Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo,Bunkyo-ku, Tokyo, Japan.
Clin Drug Investig. 2012 Aug 8;32 Suppl 2:25-35. doi: 10.1007/BF03265494.
The efficacy of sorafenib in hepatocellular carcinoma (HCC) has been demonstrated in two pivotal clinical trials: the European SHARP trial and a second trial that recruited patients in the Asia-Pacific region. Sorafenib was approved for the treatment of advanced HCC in Japan based on the results of these studies. This article presents experiences with sorafenib in patients with HCC at three institutions in Japan, representing the viewpoints of a liver surgeon and a hepatologist at university hospitals, and a hepatologist at a community hospital. The three physicians discuss representative cases and current clinical practice at their institutions, and their recommendations for the use of sorafenib in the wider clinical setting. Overall, the experiences at these institutions show that sorafenib is most effective when administered for a long time, and the management of adverse events (AEs) [including dose-reduction and modification] is critical to achieving high levels of adherence to treatment. A team-focussed treatment strategy that includes patient counselling and follow-up can contribute to managing AEs to ensure successful continuation of sorafenib therapy. In addition, a proposed definition of unresponsiveness to transarterial chemoembolization and the implications of treatment lag on the outcomes of sorafenib therapy, as well as measures for the prevention and treatment of hand-foot skin reaction are discussed.
索拉非尼在肝细胞癌(HCC)中的疗效已在两项关键临床试验中得到证实:欧洲 SHARP 试验和在亚太地区招募患者的第二项试验。基于这些研究的结果,索拉非尼在日本被批准用于治疗晚期 HCC。本文介绍了日本三家医疗机构的 HCC 患者使用索拉非尼的经验,代表了大学医院的肝外科医生和肝病学家以及社区医院的肝病学家的观点。这三位医生讨论了他们所在机构的典型病例和当前的临床实践,并就更广泛的临床应用中索拉非尼的使用提出了建议。总体而言,这些机构的经验表明,索拉非尼长期使用效果最佳,管理不良反应(AE)[包括剂量减少和调整]对于实现高水平的治疗依从性至关重要。以团队为中心的治疗策略,包括患者咨询和随访,可以有助于管理不良反应,确保索拉非尼治疗的成功延续。此外,还讨论了对经动脉化疗栓塞治疗无反应的定义以及治疗延迟对索拉非尼治疗结果的影响,以及预防和治疗手足皮肤反应的措施。