TY - JOUR
T1 - A Multicenter Real-life Prospective Study of Axicabtagene Ciloleucel versus Tisagenlecleucel Toxicity and Outcomes in Large B-cell Lymphomas
AU - Stella, Federico
AU - Chiappella, Annalisa
AU - Casadei, Beatrice
AU - Bramanti, Stefania
AU - Ljevar, Silva
AU - Chiusolo, Patrizia
AU - Rocco, Alice Di
AU - Tisi, Maria C.
AU - Carrabba, Matteo G.
AU - Cutini, Ilaria
AU - Martino, Massimo
AU - Dodero, Anna
AU - Bonifazi, Francesca
AU - Santoro, Armando
AU - Sorà, Federica
AU - Botto, Barbara
AU - Barbui, Anna M.
AU - Russo, Domenico
AU - Musso, Maurizio
AU - Grillo, Giovanni
AU - Krampera, Mauro
AU - Olivieri, Jacopo
AU - Ladetto, Marco
AU - Cavallo, Federica
AU - Massaia, Massimo
AU - Arcaini, Luca
AU - Pennisi, Martina
AU - Zinzani, Pier L.
AU - Miceli, Rosalba
AU - Corradini, Paolo
N1 - Publisher Copyright:
©2024 The Authors;
PY - 2024/9/1
Y1 - 2024/9/1
N2 - aBstRact 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.
AB - aBstRact 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.
UR - https://www.scopus.com/pages/publications/85203118117
U2 - 10.1158/2643-3230.BCD-24-0052
DO - 10.1158/2643-3230.BCD-24-0052
M3 - Article
SN - 2643-3230
VL - 5
SP - 318
EP - 330
JO - Blood cancer discovery
JF - Blood cancer discovery
IS - 5
ER -