简介:尿路上皮癌(UC)是一种难治性疾病,目前的手术干预措施仍具有挑战性。抗体-药物缀合物(ADC)是一类新的靶向治疗剂,其已经证明对UC的令人鼓舞的结果。尽管有数量有限的高质量随机对照试验(RCT)检查ADC在UC患者中的使用,一些前瞻性非随机干预研究(NRSIs)提供了有价值的见解和相关信息.我们的目的是评估ADC在UC患者中的疗效和安全性,特别是那些患有局部晚期和转移性疾病的人。方法:对PubMed进行了系统搜索,Embase,Cochrane图书馆,和WebofScience数据库来确定相关研究。结果,例如总反应率(ORR),疾病控制率(DCR),无进展生存期(PFS),总生存期(OS),不良事件(AE),和治疗相关的不良事件(TRAE),被提取用于进一步分析。结果:该荟萃分析包括12项研究,涉及1,311例患者。就肿瘤反应而言,合并的ORR和DCR分别为40%和74%,分别。关于生存分析,合并的中位PFS和OS分别为5.66个月和12.63个月,分别。合并的6个月PFS和OS分别为47%和80%,而合并的1年PFS和OS分别为22%和55%,分别。ADC最常见的TRAE是脱发(所有等级:45%,≥III级:0%),食欲下降(所有年级:34%,≥III级:3%),发育不良(所有年级:40%,≥III级:0%),疲劳(所有等级:39%,≥III级:5%),恶心(所有等级:45%,≥III级:2%),周围感觉神经病变(所有等级:37%,≥III级:2%),瘙痒(所有等级:32%,≥III级:1%)。结论:本研究的荟萃分析表明,ADC对晚期或转移性UC患者具有良好的疗效和安全性。系统审查注册:https://www。crd.约克。AC.英国/普华永道/,标识符:CRD42023460232。
Introduction: Urothelial carcinoma (UC) is a refractory disease for which achieving satisfactory outcomes remains challenging with current surgical interventions. Antibody-drug conjugates (ADCs) are a novel class of targeted therapeutics that have demonstrated encouraging results for UC. Although there is a limited number of high-quality randomized control trials (RCTs) examining the use of ADCs in patients with UC, some prospective non-randomized studies of interventions (NRSIs) provide valuable insights and pertinent information. We aim to assess the efficacy and safety of ADCs in patients with UC, particularly those with locally advanced and metastatic diseases. Methods: A systematic search was conducted across PubMed, Embase, the Cochrane Library, and Web of Science databases to identify pertinent studies. Outcomes, such as the overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), adverse events (AEs), and treatment-related adverse events (TRAEs), were extracted for further analyses. Results: Twelve studies involving 1,311 patients were included in this meta-analysis. In terms of tumor responses, the pooled ORR and DCR were 40% and 74%, respectively. Regarding survival analysis, the pooled median PFS and OS were 5.66 months and 12.63 months, respectively. The pooled 6-month PFS and OS were 47% and 80%, while the pooled 1-year PFS and OS were 22% and 55%, respectively. The most common TRAEs of the ADCs were alopecia (all grades: 45%, grades ≥ III: 0%), decreased appetite (all grades: 34%, grades ≥ III: 3%), dysgeusia (all grades: 40%, grades ≥ III: 0%), fatigue (all grades: 39%, grades ≥ III: 5%), nausea (all grades: 45%, grades ≥ III: 2%), peripheral sensory neuropathy (all grades: 37%, grades ≥ III: 2%), and pruritus (all grades: 32%, grades ≥ III: 1%). Conclusion: The meta-analysis in this study demonstrates that ADCs have promising efficacies and safety for patients with advanced or metastatic UC. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier: CRD42023460232.