Yozo Sato1, Hideyuki Nishiofuku2, Taku Yasumoto3, Atsuhiro Nakatsuka4, Kunihiro Matsuo5, Yoshihisa Kodama6, Hironao Okubo7, Daisuke Abo8, Haruyuki Takaki9, Yoshitaka Inaba10, Koichiro Yamakado9. 1. Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan. Electronic address: ysato@aichi-cc.jp. 2. Department of Radiology, Nara Medical University, Kashihara, Japan. 3. Department of Radiology, Toyonaka Municipal Hospital, Toyonaka, Japan. 4. Department of Radiology, Mie University School of Medicine, Tsu, Japan. 5. Department of Radiology, Narumi Hospital, Hirosaki, Japan. 6. Department of Radiology, Teine Keijinkai Hospital, Sapporo, Japan. 7. Department of Gastroenterology, Juntendo University Nerima Hospital, Tokyo, Japan. 8. Department of Radiology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. 9. Department of Radiology, Hyogo College of Medicine, Nishinomiya, Japan. 10. Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan.
Abstract
PURPOSE: To evaluate safety and efficacy of combining sorafenib with transarterial chemoembolization in patients with advanced stage hepatocellular carcinomas (HCCs). MATERIALS AND METHODS: Systemic chemotherapy-naïve patients with a Child-Pugh class A liver profile and advanced stage HCCs were enrolled. Sorafenib therapy (daily dose 800 mg) was initiated within 4 weeks after initial conventional transarterial chemoembolization with an allowance of subsequent on-demand conventional chemoembolization. The primary endpoint was rate of protocol treatment completion, which was defined as sorafenib administration for at least 2 months. Secondary endpoints included objective response rate, disease control rate, overall survival, progression-free survival, and incidence of adverse events. Thirty-one patients (24 men, 7 women; median age, 75 years; vascular invasion, n = 19; extrahepatic metastases, n = 18; both, n = 6) who met the inclusion criteria were enrolled. RESULTS: Protocol treatment was completed in 28 patients (90.3%, 28/31) with median protocol treatment duration of 7.0 months (range, 0.5-30 months) and median of 2 (range, 1-4) transarterial chemoembolization sessions. Objective response rate was 77.4% with median overall and progression-free survival of 17.3 months (95% confidence interval, 11.9-22.6 months) and 5.4 months (95% confidence interval, 4.6-6.2 months), respectively. The most common grade 3 or 4 adverse events were self-limiting elevation of aspartate aminotransferase (54.8%, 17/31) and alanine aminotransferase (45.2%, 14/31). CONCLUSIONS: This combination therapy is feasible and promising in patients with advanced stage HCCs.
PURPOSE: To evaluate safety and efficacy of combining sorafenib with transarterial chemoembolization in patients with advanced stage hepatocellular carcinomas (HCCs). MATERIALS AND METHODS: Systemic chemotherapy-naïve patients with a Child-Pugh class A liver profile and advanced stage HCCs were enrolled. Sorafenib therapy (daily dose 800 mg) was initiated within 4 weeks after initial conventional transarterial chemoembolization with an allowance of subsequent on-demand conventional chemoembolization. The primary endpoint was rate of protocol treatment completion, which was defined as sorafenib administration for at least 2 months. Secondary endpoints included objective response rate, disease control rate, overall survival, progression-free survival, and incidence of adverse events. Thirty-one patients (24 men, 7 women; median age, 75 years; vascular invasion, n = 19; extrahepatic metastases, n = 18; both, n = 6) who met the inclusion criteria were enrolled. RESULTS: Protocol treatment was completed in 28 patients (90.3%, 28/31) with median protocol treatment duration of 7.0 months (range, 0.5-30 months) and median of 2 (range, 1-4) transarterial chemoembolization sessions. Objective response rate was 77.4% with median overall and progression-free survival of 17.3 months (95% confidence interval, 11.9-22.6 months) and 5.4 months (95% confidence interval, 4.6-6.2 months), respectively. The most common grade 3 or 4 adverse events were self-limiting elevation of aspartate aminotransferase (54.8%, 17/31) and alanine aminotransferase (45.2%, 14/31). CONCLUSIONS: This combination therapy is feasible and promising in patients with advanced stage HCCs.