伊布替尼联合维奈托克方案治疗复发难治性弥漫大B细胞淋巴瘤的临床研究

Clinical Study of Ibrutinib Combined with Venetoclax Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

目的:探讨伊布替尼联合维奈托克治疗复发难治性弥漫大B细胞淋巴瘤(R/R DLBCL)的临床疗效,并分析影响疗效及预后的因素。方法:回顾性分析2017年8月至2022年7月本院收治的62例R/R DLBCL患者的临床资料,患者均接受伊布替尼联合维奈托克治疗,评估临床疗效及药物安全性,观察患者的临床特征对化疗近期疗效、总生存期(OS)的影响。结果:62例患者的客观缓解率(ORR)为48.39%。病变部位在结外、NCCN-IPI中高危/高危、IPI中高危/高危、进展或复发时间<12个月是影响R/R DLBCL患者化疗近期疗效的危险因素(均P<0.05)。最常见的毒副作用为中性粒细胞减少(75.19%),其中Ⅲ-Ⅳ级中性粒细胞减少的发生率高达52.71%。62例患者1年和2年OS率分别为48.51%和31.56%,中位OS时间为12个月。多因素分析结果显示,化疗后客观缓解[HR=0.080(95%CI:0.028-0.235)]是R/R DLBCL患者OS的保护性因素,NCCN-IPI中高危/高危[HR=4.828(95%CI:1.546-15.080)]是影响R/R DLBCL患者预后的独立危险因素。结论:伊布替尼联合维奈托克可作为R/R DLBCL的有效治疗方案,NCCNIPI可作为预后的评价指标,化疗后客观缓解能使患者获得更好的OS。

Objective:To investigate the clinical efficacy of ibrutinib combined with venetoclax in the treatment of relapsed/refractory diffuse large B-cell lymphoma(R/R DLBCL),and to analyze the factors affecting efficacy and prognosis.Methods:Clinical data of 62 R/R DLBCL patients admitted to our hospital from August 2017 to July 2022 were retrospectively analyzed.All patients were treated with ibrutinib combined with venetoclax.The clinical efficacy and drug safety were evaluated.The effects of clinical features on short-term efficacy and overall survival(OS)were analyzed.Results:The objective response rate(ORR)of 62 patients was 48.39%.The extranodal lesions,intermediate-high/high risk of NCCN-IPI,intermediate-high/high risk of IPI,progression or recurrence time<12 months were the risk factors affecting the short-term efficacy of chemotherapy in R/R DLBCL patients(all P<0.05).The most common adverse effect was neutropenia(75.19%),and the incidence of gradeⅢ-Ⅳneutropenia was 52.71%.The 1-year and 2-year OS rates of 62 patients were 48.51%and 31.56%,respectively,and the median OS time was 12 months.Multivariate analysis showed that objective remission after chemotherapy[HR=0.080(95%CI:0.028--0.235)]was a protective factor for OS in R/R DLBCL patients,and intermediate-high/high risk of NCCN-IPI[HR=4.828(95%CI:1.546-15.080)]was an independent risk factor affecting the prognosis of R/R DL.BCL patients.Conclusion:Ibrutinib combined with venetoclax can be used as an effective treatment regimen for R/R DLBCL,and NCCN-IPI can be used as a prognostic indicator.Objective remission after chemotherapy is beneficial for R/R DLBCL patients to achieve better OS.