axicabtagene ciloleucel 与 tisagenlecleucel 在大型 B 细胞淋巴瘤中毒性及结局的多中心真实世界前瞻性研究

This real-world prospective observational study across 21 Italian centers (CART-SIE) compares axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) outcomes in 485 patients with relapsed/refractory large B-cell lymphoma with baseline characteristics matched by stabilized inverse propensity score weighting. Axi-cel versus tisa-cel had higher all-grade cytokine release syndrome (78. 6% vs. 89. 3%, P = 0. 0017) and neurotoxicity (9. 9% vs. 32. 2%, P < 0. 0001) but also superior progression-free survival (PFS) at 1 year (46.

5% vs. 34. 1%, P = 0. 0009). Even among patients who failed bridging therapy, axi-cel PFS was superior to tisa-cel (37. 5% vs. 22. 7%, P = 0. 0059). Differences in overall survival and high-grade immune toxicities were not significant. The CAR-HEMATOTOX score not only predicted hematologic toxicity but also 1-year survival outcomes (51. 5% in CAR-HEMATOTOX high vs. 77. 2% in CAR-HEMATOTOX low, P < 0. 0001). Twenty patients developed second primary malignancies, including two cases of T-cell neoplasms.

These findings enable more informed selection of anti-CD19 CAR T-cell therapy, balancing bridging, safety, and efficacy considerations for individual patients. Significance: The findings of this study on 485 patients with relapsed/refractory large B-cell lymphoma treated with commercial axi-cel and tisa-cel indicate axi-cel's superior PFS after propensity score weighting. The predictive utility of CAR-HEMATOTOX in assessing not only toxicity but also outcomes across both CAR T-cell products may guide future risk-stratified management strategies.