Pensato Umberto, Muccioli Lorenzo, Taurino Daniela, Pondrelli Federica, Asioli Gian Maria, de Philippis Chiara, Mannina Daniele, Bagnato Gianmarco, Marcheselli Simona, Zinzani Pier Luigi, Bonifazi Francesca, Bramanti Stefania, Guarino Maria
IRCCS Humanitas Research Hospital, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Neurooncol Pract. 2024 Dec 31;12(3):531-539. doi: 10.1093/nop/npae128. eCollection 2025 Jun.
Immune effector cell-associated neurotoxicity syndrome (ICANS) is a frequent complication of chimeric antigen receptor (CAR) T-cell therapy. Most patients achieve complete symptom resolution without long-term neurological sequelae, yet the impact of ICANS and steroid therapy on oncological outcomes remains inadequately explored. We investigated the association between ICANS and steroid therapy with progression-free survival (PFS).
We included large B-cell lymphoma patients treated with anti-CD19 CAR T cells. The primary outcome was 90-day PFS. The secondary outcomes included PFS, complete response, and overall survival (OS) at 30, 90, 180, and 365 days. The association between outcomes and ICANS and steroid treatment was assessed using logistic regression analyses adjusted for baseline factors.
Overall, 241 patients were included. The median age was 60 years (interquartile range [IQR] = 51-66), 81 (33.6%) were females, 67 (27.8%) developed ICANS, and 142 (58.9%) achieved 90-day PFS. There was no association between 90-day PFS and ICANS development (adjusted odds ratio [aOR] 1.39 [95% confidence interval {CI} = 0.75-2.61]), maximum grade (aOR 1.24 [0.97-1.59]), duration (aOR 1.00 [95% CI = 0.95-1.05] per 1-day increase), or day of onset (aOR 0.98 [95% CI = 0.86-1.11] per 1-day increase). There was no association between 90-day PFS and steroid therapy (aOR 1.25 [95% CI = 0.73-2.14]) or cumulative dose (aOR 1.00 [95% CI = 0.98-1.01] per 100-mg increase). Similar results were observed for secondary outcomes, except for an association between ICANS and OS at 30 days (aOR 0.05 [95% CI = 0.01-0.54]) and 90 days (aOR 0.35 [95% CI = 0.15-0.80]).
Our findings suggest that ICANS and steroid therapy do not adversely impact the PFS in lymphoma patients receiving anti-CD19 CAR T cells. Yet, ICANS might be associated with reduced early OS.
免疫效应细胞相关神经毒性综合征(ICANS)是嵌合抗原受体(CAR)T细胞疗法常见的并发症。大多数患者症状完全缓解,无长期神经后遗症,但ICANS和类固醇疗法对肿瘤学结局的影响仍未得到充分研究。我们调查了ICANS和类固醇疗法与无进展生存期(PFS)之间的关联。
我们纳入了接受抗CD19 CAR T细胞治疗的大B细胞淋巴瘤患者。主要结局是90天无进展生存期。次要结局包括30、90、180和365天时的无进展生存期、完全缓解率和总生存期(OS)。使用针对基线因素进行调整的逻辑回归分析评估结局与ICANS及类固醇治疗之间的关联。
总体而言,共纳入241例患者。中位年龄为60岁(四分位间距[IQR]=51-66),81例(33.6%)为女性,67例(27.8%)发生ICANS,142例(58.9%)实现90天无进展生存期。90天无进展生存期与ICANS的发生(调整优势比[aOR]为1.39[95%置信区间{CI}=0.75-2.61])、最高分级(aOR为1.24[0.97-1.59])、持续时间(每增加1天aOR为1.00[95%CI=0.95-1.05])或发病日(每增加1天aOR为0.98[95%CI=0.86-1.11])之间均无关联。90天无进展生存期与类固醇疗法(aOR为1.25[95%CI=0.73-2.14])或累积剂量(每增加100mg aOR为1.00[95%CI=0.98-1.01])之间也无关联。除了ICANS与30天(aOR为0.05[95%CI=0.01-0.54])和90天(aOR为0.35[95%CI=0.15-0.80])时的总生存期之间存在关联外,次要结局也观察到类似结果。
我们的研究结果表明,ICANS和类固醇疗法不会对接受抗CD19 CAR T细胞治疗的淋巴瘤患者的无进展生存期产生不利影响。然而,ICANS可能与早期总生存期降低有关。