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Background <p>Primary central nervous system lymphoma (PCNSL) is a rare and aggressive lymphoma subtype. Orelabrutinib (O), a novel and potent second-generation Bruton tyrosine kinase inhibitor, has shown impressive efficacy in PCNSL. This study aimed to evaluate the effectiveness and safety of the O-based regimen in the treatment of intensive chemotherapy-unfit patients with newly diagnosed PCNSL.</p> Methods <p>In this single-center, retrospective case series, we consecutively included 10 patients with PCNSL who were unfit for intensive chemotherapy, defined as an Eastern Cooperative Oncology Group performance status score of ≥ 3, a Karnofsky Performance Status score of ≤ 70, or a Sequential Organ Failure Assessment score of ≥ 2. All patients received the O-based regimen, including the combination of O, rituximab (R), and temozolomide (T; ORT), with or without methotrexate (M) or cytarabine (A; ORT-M/A), followed by ORT maintenance. The effectiveness outcomes were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).</p> Results <p>Following ORT-M/A treatment, six patients achieved a complete response (60.0% [95% CI 26.2–87.8]) and four achieved a partial response, yielding an ORR of 100.0% (95% CI 69.2–100.0). As of the data cutoff (September 7, 2025), the median follow-up of 23.7&#xa0;months (range, 9.2–40.2). The corresponding 24-month PFS rate and 36-month OS rate were 80.0% (95% CI 51.6–100.0) and 90.0% (95% CI 73.2–100.0), respectively. The most common grade 3–4 treatment-related adverse events (AEs) were thrombocytopenia (100.0%) and leukopenia (90.0%). No serious AEs or treatment-related&#xa0;deaths were observed.</p> Conclusion <p>The ORT-M/A chemotherapy regimen was efficacious and well-tolerated in our patients with PCNSL. This retrospective study provided a potential therapeutic strategy for PCNSL patients who are unfit for intensive chemotherapy and warrant further investigation.</p>

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Effectiveness and safety of orelabrutinib combined with rituximab, temozolomide, methotrexate, and cytarabine in intensive chemotherapy-unfit patients with PCNSL in China

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月11日

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  • Zhigang Fang,
  • Fenfen He,
  • Jin Gong,
  • Jia Liu,
  • Xiaozhen Wang,
  • Hongyan Ling,
  • Jiajun Liu,
  • Zhengzhi Zou,
  • Chaofeng Liang,
  • Lingling Liu

摘要

Background

Primary central nervous system lymphoma (PCNSL) is a rare and aggressive lymphoma subtype. Orelabrutinib (O), a novel and potent second-generation Bruton tyrosine kinase inhibitor, has shown impressive efficacy in PCNSL. This study aimed to evaluate the effectiveness and safety of the O-based regimen in the treatment of intensive chemotherapy-unfit patients with newly diagnosed PCNSL.

Methods

In this single-center, retrospective case series, we consecutively included 10 patients with PCNSL who were unfit for intensive chemotherapy, defined as an Eastern Cooperative Oncology Group performance status score of ≥ 3, a Karnofsky Performance Status score of ≤ 70, or a Sequential Organ Failure Assessment score of ≥ 2. All patients received the O-based regimen, including the combination of O, rituximab (R), and temozolomide (T; ORT), with or without methotrexate (M) or cytarabine (A; ORT-M/A), followed by ORT maintenance. The effectiveness outcomes were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).

Results

Following ORT-M/A treatment, six patients achieved a complete response (60.0% [95% CI 26.2–87.8]) and four achieved a partial response, yielding an ORR of 100.0% (95% CI 69.2–100.0). As of the data cutoff (September 7, 2025), the median follow-up of 23.7 months (range, 9.2–40.2). The corresponding 24-month PFS rate and 36-month OS rate were 80.0% (95% CI 51.6–100.0) and 90.0% (95% CI 73.2–100.0), respectively. The most common grade 3–4 treatment-related adverse events (AEs) were thrombocytopenia (100.0%) and leukopenia (90.0%). No serious AEs or treatment-related deaths were observed.

Conclusion

The ORT-M/A chemotherapy regimen was efficacious and well-tolerated in our patients with PCNSL. This retrospective study provided a potential therapeutic strategy for PCNSL patients who are unfit for intensive chemotherapy and warrant further investigation.