CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Efficacy and safety of idecabtagene vicleucel in patients with relapsed-refractory multiple myeloma not meeting the KarMMa-1 trial eligibility criteria: A real-world multicentre study.
Efficacy and safety of idecabtagene vicleucel in patients with relapsed-refractory multiple myeloma not meeting the KarMMa-1 trial eligibility criteria: A real-world multicentre study.
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
Ide-cel 基于 KarMMa-1 试验的结果获批用于复发难治性多发性骨髓瘤。然而，具有显著合并症、侵袭性疾病以及既往接受过 B 细胞成熟抗原靶向治疗（BCMA-DT）的患者被排除在外。这项回顾性研究评估了不符合 KarMMa-1 入组标准并接受标准治疗（SOC）ide-cel 的患者的真实世界结局。来自三个美国中心的共 69 名不符合 KarMMa-1 标准的患者接受了 ide-cel 输注。试验不合格的主要原因包括基线 3-4 级血细胞减少（39%）、既往 BCMA-DT（26%）、肾功能损害（19%）和 美国东部肿瘤协作组 体能状态 ≥2（14.5%）。
SOC 与 KarMMa-1 患者相比，细胞因子释放综合征发生率分别为 81% vs. 84%，免疫效应细胞相关神经毒性综合征发生率分别为 28% vs. 18%。SOC 与 KarMMa-1 队列的早期感染（输注后 ≤8 周）和严重感染率分别为 42% vs. 49% 和 30% vs. 22%。SOC 与 KarMMa-1 队列的 3-4 级血细胞减少分别为：中性粒细胞减少（87% vs. 89%）、贫血（51% vs. 60%）和血小板减少（65% vs. 52%）。SOC 队列的总体缓解率更高（93% vs. 73%），完全缓解或更好率也更高（48% vs. 33%）。
然而，两组之间的中位无进展生存期和总生存期相当。我们的发现支持放宽未来评估 ide-cel 试验的入组标准。
Ide-cel received approval for relapsed-refractory multiple myeloma based on the results of the KarMMa-1 trial.
However, patients with significant comorbidities, aggressive disease and prior B-cell maturation antigen-directed therapy (BCMA-DT) were excluded. This retrospective study evaluated real-world outcomes of patients who did not meet the KarMMa-1 eligibility criteria and were treated with standard of care (SOC) ide-cel. A total of 69 patients from three US centres who did not meet the KarMMa-1 criteria underwent ide-cel infusion. The main reasons for trial ineligibility included baseline grade 3-4 cytopenia (39%), prior BCMA-DT (26%), renal impairment (19%) and Eastern Cooperative Oncology Group performance status ≥2 (14.
5%). Cytokine-release syndrome occurred in 81% vs. 84%, and immune effector cell-associated neurotoxicity syndrome occurred in 28% vs. 18% of SOC versus KarMMa-1 patients, respectively. Early infection (≤8 weeks post-infusion) and severe infection rates were 42% vs. 49% and 30% vs. 22% for the SOC versus KarMMa-1 cohorts, respectively. Grade 3-4 cytopenias for SOC versus KarMMa-1 cohorts were: neutropenia (87% vs. 89%), anaemia (51% vs. 60%) and thrombocytopenia (65% vs. 52%).
Overall response rate was higher for the SOC cohort (93% vs. 73%), as was the complete response or better rate (48% vs. 33%).
However, median progression-free survival and overall survival were comparable between the two groups.
Our findings support broadening the inclusion criteria of future trials evaluating ide-cel.
MEMBER ACCOUNT
登录成功会直接打开下一页。
