Lenvatinib versus Sorafenib as first-line treatment in hepatocellular carcinoma: A multi-institutional matched case-control study

Lenvatinib versus Sorafenib as first-line treatment in hepatocellular carcinoma: A multi-institutional matched case-control study
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DOI:
10.1111/hepr.13718
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发表时间:
2021-10-21
影响因子:
4.2
通讯作者:
Casadei-Gardini, Andrea
Casadei-Gardini, Andrea
中科院分区:
医学2区
文献类型:
--
作者:
Rimini, Margherita;Shimose, Shigeo;Casadei-Gardini, Andrea

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背景:晚期肝癌是世界性的重大健康问题。最近,Reflect试验证明了Lenvatinib在I线设置方面与索拉非尼相比并不逊色,从而导致与索拉非尼一起批准了新的一线治疗标准。目的与方法为评价索拉非尼和列瓦替尼作为首发治疗方案在临床实践中的最佳选择,我们对184例肝细胞癌患者进行了倾向评分匹配的多中心分析。结果Lenvatinib和Sorafenib ARM的中位总生存期(OS)分别为15.2和10.5个月。Lenvatinib和Sorafenib ARM的中位无进展生存期(PFS)分别为7.0个月和4.5个月。接受Lenvatinib治疗的患者死亡风险降低36%(p=0.0156),进展风险降低29%(p=0.0446),有效率更高(p<0.00001),疾病控制率更高(p=0.002)。索拉非尼与更多的手足皮肤反应相关,Lenvatinib与更多的高血压和疲倦相关。我们强调了巴塞罗那临床肝癌(BCLC)分期、东部合作肿瘤组表现状态(ECOG-PS)、胆红素、碱性磷酸酶和嗜酸性粒细胞对索拉非尼预后的影响。相反,白蛋白、天冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)和中性粒细胞/淋巴细胞比率(NLR)是Lenvatinib组的预后指标。最后,我们强调了白蛋白正常值(NV)、ECOG>0、NLR<3、无丙型肝炎病毒阳性、门静脉血栓形成有利于Lenvatinib ARM的阳性预测作用。嗜酸性粒细胞0对索拉非尼的疗效有负面预测作用。结论与索拉非尼相比,SLenvatinib在真实世界中表现得更好。需要更多的研究来验证对Lenvatinib的反应的预测因素,而不是索拉非尼。
Background Advanced Hepatocarcinoma (HCC) is an important health problem worldwide. Recently, the REFLECT trial demonstrated the non-inferiority of Lenvatinib compared to Sorafenib in I line setting, thus leading to the approval of new first-line standard of care, along with Sorafenib. Aims and methods With aim to evaluate the optimal choice between Sorafenib and Lenvatinib as primary treatment in clinical practice, we performed a multicentric analysis with the propensity score matching on 184 HCC patients. Results The median overall survival (OS) were 15.2 and 10.5 months for Lenvatinib and Sorafenib arm, respectively. The median progression-free survival (PFS) was 7.0 and 4.5 months for Lenvatinib and Sorafenib arm, respectively. Patients treated with Lenvatinib showed a 36% reduction of death risk (p = 0.0156), a 29% reduction of progression risk (p = 0.0446), a higher response rate (p < 0.00001) and a higher disease control rate (p = 0.002). Sorafenib showed to be correlated with more hand-foot skin reaction and Lenvatinib with more hypertension and fatigue. We highlighted the prognostic role of Barcelona Clinic Liver Cancer (BCLC) stage, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), bilirubin, alkaline phosphatase and eosinophils for Sorafenib. Conversely, albumin, aspartate aminotransferase (AST), alkaline phosphatase and Neutrophil-Lymphocyte Ratio (NLR) resulted prognostic in Lenvatinib arm. Finally, we highlighted the positive predictive role of albumin > Normal Value (NV), ECOG > 0, NLR < 3, absence of Hepatitis C Virus positivity, and presence of portal vein thrombosis in favor of Lenvatinib arm. Eosinophil 0 negatively predicted the response to Sorafenib. Conclusion SLenvatinib showed to better perform in a real-word setting compared to Sorafenib. More researches are needed to validate the predictor factors of response to Lenvatinib rather than Sorafenib.