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
邢彤瑶 1王韦婷 1申浩睿 1吴佳竹 1尹华 1李悦 1王莉 1梁金花 1李建勇 1徐卫1
作者信息
- 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
- 折叠
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x2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.
Abstract
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 model,there was no significant difference in survival outcomes among risk groups.23.3％of patients experienced progression of disease within 24 months(POD＜24).OS estimates differed significantly(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Key words
Lymphoma,extranodal NK-T-Cell/Pegaspargase/Prognosis/Survival引用本文复制引用
基金项目
国家自然科学基金(82200887)
国家自然科学基金(82370194)
江苏省科技厅项目(BK20220716)
中国博士后科学基金(2022M711404)
中国博士后科学基金(2023M741463)
出版年
2024
NETL
NSTL
维普
万方数据