8/16/18美国FDA已批准lenvatinib用于无法切除的HCC患者的一线治疗

StephenW

Lenvatinib

Lenvatinib is a multikinase inhibitor of VEGF receptors 1-3, PDGF receptor alpha, and FGF receptors 1-4, among others.25 Currently approved for thyroid and kidney cancer, lenvatinib also was investigated as a first-line treatment for HCC.  8/16/18 The U.S. FDA has approved lenvatinib for first-line treatment of patients with unresectable HCC. In a phase III open-label noninferiority study conducted by Cheng and colleagues, patients (N=954) with BCLC stage B or C HCC and Child-Pugh A cirrhosis were randomly assigned to weight-based lenvatinib (8 or 12 mg) or sorafenib.26 Median overall survival was 13.6 and 12.3 months with lenvatinib and sorafenib, respectively (HR 0.92;95% CI, 0.79-1.06). Median progression-free survival was significantly longer with lenvatinib than sorafenib (7.4 months vs 3.7 months; <.00001). Lenvatinib also significantly increased time to progression (8.9 months vs 3.7 months; <.00001) and overall response rate (24% vs 9%; <.00001). The most common adverse effects in the lenvatinib treatment group were hypertension (42%), diarrhea (39%), decreased appetite (34%), weight loss (31%), and fatigue (30%).26

StephenW

Lenvatinib

Lenvatinib是VEGF受体1-3，PDGF受体α和FGF受体1-4等的多激酶抑制剂.25目前被批准用于治疗甲状腺癌和肾癌，Lenvatinib也作为HCC的一线治疗进行了研究。 8/16/18美国FDA已批准lenvatinib用于无法切除的HCC患者的一线治疗。在Cheng和同事进行的III期开放标签非劣效性研究中，患有BCLC B期或C期HCC和Child-Pugh A肝硬化的患者（N = 954）被随机分配到基于体重的lenvatinib（8或12 mg）或索拉非尼.26使用lenvatinib和索拉非尼的中位总生存期分别为13.6和12.3个月（HR 0.92; 95％CI，0.79-1.06）。使用lenvatinib的中位无进展生存期明显长于索拉非尼（7.4个月vs 3.7个月; P <.00001）。 Lenvatinib也显着增加了进展时间（8.9个月vs 3.7个月; P <.00001）和总体反应率（24％vs 9％; P <.00001）。 Lenvatinib治疗组最常见的不良反应是高血压（42％），腹泻（39％），食欲减退（34％），体重减轻（31％）和疲劳（30％）。