J Gastroenterol:乐伐替尼晚期肝细胞癌2期临床研究

2017-03-27 MedSci MedSci原创

背景:乐伐替尼是一种口服的血管内皮生长因子受体1-3、成纤维细胞生长因子受体1-4、血小板源性生长因子受体α、RET及KIT抑制剂。该2期、单组、非盲、多中心研究旨在评估乐伐替尼在晚期肝细胞癌中的作用。方法:病理或临床确诊的晚期肝细胞癌患者,不适合外科手术切除或局部治疗者,接受每天12mg的乐伐替尼治疗,28天为一周期。主要观察终点为肿瘤进展时间/校正的实体肿瘤疗效评价标准V1.1。次要终点包括客

背景:乐伐替尼是一种口服的血管内皮生长因子受体1-3、成纤维细胞生长因子受体1-4、血小板源性生长因子受体α、RET及KIT抑制剂。该2期、单组、非盲、多中心研究旨在评估乐伐替尼在晚期肝细胞癌中的作用。

方法:病理或临床确诊的晚期肝细胞癌患者,不适合外科手术切除或局部治疗者,接受每天12mg的乐伐替尼治疗,28天为一周期。主要观察终点为肿瘤进展时间/校正的实体肿瘤疗效评价标准V1.1。次要终点包括客观反应率、疾病控制率和总体生存率。

结果:2010年7月至2011年6月,在日本和韩国共有46例患者接受乐伐替尼治疗。中位肿瘤进展时间(由独立的放射学评估决定)为7.4个月(95%置信区间5.5-9.4)。17位患者(37%)部分缓解,19位患者(41%)保持稳定。中位生存期为18.7个月(95%置信区间12.7-25.1)。最常见的不良反应(不论等级)为高血压(76%)、掌足红肿综合征(65%)、食欲减退(61%)和蛋白尿(61%)。34位患者(74%)因为不良反应而减量,10位患者(22%)停用药物。早期停药(小于30天)或减量的患者中位体重要低于未停药或减药患者。

结论:在晚期肝癌患者中,每天12mg乐伐替尼表现出临床收益及可接受的副作用,但对于低体重患者,早期剂量更改是必要的。乐伐替尼在肝细胞癌患者的进一步应用中应考虑通过体重进行剂量调整。

原始出处:
Ikeda, K, Kudo, M, Kawazoe, S. et al. Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma. J Gastroenterol (2017) 52: 512. doi:10.1007/s00535-016-1263-4.

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    2017-11-26 xjy02
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    2017-12-08 许安
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