Itokawa Norio, Atsukawa Masanori, Tsubota Akihito, Okubo Tomomi, Arai Taeang, Nakagawa Ai, Kondo Chisa, Iwakiri Katsuhiko
Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamakari, Inzai, Chiba, Japan.
Core Research Facilities for Basic Science, Research Center for Medical Sciences, Jikei University, School of Medicine, Tokyo, Japan.
Int J Clin Oncol. 2016 Aug;21(4):676-683. doi: 10.1007/s10147-015-0942-0. Epub 2015 Dec 23.
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.
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.
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.
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.
索拉非尼是晚期肝细胞癌（HCC）的标准治疗药物。一项体外研究显示索拉非尼与干扰素对HCC具有协同作用。为明确疗效，对晚期HCC患者进行了索拉非尼与干扰素联合治疗。
聚乙二醇化干扰素α-2a在最初4周每2周给药1次。随后，将其与索拉非尼联合使用。我们在治疗期间评估了抗肿瘤效果和生物标志物。
研究对象为13例合并丙型肝炎病毒（HCV）相关肝硬化的晚期HCC患者。分别有4例、6例和3例患者出现部分缓解、疾病稳定和疾病进展。缓解率、疾病控制率、平均进展时间和中位生存时间（MST）分别为30.8%（4/13）、76.9%（10/13）、12.2个月和17.5个月。在8例Child-Pugh A级和5例Child-Pugh B级患者中，MST分别为22.0个月和11.0个月（p = 0.001）。在血浆血管内皮生长因子（VEGF）、血清甲胎蛋白（AFP）、AFP-L3、维生素K缺乏或拮抗剂-II诱导蛋白（PIVKA II）和肝细胞生长因子（HGF）方面，本研究中没有预处理因素和联合治疗期间的生物标志物可预测治疗效果。
本研究结果表明，索拉非尼与干扰素联合治疗对合并HCV相关肝硬化的晚期HCC患者可能有效且安全。
