Caracciolo Daniele, Canale Filippo Antonio, Naso Virginia, Alati Caterina, Marafioti Violetta, Porto Gaetana, Tedesco Ludovica, Pensabene Giulia, Martino Enrica Antonia, Allegra Alessandro, Gerace Demetrio Gabriele, Cimminiello Michele, Gentile Massimo, Tagliaferri Pierosandro, Tassone Pierfrancesco, Martino Massimo
Department of Experimental and Clinical Medicine (DMSC), Magna Graecia University, 88100 Catanzaro, Italy.
Medical and Translational Medical Oncology Units, Phase 1 Trial Center in Oncology and Onco-Hematology, AOU Renato Dulbecco, 88100 Catanzaro, Italy.
Cancers (Basel). 2025 Aug 27;17(17):2796. doi: 10.3390/cancers17172796.
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.
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).
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.
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.
嵌合抗原受体(CAR)T细胞疗法改变了复发或难治性(R/R)弥漫性大B细胞淋巴瘤(DLBCL)的治疗格局。我们的研究旨在描述在意大利一个地区中心接受治疗的R/R DLBCL患者接受CAR T细胞疗法的临床结果,目的是将这些结果与大型学术中心报告的结果进行比较。
回顾性收集了2020年6月至2024年9月在意大利雷焦卡拉布里亚CAR-T中心接受CD19 CAR-T输注的连续41例患者的数据。
中位年龄为66岁,60.9%的患者对其最近的治疗方案耐药,24.4%的患者先前自体干细胞移植失败。82.9%的病例接受了桥接治疗。共有27例患者(65.8%)接受了阿基仑赛,14例(34.2%)接受了替雷利珠单抗。中位随访6.9个月时,最佳客观缓解率(ORR)和完全缓解(CR)率分别为63.4%和51.2%。中位无进展生存期(PFS)为3个月,中位总生存期(OS)为8.4个月。共有81.4%的患者发生了细胞因子释放综合征(CRS),大多数病例为1级(78.4%);26.8%的患者发生了免疫效应细胞相关神经毒性综合征(ICANS):2例(5.4%)为2级,3例(8.1%)为3级。在单因素分析中,早期缓解预示着更长的生存期,而高肿瘤负荷和多个结外部位与较差的结果相关。
我们的回顾性队列研究报告的临床反应数据与关键试验和其他报告相似,证实了在我们的实际临床环境中,CAR-T可能为R/R DLBCL提供更持久的缓解率和更长的无进展生存期。