Division of Hematology, Department of Medicine, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.
Stanford University School of Medicine, Stanford, CA, USA.
J Hematol Oncol. 2024 Jun 6;17(1):42. doi: 10.1186/s13045-024-01555-4.
Idecabtagene vicleucel (Ide-cel) has demonstrated excellent efficacy and durable responses in patients with relapsed/refractory multiple myeloma (RRMM). However, the outcomes with ide-cel in patients with extramedullary disease (EMD) remain incompletely characterized. We included patients with RRMM treated with ide-cel between May 2021 and April 2023 across 11 US academic institutions. Visceral or soft tissue lesions non-contiguous from bone was classified as EMD. Time-to-event analyses were performed from date of ide-cel infusion. Among 351 patients, 84 (24%) had EMD prior to infusion. The median follow-up from ide-cel infusion was 18.2 months (95% CI: 17-19.3). The day 90 overall response rates (ORR) were 52% vs. 82% for the EMD and non-EMD cohorts, respectively (p < 0.001). The median progression-free survival (PFS) was 5.3 months (95% CI: 4.1-6.9) for the EMD cohort vs. 11.1 months (95% CI: 9.2-12.6; p < 0.0001) for the non-EMD cohort. In a multivariable analysis, EMD was an independent predictor of inferior PFS [hazard ratio 1.5 (1.1-2.2), p = 0.02]. The median overall survival was 14.8 months [95% CI: 9-Not reached (NR)] vs. 26.9 months (26.3 vs. NR, p = 0.006) for the EMD and non-EMD cohorts, respectively. Extramedullary disease represents an independent predictor of inferior day 90 ORR and PFS among patients treated with ide-cel.
依达珠单抗(Ide-cel)在复发/难治性多发性骨髓瘤(RRMM)患者中表现出了优异的疗效和持久的缓解。然而,Ide-cel 在有髓外疾病(EMD)患者中的疗效仍不完全明确。我们纳入了 2021 年 5 月至 2023 年 4 月在 11 个美国学术机构接受 Ide-cel 治疗的 RRMM 患者。将与骨骼不连续的内脏或软组织病变归类为 EMD。从 Ide-cel 输注日期开始进行时间事件分析。在 351 名患者中,84 名(24%)在输注 Ide-cel 前有 EMD。从 Ide-cel 输注开始的中位随访时间为 18.2 个月(95%CI:17-19.3)。第 90 天的总缓解率(ORR)分别为 EMD 组和非 EMD 组的 52%和 82%(p<0.001)。EMD 组的中位无进展生存期(PFS)为 5.3 个月(95%CI:4.1-6.9),而非 EMD 组为 11.1 个月(95%CI:9.2-12.6;p<0.0001)。在多变量分析中,EMD 是 PFS 较差的独立预测因素[风险比 1.5(1.1-2.2),p=0.02]。中位总生存期分别为 14.8 个月[95%CI:9-NR]和 26.9 个月(26.3-NR,p=0.006)。EMD 是 Ide-cel 治疗患者第 90 天 ORR 和 PFS 较差的独立预测因素。