Abstract
BackgroundSorafenib remains one major first-line therapeutic options for advanced hepatocellular carcinoma (aHCC), with modest efficacy. We investigated the addition of gemcitabine and oxaliplatin (GEMOX) to sorafenib in aHCC patients.MethodsOur multicentre phase II trial randomised aHCC first-line patients to sorafenib (400 mg BID) or sorafenib-GEMOX every 2 weeks (1000 mg/m2 gemcitabine; 100 mg/m2 oxaliplatin). Primary endpoint was the 4-month progression-free survival (PFS) rate.ResultsNinety-four patients were randomised (sorafenib-GEMOX: n = 48; sorafenib: n = 46). Median age was 64 years, PS 0 (69%) or 1 (31%), 63% patients had cirrhosis, 29% portal vein thrombosis and 70% extra-hepatic disease. Median duration of sorafenib treatment was 4 months (1–51); median number of GEMOX cycles was 7 (1–16). The 4-month PFS rates were 64% and 61% in the sorafenib-GEMOX and sorafenib arms, respectively; median PFS and OS were 6.2 (95% CI: 3.8–6.8) and 13.5 (7.5–16.2) months, and 4.6 (3.9–6.2) months and 14.8 (12.2–22.2), respectively. The ORR/DCR were 9%/70% and 15%/77% in the sorafenib-GEMOX and sorafenib alone arms, respectively. Main toxicities were (sorafenib-GEMOX/sorafenib) neutropenia (23%/0), thrombocytopenia (33%/0), diarrhoea (18%/9), peripheral neuropathy (5%/0) and hand–foot syndrome (5%/18).ConclusionsAddition of GEMOX had an inpact on ORR and was well-tolerated as frontline systemic therapy. The benefit on PFS seems moderate; no subsequent study was planned.
Highlights
Sorafenib remains one major first-line therapeutic options for advanced hepatocellular carcinoma, with modest efficacy
Patients were excluded if they had previously been treated with systemic chemotherapy or antiangiogenic therapy for their Hepatocellular carcinoma (HCC), stage B or C cirrhosis according to the Child Pugh classification, or if they were concomitantly treated with any other anticancer treatment or any strong CYP3A4 inducer; if they had history of epilepsy or organ graft associated with immunosuppressive agents, or of other cancer
Our results show the feasibility of the addition of gemcitabine and oxaliplatin (GEMOX) to sorafenib in advanced HCC patients
Summary
Sorafenib remains one major first-line therapeutic options for advanced hepatocellular carcinoma (aHCC), with modest efficacy. We investigated the addition of gemcitabine and oxaliplatin (GEMOX) to sorafenib in aHCC patients. METHODS: Our multicentre phase II trial randomised aHCC first-line patients to sorafenib (400 mg BID) or sorafenib-GEMOX every 2 weeks (1000 mg/m2 gemcitabine; 100 mg/m2 oxaliplatin). Median age was 64 years, PS 0 (69%) or 1 (31%), 63% patients had cirrhosis, 29% portal vein thrombosis and 70% extra-hepatic disease. Most patients with HCC are not eligible for any potentially curative therapy due to the high burden of the liver disease, extra-hepatic spread, or poor background liver function related to cirrhosis. HCC is often considered resistant to common cytotoxic chemotherapies
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