Linchun Xu, Shaoze Lin, Xueyang Xing, Yongzhong Su
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Safety was evaluated by the incidences of grade ≧3 adverse events. Subgroup analysis and meta-regression were performed to identify the causes of heterogeneities. All the analyses were conducted by STATA 15.0 software.</p><p><strong>Results: </strong>A total of 14 studies with 713 patients were included for analysis. The pooled ORR, rate of ≧VGPR, and CR for all patients were 59% [95% confidence interval (CI) = 45-71%], 38% (95% CI = 26-51%), and 17% (95% CI = 10-26%), respectively. The median progression-free survival (PFS) ranged from 2.0 months to not reached (NR), and the median overall survival (OS) ranged from 12.0 months to NR. Meta-regression showed that patients treated with more drugs combined or less heavily pretreated had higher response rates. Patients with t(11;14) had superior ORR [relative risk (RR) = 1.47, 95% CI = 1.05-2.07], ≧VGPR (RR = 1.71, 95% CI = 1.12-2.60), CR (RR = 1.86, 95% CI = 1.34-2.57), PFS [hazard ratio (HR) = 0.47, 95% CI = 0.30-0.65], and OS (HR = 0.30, 95% CI = 0.08-0.52) compared with patients without t(11;14). 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引用次数: 0
摘要
背景:复发/难治性多发性骨髓瘤(RRMM)患者通常预后不佳。Venetoclax是一种抗凋亡蛋白b细胞淋巴瘤-2 (BCL-2)的选择性抑制剂，在t(11;14)或BCL-2高表达的浆细胞中显示出抗骨髓瘤活性。目的:本荟萃分析旨在探讨以维托克拉克斯为基础的治疗RRMM的有效性和安全性。设计:这是一项荟萃分析研究。数据来源和方法:检索PubMed、Embase和Cochrane，检索截至2021年12月20日发表的研究。总缓解率(ORR)、极好或较好部分缓解率(≧VGPR)和完全缓解率(CR)采用随机效应模型进行汇总。以≥3级不良事件发生率评价安全性。采用亚组分析和元回归来确定异质性的原因。所有分析均采用STATA 15.0软件进行。结果:共纳入14项研究，713例患者。所有患者的总ORR、≧VGPR率和CR分别为59%[95%可信区间(CI) = 45-71%]、38% (95% CI = 26-51%)和17% (95% CI = 10-26%)。中位无进展生存期(PFS)从2.0个月到未达到(NR)，中位总生存期(OS)从12.0个月到NR。meta回归显示，联合使用更多药物或较少预处理的患者具有更高的缓解率。有t(11;14)的患者的ORR[相对危险度(RR) = 1.47, 95% CI = 1.05-2.07]、≧VGPR (RR = 1.71, 95% CI = 1.12-2.60)、CR (RR = 1.86, 95% CI = 1.34-2.57)、PFS[危险比(HR) = 0.47, 95% CI = 0.30-0.65]和OS (HR = 0.30, 95% CI = 0.08-0.52)优于无t(11;14)的患者。大多数≧3级不良事件与血液学、胃肠道和感染性相关，且可控制。结论:以venetoclax为基础的治疗是RRMM患者的有效和安全的选择，特别是那些有t的患者(11;14)。
Efficacy and safety of venetoclax-based regimens for the treatment of relapsed/refractory multiple myeloma: a systemic review and meta-analysis.
Background: Patients with relapsed/refractory multiple myeloma (RRMM) usually have dismal prognostic outcomes. Venetoclax, a selective inhibitor of antiapoptotic protein B-cell lymphoma-2 (BCL-2), demonstrates antimyeloma activity in plasma cells with t(11;14) or high BCL-2 expression.
Objectives: This meta-analysis aimed to investigate the efficacy and safety of venetoclax-based therapy in RRMM.
Design: This is a meta-analysis study.
Data sources and methods: PubMed, Embase, and Cochrane were searched for studies published up to 20 December 2021. Overall response rate (ORR), rate of very good partial response or better (≧VGPR), and complete response (CR) rate were pooled with the random-effects model. Safety was evaluated by the incidences of grade ≧3 adverse events. Subgroup analysis and meta-regression were performed to identify the causes of heterogeneities. All the analyses were conducted by STATA 15.0 software.
Results: A total of 14 studies with 713 patients were included for analysis. The pooled ORR, rate of ≧VGPR, and CR for all patients were 59% [95% confidence interval (CI) = 45-71%], 38% (95% CI = 26-51%), and 17% (95% CI = 10-26%), respectively. The median progression-free survival (PFS) ranged from 2.0 months to not reached (NR), and the median overall survival (OS) ranged from 12.0 months to NR. Meta-regression showed that patients treated with more drugs combined or less heavily pretreated had higher response rates. Patients with t(11;14) had superior ORR [relative risk (RR) = 1.47, 95% CI = 1.05-2.07], ≧VGPR (RR = 1.71, 95% CI = 1.12-2.60), CR (RR = 1.86, 95% CI = 1.34-2.57), PFS [hazard ratio (HR) = 0.47, 95% CI = 0.30-0.65], and OS (HR = 0.30, 95% CI = 0.08-0.52) compared with patients without t(11;14). Most grade ≧3 adverse events were hematologic, gastrointestinal, and infectious related and were manageable.
Conclusion: Venetoclax-based therapy is an effective and safe option for RRMM patients, especially those with t(11;14).
期刊介绍：
Therapeutic Advances in Hematology delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of hematology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in hematology, providing a forum in print and online for publishing the highest quality articles in this area.
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