Sorafenib for non-selected patient population with advanced hepatocellular carcinoma: efficacy and safety data according to liver function

ABSTRACT

OBJECTIVE: Sorafenib is the standard treatment of patients with advanced hepatocellular carcinoma, regardless of the liver functional reserve. We present a single institutional series of Child-Pugh A and Child-Pugh B patients treated with sorafenib with the aim to establish the efficacy and safety of sorafenib in patients of daily clinical conditions and to compare these results between Child-Pugh A and Child-Pugh B patients. MATERIALS AND METHODS: A total of 51 patients were treated with sorafenib 400 mg/12 h until disease progression or unacceptable toxicity. RESULTS: The median progression-free survival and overall survival for the overall population were 3.5 and 8.2 months, respectively, with a 1-year survival rate of 27 %. Overall survival was significantly longer for patients Child-Pugh A compared with those with Child-Pugh B liver function (8.7 vs. 4.7 months, respectively). The most common adverse events were fatigue (62.7 %), diarrhea (58 %), hypertension (31.3 %), and hand-foot syndrome (31.3 %), and in most cases grade 1 or 2 according to the NCI-CTC 3.0. Grade 4 liver-related events occurred mainly in Child-Pugh B patients with decompensated cirrhosis at the time of sorafenib initiation (54.5 % of that group). DISCUSSION: The benefit of sorafenib in Child-Pugh B patients, if exist, may be limited by frequent liver-related events, especially in decompensated patients, and then, toxicity and impact in quality of life should be carefully monitored (AU)