Abstract
Background: Sorafenib was the first systemic therapy approved for the treatment of Child-Turcotte-Pugh (CTP) class A patients with advanced hepatocellular carcinoma (HCC). However, there are no biomarkers to predict survival and treatment outcomes and guide HCC systemic therapy. Type 1 insulin-like growth factor (IGF-1)/CTP composite score has emerged as a potential hepatic reserve assessment tool. Our study investigated the association of the IGF/CTP score with overall survival (OS) and progression-free survival (PFS) of HCC patients treated with sorafenib.Materials and Methods: In this prospective study, patients with HCC were treated with sorafenib and followed up until progression/death. We calculated the IGF/CTP score and used the Kaplan-Meier method and log-rank test to estimate and compare the time-to-event outcomes between patient subgroups.Results: 171 patients were included, 116 of whom were CTP class A. Median PFS for IGF/CTP score AA and AB patients were 6.88 and 4.28 months, respectively (p = 0.1359). Median OS for IGF/CTP score AA and AB patients were 14.54 and 7.60 months, respectively (p = 0.1378). The PFS and OS was superior in AA patients, but the difference was not significant, likely due to the sample size. However, there was a significant difference in early OS and PFS curves between AA and AB (p = 0.0383 and p = 0.0099), respectively.Conclusions: In CTP class A patients, IGF/CTP score B was associated with shorter PFS and OS, however, study was underpowered to reach statistical significance. If validated in larger cohorts, IGF/CTP score may serve as stratification tool in clinical trials, a hepatic reserve assessment tool for HCC outcomes prediction and to assist in therapy decisions.
Highlights
Accurate assessment of the functional hepatic reserve is important to the prognostic and treatment prediction for patients with liver disease [1, 2]
If validated in larger cohorts, insulin–like growth factor (IGF)/CTP score may serve as stratification tool in clinical trials, a hepatic reserve assessment tool for hepatocellular carcinoma (HCC) outcomes prediction and to assist in therapy decisions
The first drug approved for the treatment of HCC, was approved after randomized, placebo-controlled trials demonstrated that it improved the overall survival (OS) of CTP class A patients with advanced HCC [26, 27]; the purpose of our current study was to investigate the usefulness of the IGF/CTP score in predicting overall survival (OS) and progression-free survival (PFS) in CTP class A patients with advanced HCC who were treated with sorafenib
Summary
Accurate assessment of the functional hepatic reserve is important to the prognostic and treatment prediction for patients with liver disease [1, 2]. The Child-TurcottePugh (CTP) qualitative scoring system is used to assess severity of cirrhosis, survival prospects hepatic reserve, guiding treatment decisions, and stratifying patients with hepatocellular carcinoma (HCC) for clinical trial entry; It classifies patients with liver disease into 3 groups (A, B, and C), this classification is based on bilirubin and albumin levels, prothrombin time, and subjective assessments of encephalopathy and ascites [1, 2]. Clinical trials studying systemic therapies for HCC; include only those with CTP A classification, to assess the effects of the systemic therapy under investigation without the confounding issues of hepatic failure or death which may result from an underlying poor liver reserves [3,4,5]. Our study investigated the association of the IGF/CTP score with overall survival (OS) and progression-free survival (PFS) of HCC patients treated with sorafenib
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