Background and importance Chimeric antigen receptor-T (CAR-T) has demonstrated clinical efficacy in haematologic malignancies but it also has a relevant toxic side effect profile.
Aim and objectives To describe the toxicity and management of CAR-T cell therapies (CARTs) (tisagenlecleucel (Tisa-cel) and axicabtagene ciloleucel (Axi-cel)) in a real world population with haematological malignancies.
Material and methods A retrospective study was conducted in all patients treated with CARTs in our hospital (August 2019 to September 2020). Data collected included age, gender, diagnosis, hospital stay, admission to the intensive care unit (ICU), length of ICU stay and the main adverse events (AE) detected (cytokine release syndrome (CRS), neurological toxicity, hypogammaglobulinaemia, febrile neutropenia and infections) and need for tocilizumab and/or corticosteroids to treat AE. Statistical analysis was performed using SPSS V.21.0.
Results 32 patients were included (53.1% men). Axi-cel was administered to 53.1% of patients, of whom 70.6% had diffuse large B-cell lymphoma (DLBCL) and the remaining had primary mediastinal large B-cell lymphoma (PMBCL). The rest were treated with Tisa-cel; 60.0% had DLBCL and the others had B-cell precursor acute lymphoblastic leukaemia (ALL). Median age in the ALL population was 9 years (6–14) and mean age in patients with DLBCL and PMBCL was 57.7 years (± 8.8). Median hospital stay was 15 days (13–21). Two patients died during admission and one remained admitted at the data cut-off date. 15.6% required admission to the ICU and mean stay was 7 days (±6.1). Two patients presented with mild hypersensitivity reaction during CAR-T cell infusion. 81.3% presented CRS and neurological toxicity occurred in 37.5%. During admission, 78.1% presented with febrile neutropenia and 15.6% had active infections. Hypogammaglobulinaemia was observed in three patients. Tocilizumab and corticosteroids were administered in 21.9% of patients in both cases. CRS and febrile neutropenia rates were similar in patients treated with Tisa-cel and Axi-cel (73.7% vs 88.2% and 80.0% vs 76.5%, respectively). Neurological toxicity was more frequent with Axi-cel (52.9% vs 20%).
Conclusion and relevance CAR-T cell therapy was generally well tolerated with a low rate of severe or life threatening AE. CRS was the most frequent AE and no differences were found between Axi-cel and Tisa-cel. Neurological toxicity rates were similar to those observed in clinical trials with Tisa-cel and lower than with Axi-cel. The need for tocilizumab and/or corticosteroids in Axi-cel patients was lower than in clinical trials.
Conflict of interest No conflict of interest