CAR-T 细胞时代难治性侵袭性 B 细胞淋巴瘤患者的最佳治疗选择：来自 GELTAMO/GETH 西班牙协作组的真实世界证据

Real-world evidence comparing the efficacy of chimeric antigen receptor (CAR) T-cell therapy against that of the previous standard of care (SOC) for refractory large B-cell lymphoma (LBCL) is scarce.

We retrospectively collected data from patients with LBCL according to SCHOLAR-1 criteria treated with commercial CAR T-cell therapy in Spain (204 patients included and 192 treated, 101 with axicabtagene ciloleucel [axi-cel], and 91 with tisagenlecleucel [tisa-cel]) and compared the results with a historical refractory population of patients (n = 81) obtained from the GELTAMO-IPI study.

We observed superior efficacy for CAR-T therapy (for both axi-cel and tisa-cel) over pSOC, with longer progression-free survival (PFS) (median of 5. 6 vs. 4-6 months, p 0. 001) and overall survival (OS) (median of 15 vs. 8 months, p < 0. 001), independently of other prognostic factors (HR: 0. 59 (95% CI: 0. 44-0. 80); p < 0. 001] for PFS, and 0. 45 [(95% CI: 0. 31-0. 64)] for OS).

Within the CAR-T cohort, axi-cel showed longer PFS (median of 7. 3 versus 2. 8 months, respectively, p = 0. 027) and OS (58% versus 42% at 12 months, respectively, p = 0. 048) than tisa-cel. These differences were maintained in the multivariable analysis. On the other hand, axi-cel was independently associated with a higher risk of severe cytokine release syndrome and neurotoxicity.

Our results suggest that the efficacy of CAR-T cell therapy is superior to pSOC in the real-world setting.

Furthermore, axi-cel could be superior in efficacy to tisa-cel, although more toxic, in this group of refractory patients according to SCHOLAR-1 criteria.