Background: Chimeric antigen receptor (CAR) T-cell therapy has transformed the therapeutic landscape for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Our study aims to describe the clinical outcomes of CAR T-cell therapy in patients with R/R DLBCL treated at a single regional center in Italy, with the goal of comparing these outcomes to those reported by high-volume academic centers. Methods: Data were retrospectively collected from a cohort of consecutive 41 patients who underwent to CD19 CAR-T infusion from June 2020 until September 2024 at CAR-T center of Reggio Calabria (Italy). Results: The median age was 66 years, 60.9% were refractory to their most recent regimen, and 24.4% had previously failed autologous stem cell transplant. Bridging therapy was administered in 82.9% of cases. A total of 27 patients (65.8%) received Axi-cel, and 14 (34.2%) received Tisa-cel. At median follow-up of 6.9 months, the best ORR and CR rate were 63.4% and 51.2%, respectively. Median PFS was 3 months, and median OS was 8.4 months. A total of 81.4% of patients developed a CRS, grade 1 in most cases (78.4%); 26.8% developed ICANS: two (5.4%) and three (8.1%) had grade 2 and 3, respectively. In univariate analyses, early response predicted longer survival, whereas high tumor burden and more than one extranodal site were associated with worse outcomes. Conclusions: Our retrospective cohort study reports similar data in terms of clinical response as compared to pivotal trials and other reports, confirming that CAR-T may offer more durable response rates and longer progression-free intervals in R/R DLBCL in our real-world context.
背景：嵌合抗原受体（CAR）T细胞疗法已彻底改变了复发或难治性弥漫性大B细胞淋巴瘤的治疗格局。本研究旨在描述意大利单一区域中心接受CAR-T细胞治疗的R/R DLBCL患者的临床结局，并与高容量学术中心报告的数据进行比较。方法：回顾性收集2020年6月至2024年9月期间在意大利雷焦卡拉布里亚CAR-T中心连续接受CD19 CAR-T输注的41例患者数据。结果：患者中位年龄为66岁，60.9%对最近治疗方案耐药，24.4%曾自体干细胞移植失败。82.9%的患者接受了桥接治疗。27例（65.8%）接受Axi-cel治疗，14例（34.2%）接受Tisa-cel治疗。中位随访6.9个月时，最佳总缓解率和完全缓解率分别为63.4%和51.2%。中位无进展生存期为3个月，中位总生存期为8.4个月。81.4%的患者发生细胞因子释放综合征，其中78.4%为1级；26.8%出现免疫效应细胞相关神经毒性综合征：2例（5.4%）和3例（8.1%）分别为2级和3级。单因素分析显示早期缓解预示更长生存期，而高肿瘤负荷及多发性结外病灶与不良预后相关。结论：本回顾性队列研究显示的临床缓解数据与关键试验及其他报告结果相似，证实了在真实世界临床环境中，CAR-T疗法能为R/R DLBCL患者带来更持久的缓解率和更长的无进展生存期。
肿瘤(癌症)患者之家