Sorafenib in Advanced Hepatocellular Carcinoma: A Nationwide Retrospective Study of Efficacy and Tolerability

Abstract

Background. Advanced HCC is a clinical challenge with limited treatment options. The multikinase inhibitor sorafenib is the first and only agent showing a survival benefit in these patients. In this study we evaluate the efficacy and tolerability of sorafenib in an unselected patient population. Furthermore we explore the role of alpha-fetoprotein (αFP) as a potential biomarker for treatment efficacy and correlation to survival. Methods. Seventy-six patients with advanced HCC, not eligible for locoregional therapy, treated with sorafenib between 2007 and 2009 were included. Followup was until 2011. Results. Patients in PS 0-1 had a median overall survival (mOS) of 6.2 months, compared to 1.8 months in patients with poorer PS (P = 0.005). Child-Pugh A patients had a mOS of 6.6 months versus 3.6 months among patients in Child-Pugh B or C (P = 0.0001). Serum αFP ≥ 200 at baseline was prognostic for a shorter survival. All patients with radiologically verified tumor response and baseline αFP ≥ 200 experienced a significant decline in αFP within the first four weeks of treatment. Conclusion. The survival of patients with advanced HCC treated with sorafenib is dependent on performance status and liver function. Treatment of patients with compromised liver function and poor performance status cannot be recommended. The correlation between αFP and objective tumor response warrants further investigation.

Efficiency and Side Effects of Sorafenib Therapy for Advanced Hepatocellular Carcinoma: A Retrospective Study by the Anatolian Society of Medical Oncology

“…These findings have not been clearly shown in randomized studies but have been demonstrated in some retrospective studies. In a retrospective study, Køstner AH et al found the median OS as 6.2 months in patients with an ECOG performance status of 0-1, and 1.8 months in those with a PS of 2-3 (Køstner et al, 2013). OS was 67 weeks in patients with PS 0 in the present study.…”

Clinical profile of hepatocellular carcinoma and experience with sorafenib from a tertiary cancer centre in Southern India

“…22 patients on sorafenib had BCLC stage C, with only 1 patient being in BCLC stage B. We observed a median OS of 3 months in patients on sorafenib whereas patients on best supportive care had median OS of 2 months, which is similar to outcomes reported by Kostner et al 23 Lee et al too report a poor median OS of 4 months and similar toxicity profile of advanced HCC patients on sorafenib.…”

“…21,22 Kostner et al in their retrospective study of sorafenib in HCC, noted median OS of only 1.8 months of patients in PS 2-3. 23 In our study, 66% of our patients had PS≥2. 22 patients on sorafenib had BCLC stage C, with only 1 patient being in BCLC stage B.…”

Evaluation of antiangiogenic efficacy in advanced hepatocellular carcinoma: Biomarkers and functional imaging

“…Small series reported the value of baseline and changes in AFP plasma levels to predict response and outcome for patients with advanced HCC treated with sorafenib. Several studies showed consistent correlation between early (varying from 2 to 8 wk) decrease of AFP level more than 20% following sorafenib and objective response [69][70][71][72][73] and better outcome [69][70][71]73] in patients with advanced HCC. Personeni et al [71] showed that early responders, defined by a 20% decrease of AFP 8 wk after sorafenib treatment, had significantly better median OS and TTP compared to non-responders (13.8 mo vs 8.2 mo, P = 0.022 and 7.9 mo vs 2.4 mo, P = 0.004; respectively) [71] .…”

“…Køstner et al [72] 76 Retrospective Sorafenib AFP response (> 20% decrease from baseline within the first four weeks)…”