Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 Anesaki, Ichihara, 299-0111, Chiba, Japan.
Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 Fujimi, Kofu, 400-8506, Yamanashi, Japan.
Hepatol Int. 2019 Mar;13(2):199-204. doi: 10.1007/s12072-019-09929-4. Epub 2019 Jan 22.
BACKGROUND/PURPOSE: Lenvatinib (an inhibitor of vascular endothelial growth factor (GF) receptors 1-3, fibroblast GF receptors 1-4, platelet-derived GF receptor α, rearranged during transfection, and stem cell factor receptor) was non-inferior to sorafenib in a phase 3 (REFLECT) trial of advanced hepatocellular carcinoma. This study examined the efficacy and safety of lenvatinib in a real-world setting.
This was a retrospective, multicenter, observational study. Inclusion and exclusion criteria were based on the phase 3 trial, and participants were observed for at least 12 weeks. Therapeutic effect was determined using the modified Response Evaluation Criteria In Solid Tumors (m-RECIST) at the 8th week. Patients received oral lenvatinib 12 mg/day (body weight > 60 kg) or 8 mg/day (body weight < 60 kg). Dose interruptions followed by reductions for lenvatinib-related toxicities were permitted. Grades of adverse events (AEs) complied with the Common Terminology Criteria for Adverse Events version 4.0.
All 16 patients included in this study had prior treatment history, and a median 3.9 years had passed since the first treatment. Fatigue, hypertension, and proteinuria were the most frequent AEs, and were higher than Grade 2. AEs could be controlled by appropriate dose reduction, interruption, and symptomatic treatment according to the protocol. In the m-RECIST evaluation at the 8th week, 0, 6, 8, and 1 patients had achieved complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 40%.
Lenvatinib treatment could be accomplished with safety and good response in a real-world setting.
背景/目的：仑伐替尼（一种血管内皮生长因子（VEGF）受体 1-3、成纤维细胞生长因子受体 1-4、血小板衍生生长因子受体α、转染后重排、干细胞因子受体的抑制剂）在晚期肝细胞癌的 3 期（REFLECT）试验中与索拉非尼非劣效。本研究在真实环境中检查了仑伐替尼的疗效和安全性。
这是一项回顾性、多中心、观察性研究。纳入和排除标准基于 3 期试验，参与者至少观察 12 周。在第 8 周使用改良的实体瘤反应评估标准（m-RECIST）确定治疗效果。患者接受仑伐替尼口服 12 毫克/天（体重>60 公斤）或 8 毫克/天（体重<60 公斤）。仑伐替尼相关毒性允许剂量中断和减少。根据通用不良事件术语标准 4.0 对不良事件（AE）进行分级。
本研究共纳入 16 例患者，均有既往治疗史，自首次治疗以来中位时间为 3.9 年。疲劳、高血压和蛋白尿是最常见的 AE，且高于 2 级。根据方案，AE 可通过适当的剂量减少、中断和对症治疗得到控制。在第 8 周的 m-RECIST 评估中，分别有 0、6、8 和 1 例患者完全缓解、部分缓解、疾病稳定和疾病进展，客观缓解率为 40%。
在真实环境中，仑伐替尼治疗安全且疗效良好。
