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来那度胺治疗弥漫性大 B 细胞淋巴瘤的疗效和安全性:一项随机对照试验的荟萃分析。

Efficacy and safety of lenalidomide in diffuse large B-cell lymphoma: a meta-analysis of randomized controlled trials.

机构信息

The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.

出版信息

Clin Exp Med. 2023 Aug;23(4):1161-1169. doi: 10.1007/s10238-022-00920-2. Epub 2022 Oct 31.

DOI:10.1007/s10238-022-00920-2
PMID:36315313
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10390621/
Abstract

As an immunomodulatory agent with antitumor activity, lenalidomide has been evaluated for its value in diffuse large B-cell lymphoma (DLBCL). We performed a meta-analysis to gain a better understanding of the efficacy and safety of lenalidomide in DLBCL. PubMed, Cochrane Library, and Embase were searched up to March 2022 for potential studies. The pooled hazard ratio (HR) and relative risk (RR) with 95% confidence interval (CI) were estimated by the fixed/random effects model. Overall, 6 randomized controlled trials including 1938 patients were included. The complete response rate (CRR) of the group containing lenalidomide was 47.7% (95%CI 28.5-67.2%), which was higher than the 37.8% (95%CI 16.7-61.5%) of the control group without lenalidomide (RR = 1.11, 95%CI 1.03-1.20, P = 0.008). The overall estimation of survival showed a benefit for progression-free survival (PFS) (HR = 0.77, 95%CI 0.66-0.90, P = 0.001) but not overall survival (OS) or event-free survival (EFS). The lenalidomide group had a significant incidence of grade ≥ 3 hematological adverse events (AEs) involving neutropenia (RR = 1.56, 95%CI 1.15-2.11, P = 0.004) and febrile neutropenia (RR = 1.81, 95%CI 1.31-2.49, P < 0.001), with the incidence of neutropenia (48.3%, 95%CI 37.5-59.1%) being highest. In conclusion, addition of lenalidomide results in a higher CRR and better PFS but a higher incidence of grade ≥ 3 hematological AEs involving neutropenia and febrile neutropenia.

摘要

来那度胺作为一种具有抗肿瘤活性的免疫调节剂,已在弥漫性大 B 细胞淋巴瘤(DLBCL)中评估其价值。我们进行了一项荟萃分析,以更好地了解来那度胺在 DLBCL 中的疗效和安全性。检索了 PubMed、Cochrane 图书馆和 Embase,以获取截至 2022 年 3 月的潜在研究。使用固定/随机效应模型估计合并的风险比(HR)和相对风险(RR)及其 95%置信区间(CI)。总的来说,纳入了 6 项随机对照试验,共 1938 名患者。含有来那度胺的组的完全缓解率(CRR)为 47.7%(95%CI 28.5-67.2%),高于不含来那度胺的对照组的 37.8%(95%CI 16.7-61.5%)(RR=1.11,95%CI 1.03-1.20,P=0.008)。总体生存情况的估计显示无进展生存期(PFS)有获益(HR=0.77,95%CI 0.66-0.90,P=0.001),但总生存期(OS)或无事件生存期(EFS)没有获益。来那度胺组有显著更高的 3 级及以上血液学不良事件(AE)发生率,包括中性粒细胞减少症(RR=1.56,95%CI 1.15-2.11,P=0.004)和发热性中性粒细胞减少症(RR=1.81,95%CI 1.31-2.49,P<0.001),中性粒细胞减少症发生率最高(48.3%,95%CI 37.5-59.1%)。总之,添加来那度胺可提高 CRR 和 PFS,但导致更高的 3 级及以上血液学 AE 发生率,包括中性粒细胞减少症和发热性中性粒细胞减少症。

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