Sorafenib alone vs. sorafenib plus GEMOX as 1^st-line treatment for advanced HCC: the phase II randomised PRODIGE 10 trial.

ABSTRACT:

Background

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). Primary endpoint was the 4-month progression-free survival (PFS) rate.

Results

Ninety-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 w

SUBMITTER: Assenat E 

PROVIDER: S-EPMC6734663 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature