CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse.
A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse.
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短程 Elo-KRd 诱导后接 Elo-来那度胺维持治疗，在主要为来那度胺难治性和/或高危 MM 中显示出活性。
入组患者接受 4 个周期 Elo-KRd 诱导治疗，随后接受 Elo-lenalidomide 维持治疗直至疾病进展。主要终点为诱导治疗后达到 VGPR 或更佳缓解的比例（≥VGPR）。次要终点包括流式细胞术检测微小残留病（MRD）、OS、PFS 和安全性。相关研究通过流式细胞术分析 Elo-KRd 对 NK 和 T 细胞亚群的影响。因 COVID-19 疫情影响，未达到目标入组人数 40 例。
15 例入组患者中，10 例（67%）具有高危特征（del17p、t[4;14]、t[14;16]、1q 获得/扩增、浆细胞白血病、髓外 MM 或功能性高危），12 例（80%）对 lenalidomide 难治，5 例（33.3%）对 bortezomib 难治。诱导治疗后 7/15（46.7%）达到 VGPR，MRD 阴性率（10⁻⁵）为 20%。研究期间总体缓解率为 80%，最佳疗效为 VGPR 的比例为 53.3%。中位随访 28.2 个月（范围 3.8–44.2）时，中位 PFS 为 11.5 个月（95% CI：1.9–18），中位 OS 尚未达到（95% CI：10.1–不可估计）。未报告新的安全性问题。Elo-KRd 治疗未增加血液或骨髓中 NK 细胞分布或活性。诱导治疗后效应 CD4⁺ 和 CD8⁺ T 细胞显著减少，同时获得 T 中央记忆表型；VGPR 组中特别常见。
短程 Elo-KRd 诱导治疗后接续 Elo-lenalidomide 维持治疗，对以 lenalidomide 难治和/或高危患者为主的 MM 显示出活性。该耐受性良好联合方案的结果与其他当代获批三药联合方案相当。
Enrolled patients received Elo-KRd induction for 4 cycles, and Elo-lenalidomide maintenance until progression. The primary endpoint was VGPR or better ( VGPR) postinduction. Secondary endpoints were MRD by flow cytometry, OS, PFS, and safety. Correlatives included characterization of the impact of Elo-KRd on NK and T cell subsets via flow cytometry. Target accrual of 40 patients was not met due to COVID-19 pandemic.
Of 15 patients enrolled, 10 (67%) had high-risk features (del17p, t[4;14], t[14;16], 1q gain/amplification, plasma cell leukemia, extramedullary MM, or functional high risk), 12 (80%) were lenalidomide-refractory, and 5 (33.3%) bortezomib-refractory. Postinduction VGPR was 7/15 (46.7%) and MRD-negative (10 -5 ) rate 20%. Overall response during study was 80%, including VGPR as best response of 53.3%. At median follow-up of 28.2 (range, 3.8 to 44.2) months, the median PFS was 11.5 months (95% CI 1.9, 18), and median OS not reached (95% CI 10.1, NA). No new safety concerns were reported. Elo-KRd treatment did not augment NK cell distribution or activity in blood or bone marrow. Effector CD4+ and CD8+ T cells significantly decreased postinduction, with concomitant acquisition of T central memory phenotype, particularly at a high rate in VGPR group.
A short course of Elo-KRd induction followed by Elo-lenalidomide maintenance demonstrated activity in predominantly lenalidomide-refractory and / or high-risk MM. The results with this well-tolerated combination are comparable to other contemporary approved triplet combinations.
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