Italian Medicine Agency.

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Background: Sorafenib (SOR) is currently used for hepatocellular carcinoma (HCC) recurring after liver transplantation (LT) when HCC is unsuitable for surgical/locoregional treatments. We evaluated safety and effectiveness of early introduction of SOR after HCC-recurrence. Methods: All patients with HCC-recurrence after LT treated with SOR in 2 centers were included (01/2008-06/2018). Baseline and on-treatment data were collected. Results: Fifty patients early treated with SOR for HCC-recurrence after LT (74% mammalian target of rapamycin inhibitor (mTORi), 54% HCCtreated at baseline) were enrolled. During 7.3 (0.3-88) months of SOR, all patients had at least one adverse event (AE), 56% graded 3-4. SOR was reduced in 68%, being AEs the main cause of reduction, and discontinued in 84% (60% symptomatic progression, 33% AE). Objective response was obtained in 16% and stable disease in 50%. Median time to radiological progression was 6 months (95% Confidence Interval [CI] 4-8). Thirty-three patients (69%) died, 94% for HCC progression. Median overall survival (OS) was 18 months (95%CI 8-27); 5-year OS was 18% (95%CI 4-32%). Baseline predictors of OS were SOR+mTORi (HR 0.4, 95%CI 0.2-0.9, p=0.04), previous curative treatments (HR 0.3, 95%CI 0.2-0.7, p=0.003) and alpha-fetoprotein>100ng/ml (HR 2.5, 95%CI 1.1-5.0, p=0.02). At multivariate analysis, HCC curative treatment was the only independent predictor (HR 0.4, 95%CI 0.2-1.0, p=0.04). Conclusions: Early and combined treatment with sorafenib and mTORi resulted in a favourable safety profile, while its effectiveness should be confirmed by meta-analysis of previous studies or by larger studies. Curative treatment for HCC resulted the only independent predictor of OS.

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