Abstract
The gold standard endpoint to evaluate the effect of treatment for hepatocellular carcinoma (HCC) is overall survival (OS), but it requires a longer follow-up period to observe. This study aimed to identify whether disease-free survival (DFS) could be used as a surrogate endpoint for OS to assess the efficacy of adjuvant therapies after curative treatment (surgical resection and ablation) for HCC patients. A systematic review was conducted to identify trials about curative treatment combined with or without adjuvant therapies (interferon, IFN; or transarterial chemoembolization, TACE) for HCC. Total of 2211 patients’ data from 17 trials were analyzed. At the individual study level, DFS was strongly correlated to OS (ρ = 0.988 and 0.930, 95% CI: 0.965–0.996 and 0.806–0.976 for the studies comparing Radiofrequency ablation (RFA) + TACE to RFA alone; and for the studies comparing curative treatment + IFN to curative treatment alone, respectively). At the trial level, the effects of treatment on DFS and OS were also strongly correlated to each other (R = 0.815 and 0.854, 95% CI: 0.536–0.934 and 0.621–0.948, respectively). In conclusion, DFS could be used as a potential surrogate endpoint for OS to assess the effect of adjuvant therapies after curative treatment for HCC.
Highlights
Liver cancer is the second most common cause of cancer-related death, with 782,500 new cases and 745,500 cancer deaths occurred in 2012 worldwide [1]
This study aimed to identify whether disease-free survival (DFS) could be used as a surrogate endpoint for overall survival (OS) to assess the efficacy of adjuvant therapies after curative treatment for hepatocellular carcinoma (HCC) patients
This study is based on the individual study data of 2211 patients in 17 studies that were included in 8 meta-analyses
Summary
Liver cancer is the second most common cause of cancer-related death, with 782,500 new cases and 745,500 cancer deaths occurred in 2012 worldwide [1]. For the treatment of HCC, surgical resection, liver transplantation and local ablative therapy are considered to be the curative treatment [4]. HCC patients with normal concentration of bilirubin and no portal hypertension, the probability that survival time reaches 5 years is 70% after surgical resection [5]. It has been confirmed that IFN decreased the rates of tumor recurrence and mortality for hepatitis B virus (HBV) or/and hepatitis C virus (HCV) related HCC [9, 11]. Pre- and post-operative antiviral and antiinflammatory treatment with IFN has been shown to reduce early and late tumor recurrence rates in HCC patients with HBV or/and HCV infection [11, 12]. It requires strict evaluation criteria to study the effect of adjuvant therapies
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