Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: A Nationwide Study

objective response rate is defined as the proportion of subjects who respond either Complete response (CR), Partial response (PR), or unconfirmed Complete response (CRu) to therapy, according to International PCNSL Collaborative Group (IPCG) criteria.

Duration of response is defined as the time from onset of response* to disease progression or death, wichever occurs earlier.

*for patients who achieve complete response (CR), partial response (PR), or unconfirmed complete response (CRu), according to IPCG criteria.

Time-to-treatment response was defined as time from newly started tirabrutinib treatment to the first objective tumor response observed for patients who achieved a complete response (CR), partial response (PR), or unconfirmed complete response (CRu), according to IPCG criteria.

Drug-related adverse events for treatment interruption, dose reduction, and discontinuation of tirabrutinib: febrile neutropenia (grade≥3), thrombocytopenia with hemorrhage (grade 3), neutropenia (grade 4), thrombocytopenia (grade 4), interstitial lung disease (grade≥2), skin disorder (grade≥2), hematotoxicity (grade≥3, other than events described above) and nonhematological toxicity (other than interstitial lung disease and skin disorder, grade≥3) (the grading will be according to CTCAE v5.0.) important identified risks: infection, severe skin disorder, bone marrow depression, hypersensitivity, interstitial lung disease (ILD), hepatic dysfunction, hemorrhage, arrhythmia.

Clinical laboratory tests (hematology, blood biochemistry, urinalysis, etc.) will be summarized with dexcriptive statistics. The change from baseline will be presented also, if possible.

in this study, an AE is defined as any unfavorable or unintended injury/disease or sign (including an abnormal laboratory finding) in a subject administered tirabrutinib, regardless of causality. AE also includes suspected transmission of infectious agents by tirabrutinib. TEAE is defined as an AE that began after the start of tirabrutinib treatment. Concurrent disease at the start of tirabrutinib treatment that has worsened during tirabrutinib treatment for the subject is also included. worsening of the primary disease is not an TEAE. all severity of AEs will be graded according to CTCAE v5.0. All AE that are not considered serious AE are not-serious AE.

overall survival is defined as time from newly started tirabrutinib treatment to death.

Progression-free survival is defined as time from newly started tirabrutinib treatment to either first evidence of progression disease (PD), according to IPCG criteria, or death.

the ECOG performance status scale was developed by the Eastern Cooperative Oncology Group, now the ECOG-ACRIN Cancer Research Group, and published in 1982. From Grade 0 fully active, able to carry on all pre-disease performance without restriction, to Grade 5 Dead. ECOG performance status scale will be listed and summarized by number and percentage by scoring categories.

For the clinical usage and pattern of tirabrutinib, exposure duration and daily dose for tirabrutinib during study period will be listed for each subject and summarized with descriptive statistics.

the premedications for infection and skin-related disorders will be listed and tabulated with number and percentage.