Stanford University School of Medicine.
H. Lee Moffitt Cancer Center and Research Institute.
Haematologica. 2024 Mar 1;109(3):777-786. doi: 10.3324/haematol.2023.283940.
We evaluated patients with relapsed multiple myeloma with renal impairment (RI) treated with standard of care idecabtagene vicleucel (ide-cel), as outcomes with chimeric antigen receptor (CAR) T-cell therapy are unknown in this population. RI was defined as creatinine clearance (CrCl) <50 mL/min. CrCl of <30 mL/min or dialysis dependence were defined as severe RI. The study cohort included 214 patients, 28 (13%) patients with RI, including 11 patients severe RI (dialysis, N=1). Patients with RI were older, more likely to be female and had higher likelihood of having Revised International Staging System stage 3 disease. Rates and severity of cytokine release syndrome (89% vs. 84%, grade ≥3: 7% vs. 2%) and immune effector cell-associated neurotoxicity syndrome (23% vs. 20%) were similar in patients with and without RI, respectively. Patients with RI had higher incidence of short-term grade ≥3 cytopenias, although cytopenias were similar by 3 months following CAR T-cell therapy. Renal function did not worsen after CAR T-cell therapy in patients with RI. Response rates (93% vs. 82%) and survival outcomes (median progression-free survival: 9 vs. 8 months; P=0.26) were comparable in patients with and without RI, respectively. Treatment with ide-cel is feasible in patients with RI, with a comparable safety and efficacy profile as patients without RI, with notable exception of higher short-term high-grade cytopenias.
我们评估了接受标准治疗伊达卡替（ide-cel）治疗的伴有肾功能损害（RI）的复发性多发性骨髓瘤患者，因为嵌合抗原受体（CAR）T 细胞疗法在该人群中的结果尚不清楚。RI 定义为肌酐清除率（CrCl）<50 mL/min。CrCl<30 mL/min 或透析依赖定义为严重 RI。研究队列包括 214 例患者，28 例（13%）患者伴有 RI，包括 11 例严重 RI（透析，N=1）。伴有 RI 的患者年龄较大，更可能为女性，且更有可能患有修订后的国际分期系统（ISS）3 期疾病。伴有和不伴有 RI 的患者的细胞因子释放综合征（CRS）（89% vs. 84%，≥3 级：7% vs. 2%）和免疫效应细胞相关神经毒性综合征（ICANS）（23% vs. 20%）发生率和严重程度相似。伴有 RI 的患者短期≥3 级血细胞减少症的发生率较高，尽管在 CAR T 细胞治疗后 3 个月时血细胞减少症相似。伴有 RI 的患者在 CAR T 细胞治疗后肾功能没有恶化。伴有和不伴有 RI 的患者的反应率（93% vs. 82%）和生存结果（中位无进展生存期：9 个月 vs. 8 个月；P=0.26）相似。在伴有 RI 的患者中，ide-cel 的治疗是可行的，具有与不伴有 RI 的患者相似的安全性和疗效特征，但有一个显著的例外，即短期高等级血细胞减少症的发生率更高。
