索拉非尼治疗晚期肝癌的生存趋势:随机试验的重建个体患者数据荟萃分析。

IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Liver Cancer Pub Date : 2023-03-28 eCollection Date: 2023-10-01 DOI:10.1159/000529824
Darren Jun Hao Tan, Ansel Shao Pin Tang, Wen Hui Lim, Cheng Han Ng, Benjamin Nah, Clarissa Fu, Jieling Xiao, Benjamin Koh, Phoebe Wen Lin Tay, Eunice X Tan, Margaret Teng, Nicholas Syn, Mark D Muthiah, Nobuharu Tamaki, Sung Won Lee, Beom Kyung Kim, Thomas Yau, Arndt Vogel, Rohit Loomba, Daniel Q Huang
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引用次数: 0

摘要

背景:新出现的数据表明,索拉非尼治疗晚期肝细胞癌(HCC)的疗效可能会随着时间的推移而改善。我们旨在为索拉非尼治疗晚期HCC的生存结果提供可靠的、及时的估计。总结:在这项随机对照试验(RCT)的系统综述和个体患者数据荟萃分析中,我们从开始到2022年9月搜索了MEDLINE和Embase的随机对照试验,这些试验提供了索拉非尼单药治疗作为晚期HCC一线系统治疗的总生存率(OS)和无进展生存率(PFS)数据。我们使用从已发表的Kaplan-Meier曲线重建的个体参与者数据进行了汇总分析,以获得OS和PFS的稳健估计。在确定的1599篇文章中,29项研究(5525名患者)符合纳入标准。总体而言,中位OS为10.4个月(95%CI:9.6-11.4)。中位OS随着时间的推移而增加,从2015年之前研究的9.8个月(95%CI:8.8-10.7)增加到2015年以后研究的13.4个月(95%CI:11.03-15.24)(p<0.001)。OS在试验阶段、地理区域或研究设计方面没有差异。总体中位PFS为4.4个月(95%CI:3.9-4.8),但PFS并没有随着时间的推移而改善。考虑到直接作用抗病毒药物的引入,对2015年及以后的研究进行了敏感性分析,确定丙型肝炎病毒与死亡率降低有关(p<0.001)。OS的估计值具有最小的异质性(所有I2≤33)。关键信息:索拉非尼治疗晚期HCC的生存结果随着时间的推移而改善。这些数据对临床试验设计具有重要意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Survival Trends in Sorafenib for Advanced Hepatocellular Carcinoma: A Reconstructed Individual Patient Data Meta-Analysis of Randomized Trials.

Background: Emerging data suggest that outcomes for advanced hepatocellular carcinoma (HCC) treated with sorafenib may have improved over time. We aimed to provide robust, time-to-event estimates of survival outcomes for sorafenib in advanced HCC.

Summary: In this systematic review and individual patient data meta-analysis of randomized-controlled trials (RCTs), we searched MEDLINE and Embase from inception till September 2022 for RCTs that provided data for overall survival (OS) and progression-free survival (PFS) for sorafenib monotherapy as first-line systemic therapy for advanced HCC. We performed a pooled analysis using reconstructed individual participant data from published Kaplan-Meier curves to obtain robust estimates for OS and PFS. Of 1,599 articles identified, 29 studies (5,525 patients) met the inclusion criteria. Overall, the median OS was 10.4 (95% CI: 9.6-11.4) months. Median OS increased over time, from 9.8 (95% CI: 8.8-10.7) months in studies before 2015 to 13.4 (95% CI: 11.03-15.24) months in studies from 2015 onwards (p < 0.001). OS did not differ by trial phase, geographical region, or study design. The overall median PFS was 4.4 (95% CI: 3.9-4.8) months, but PFS did not improve over time. Sensitivity analysis of studies from 2015 and onwards to account for the introduction of direct-acting antivirals determined that hepatitis C virus was associated with reduced mortality (p < 0.001). There was minimal heterogeneity in the estimates for OS (all I2 ≤ 33).

Key messages: Survival outcomes for sorafenib in advanced HCC have improved over time. These data have important implications for clinical trial design.

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来源期刊
Liver Cancer
Liver Cancer Medicine-Oncology
CiteScore
20.80
自引率
7.20%
发文量
53
审稿时长
16 weeks
期刊介绍: Liver Cancer is a journal that serves the international community of researchers and clinicians by providing a platform for research results related to the causes, mechanisms, and therapy of liver cancer. It focuses on molecular carcinogenesis, prevention, surveillance, diagnosis, and treatment, including molecular targeted therapy. The journal publishes clinical and translational research in the field of liver cancer in both humans and experimental models. It publishes original and review articles and has an Impact Factor of 13.8. The journal is indexed and abstracted in various platforms including PubMed, PubMed Central, Web of Science, Science Citation Index, Science Citation Index Expanded, Google Scholar, DOAJ, Chemical Abstracts Service, Scopus, Embase, Pathway Studio, and WorldCat.
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