Objective: To explore the short-term efficacy and adverse reactions of orelabrutinib combined with high-dose methotrexate (HD-MTX) in the first-line treatment of elderly high-risk primary central nervous system lymphoma (PCNSL), as well as the survival of patients.
Methods: Twenty-five elderly patients with high-risk primary central nervous system diffuse large B-cell lymphoma admitted to Fujian Provincial Hospital from June 2016 to June 2022 were enrolled in this study, and complete clinical data from all patients were collected retrospectively, and the cut-off for follow-up was December 2022. 15 patients had received temmozolomide combined with HD-MTX regimen for at least four cycles, sequential lenalidomide maintenance therapy, while 10 patients had received orelabrutinib combined with HD-MTX regimen for at least four cycles, sequential orelabrutinib maintenance therapy. The short-term efficacy and adverse reactions of the two groups of patients after treatment were observed. Kaplan-Meier was used to analyze the progression-free survival (PFS) and time to progression (TTP).
Results: The objective response rate (ORR) and 2-year median FPS of orelabrutinib combined with HD-MTX regimen group were similar to the temozolomide combined with HD-MTX regimen group (ORR: 100% vs 66.7%; 2-year median PFS: 16 months vs 15 months, P>0.05). The 2-year median TTP of the orelabrutinib+HD-MTX regimen group was better than that of the temozolomide+HD-MTX regimen group (not reached vs 12 months, P<0.05). There were no significant differences in adverse reactions such as gastrointestinal reactions, bone marrow suppression, liver and kidney damage, cardiotoxicity, pneumonia and bleeding between these two groups (P>0.05).
Conclusion: For elderly patients with high-risk PCNSL, orelabrutinib combined with HD-MTX has reliable short-term efficacy, good safety, and tolerable adverse reactions, which is worthy of clinical promotion.
题目: 奥布替尼联合大剂量甲氨蝶呤一线治疗老年高危原发中枢神经系统淋巴瘤的近期疗效和安全性评价.
目的: 探讨奥布替尼联合大剂量甲氨蝶呤(high dose methotrexate, HD-MTX) 一线治疗老年高危原发中枢神经系统淋巴瘤的近期疗效和不良反应，并随访生存情况.
方法: 选择2016年6月-2022年6月在福建省立医院初次确诊的原发中枢神经系统弥漫大B细胞淋巴瘤老年高危患者25例，回顾性收集患者的临床资料。随访截止至2022年12月。15例患者接受替莫唑胺联合HD-MTX方案至少4个疗程，序贯来那度胺维持治疗；10例患者接受奥布替尼联合HD-MTX方案至少4个疗程，序贯奥布替尼维持治疗。观察两组患者治疗后近期疗效和不良反应，采用Kaplan-Meier分析无进展生存期(PFS)和肿瘤进展时间（TTP）.
结果: 奥布替尼联合HD-MTX方案组客观有效率(ORR)、2年中位PFS与替莫唑胺联合HD-MTX方案组比较无统计学差异（ORR：100% vs 66.7%； 2年PFS：16个月 vs 15个月，P>0.05），而两组2年中位TTP比较具有统计学差异（未达到 vs 12个月，P<0.05）。两组患者的胃肠反应、骨髓抑制、肝肾功能损伤、心脏毒性、肺炎和出血等不良反应相比较差异均无统计学意义(P>0.05).
结论: 奥布替尼联合HD-MTX并序贯奥布替尼维持治疗初治老年高危PCNSL患者，近期疗效好，安全可靠，值得临床推广.
Keywords: high-risk; orelabrutinib; primary central nervous system lymphoma; safety; short-term efficacy.