Some patients with advanced
hepatocellular carcinoma (HCC) progressing under
sorafenib remain eligible for further systemic
therapy. Little is known on the feasibility of systemic treatment beyond
sorafenib in this setting. Consecutive HCC patients pre-treated with
sorafenib received
gemcitabine 1,000 mg/m² and
oxaliplatin 100 mg/m² every 14 days. Exclusion criteria included Child C
cirrhosis, PS≥3,
creatinine clearance<20 ml/min,
albumin<25 g/L and
bilirubin>54 μmol/L. Pre-treatment body composition was evaluated by CT scan to detect muscle wasting (
sarcopenia). The primary evaluation criterion was safety. Secondary evaluation criteria were response rate, and progression-free (PFS) and overall survival (OS). Eighteen patients (median age: 64 years, range 25-77) received a total of 90 cycles (median per patient: 4, range 1-16). Eight patients (44.4 %) had a PS of 2, 5 (27.8%) had Child-Pugh B
cirrhosis and 13 (72.2%) had a
CLIP score>3. The most frequent toxicities were
thrombocytopenia (grade 2-4: n=7, 38.9%) and
peripheral neuropathy (grade 2-3: n=7, 38.9%). The overall response rate was 18.8% (95% CI: 0-37.9), and another 18.8 % of patients had stable disease. The median PFS and OS were 3.2 (95% CI: 2.3-3.9) and 4.7 (95% CI: 3.8-8.1) months, respectively. Overall survival was significantly longer in patients without
sarcopenia [10.0 months (95% CI: 7.0-13.8) vs. 3.0 months (95 % CI: 2.5-3.9), p<0.001] and in patients with an ECOG PS<2 [8.1 months (95% CI: 7.0-13.8) vs. 3.8 months (95% CI: 2.5-3.9), p=0.017]. In our experience,
gemcitabine-
oxaliplatin was feasible and had detectable clinical activity in HCC patients pre-treated with
sorafenib. Further studies are needed to confirm these findings.