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Comparative efficacy and toxicity of Axicabtagene Ciloleucel versus Tisagenlecleucel in European patients with large B-cell lymphoma: a systematic review and meta-analysis

evidence-based-medicine
hematology
immunology
internal-medicine
oncology

Abstract

Background and Objective: Axicabtagene ciloleucel (Axi-cel) and Tisagenlecleucel (Tisa-cel) represent the two most established chimeric antigen receptor T-cell (CAR-T) therapies for large B-cell lymphoma (LBCL). However, systematic evaluation comparing their efficacy and safety in European populations remains lacking. This systematic review and meta-analysis aims to comprehensively assess differences in treatment effectiveness and adverse reactions between Axi-cel and Tisa-cel for European LBCL patients.
Materials and Methods: We searched multiple databases for literature published between January 2020 and August 2025, including PubMed、MEDLINE、Google Scholar、Cochrane Library Together with the clinical trial registry, a total of 8 cohort studies from European countries were included, involving 2178 patients. Efficacy and survival outcomes included 3-month overall response (OR), 3-month complete remission (CR), 12-month progression-free survival (PFS), and 12-month overall survival (OS). Toxicity and adverse reaction outcomes encompassed 12-month non-relapse mortality (NRM), all-grade cytokine release syndrome (CRS), grade≥3 CRS, all-grade immune effector cell-associated neurotoxicity syndrome (ICANS), grade≥3 ICANS, all-grade neutropenia, grade≥3 neutropenia, all-grade thrombocytopenia, grade≥3 thrombocytopenia, all-grade anemia, grade≥3 anemia, Tocilizumab use, and ICU support. Meta-analysis was performed using random-effects models, with sensitivity analysis based on heterogeneity.
Results: Regarding efficacy, Axi-cel demonstrated higher 3-month OR and CR rates compared to Tisa-cel, but showed lower 12-month PFS rates. For toxicity, Axi-cel exhibited significantly higher incidences of all-grade CRS, all-grade ICANS, and grade≥3 ICANS, with more frequent Tocilizumab use. Other parameters showed no statistical differences.
Conclusion: For European LBCL patients, Axi-cel provides superior short-term efficacy compared to Tisa-cel but shows inferior intermediate-term outcomes with greater toxicity, potentially requiring more healthcare resources. Clinical CAR-T selection should integrate individual patient factors with comprehensive consideration of efficacy, toxicity, and cost-effectiveness.
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