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乐伐替尼与索拉非尼作为不可切除肝细胞癌经动脉治疗挽救疗法的真实世界比较分析

A Real-World Comparative Analysis of Lenvatinib and Sorafenib as a Salvage Therapy for Transarterial Treatments in Unresectable HCC.

作者信息

Lee Jaejun, Sung Pil Soo, Yang Hyun, Lee Soon Kyu, Nam Hee Chul, Yoo Sun Hong, Lee Hae Lim, Kim Hee Yeon, Lee Sung Won, Kwon Jung Hyun, Jang Jeong Won, Kim Chang Wook, Nam Soon Woo, Bae Si Hyun, Choi Jong Young, Yoon Seung Kew

机构信息

The Catholic University Liver Research Center, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.

Division of Gastroenterology and Hepatology, Department of Internal Medicine, College of Medicine, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul 03382, Korea.

出版信息

J Clin Med. 2020 Dec 21;9(12):4121. doi: 10.3390/jcm9124121.

Abstract

BACKGROUND/AIMS: Lenvatinib was recently approved as a first-line oral multikinase inhibitor for unresectable hepatocellular carcinoma (HCC). In this study, we aimed to compare the efficacy and safety of lenvatinib and sorafenib for the treatment of unresectable HCC in patients with prior failure of transarterial treatment.

METHODS

Between January 2019 and September 2020, 98 unresectable HCC patients treated with lenvatinib or sorafenib as salvage therapy were enrolled from five Korean university-affiliated hospitals. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate were calculated to assess the antitumor response.

RESULTS

A total of 43 and 55 patients were treated with lenvatinib and sorafenib, respectively, as salvage therapy after the failure of transarterial treatments. The median PFS was 4.97 months in the lenvatinib group and 2.47 months in the sorafenib group ( = 0.001, log-rank test). The ORR was significantly higher in the lenvatinib group (25.6%) than in the sorafenib group (3.6%, = 0.002). Use of lenvatinib over sorafenib (hazard ratio: 0.359, 95% confidence interval: 0.203-0.635, < 0.001) was the most significant factor for a favorable PFS after the failure of transarterial treatments in all enrolled patients. For favorable OS, achieving objective response was the significant factor (hazard ratio 0.356, 95% confidence interval: 0.132-0.957, = 0.041). There were no significant differences in the safety profile between the two groups.

CONCLUSIONS

In this real-world study, lenvatinib was demonstrated to be more efficacious than sorafenib as a salvage therapy for transarterial treatments in unresectable HCC.

摘要

背景/目的:乐伐替尼最近被批准作为不可切除肝细胞癌(HCC)的一线口服多激酶抑制剂。在本研究中,我们旨在比较乐伐替尼和索拉非尼在经动脉治疗失败的患者中治疗不可切除HCC的疗效和安全性。

方法

2019年1月至2020年9月期间,从韩国五家大学附属医院招募了98例接受乐伐替尼或索拉非尼作为挽救治疗的不可切除HCC患者。计算无进展生存期(PFS)、总生存期(OS)、客观缓解率(ORR)和疾病控制率以评估抗肿瘤反应。

结果

共有43例和55例患者分别接受乐伐替尼和索拉非尼作为经动脉治疗失败后的挽救治疗。乐伐替尼组的中位PFS为4.97个月,索拉非尼组为2.47个月(P = 0.001,对数秩检验)。乐伐替尼组的ORR显著高于索拉非尼组(25.6%对3.6%,P = 0.002)。在所有入组患者中,经动脉治疗失败后,使用乐伐替尼而非索拉非尼(风险比:0.359,95%置信区间:0.203 - 0.635,P < 0.001)是PFS良好的最显著因素。对于良好的OS,实现客观缓解是显著因素(风险比0.356,95%置信区间:0.132 - 0.957,P = 0.041)。两组的安全性概况无显著差异。

结论

在这项真实世界研究中,乐伐替尼作为不可切除HCC经动脉治疗的挽救治疗比索拉非尼更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/488d/7767204/a75cc6b9fb03/jcm-09-04121-g001.jpg

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