新诊断的原发性中枢神经系统淋巴瘤（PCNSL）的最佳治疗策略尚未确定，特别是对于老年人。在本研究中，我们进行了一项 II 期研究，以评估利妥昔单抗联合大剂量 MTX，随后利妥昔单抗联合阿糖胞苷对 60 岁以上新诊断 PCNSL 患者的疗效和安全性。患者接受大剂量甲氨蝶呤加利妥昔单抗的诱导治疗，然后接受两个周期的阿糖胞苷加利妥昔单抗的巩固治疗。主要终点是 2 年无进展生存率 (PFS)。总共招募了 35 名患者，中位年龄为 73 岁（范围：60-81 岁）。诱导治疗后，完全缓解（PR）和部分缓解（PR）分别为 56% 和 20%。 26名患者进行了巩固治疗；完成率和 PR 分别为 59% 和 9%。中位随访时间为 36.0 个月后，2 年 PFS 率为 58.7%。治疗总体耐受性良好，只有三名患者因毒性退出研究，并且没有报告与治疗相关的死亡。 2年总生存率为77.9%。目前的研究可能表明对 60 岁以上的 PCNSL 患者给予高剂量 MTX 加阿糖胞苷的可行性以及添加利妥昔单抗的潜在作用。© 2024 英国血液学会和 John Wiley

The optimal treatment strategy for newly diagnosed primary central nervous system lymphoma (PCNSL) has yet to be established, especially in the elderly. In the current study, we conducted a phase II study to evaluate the efficacy and safety of rituximab plus high-dose MTX followed by rituximab plus cytarabine in patients aged ≥60 years newly diagnosed with PCNSL. Patients received an induction treatment of high-dose methotrexate plus rituximab followed by two cycles of a consolidation treatment of cytarabine plus rituximab. The primary end-point was a 2-year progression-free survival (PFS) rate. A total of 35 patients were recruited, and their median age was 73 (range: 60-81). After induction treatment, the complete and partial responses (PRs) were 56% and 20% respectively. Twenty-six patients proceeded to the consolidation treatment; the complete and PRs were 59% and 9% respectively. After a median follow-up duration of 36.0 months, the 2-year PFS rate was 58.7%. Treatment was generally well-tolerated as only three patients were withdrawn from the study due to toxicity, and no treatment-related mortality was reported. The 2-year overall survival rate was 77.9%. The current study may suggest the feasibility of administering high-dose MTX plus cytarabine in PCNSL patients aged ≥60 years and the potential role of additive rituximab.© 2024 British Society for Haematology and John Wiley & Sons Ltd.