Abstract
e14605 Background: The therapeutic effect of TACE plus Sorafenib (Sor) for unresectable hepatocellular carcinoma (uHCC) was evaluated in the START (Study in Asia of the Combination of TACE with Sor in Patients with Hepatocellular Carcinoma) trial. The preliminary results presented at ILCA 2011 showed encouraging safety and efficacy profiles of TACE plus Sor in HCC, with a median time to progression (TTP) of 9.3 months and median overall survival (OS) not reached. Here we present results of a subgroup analysis of Chinese patients with more updated data. Methods: Patients with uHCC and candidates for TACE were enrolled. TACE with lipiodol and doxorubicin (30-60 mg) was performed every 6 to 8 weeks. Sor (400mg bid) was administrated 4 days after first TACE, and then continuously with interruption 3 days before and after the TACE procedure. Tumors were assessed 4 weeks after every TACE, and every 3 months thereafter if no TACE was indicated. Patients who do not require TACE due to complete response or intolerability continued to receive Sor until disease progression (PD) or unacceptable toxicity. This analysis was conducted to evaluate the efficacy of TACE plus Sor on TTP based on modified RECIST criteria, OS and response rate (RR) in Chinese patients with uHCC. Cut-off date for the efficacy analysis is Sep 30th, 2011. Because no new or unexpected side effects were noted during this study period, safety data were not collected in this subgroup analysis. Results: A total of 64 patients enrolled from Sep. 2009 to Apr. 2010, were evaluated. The median age was 62 yr (range, 31-75) and all patients were ECOG Performance Status 0-1. The main etiology for HCC was hepatitis B in 94.9% of patients. The mean dose of Sor in this group of patients is 787.63mg.The median treatment duration was 6.4 months. The median TTP was 10.6 months, and the median OS was 16.5 months. The objective RR was 44.3%, and 11.5% of patients had PD. Conclusions: This subgroup analysis suggests that Chinese patients with uHCC may benefit from TACE and Sor combination therapy, with better improvement of TTP, compared to the interim analysis results of the overall population from the START trial.
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