Norio Itokawa1, Masanori Atsukawa2, Akihito Tsubota3, Tomomi Okubo1, Taeang Arai1, Ai Nakagawa1, Chisa Kondo1, Katsuhiko Iwakiri1. 1. Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamakari, Inzai, Chiba, Japan. 2. Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamakari, Inzai, Chiba, Japan. momogachi@yahoo.co.jp. 3. Core Research Facilities for Basic Science, Research Center for Medical Sciences, Jikei University, School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: Sorafenib is a standard of care for advanced hepatocellular carcinoma (HCC). An in vitro study showed the synergistic effects of sorafenib and interferon for HCC. To clarify the efficacy, combination therapy with sorafenib and interferon was performed for patients with advanced HCC. METHODS: Pegylated interferon α-2a was administered every 2 weeks for the initial 4 weeks. Subsequently, it was combined with sorafenib. We evaluated the anti-tumor effect and biomarkers during treatment period. RESULTS: The subjects were 13 patients with advanced HCC complicated by hepatitis C virus (HCV)-related liver cirrhosis. A partial response, stable disease and progressive disease were noted in 4, 6, and 3 patients, respectively. The response rate, the disease control rate, the mean time to progression and the median survival time (MST) were 30.8 % (4/13), 76.9 % (10/13), 12.2 months, and 17.5 months, respectively. In 8 Child-Pugh class A and 5 Child-Pugh class B patients, the MST was 22.0 and 11.0 months, respectively (p = 0.001). In plasma vascular endothelial growth factor (VEGF), serum alpha-fetoprotein (AFP), AFP-L3, a protein induced by vitamin K absence or antagonist-II (PIVKA II), and hepatocyte growth factor (HGF), there was no pretreatment factor and no biomarker during the combination therapy to predict therapeutic effect in the present study. CONCLUSIONS: The results of this study suggest that combination therapy with sorafenib and interferon could be effective and safe in advanced HCC patients with HCV-related liver cirrhosis.
BACKGROUND:Sorafenib is a standard of care for advanced hepatocellular carcinoma (HCC). An in vitro study showed the synergistic effects of sorafenib and interferon for HCC. To clarify the efficacy, combination therapy with sorafenib and interferon was performed for patients with advanced HCC. METHODS: Pegylated interferon α-2a was administered every 2 weeks for the initial 4 weeks. Subsequently, it was combined with sorafenib. We evaluated the anti-tumor effect and biomarkers during treatment period. RESULTS: The subjects were 13 patients with advanced HCC complicated by hepatitis C virus (HCV)-related liver cirrhosis. A partial response, stable disease and progressive disease were noted in 4, 6, and 3 patients, respectively. The response rate, the disease control rate, the mean time to progression and the median survival time (MST) were 30.8 % (4/13), 76.9 % (10/13), 12.2 months, and 17.5 months, respectively. In 8 Child-Pugh class A and 5 Child-Pugh class B patients, the MST was 22.0 and 11.0 months, respectively (p = 0.001). In plasma vascular endothelial growth factor (VEGF), serum alpha-fetoprotein (AFP), AFP-L3, a protein induced by vitamin K absence or antagonist-II (PIVKA II), and hepatocyte growth factor (HGF), there was no pretreatment factor and no biomarker during the combination therapy to predict therapeutic effect in the present study. CONCLUSIONS: The results of this study suggest that combination therapy with sorafenib and interferon could be effective and safe in advanced HCC patients with HCV-related liver cirrhosis.
Authors: K Ikeda; S Saitoh; Y Arase; K Chayama; Y Suzuki; M Kobayashi; A Tsubota; I Nakamura; N Murashima; H Kumada; M Kawanishi Journal: Hepatology Date: 1999-04 Impact factor: 17.425
Authors: Zofia von Marschall; Arne Scholz; Thorsten Cramer; Georgia Schäfer; Michael Schirner; Kjell Oberg; Bertram Wiedenmann; Michael Höcker; Stefan Rosewicz Journal: J Natl Cancer Inst Date: 2003-03-19 Impact factor: 13.506
Authors: Christopher W Ryan; Bryan H Goldman; Primo N Lara; Philip C Mack; Tomasz M Beer; Catherine M Tangen; Dianne Lemmon; Chong-Xian Pan; Harry A Drabkin; E David Crawford Journal: J Clin Oncol Date: 2007-08-01 Impact factor: 44.544