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利妥昔单抗联合甲氨蝶呤,继以利妥昔单抗联合阿糖胞苷治疗老年原发性中枢神经系统淋巴瘤患者。

Combination of rituximab and methotrexate followed by rituximab and cytarabine in elderly patients with primary central nervous system lymphoma.

机构信息

Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

Br J Haematol. 2024 Nov;205(5):1773-1781. doi: 10.1111/bjh.19659. Epub 2024 Aug 5.

Abstract

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 Treatment was generally well-tolerated as only three patients were withdrawn from the study due to toxicity, and no treatment-related mortality was reported.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.

摘要

原发性中枢神经系统淋巴瘤(PCNSL)新诊断患者的最佳治疗策略尚未确定,尤其是在老年人中。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甲氨蝶呤(MTX)随后联合阿糖胞苷治疗新诊断为 PCNSL 且年龄≥60 岁的患者的疗效和安全性。患者接受大剂量 MTX 联合利妥昔单抗诱导治疗,随后进行两个周期的阿糖胞苷联合利妥昔单抗巩固治疗。主要终点为 2 年无进展生存(PFS)率。共招募了 35 名患者,其中位年龄为 73 岁(范围:60-81 岁)。诱导治疗后,完全缓解和部分缓解(PR)率分别为 56%和 20%。26 名患者继续进行巩固治疗,完全缓解和 PR 率分别为 59%和 9%。中位随访 36.0 个月后,2 年 PFS 率为 58.7%。治疗总体耐受良好,仅 3 名患者因毒性而退出研究,无治疗相关死亡报告。2 年总生存率为 77.9%。本研究可能提示在≥60 岁的 PCNSL 患者中应用大剂量 MTX 联合阿糖胞苷的可行性,以及利妥昔单抗的附加作用。

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