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奥雷巴替尼联合R-CHOP方案治疗初诊高危伴结外受累非生发中心型弥漫大B细胞淋巴瘤的临床研究

[Clinical study of orelabrutinib combined with R-CHOP regimen for newly diagnosed high-risk non-GCB diffuse large B-cell lymphoma with extranodal involvement].

作者信息

Guo B P, Wang M Y, Liao C C, Zhou D, Ke Q, Li Z, Cen H

机构信息

Department of Hematology, Guangxi Medical University Cancer Hospital, Nanning 530021, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2025 Feb 14;46(2):169-173. doi: 10.3760/cma.j.cn121090-20240914-00347.

DOI:10.3760/cma.j.cn121090-20240914-00347
PMID:40134200
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11951224/
Abstract

To explore the efficacy and safety of orelabrutinib combined with R-CHOP in patients with high-risk nongerminal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL) with extranodal involvement. This retrospective study was conducted on 35 patients who were seen at Guangxi Medical University Cancer Hospital and were immunohistochemically confirmed to have non-GCB DLBCL, had an International Prognostic Index score of 3 - 5, and confirmed to have ≥2 extranodal involvement on PET/CT. The treatment comprised the standard R-CHOP regimen combined with oral orelabrutinib (150 mg/day) for six cycles. In patients who developed neutropenia or grade 3 neutropenia with fever during treatment, administration of prophylactic pegylated granulocyte colony-stimulating factor 48 h after the end of chemotherapy was started on the next cycle. The endpoints included overall response rate (ORR), complete response (CR) rate, progression-free survival (PFS) time, overall survival (OS) time, and safety assessment. The 35 eligible patients enrolled had a median age of 53 years (21 - 72 years) and a median follow-up time of 28 months (12 - 36 months) ; 19 patients had double-expressor (DE) status. The ORR was 88.6%, and the CR rate was 68.6%. The 2-year PFS and OS rates were 68.6% (95% 54.0% - 7.2%) and 87.5% (95% 76.7% - 100%), respectively. The 2-year PFS rate was significantly lower in patients with DE status than in those without DE status [54.4% (95% 35.4% - 84.2%) . 85.2% (95% 68.3% - 100%), =0.048]. Serious adverse events included febrile neutropenia, pneumonia, and atrial flutter, but no treatment-related deaths. In patients with high-risk non-GCB DLBCL and extranodal involvement, the combination of orelabrutinib with R-CHOP regimen had good efficacy and manageable toxicity.

摘要

探讨奥布替尼联合R-CHOP方案治疗高危非生发中心B细胞(non-GCB)弥漫性大B细胞淋巴瘤(DLBCL)伴结外受累患者的疗效和安全性。本回顾性研究纳入了35例在广西医科大学附属肿瘤医院就诊的患者,这些患者经免疫组织化学确诊为non-GCB DLBCL,国际预后指数评分为3-5分,且PET/CT证实有≥2处结外受累。治疗方案为标准R-CHOP方案联合口服奥布替尼(150 mg/天),共6个周期。对于治疗期间出现中性粒细胞减少或3级中性粒细胞减少伴发热的患者,在下一周期化疗结束后48小时开始给予预防性聚乙二醇化粒细胞集落刺激因子。观察终点包括总缓解率(ORR)、完全缓解(CR)率、无进展生存期(PFS)、总生存期(OS)以及安全性评估。35例符合条件的患者中位年龄为53岁(21-72岁),中位随访时间为28个月(12-36个月);19例患者为双表达(DE)状态。ORR为88.6%,CR率为68.6%。2年PFS率和OS率分别为68.6%(95%CI 54.0%-87.2%)和87.5%(95%CI 76.7%-100%)。DE状态患者的2年PFS率显著低于非DE状态患者[54.4%(95%CI 35.4%-84.2%)对85.2%(95%CI 68.3%-100%),P=0.048]。严重不良事件包括发热性中性粒细胞减少、肺炎和心房扑动,但无治疗相关死亡。对于高危non-GCB DLBCL伴结外受累患者,奥布替尼联合R-CHOP方案疗效良好且毒性可控。

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