Xu Linchun, Lin Shaoze, Xing Xueyang, Su Yongzhong
Shantou University Medical College, Shantou, China.
The First Affiliated Hospital of Shantou University Medical College, Shantou, China.
Ther Adv Hematol. 2023 Mar 6;14:20406207231155028. doi: 10.1177/20406207231155028. eCollection 2023.
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.
This meta-analysis aimed to investigate the efficacy and safety of venetoclax-based therapy in RRMM.
This is a meta-analysis study.
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.
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.
Venetoclax-based therapy is an effective and safe option for RRMM patients, especially those with t(11;14).
复发/难治性多发性骨髓瘤（RRMM）患者的预后通常较差。维奈克拉是一种抗凋亡蛋白B细胞淋巴瘤-2（BCL-2）的选择性抑制剂，在伴有t(11;14)或高BCL-2表达的浆细胞中显示出抗骨髓瘤活性。
本荟萃分析旨在研究基于维奈克拉的治疗方案在RRMM中的疗效和安全性。
这是一项荟萃分析研究。
检索了PubMed、Embase和Cochrane数据库中截至2021年12月20日发表的研究。采用随机效应模型汇总总缓解率（ORR）、非常好的部分缓解或更好的缓解率（≧VGPR）以及完全缓解（CR）率。通过≥3级不良事件的发生率评估安全性。进行亚组分析和荟萃回归以确定异质性的原因。所有分析均使用STATA 15.0软件进行。
共纳入14项研究，713例患者进行分析。所有患者的汇总ORR、≧VGPR率和CR率分别为59%[95%置信区间（CI）=45-71%]、38%（95%CI=26-51%）和17%（95%CI=10-26%）。中位无进展生存期（PFS）为2.0个月至未达到（NR），中位总生存期（OS）为12.0个月至NR。荟萃回归显示，联合使用更多药物治疗或预处理程度较轻的患者缓解率更高。与无t(11;14)的患者相比，伴有t(11;14)的患者ORR更高[相对危险度（RR）=1.47，95%CI=1.05-2.07]、≧VGPR更高（RR=1.71，95%CI=1.12-2.60）、CR更高（RR=1.86，95%CI=1.34-2.57）、PFS更好[风险比（HR）=0.47，95%CI=0.30-0.65]以及OS更好（HR=0.30，95%CI=0.08-0.52）。大多数≥3级不良事件与血液学、胃肠道和感染相关，且可控制。
基于维奈克拉的治疗方案是RRMM患者，尤其是伴有t(11;14)患者的一种有效且安全的选择。
