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

 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 
 LIVER CANCER, Vol.12(5) : 445-456, 2023-10 
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Issue Date
Hepatocellular carcinoma ; Liver cancer ; Systemic therapy
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. © 2023 S. Karger AG. All rights reserved.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Beom Kyung(김범경) ORCID logo https://orcid.org/0000-0002-5363-2496
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