Efficacy and safety of anti-CD38 monoclonal antibodies in patients with newly diagnosed multiple myeloma: an updated systematic review and meta-analysis based on randomized controlled trials.
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引用次数: 0
Abstract
This meta-analysis of eight phase 3 rcts assessed efficacy and safety of anti-cd38 monoclonal antibodies (mabs) in patients with newly diagnosed multiple myeloma (ndmm). anti-cd38 mabs significantly improved progression-free survival (pfs: HR 0.50, 95% CI 0.42-0.59) and overall survival (OS: HR 0.63, 95% CI 0.55-0.71) in the overall population, alongside enhanced minimal residual disease (MRD) negativity rates (RR 1.85, 95% CI 1.43-2.39). While PFS benefits were universal across subgroups, OS showed no improvement in high-risk, ISS-I, or hepatic impairment subgroups, and non-IgG subtypes lacked MRD benefit. Safety analyses demonstrated an elevated risk of multiple infection-related adverse events in the entire cohort. The risk of second primary malignancies (SPMs) also increased (RR 1.44, 95% CI 1.14-1.81). Although anti-CD38 mAbs enhance treatment efficacy with manageable toxicity, the absence of OS benefit in high-risk subgroups warrants attention, and the risk of SPMs needs further investigation.
这项荟萃分析了8项3期试验，评估了抗cd38单克隆抗体（mabs）在新诊断的多发性骨髓瘤（ndmm）患者中的疗效和安全性。抗cd38单抗显著改善了总体人群的无进展生存期（pfs: HR 0.50, 95% CI 0.42-0.59）和总生存期（OS: HR 0.63, 95% CI 0.55-0.71），同时提高了最小残留病（MRD）阴性率（RR 1.85, 95% CI 1.43-2.39）。虽然PFS的益处在各个亚组中都是普遍的，但OS在高风险、ISS-I或肝功能损害亚组中没有改善，非igg亚型缺乏MRD益处。安全性分析表明，在整个队列中，多种感染相关不良事件的风险升高。第二原发恶性肿瘤（SPMs）的风险也增加（RR 1.44, 95% CI 1.14-1.81）。尽管抗cd38单克隆抗体提高了治疗效果，毒性可控，但在高风险亚组中缺乏OS益处值得关注，SPMs的风险需要进一步调查。普洛斯彼罗注册号：CRD42024599221。
期刊介绍：
Leukemia & Lymphoma in its fourth decade continues to provide an international forum for publication of high quality clinical, translational, and basic science research, and original observations relating to all aspects of hematological malignancies. The scope ranges from clinical and clinico-pathological investigations to fundamental research in disease biology, mechanisms of action of novel agents, development of combination chemotherapy, pharmacology and pharmacogenomics as well as ethics and epidemiology. Submissions of unique clinical observations or confirmatory studies are considered and published as Letters to the Editor
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