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Background <p>Primary central nervous system lymphoma (PCNSL) is a rare, aggressive malignancy presenting significant therapeutic challenges. Optimal maintenance therapy following initial remission remained debated. </p> Methods <p>We conducted a multicentre, real-world study comparing BTK inhibitors (BTKi, <i>n</i> = 23) versus lenalidomide (<i>n</i> = 48) as maintenance in 71 newly diagnosed PCNSL patients in remission. </p> Results <p>With a median follow-up of 41.2 months, median overall survival (OS) and progression-free survival (PFS) remained unachieved for the total cohort. BTKi maintenance was associated with significantly superior PFS compared with lenalidomide (not achieved vs. 61.0 months; <i>p</i> = 0.016), with a substantially higher 6-year PFS rate (91.3% [95% CI: 69.5–97.7%] vs. 41.5% [95% CI: 23.8–58.4%], <i>P</i> &lt; 0.001). This benefit was confirmed as an independent favourable prognostic factor in multivariate analysis (HR = 0.22, 95% CI: 0.05–0.87; <i>P</i> = 0.036). While PFS differed significantly, OS was comparable between the two groups. It is notable that 86.4% of patients who relapsed during lenalidomide maintenance transitioned to BTKi-based regimens, achieving a substantial second-line PFS (median 20.5 months). Furthermore, BTKi benefit was stable regardless of maintenance duration. In contrast, lenalidomide maintenance showed significant heterogeneity: optimal cutoffs for duration were identified separately for PFS (21.3 months) and OS (6.3 months). No treatment-related deaths occurred. </p> Conclusion <p>These data suggest that BTKi maintenance is a highly effective strategy for newly diagnosed PCNSL, offering prolonged progression-free survival compared with lenalidomide. The significant efficacy of BTKi in both first-line maintenance and second-line salvage settings provides a preliminary basis for re-evaluating current treatment paradigms, pending confirmation by prospective trials.</p>

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Real-world comparison of BTK inhibitors and lenalidomide as first-line maintenance in primary CNS lymphoma: a multi-center retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月2日

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  • Xiaoli Chang,
  • Zhangyuting He,
  • Huanyuan Wang,
  • Huiying Zhu,
  • Yixian Guo,
  • Dongmei Zou,
  • Zhilian Zhao,
  • Tianbin Song,
  • Ronghua Hu,
  • Jing Ni,
  • Hong Zhao,
  • Wuhan Hui,
  • Zixian Liu,
  • Zhenling Li,
  • Wei Zhang,
  • Daobin Zhou,
  • Yan Zhang,
  • Wanling Sun

摘要

Background

Primary central nervous system lymphoma (PCNSL) is a rare, aggressive malignancy presenting significant therapeutic challenges. Optimal maintenance therapy following initial remission remained debated.

Methods

We conducted a multicentre, real-world study comparing BTK inhibitors (BTKi, n = 23) versus lenalidomide (n = 48) as maintenance in 71 newly diagnosed PCNSL patients in remission.

Results

With a median follow-up of 41.2 months, median overall survival (OS) and progression-free survival (PFS) remained unachieved for the total cohort. BTKi maintenance was associated with significantly superior PFS compared with lenalidomide (not achieved vs. 61.0 months; p = 0.016), with a substantially higher 6-year PFS rate (91.3% [95% CI: 69.5–97.7%] vs. 41.5% [95% CI: 23.8–58.4%], P < 0.001). This benefit was confirmed as an independent favourable prognostic factor in multivariate analysis (HR = 0.22, 95% CI: 0.05–0.87; P = 0.036). While PFS differed significantly, OS was comparable between the two groups. It is notable that 86.4% of patients who relapsed during lenalidomide maintenance transitioned to BTKi-based regimens, achieving a substantial second-line PFS (median 20.5 months). Furthermore, BTKi benefit was stable regardless of maintenance duration. In contrast, lenalidomide maintenance showed significant heterogeneity: optimal cutoffs for duration were identified separately for PFS (21.3 months) and OS (6.3 months). No treatment-related deaths occurred.

Conclusion

These data suggest that BTKi maintenance is a highly effective strategy for newly diagnosed PCNSL, offering prolonged progression-free survival compared with lenalidomide. The significant efficacy of BTKi in both first-line maintenance and second-line salvage settings provides a preliminary basis for re-evaluating current treatment paradigms, pending confirmation by prospective trials.