor staging system, 37 patients (97.4%) were classified as stage Ⅲ-Ⅳ. The median number of treatment cycles was 5 (1-6), and the median follow-up duration was 60 months (24 - 101 months). Interim efficacy assessment revealed an overall response rate of 52.7%. At 2 and 4 years, the progression-free survival (PFS) rates were 34.2% (95% 22.0%-53.2%) and 25.5% (95% 14.7%-44.4%), respectively, and the overall survival rates were 50.0% (95% 36.4%-68.7%) and 45.5% (95% 31.4%-65.7%), respectively. The risk factors for worse PFS were ECOG performance score >1 [=3.711 (95% 1.494-9.218), =0.005]; bone marrow infiltration [=2.251 (95% 1.026 - 4.938), =0.043]; and Prognostic Index for Natural Killer/T-Cell Lymphoma score of 3 - 5 [=2.350 (95% 1.009 - 5.476), =0.048]. Multivariate analysis identified ECOG performance score >1 as an independent risk factor for PFS [=7.971 (95% 2.222 - 28.591), =0.001]. The main adverse effect was anemia in 31 patients (81.6%) . The PEMD regimen was safe and effective for patients with newly diagnosed early-stage non-upper respiratory digestive tract or advanced ENKTL.

摘要

评估聚乙二醇天冬酰胺酶、依托泊苷、甲氨蝶呤和地塞米松(PEMD)方案在早期非上呼吸道消化道或晚期结外自然杀伤/T细胞淋巴瘤(ENKTL)患者中的疗效和安全性。这项回顾性分析纳入了38例新诊断的早期非上呼吸道消化道或晚期ENKTL患者,这些患者于2016年1月至2022年12月在南京医科大学第一附属医院接受PEMD方案诱导化疗。采用Kaplan-Meier法检查生存结局和预后因素,并用Log-rank检验比较生存率。研究人群的中位年龄为48岁(范围26 - 72岁),包括30例男性(78.9%)和8例女性(21.1%)。7例患者年龄>60岁(18.4%)。东部肿瘤协作组(ECOG)体能状态评分>1的患者有7例(18.4%);20例患者(52.6%)乳酸脱氢酶水平升高;37例患者(97.4%)有结外受累。根据Ann Arbor分期系统,37例患者(97.4%)被分类为Ⅲ - Ⅳ期。治疗周期的中位数为5(1 - 6),中位随访时间为60个月(24 - 101个月)。中期疗效评估显示总缓解率为52.7%。在2年和4年时,无进展生存率(PFS)分别为34.2%(95% 22.0% - 53.2%)和25.5%(95% 14.7% - 44.4%),总生存率分别为50.0%(95% 36.4% - 68.7%)和45.5%(95% 31.4% - 65.7%)。PFS较差的危险因素为ECOG体能状态评分>1[=3.711(95% 1.494 - 9.218),=0.005];骨髓浸润[=2.251(95% 1.026 - 4.938),=0.043];以及自然杀伤/T细胞淋巴瘤预后指数评分为3 - 5[=2.350(95% 1.009 - 5.476),=0.048]。多因素分析确定ECOG体能状态评分>1是PFS的独立危险因素[=7.971(95% 2.222 - 28.591),=0.001]。主要不良反应是31例患者(81.6%)出现贫血。PEMD方案对新诊断的早期非上呼吸道消化道或晚期ENKTL患者安全有效。

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