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索拉非尼和乐伐替尼作为肝细胞癌一线治疗的疗效比较:聚焦分子靶向药物序贯治疗的倾向评分匹配分析

Comparison of therapeutic outcomes of sorafenib and lenvatinib as primary treatments for hepatocellular carcinoma with a focus on molecular-targeted agent sequential therapy: A propensity score-matched analysis.

作者信息

Tomonari Tetsu, Sato Yasushi, Tani Joji, Hirose Akira, Ogawa Chikara, Morishita Akihiro, Tanaka Hironori, Tanaka Takahiro, Taniguchi Tatsuya, Okamoto Koichi, Sogabe Masahiro, Miyamoto Hiroshi, Muguruma Naoki, Uchida Kazushige, Masaki Tsutomu, Takayama Tetsuji

机构信息

Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School of Medicine, Tokushima, Tokushima, Japan.

Department of Community Medicine for Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School of Medicine, Tokushima, Tokushima, Japan.

出版信息

Hepatol Res. 2021 Apr;51(4):472-481. doi: 10.1111/hepr.13597. Epub 2021 Mar 1.

Abstract

AIM

The optimal choice between sorafenib (SOR) or lenvatinib (LEN) as the first-line treatment for unresectable hepatocellular carcinoma (u-HCC) remains debatable. Using propensity score matching, this study compares the outcomes of SOR and LEN in the molecular-targeted agent (MTA) sequential treatment of u-HCC patients.

METHODS

This retrospective, multicenter, observational study recruited 137 u-HCC patients who underwent primary treatment with LEN (n = 52) or SOR (n = 85) between June 2017 and June 2020 after regorafenib was approved as the secondary treatment for u-HCC. Propensity score matching was used to reduce confounding, resulting in the selection of 104 patients (n = 52 for the SOR and LEN cohorts).

RESULTS

The median overall survival was 21.8 months for LEN and 20.4 months for SOR. LEN exhibited significantly greater therapeutic efficacy as compared to SOR (objective response rate: 3.8% [SOR] vs. 42.3% [LEN], p < 0.01; progression-free survival: 10 months [LEN] vs. 5.1 months [SOR], p < 0.01). No significant intergroup differences were noted in the rate of transition to secondary MTA treatments (SOR: 58.7%; LEN: 48.4%), adverse events (SOR: 86%; LEN: 95%), and maintenance of the Child-Pugh (CP) score during treatment. Compared to non-MTA treatments, secondary MTA treatment achieved a greater improvement in survival (4.3  vs. 2.8 months, p = 0.0047). Multivariate analysis demonstrated that the CP score (p < 0.01) and alpha-fetoprotein level (p < 0.01) were independent prognostic factors.

CONCLUSIONS

Both SOR and LEN treatments showed a clinically comparable therapeutic efficacy as the first-line treatments for u-HCC patients in an MTA sequential therapy.

摘要

目的

对于不可切除肝细胞癌(u-HCC)的一线治疗,索拉非尼(SOR)和仑伐替尼(LEN)之间的最佳选择仍存在争议。本研究采用倾向评分匹配法,比较SOR和LEN在u-HCC患者分子靶向药物(MTA)序贯治疗中的疗效。

方法

本回顾性、多中心、观察性研究纳入了137例u-HCC患者,这些患者在2017年6月至2020年6月期间接受了LEN(n = 52)或SOR(n = 85)的初始治疗,瑞戈非尼被批准作为u-HCC的二线治疗之后。采用倾向评分匹配法以减少混杂因素,最终选择了104例患者(SOR组和LEN组各52例)。

结果

LEN组的中位总生存期为21.8个月,SOR组为20.4个月。与SOR相比,LEN表现出显著更高的治疗效果(客观缓解率:3.8% [SOR] 对42.3% [LEN],p < 0.01;无进展生存期:10个月 [LEN] 对5.1个月 [SOR],p < 0.01)。在二线MTA治疗的转换率(SOR:58.7%;LEN:48.4%)不良事件(SOR:86%;LEN:95%)以及治疗期间Child-Pugh(CP)评分的维持方面,两组间未观察到显著差异。与非MTA治疗相比,二线MTA治疗在生存期方面有更大改善(4.3个月对2.8个月,p = 0.0047)。多因素分析表明,CP评分(p < 0.01)和甲胎蛋白水平(p < 0.01)是独立的预后因素。

结论

在MTA序贯治疗中,SOR和LEN治疗作为u-HCC患者的一线治疗,在临床上显示出相当的治疗效果。

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