Francisco Cezar Aquino de Moraes, Michele Kreuz, Isabella Christina Amaral de Lara, Artur de Oliveira Macena Lôbo, Rommel Mario Rodríguez Burbano
{"title":"Efficacy and safety of PD-1/PD-L1 inhibitors in patients with Merkel Cell Carcinoma: a systematic review and Meta-analysis.","authors":"Francisco Cezar Aquino de Moraes, Michele Kreuz, Isabella Christina Amaral de Lara, Artur de Oliveira Macena Lôbo, Rommel Mario Rodríguez Burbano","doi":"10.1186/s12885-024-13129-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Merkel cell carcinoma (MCC) is a rare and aggressive neuroendocrine skin cancer characterized by high rates of metastasis. Emerging evidence suggests that PD-L1/PD1 blockade holds promise as a therapeutic option for MCC. However, the efficacy and safety of this approach in treating MCC remain incompletely understood. This systematic review and meta-analysis aims to analyze the efficacy and safety of PD-1/PD-L1 blockade for patients with MCC.</p><p><strong>Methods: </strong>PubMed, Cochrane, and Embase were searched for studies evaluating patients with MCC undergoing PD-1/PD-L1 treatment. The estimated outcomes were overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). We performed the meta-analysis using RStudio v4.4.2 software.</p><p><strong>Results: </strong>A total of 14 reports of 13 different studies encompassing 615 patients were included. The median age ranged from 64 to 77 years. Median follow-up ranged from 7.9 months to 59.3 months. Pooled OS rates at 24 and 36 months were 65.05% (95% CI 44.04-81.49) and 59.58% (95% CI 39.62-76.81), respectively, while pooled PFS rates at 6, 12, and 36 months were 51.78% (95% CI 37.83-65.45), 46.12% (95% CI 29.44-63.72), and 28.73% (95% CI 16.57-45.02), in the same order. DCR proportion was 61.65% (95% CI 54.85-68.03) and ORR was 53.79% (95% CI 47.80-59.68). The frequency of TRAEs of any grade was 61.72% (95% CI 45.75-75.51) and for TRAEs of grade ≥ 3 was 17.60% (95% CI 12.28 to 24.57).</p><p><strong>Conclusions: </strong>This systematic review and meta-analysis revealed that patients with MCC undergoing treatment with PD-1/PDL-1 showed durable responses with continuous and clinically meaningful survival outcomes.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11539798/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12885-024-13129-1","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Merkel cell carcinoma (MCC) is a rare and aggressive neuroendocrine skin cancer characterized by high rates of metastasis. Emerging evidence suggests that PD-L1/PD1 blockade holds promise as a therapeutic option for MCC. However, the efficacy and safety of this approach in treating MCC remain incompletely understood. This systematic review and meta-analysis aims to analyze the efficacy and safety of PD-1/PD-L1 blockade for patients with MCC.
Methods: PubMed, Cochrane, and Embase were searched for studies evaluating patients with MCC undergoing PD-1/PD-L1 treatment. The estimated outcomes were overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). We performed the meta-analysis using RStudio v4.4.2 software.
Results: A total of 14 reports of 13 different studies encompassing 615 patients were included. The median age ranged from 64 to 77 years. Median follow-up ranged from 7.9 months to 59.3 months. Pooled OS rates at 24 and 36 months were 65.05% (95% CI 44.04-81.49) and 59.58% (95% CI 39.62-76.81), respectively, while pooled PFS rates at 6, 12, and 36 months were 51.78% (95% CI 37.83-65.45), 46.12% (95% CI 29.44-63.72), and 28.73% (95% CI 16.57-45.02), in the same order. DCR proportion was 61.65% (95% CI 54.85-68.03) and ORR was 53.79% (95% CI 47.80-59.68). The frequency of TRAEs of any grade was 61.72% (95% CI 45.75-75.51) and for TRAEs of grade ≥ 3 was 17.60% (95% CI 12.28 to 24.57).
Conclusions: This systematic review and meta-analysis revealed that patients with MCC undergoing treatment with PD-1/PDL-1 showed durable responses with continuous and clinically meaningful survival outcomes.
背景:梅克尔细胞癌(MCC)是一种罕见的侵袭性神经内分泌皮肤癌,其特点是转移率高。新的证据表明,PD-L1/PD1阻断疗法有望成为治疗梅克尔细胞癌的一种选择。然而,人们对这种方法治疗 MCC 的有效性和安全性仍不甚了解。本系统综述和荟萃分析旨在分析PD-1/PD-L1阻断治疗MCC患者的有效性和安全性:方法:检索了PubMed、Cochrane和Embase上对接受PD-1/PD-L1治疗的MCC患者进行评估的研究。估计结果包括总反应率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)和治疗相关不良事件(TRAEs)。我们使用 RStudio v4.4.2 软件进行了荟萃分析:结果:共纳入了 13 项不同研究的 14 篇报告,涉及 615 名患者。中位年龄从 64 岁到 77 岁不等。中位随访时间从 7.9 个月到 59.3 个月不等。24个月和36个月的汇总OS率分别为65.05%(95% CI 44.04-81.49)和59.58%(95% CI 39.62-76.81),6个月、12个月和36个月的汇总PFS率依次为51.78%(95% CI 37.83-65.45)、46.12%(95% CI 29.44-63.72)和28.73%(95% CI 16.57-45.02)。DCR比例为61.65%(95% CI 54.85-68.03),ORR为53.79%(95% CI 47.80-59.68)。任何等级的TRAEs发生率为61.72%(95% CI 45.75-75.51),等级≥3的TRAEs发生率为17.60%(95% CI 12.28-24.57):这项系统综述和荟萃分析显示,接受PD-1/PDL-1治疗的MCC患者表现出持久的应答,并获得持续且有临床意义的生存结果。
期刊介绍:
BMC Cancer is an open access, peer-reviewed journal that considers articles on all aspects of cancer research, including the pathophysiology, prevention, diagnosis and treatment of cancers. The journal welcomes submissions concerning molecular and cellular biology, genetics, epidemiology, and clinical trials.