A phase II randomized dose escalation trial of sorafenib in patients with advanced hepatocellular carcinoma.

ABSTRACT:

Background

Sorafenib has proven survival benefits in patients with advanced hepatocellular carcinoma (HCC). The viability of continuing sorafenib at a higher dosage in patients who experienced radiologic disease progression was investigated.

Methods

Patients who experienced disease progression while on sorafenib 400 mg twice daily were randomized to sorafenib 600 mg twice daily (n = 49) or best supportive care (n = 52). The primary end point was progression-free survival (PFS). Time to progression, overall survival, and safety were also evaluated.

Results

The study did not meet its primary end point. The difference in PFS between the sorafenib arm (3.91 months) and the best supportive care arm (2.69 months) did not reach statistical significance (p = 0.086). Adverse e

SUBMITTER: Rimassa L 

PROVIDER: S-EPMC3639524 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature