CLIN CANCER RES:索拉菲尼联合改良FOLFOX治疗晚期肝细胞癌

2019-01-20 MedSci MedSci原创

索拉非尼是晚期肝细胞癌(HCC)的标准一线治疗药物。III期SHARP试验表明索拉非尼的中位进展时间(mTTP)为5.5个月,总反应率(ORR)为2%,中位总生存期(mOS)为10.7个月。FOLFOX4在晚期HCC中表现出一定的抗肿瘤活性。CLIN CANCER RES近期发表了一篇文章,评估了索拉非尼联合改良(m)FOLFOX方案的抗肿瘤效果。

索拉非尼是晚期肝细胞癌(HCC)的标准一线治疗药物。III期SHARP试验表明索拉非尼的中位进展时间(mTTP)为5.5个月,总反应率(ORR)为2%,中位总生存期(mOS)为10.7个月。FOLFOX4在晚期HCC中表现出一定的抗肿瘤活性。CLIN CANCER RES近期发表了一篇文章,评估了索拉非尼联合改良(m)FOLFOX方案的抗肿瘤效果。

研究纳入Child-Pugh A级,患有晚期HCC并且之前没有接受全身治疗的患者。患者每天两次接受索拉非尼400 mg治疗,持续2周,同时接受mFOLFOX治疗 [5-氟尿嘧啶(5-FU)1,200 mg / m 2 /天,持续46小时,甲酰四氢叶酸200 mg / m 2,奥沙利铂85 mg / m 2双周]。主要研究终点是mTTP,次要终点包括ORR,mOS和循环生物标志物。研究最终纳入40例患者:HCV / EtOH / HBV,43%/ 28%/ 13%; Child-Pugh A5,70%。显着的3/4级不良事件(AE)包括AST / ALT升高(28%/ 15%),腹泻(13%),高胆红素血症(10%),手足综合征(8%)和出血(8%) 。mTTP为7.7个月,ORR为18%,mOS为15.1个月。索拉非尼+ mFOLFOX增加血浆PlGF,VEGF-D,sVEGFR1,IL12p70,CAIX和CD4 +、 CD8 +效应T淋巴细胞水平并降低血浆sVEGFR2和sc-KIT和调节性T细胞(Tregs)水平。较短的TTP与基线sVEGFR1水平高有关。较短的TTP和OS与Tregs和CD56 Dim的增加有关。

文章最后认为,索拉非尼+ mFOLFOX符合预定的终点,具有疗效,同时存在中等肝毒性。因此,该方案可能对肝储备足够的患者有效。进展时间(TTP)与血管生成生物标志物和循环Tregs之间存在相关性。


原始出处:

Lipika Goyal, Hui Zheng, et al. A Phase II and Biomarker Study of Sorafenib Combined with Modified FOLFOX in Patients with Advanced Hepatocellular Carcinoma. CLIN CANCER RES. January 2019 doi: 10.1158/1078-0432.CCR-18-0847

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    2019-08-14 xjy02
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    2019-01-22 linlin2314

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