Clinical study of orelabrutinib combined with R-CHOP regimen for newly diagnosed high-risk non-GCB diffuse large B-cell lymphoma with extranodal involvement
10.3760/cma.j.cn121090-20240914-00347
- VernacularTitle:奥布替尼联合R-CHOP方案治疗初治高危伴结外累及的非生发中心起源的弥漫大B细胞淋巴瘤的临床研究
- Author:
Baoping GUO
1
;
Mingyue WANG
1
;
Chengcheng LIAO
1
;
Da ZHOU
1
;
Qing KE
1
;
Zhe LI
1
;
Hong CEN
1
Author Information
1. 广西医科大学附属肿瘤医院淋巴血液肿瘤科，南宁 530021
- Publication Type:Journal Article
- Keywords:
Lymphoma, large B-Cell, diffuse;
non-GCB;
High-risk IPI;
Extranodal disease;
Orelabrutinib
- From:
Chinese Journal of Hematology
2025;46(2):169-173
- CountryChina
- Language:Chinese
-
Abstract:
Objective: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.Methods: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.Results: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% CI 54.0% - 7.2%) and 87.5% (95% CI 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% CI 35.4% - 84.2%) vs. 85.2% (95% CI 68.3% - 100%), P=0.048]. Serious adverse events included febrile neutropenia, pneumonia, and atrial flutter, but no treatment-related deaths. Conclusion: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.
