Chimeric antigen receptor T-cell (CAR T-cell) therapy has revolutionized the treatment of relapsed/refractory (R/R) large B-cell lymphoma (LBCL). We describe the real-world baseline characteristics, efficacy, safety, and post-relapse outcomes of adult patients with R/R LBCL who received CAR T-cell therapy at the University of California San Diego. A total of 66 patients with LBCL were treated with tisagenlecleucel or axicabtagene ciloleucel. The median age was 59.5, and 21% were over 70 years old. Additionally, 20% of the patients had an Eastern Cooperative Oncology Group (ECOG) performance score of ≥2. Cytokine release syndrome incidence was 88%; immune effector cell-associated neurotoxicity syndrome incidence was 56%. All-grade infection occurred in 48% of patients and in 79% of patients > 70 years old. Complete response (CR) was achieved in 53% and partial response in 14%. Median progression-free survival (PFS) was 10.3 months; median overall survival (OS) was 28.4 months. Patients who relapsed post-CAR T-cell therapy had poor outcomes, with a median OS2 of 4.8 months. Upon multivariate analysis, both ECOG (HR 2.65, 95% CI: 1.30–5.41;p= 0.007) and ≥2 sites of extranodal involvement (HR 2.22, 95% CI: 1.15–4.31;p= 0.018) were significant predictors of PFS. Twenty-six patients were R/R to CAR T-cell therapy; six patients were in remission at the time of data cut off, one of whom received allogeneic transplant. Overall, older patients can safely undergo CAR T-cell therapy, despite the increased risk of all-grade infection. In our cohort, ECOG performance score and ≥2 sites of extranodal disease are significant predictors of PFS.
嵌合抗原受体T细胞(CAR-T细胞)疗法已彻底改变复发/难治性大B细胞淋巴瘤的治疗格局。本研究描述了在加州大学圣地亚哥分校接受CAR-T细胞治疗的成人R/R LBCL患者的真实世界基线特征、疗效、安全性及复发后结局。共66例LBCL患者接受替沙仑基奥仑赛或阿基仑赛治疗,中位年龄59.5岁,21%患者年龄超过70岁,20%患者美国东部肿瘤协作组体能状态评分≥2分。细胞因子释放综合征发生率为88%,免疫效应细胞相关神经毒性综合征发生率为56%。48%患者发生全级别感染,其中70岁以上患者感染率达79%。完全缓解率为53%,部分缓解率为14%。中位无进展生存期为10.3个月,中位总生存期为28.4个月。CAR-T治疗后复发患者预后较差,中位二次总生存期仅4.8个月。多变量分析显示ECOG评分(风险比2.65,95%置信区间:1.30-5.41;p=0.007)与≥2处结外侵犯(风险比2.22,95%置信区间:1.15-4.31;p=0.018)均为PFS的显著预测因子。26例患者对CAR-T治疗呈复发/难治状态,其中6例患者在数据截止时处于缓解期,包括1例接受异基因移植者。总体而言,尽管全级别感染风险增加,老年患者仍可安全接受CAR-T治疗。在本研究队列中,ECOG体能状态评分与≥2处结外病变是PFS的重要预测指标。