文章：

利妥昔单抗、甲氨蝶呤和奥布替尼（R-MO）一线治疗原发性中枢神经系统淋巴瘤的前瞻性II期试验

Prospective phase II trial of first-line rituximab, methotrexate, and orelabrutinib (R-MO) in primary central nervous system lymphoma

原文发布日期：2025-04-29

DOI: 10.1038/s41408-025-01278-w

类型: Article

开放获取: 是

英文摘要：

The treatment of primary central nervous system lymphoma (PCNSL) is currently limited by the impermeability of the blood-brain barrier. This study aims to assess the efficacy and safety of the R-MO regimen (rituximab, high-dose methotrexate, and orelabrutinib) in the treatment of patients with newly diagnosed PCNSL. A total of 37 patients were enrolled in this prospective, multi-center phase II trial. The post-induction overall response rate (ORR) was 90.3%, and the complete response rate (CRR) was 87.1%. Throughout the trial, the best ORR was 97.1%, and the best CRR was 94.1%. With a median follow-up of 12.6 months, the median progression-free survival (PFS) was not reached, with a 1-year PFS rate of 83.6%, meeting the primary study endpoint. The 1-year overall survival rate was 89.6%. Notably, there was no significant difference in PFS between transplanted and non-transplanted groups (P = 0.226). The most common adverse events were neutropenia, lymphocytopenia, and infections, each occurring in 45.9% of patients. Overall, the addition of orelabrutinib to high-dose methotrexate and rituximab in newly diagnosed PCNSL patients has demonstrated promising outcomes and favorable safety profiles, advocating for the use of this combination therapy as a potential frontline treatment option for PCNSL.
 

摘要翻译： 

原发性中枢神经系统淋巴瘤（PCNSL）的治疗目前受限于血脑屏障的渗透性。本研究旨在评估R-MO方案（利妥昔单抗、大剂量甲氨蝶呤及奥布替尼）治疗新诊断PCNSL患者的疗效与安全性。这项前瞻性、多中心II期试验共纳入37例患者。诱导治疗后的总体缓解率（ORR）为90.3%，完全缓解率（CRR）为87.1%。在整个试验期间，最佳ORR达97.1%，最佳CRR达94.1%。中位随访12.6个月后，中位无进展生存期（PFS）尚未达到，1年PFS率为83.6%，达到了研究主要终点。1年总生存率为89.6%。值得注意的是，移植组与非移植组间的PFS无显著差异（P=0.226）。最常见的不良事件为中性粒细胞减少、淋巴细胞减少及感染，发生率均为45.9%。总体而言，在新诊断PCNSL患者的大剂量甲氨蝶呤和利妥昔单抗治疗方案中加入奥布替尼，显示出良好的疗效和安全性，支持该联合方案作为PCNSL潜在一线治疗选择。

原文链接：

Prospective phase II trial of first-line rituximab, methotrexate, and orelabrutinib (R-MO) in primary central nervous system lymphoma