来那度胺在异基因造血干细胞移植后治疗多发性骨髓瘤患者中的疗效和安全性：系统评价和荟萃分析。

The efficacy and safety of lenalidomide in the treatment of multiple myeloma patients after allo-hematopoietic stem-cell transplantation: a systematic review and meta-analysis.

机构信息

Department of Hematology, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, China.

Emergency Department, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.

出版信息

Ann Palliat Med. 2021 Jul;10(7):7736-7746. doi: 10.21037/apm-21-1598.

DOI:10.21037/apm-21-1598

PMID:34353061

Abstract

BACKGROUND

There has been long-standing controversy regarding the effectiveness and safety of lenalidomide as a maintenance treatment for patients with multiple myeloma (MM) after allogeneic cell transplantation. This meta-analysis aimed to explore the effectiveness and safety of lenalidomide in the maintenance treatment of MM patients after allogeneic cell transplantation based on published data.

METHODS

A systematic review and meta-analysis was conducted in English and Chinese databases, covering all available publications until 1 December 2020. Statistical analysis was performed using the software STATA 14.0, and odds ratios (ORs) combined with 95% confidence intervals (CIs) were calculated to explore the efficacy and safety of lenalidomide in the treatment of MM patients after allogeneic cell transplantation.

RESULTS

A total of 173 MM cases in 8 independent studies from 2007 to 2014 were included. Through a single-arm meta-analysis of the disease status of MM patients after lenalidomide treatment, 3.6% of patients were in minimal response (MR, P=0.006), 39.0% were in complete remission (CR, P=0.169), 20.2% in partial remission (PR, P<0.001), 12.8% in very good partial remission (VGPR, P=0.049), and 9.7% in SD (P=0.023); the PD was 5.6% (P=0.010). Through meta-analysis of adverse reactions after taking lenalidomide, 35.3% (P=0.628) of participants developed acute graft-versus-host disease (GVHD); 22.6% (P=0.049) developed chronic GVHD; 20.3% (P=0.001) developed infection; 22.5% (P=0.352) had thrombocytopenia; 32.5% (P<0.000) had neutropenia; pain occurred in 17.8% (P=0.350) of patients, and peripheral neuropathy occurred in 17.8% (P=0.995) of participants. The overall survival (OS) of ≥2 years and progression-free survival (PFS) of ≥2 years of MM patients after allo-hematopoietic-stem-cell transplantation (HSCT) taking lenalidomide were analyzed, and the results were 64.9% (P=0.049) and 58.4% (P=0.890), respectively.

DISCUSSION

Lenalidomide is effective in the treatment of MM patients after allo-HSCT, and reducing the incidence of infection and peripheral neuropathy, but it is not effective in reducing GVHD and blood system adverse reactions.

摘要

背景

异体造血干细胞移植后，来那度胺作为多发性骨髓瘤（MM）患者的维持治疗的有效性和安全性一直存在争议。本荟萃分析旨在基于已发表的数据探讨来那度胺在异体造血干细胞移植后 MM 患者维持治疗中的有效性和安全性。

方法

在英文和中文数据库中进行了系统评价和荟萃分析，涵盖截至 2020 年 12 月 1 日的所有可用出版物。使用 STATA 14.0 软件进行统计分析，并计算优势比（OR）合并 95%置信区间（CI），以探讨来那度胺在异体造血干细胞移植后 MM 患者治疗中的疗效和安全性。

结果

纳入了 2007 年至 2014 年间 8 项独立研究中的 173 例 MM 病例。通过对来那度胺治疗后 MM 患者疾病状况的单臂荟萃分析，3.6%的患者处于微小反应（MR，P=0.006），39.0%处于完全缓解（CR，P=0.169），20.2%处于部分缓解（PR，P<0.001），12.8%处于非常好的部分缓解（VGPR，P=0.049），9.7%处于稳定（SD，P=0.023）；进展为疾病（PD）的为 5.6%（P=0.010）。通过来那度胺治疗后不良反应的荟萃分析，35.3%（P=0.628）的参与者发生急性移植物抗宿主病（GVHD）；22.6%（P=0.049）发生慢性 GVHD；20.3%（P=0.001）发生感染；22.5%（P=0.352）发生血小板减少症；32.5%（P<0.000）发生中性粒细胞减少症；17.8%（P=0.350）的患者出现疼痛，17.8%（P=0.995）的患者出现周围神经病。分析了异体造血干细胞移植（HSCT）后接受来那度胺治疗的 MM 患者的≥2 年总生存率（OS）和≥2 年无进展生存率（PFS），结果分别为 64.9%（P=0.049）和 58.4%（P=0.890）。