CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Addition of Elotuzumab to Backbone Treatment Regimens for Multiple Myeloma: An Updated Meta-Analysis of Randomized Clinical Trials.
Addition of Elotuzumab to Backbone Treatment Regimens for Multiple Myeloma: An Updated Meta-Analysis of Randomized Clinical Trials.
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我们的结果表明，含 elotuzumab 的方案对于既往暴露于 PI/IMiD 的 RRMM 患者是有价值的治疗选择。相比之下，elotuzumab 在一线治疗中的作用仍然有限。
elotuzumab是一种抗SLAMF7单克隆抗体，其在治疗复发/难治性多发性骨髓瘤（RRMM）和新诊断多发性骨髓瘤（NDMM）中的疗效在随机对照试验（RCTs）中结果不一。此外，其在实际应用中的数据有限。
我们开展了一项系统评价和meta分析，纳入的RCTs探讨了在骨架抗骨髓瘤方案基础上加用elotuzumab。主要关注结局为无进展生存期（PFS）。次要疗效结局包括总生存期（OS）、总缓解率（ORR）以及非常好的部分缓解或更好（VGPR）率。同时评估了关键毒性。
纳入3项RRMM试验（n = 915）和5项NDMM试验（n = 1790），2705例患者中50%接受了含elotuzumab的三联或四联方案。在RRMM背景下，使用elotuzumab显著改善PFS（风险比[HR]，0.70；95%置信区间[CI]，0.60-0.82；P < .001；I² = 0%）。这一获益在高危细胞遗传学患者中一致（HR，0.62；95% CI，0.43-0.90；P = .01；I² = 0%），并且在既往接受过蛋白酶体抑制剂（PIs）或免疫调节药物（IMiDs）治疗的患者中尤为明显。RRMM队列还显示出更好的OS、ORR和≥VGPR率。然而，NDMM队列在任何疗效结局中均未显示显著改善。尽管严重（≥3级）感染增加，使用elotuzumab并未对严重血细胞减少、严重心脏疾病或第二原发恶性肿瘤的发生率产生不利影响。
The efficacy of elotuzumab, an anti-SLAMF7 monoclonal antibody, in treating relapsed/refractory multiple myeloma (RRMM) and newly-diagnosed multiple myeloma (NDMM) has varied in randomized controlled trials (RCTs). Moreover, there is limited data on its real-world application.
We conducted a systematic review and meta-analysis of RCTs investigating the addition of elotuzumab to backbone antimyeloma regimens. The primary outcome of interest was progression-free survival (PFS). Secondary efficacy outcomes included overall survival (OS), overall response rate (ORR), and rates of very good partial response or better (VGPR). Key toxicities were also evaluated.
Three RRMM trials (n = 915) and 5 NDMM trials (n = 1790) were included, with 50% of the 2705 patients receiving elotuzumab-containing triplets or quadruplets. In RRMM settings, elotuzumab use significantly improved PFS (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.60-0.82; P < .001; I² = 0%). This benefit was consistent among patients with high-risk cytogenetics (HR, 0.62; 95% CI, 0.43-0.90; P = .01; I² = 0%) and was particularly evident in those previously treated with proteasome inhibitors (PIs) or immunomodulatory drugs (IMiDs). The RRMM cohort also demonstrated better OS, ORR, and ≥VGPR rate. However, the NDMM cohort showed no significant improvements in any efficacy outcomes. Despite an increase in severe (grade ≥3) infections, elotuzumab use did not adversely affect rates of severe cytopenias, severe cardiac disorders, or second primary malignancies.
Our results suggest that elotuzumab-containing regimens represent valuable therapeutic options for PI/IMiD-exposed patients with RRMM. In contrast, elotuzumab's role in frontline settings remains limited.
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