背景:胰腺神经内分泌肿瘤(pNETs)治疗的最新进展突出了替莫唑胺的潜在益处,烷化剂,对于这些患者。在这个荟萃分析中,我们的目的是评估替莫唑胺的结果,单独或与其他抗癌药物联合治疗晚期pNET患者。
方法:PubMed的在线数据库,WebofScience,Embase,Cochrane图书馆,和ClinicalTrials.gov进行了系统搜索,以获得报告替莫唑胺在晚期pNET患者中的疗效和安全性的临床试验。随机效应模型用于根据实体瘤标准中的反应评估标准估计合并结局率。生化反应,和不良事件(AE)。
结果:共14项研究,提供441名拥有先进pNET的个人的详细信息,包括在内。定量分析显示汇总客观反应率(ORR)为41.2%(95%置信区间,CI,32.4%-50.6%),疾病控制率(DCR)为85.3%(95%CI为74.9%-91.9%),并且从基线嗜铬粒蛋白A水平降低了50%以上,为44.9%(95%CI为31.6%-49.0%)。关于安全,结果显示,非严重不良事件和严重不良事件的合并率分别为93.8%(95%CI为88.3%-96.8%)和23.7%(95%CI为12.0%-41.5%),分别。主要的严重AE包括血液毒性。
结论:结论:我们的荟萃分析表明,替莫唑胺治疗,对于晚期局部不可切除和转移性pNET患者,单药治疗或联合其他抗癌治疗可能是一种有效且相对安全的选择.然而,需要进行更多的临床试验来进一步加强这些发现.本研究已在PROSPERO(CRD42023409280)中注册。
BACKGROUND: Recent advances in the management of pancreatic neuroendocrine tumors (pNETs) highlight the potential benefits of temozolomide, an alkylating agent, for these patients. In this meta-analysis, we aimed to assess the outcome of temozolomide, alone or in combination with other anticancer medications in patients with advanced pNET.
METHODS: Online databases of PubMed, Web of Science, Embase, the Cochrane Library, and ClinicalTrials.gov were searched systematically for clinical trials that reported the efficacy and safety of temozolomide in patients with advanced pNET. Random-effect model was utilized to estimate pooled rates of outcomes based on Response Evaluation Criteria in Solid Tumors criteria, biochemical response, and adverse events (AEs).
RESULTS: A total of 14 studies, providing details of 441 individuals with advanced pNET, were included. The quantitative analyses showed a pooled objective response rate (ORR) of 41.2% (95% confidence interval, CI, of 32.4%-50.6%), disease control rate (DCR) of 85.3% (95% CI of 74.9%-91.9%), and a more than 50% decrease from baseline chromogranin A levels of 44.9% (95% CI of 31.6%-49.0%). Regarding safety, the results showed that the pooled rates of nonserious AEs and serious AEs were 93.8% (95% CI of 88.3%-96.8%) and 23.7% (95% CI of 12.0%-41.5%), respectively. The main severe AEs encompassed hematological toxicities.
CONCLUSIONS: In conclusion, our meta-analysis suggests that treatment with temozolomide, either as a monotherapy or in combination with other anticancer treatments might be an effective and relatively safe option for patients with advanced locally unresectable and metastatic pNET. However, additional clinical trials are required to further strengthen these findings. This study has been registered in PROSPERO (CRD42023409280).