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  

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：郭宝平[1] 王明月[1] 廖成成 周达[1] 柯晴[1] 李喆[1] 岑洪[1] Guo Baoping;Wang Mingyue;Liao Chengcheng;Zhou Da;Ke Qing;Li Zhe;Cen Hong(Department of Hematology,Guangxi Medical University Cancer Hospital,Nanning 530021,China)

机构地区：[1]广西医科大学附属肿瘤医院淋巴血液肿瘤科,南宁530021

出　　处：《中华血液学杂志》2025年第2期169-173,共5页Chinese Journal of Hematology

基　　金：广西自然科学基金区域高发疾病研究联合专项资助(2023GXNSFDA026019)。

摘　　要：目的探索奥布替尼与R-CHOP方案联合使用,治疗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(non-GCB DLBCL)患者的疗效与安全性。方法回顾性纳入2021年1月至2022年12月期间广西医科大学附属肿瘤医院淋巴血液肿瘤科收治的DLBCL患者35例。患者为经免疫组化证实、国际预后指数评分为3~5分,且经PET-CT证实存在2处或以上结外受累的non-GCB DLBCL。治疗方案为标准R-CHOP方案联合奥布替尼口服(150 mg/d),完成6个周期治疗。对于治疗中出现中性粒细胞缺乏症或3级中性粒细胞减少伴有发热的患者,下一个周期开始在化疗结束48 h后给予预防性聚乙二醇化粒细胞集落刺激因子治疗。观测终点包括有效率(ORR)、完全缓解(CR)率、无进展生存(PFS)期、总生存(OS)期和安全性评估。结果患者中位年龄53(21~72)岁,中位随访时间为28(12~36)个月,其中19例为双表达患者。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%)。双表达DLBCL患者的2年PFS率低于非双表达患者[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症、肺炎和心房扑动,未观察到治疗相关死亡病例。结论在高危伴有结外受累的non-GCB DLBCL患者中,奥布替尼联合R-CHOP方案治疗显示出较好的疗效和可控的不良反应。ObjectiveTo 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.MethodsThis 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.ResultsThe 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.ConclusionIn patients with high-risk non-GCB DLBCL and extranodal involvement,the combination of orelabrutinib with R-CHOP regimen had good efficacy and manageable toxicity.

关 键 词：淋巴瘤 大B细胞 弥漫性 非生发中心起源 国际预后指数高危 结外病变 奥布替尼 

分 类 号：R733.1[医药卫生—肿瘤]