Abstract
BackgroundThe aim of this study was to explore the relationship between follow-up imaging characteristics and overall survival (OS) in advanced hepatocellular carcinoma (HCC) patients under sorafenib treatment.MethodsAssociations between OS and objective response (OR) by mRECIST or early tumor shrinkage (ETS; ≥20% reduction in enhancing tumor diameter at the first follow-up imaging) were analyzed in HCC patients treated with sorafenib within a multicenter phase II trial (SORAMIC). 115 patients were included in this substudy. The relationship between survival and OR or ETS were explored. Landmark analyses were performed according to OR at fixed time points. Cox proportional hazards models with OR and ETS as a time-dependent covariate were used to compare survival with factors known to influence OS.ResultsThe OR rate was 29.5%. Responders had significantly better OS than non-responders (median 30.3 vs. 11.4 months; HR, 0.38 [95% CI, 0.22–0.63], p < 0.001), and longer progression-free survival (PFS; median 10.1 vs. 4.3 months, p = 0.015). Patients with ETS ≥ 20% had longer OS (median 22.1 vs. 11.4 months, p = 0.002) and PFS (median 8.0 vs. 4.3 months, p = 0.034) than patients with ETS < 20%. Besides OR and ETS, male gender, lower bilirubin and ALBI grade were associated with improved OS in univariate analysis. Separate models of multivariable analysis confirmed OR and ETS as independent predictors of OS.ConclusionOR according to mRECIST and ETS in patients receiving sorafenib treatment are independent prognostic factors for OS. These parameters can be used for assessment of treatment benefit and optimal treatment sequencing in patients with advanced HCC.
Highlights
Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer and the third leading cause of cancer-related death [1]
overall survival (OS) and time to progression were improved in the sorafenib arm in both studies, the objective response (OR) rate according to RECIST was 2–3% and this failed to capture patients with survival benefit
This study aimed to evaluate the prognostic role of OR and early tumor shrinkage (ETS) in patients receiving sorafenib therapy for the treatment of advanced hepatocellular carcinoma (HCC) in a Western cohort
Summary
Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer and the third leading cause of cancer-related death [1]. One study which combined analysis of two prospective phase II studies showed patients with an OR had significantly longer survival; this significance was lost in multivariate analysis including macrovascular invasion and extrahepatic disease [10]. Most of these studies were single-center and retrospectively conducted, and in none of them, statistical methods to exclude biased estimates of survival were applied [11]. The aim of this study was to explore the relationship between follow-up imaging characteristics and overall survival (OS) in advanced hepatocellular carcinoma (HCC) patients under sorafenib treatment
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