Increased cumulative doses and appearance of hand-foot skin reaction prolonged progression free survival in sorafenib-treated advanced hepatocellular carcinoma patients.

Sorafenib has been recommended as a new palliative therapy for advanced hepatocellular carcinoma (HCC). However, the clinical outcome of patients receiving sorafenib therapy varies. This study sought to identify which clinical method could be used to predict clinical outcome of sorafenib monotherapy in patients with advanced HCC. A total of 146 advanced HCC patients with Child-Pugh A liver function were enrolled from June 2011 to September 2015. Sorafenib doses ranged from 200 mg once daily to 400 mg twice daily. Clinical and pathological parameters were collected. There was no predefined primary endpoint. Tumor response rate, adverse events, overall survival (OS), and progression-free survival (PFS) were analyzed. The follow-up period was 1718 days (median: 859 days). The median dosage of sorafenib was 562.35 mg.Forty patients (27.4%) had stable disease and 106 patients (72.6%) had progression disease. The OS was 432.21 ± 360.52 days (median: 329 days) and PFS was 167.05 ± 166.50 days (median: 102.5 days). No sorafenib toxic effect-related mortality was encountered. The most common severe adverse events (≧grade 3) were hand-foot skin reactions (HFSR) (16, 11.0%), diarrhea (7, 4.8%), and alopecia (1, 0.7%). The following patients had longer median PFS (mPFS): those receiving total dosage > 55000 mg (217 vs.63 days; HR = 0.20,95%CI = 0.11-0.38; p < 0.001), those receiving daily dosage <562 mg (140 vs.69 days; HR = 0.27, 95%CI = 0.17-0.46; p < 0.001), those with treatment durations > 112 days (231vs.64 days; HR = 0.37, 95%CI = 0.19-0.74; p < 0.001), and those with HFSR (105 vs.75 days; HR = 0.60,95% CI = 0.6-0.98; p = 0.04). In conclusion, increased cumulative doses of sorafenib as well as the appearance of HFSR were indicators of prolonged mPFS in sorafenib-treated advanced HCC patients.