ArticleNeuro-oncology advances
Three-year follow-up analysis of phase 1/2 study on tirabrutinib in patients with relapsed or refractory primary central nervous system lymphoma.
Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Invasive fungal infections after Bruton tyrosine kinase inhibitor treatment: a systematic review and meta-analysis.Blood advances · 2026Pooled it
- A multicenter randomized phase II/III trial of salvage treatment for refractory primary central nervous system lymphoma using tirabrutinib: JCOG2314 (ReSTART).Japanese journal of clinical oncology · 2026Trial
- Phase II Trial of an Orelabrutinib-Based Combination Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma.Blood and lymphatic cancer : targets and therapy · 2025Trial
- Timing of autologous stem cell transplantation and induction response in central nervous system lymphoma.International journal of hematology · 2026Article
- Genetic orchestration of the primary central nervous system lymphoma microenvironment.Biomarker research · 2026Review
- Primary central nervous system lymphoma in the molecular era: genomic drivers, liquid biopsy, and targeted therapeutic strategies.Annals of hematology · 2026Review
- Unraveling the immune microenvironment in primary CNS lymphoma.Biomarker research · 2026Review
- Nationwide Incidence, Treatment Pattern, and Prognosis of Primary CNS Lymphoma in Taiwan, 2012-2020: A Retrospective Cohort Study.Cancer medicine · 2026Article
- Cardiovascular Safety of Bruton Tyrosine Kinase Inhibitors: From Ibrutinib to Next-Generation Agents.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026Review
- Recent advances in understanding and management of intravascular large B-cell lymphoma.Japanese journal of clinical oncology · 2025Review
- Acalabrutinib May Offer a New Therapeutic Approach for Consolidation and Maintenance of Primary CNS Lymphoma with Expression of MYD88 and CD79B Gene Variants: A Case Report and Literature Review of Primary CNS Lymphoma in the BTKi Era.International journal of molecular sciences · 2025Review
- Next-generation Bruton tyrosine kinase inhibitors and degraders in the treatment of B-cell malignancies: advances and challenges.Annals of hematology · 2025Review
- Post-marketing surveillance of tirabrutinib in 189 patients with r/r primary central nervous system lymphoma.Future oncology (London, England) · 2025Observational
- Comprehensive Characterization of Bruton's Tyrosine Kinase Inhibitor Specificity, Potency, and Biological Effects: Insights into Covalent and Noncovalent Mechanistic Signatures.ACS pharmacology & translational science · 2025Review
- Tirabrutinib for CNS relapsed primary vitreoretinal lymphoma.Annals of hematology · 2025Article
- Novel Therapies in Primary Central Nervous System Lymphoma.Clinical pharmacology : advances and applications · 2025Review
- Advances in primary large B-cell lymphoma of immune-privileged sites.Frontiers in immunology · 2025Review
- A Durable Remission Following Pseudo-Progression in Tirabrutinib Treatment for Relapsed Primary Central Nervous System Lymphoma: A Case Study.Case reports in hematology · 2025Article
- BTK inhibitors: past, present, and future.Trends in pharmacological sciences · 2024Review
- Lack of Apparent Neurotoxicity in Older Patients with Primary Central Nervous System Lymphoma Receiving Long-term Tirabrutinib: Report of 2 Cases.NMC case report journal · 2024Article
Corrections and comments
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Authors and funding
12 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The ONO-4059-02 phase 1/2 study showed favorable efficacy and acceptable safety profile of tirabrutinib, a second-generation Bruton's tyrosine kinase inhibitor, for relapsed/refractory primary central nervous system lymphoma (PCNSL). Here, we report the long-term efficacy and safety after a 3-year follow-up. Methods: Eligible patients were aged ≥ 20 years with histologically diagnosed PCNSL and KPS of ≥ 70. Patients received oral tirabrutinib once daily at 320 or 480 mg, or 480 mg under fasted conditions. Results: Between October 19, 2017, and June 13, 2019, 44 patients were enrolled: 33 and 9 had relapsed and refractory, respectively. The 320, 480, and 480 mg fasted groups included 20, 7, and 17 patients, respectively. The median follow-up was 37.1 months. The overall response rate was 63.6% (95% CI: 47.8-77.6) with complete response (CR), unconfirmed CR, and partial response in 9, 7, and 12 patients, respectively. The median duration of response (DOR) was 9.2 months, with a DOR rate of 19.8%; the median progression-free survival (PFS) and median overall survival (OS) were 2.9 months and not reached, respectively, with PFS and OS rates of 13.9% and 56.7%, respectively. Adverse events occurred in 38 patients (86.4%): grade ≥ 3 in 23 (52.3%) including 1 patient with grade 5 events. KPS and quality of life (QoL) scores were well maintained among patients receiving long-term treatment. Conclusions: The results demonstrated the long-term clinical benefit of tirabrutinib, with deep and durable response in a subset of patients and acceptable safety profile, while KPS and QoL scores were maintained.
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