tisagenlecleucel 在复发/难治性弥漫大 B 细胞淋巴瘤中的真实世界临床结局：一项单中心回顾性研究

We retrospectively analyzed 79 patients with R/R DLBCL who received Tisa-cel at the Catholic Hematology Hospital between April 2022 and January 2025.

The median decision-to-infusion and vein-to-vein times were 49 and 40 days, respectively. Bridging chemotherapy was administered to 64 patients, with an overall response rate (ORR) of 40.6% and a complete response (CR) rate of 14.1% before infusion. Three months after Tisa-cel treatment, the ORR and CR rates were 72.9% and 64.4%, respectively. Tisa-cel was administered as third-line therapy in 50.6% of the patients, and 48.1% had refractory disease. Of the patients who experienced relapse (43%), approximately half transitioned to palliative care, 8.8% were enrolled in clinical trials, and 5.9% proceeded to allogeneic transplantation. Non-relapse mortality was 11.7%, primarily due to infections (n = 7) and immune effector cell-associated neurotoxicity syndrome (ICANS)-related events (n = 2). Cytokine release syndrome occurred in 70.9% of patients (grade 3 in 22.8%) and ICANS in 21.5% (grade 3 in 8.8%), with a median onset at 2 and 5 days, respectively. Tocilizumab and dexamethasone were used in 45.6% and 13.9% of the patients, respectively. With a median follow-up of 11.6 months, the median progression-free survival was 4.9 months, and the median overall survival was 21.6 months. Achieving CR at 3 months was strongly associated with superior survival (p < 0.001). DISCUSSION: Tisa-cel demonstrated favorable efficacy and manageable safety in Korean patients with R/R DLBCL. Early CR strongly predicted long-term outcomes, whereas ICANS occurrence and steroid use were associated with poorer prognosis, underscoring the need to optimize toxicity management.