早期结外NK/T细胞淋巴瘤患者P-GemDOx方案疗效和安全性分析以及预后分层探索  

Efficacy and safety analysis of P-GemDOx regimen and stratified prognosis in patients with early extranodal NK/T cell lymphoma

作　　者：邢彤瑶 王韦婷 申浩睿 吴佳竹[1] 尹华 李悦[1] 王莉[1] 梁金花[1] 李建勇[1] 徐卫[1] Xing Tongyao;Wang Weiting;Shen Haorui;Wu Jiazhu;Yin Hua;Li Yue;Wang Li;Liang Jinhua;Li Jianyong;XuWei(Department of Hematology,the First Affiliated Hospital of Nanjing Medical University(Jiangsu Province Hospital),Nanjing 210029,China)

机构地区：[1]南京医科大学第一附属医院(江苏省人民医院)血液科,南京210029

出　　处：《中华血液学杂志》2024年第2期163-169,共7页Chinese Journal of Hematology

基　　金：国家自然科学基金(82200887、82370194);江苏省科技厅项目(BK20220716);中国博士后科学基金(2022M711404、2023M741463)。

摘　　要：目的探讨P-GemDOx方案一线治疗早期结外NK/T细胞淋巴瘤(ENKTL)患者的有效性、安全性以及相关预后因素。方法回顾性分析2015年8月至2021年5月南京医科大学第一附属医院血液科收治的60例使用P-GemDOx方案治疗的早期初诊ENKTL患者的临床资料,使用χ^(2)检验及Fisher确切概率法比较组间临床特征的差异,使用Log-rank检验比较组间生存差异,进行生存和预后因素分析。结果60例患者在完成4~6个周期P-GemDOx方案治疗后,总缓解率(ORR)为88.3%,46例(76.7%)获得完全缓解(CR)。4年的无进展生存(PFS)率和总生存(OS)率分别为(66.3±7.1)%和(79.5±6.0)%。根据PINK/PINKE预后评分系统进行分组,各组间PFS和OS差异均无统计学意义。23.3%的患者24个月内出现疾病进展(POD<24),POD<24组(14例)和24个月内未出现疾病进展(POD≥24)组(46例)的OS期差异有统计学意义(P<0.001)。分析POD<24的危险因素,并在此基础上建立了预测POD<24的国际预后指数(POD24-IPI)预后分层模型(诊断时PET-CT检查存在病灶最大标准摄取值>12.8,1分;非单个鼻腔浸润,1分;4~6个周期治疗后疗效评估未达CR,1分;低危组,0分;中危组,1分;高危组,2~3分),低危、中、高危组4年OS率分别为100%、(85.6±9.7)%、(65.0±10.2)%(P=0.014)。此外,P-GemDOx化疗方案临床应用的总体耐受良好,主要不良反应是血液学毒性。结论在早期ENKTL患者中,P-GemDOx方案是一个安全且有效的一线治疗方案;POD24-IPI是一个良好的风险分层模型。Objective To assess the efficacy,safety,and related prognostic factors associated with the P-GemDOx regimen as a first-line treatment for patients with early-stage extranodal natural killer(NK)/T cell lymphoma(ENKTL).Methods A retrospective analysis was performed on sixty early-stage ENKTL patients treated with the P-GemDOx regimen who were admitted to the First Affiliated Hospital of Nanjing Medical University between August 2015 and May 2021.The Chi-square test or Fisher's exact test was used to compare group differences,and the Log-rank test was used to compare the differences in survival.Survival outcomes and prognostic factors were examined.Results After completing 4 to 6 cycles of P-GemDOx chemotherapy,the overall response rate(ORR)was 88.3%,with forty-six patients(76.7%)achieving complete response(CR).The 4-year progression-free survival(PFS)and overall survival(OS)rates were(66.3±7.1)%and(79.5±6.0)%,respectively.According to the PINK/PINK-E experienced progression of disease within 24 months(POD<24).OS estimates differed significantiy(P<0.001)between the POD<24 group(n=14)and the POD≥24 group(n=46).Analysis showed that SUVmax>12.8 at diagnosis,non-single nasal cavity infiltration,and response less than CR after 4-6 cycles all had a significant association with POD24.We used these data as the basis for predicting POD<24 international prognostic index(POD24-IPI).Patients were stratified into low-risk(no risk factors),intermediate-risk(one risk factor),or high risk(two or three risk factors).These groups were associated with 4-year OS rate of 100%,(85.6±9.7)%,and(65.0±10.2)%,respectively(P=0.014),The P-GemDOx regimen was well tolerated,with hematological toxicity being the main side effect.Conclusion This study demonstrated that the P-GemDOx regimen is effective and safe in the first-line treatment of early-stage ENKTL,and POD24-IPI is a promising prognostic model.

关 键 词：淋巴瘤 结外NK-T细胞 培门冬酶 预后 生存 

分 类 号：R733.1[医药卫生—肿瘤]