기타학회
| Clinical Outcomes of Tisagenlecleucel in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Single Center, Real-World Study | ||
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Introduction Tisagenlecleucel (Kymriah®) is a chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19, and it is the first genetically engineered immune cell therapy approved for clinical use. This study evaluated the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Method This retrospective observational study was conducted at a single institution and included 42 adult patients with r/r DLBCL who received tisagenlecleucel at Asan Medical Center between September 26, 2022, and August 20, 2024. Efficacy endpoints included overall response rate (ORR), complete remission (CR), and progression-free survival (PFS), and survival analyses were performed by using the Kaplan-Meier method. Safety was assessed through analysis of adverse events extracted from electronic medical records and laboratory findings, classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and the Naranjo algorithm.
Results In the overall patient population, the ORR was 47.6% (95% CI: 32.3–62.9), and 40.5% of patients achieved CR. The median PFS was 2.3 months (95% CI: 1.24–3.36), and 3-months PFS probability was 40.5%. Among grade 3–4 adverse events, hematologic toxicities (100%) and hyperglycemia (92.9%) were the most frequently reported. Prolonged cytopenia persisted up to 28 days post-infusion was observed in the form of neutropenia (52.6%), thrombocytopenia (44.7%), and anemia (18.4%). Cytokine release syndrome (CRS) occurred in 37 patients (88.1%), and immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 12 patients (26.2%). The median onset time for any grade CRS and ICANS following tisagenlecleucel administration was 1 days (0-4) and 5 days (1-7), respectively. The Spearman rank correlation coefficient between CRS grade and the incidence of ICANS was 0.471 (p = 0.002). Moreover, higher CRS grades were associated with the incidence of ICANS (odds ratio: 3.35, p = 0.004).
Conclusion These findings contribute real-world evidence regarding the therapeutic efficacy and safety of tisagenlecleucel in Korean adult patients with r/r DLBCL. In particular, the observed association between CRS and ICANS may serve as clinically meaningful data to inform the development of improved protocols for adverse event prevention and management during treatment. |
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