Real Life Study of Lenvatinib Therapy for Hepatocellular Carcinoma: RELEVANT Study.
Real Life Study of Lenvatinib Therapy for Hepatocellular Carcinoma: RELEVANT Study.
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作者：
在REFLECT试验中，lenvatinib在总生存期方面不逊于sorafenib。在这里，我们分析了lenvatinib在世界各地几个中心的现实生活经验中的作用，并确定了可能与生存结果显著相关的临床因素。研究人群来源于回顾性收集的肝细胞癌患者lenvatinib治疗的数据。整个队列包括来自5个国家23个中心的西部和东部人口。在我们的分析中，我们纳入了1325例接受lenvatinib治疗的HCC患者。中位OS为16.1个月。总有效率为38.5%。OS的多因素分析显示，所有模型中HBsAg阳性、NLR >3和AST bbb38与预后不良独立相关。相反，NAFLD/ nash相关病因与良好预后独立相关。中位无进展生存期为6.3个月。无进展生存的多变量分析显示，NAFLD/NASH、BCLC、NLR和AST是无进展生存的独立预后因素。75.2%的患者在研究期间至少出现一种不良反应。多变量分析显示，≥2级与0-1级相比，食欲下降是导致无进展生存期恶化的独立预后因素。1325例患者中有924例（69.7%）在lenvatinib治疗期间出现进展，其中827例从二线治疗开始随访超过2个月。从一线治疗来看，lenvatinib +免疫治疗获得的中位生存期最长（47.0个月），其次是TACE（24.7个月）、ramucirumab（21.2个月）、sorafenib（15.7个月）、regorafenib（12.7个月）和最佳支持治疗（10.8个月）。我们的研究在全球大量晚期HCC患者中证实了注册研究中报告的OS和lenvatinib的高应答率，这些患者不适合局部治疗。
In the REFLECT trial, lenvatinib was found to be noninferior compared to sorafenib in terms of overall survival. Here, we analyze the effects of lenvatinib in the real-life experience of several centers across the world and identify clinical factors that could be significantly associated with survival outcomes. The study population was derived from retrospectively collected data of HCC patients treated with lenvatinib. The overall cohort included western and eastern populations from 23 center in five countries. We included 1,325 patients with HCC and treated with lenvatinib in our analysis. Median OS was 16.1 months. Overall response rate was 38.5%. Multivariate analysis for OS highlighted that HBsAg positive, NLR >3, and AST >38 were independently associated with poor prognosis in all models. Conversely, NAFLD/NASH-related etiology was independently associated with good prognosis. Median progression-free survival was 6.3 months. Multivariate analysis for progression-free survival revealed that NAFLD/NASH, BCLC, NLR, and AST were independent prognostic factors for progression-free survival. A proportion of 75.2% of patients suffered from at least one adverse effect during the study period. Multivariate analysis exhibited the appearance of decreased appetite grade ≥2 versus grade 0–1 as an independent prognostic factor for worse progression-free survival. 924 patients of 1,325 progressed during lenvatinib (69.7%), and 827 of them had a follow-up over 2 months from the beginning of second-line treatment. From first-line therapy, the longest median OS was obtained with the sequence lenvatinib and immunotherapy (47.0 months), followed by TACE (24.7 months), ramucirumab (21.2 months), sorafenib (15.7 months), regorafenib (12.7 months), and best supportive care (10.8 months). Our study confirms in a large and global population of patients with advanced HCC, not candidates for locoregional treatment the OS reported in the registration study and a high response rate with lenvatinib.
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影响因子：
158.5
作者：
Llovet, Josep M.;Ricci, Sergio;Bruix, Jordi
通讯作者：
Bruix, Jordi
影响因子：
2.2
作者：
Jefremow, A.;Wiesmueller, M.;Siebler, J.
通讯作者：
Siebler, J.
DOI：
10.2169/internalmedicine.5185-20
发表时间：
2021-02-01
期刊：
Internal medicine (Tokyo, Japan)
影响因子：
--
作者：
Kasuya K;Kawamura Y;Kobayashi M;Shindoh J;Kobayashi Y;Kajiwara A;Iritani S;Fujiyama S;Hosaka T;Saitoh S;Sezaki H;Akuta N;Suzuki F;Suzuki Y;Ikeda K;Arase Y;Eguchi Y;Hashimoto M;Kumada H
通讯作者：
Kumada H
影响因子：
158.5
作者：
Finn, Richard S.;Qin, Shukui;Cheng, Ann-Lii
通讯作者：
Cheng, Ann-Lii
索拉非尼对亚太地区晚期肝细胞癌患者的疗效和安全性：一项 III 期随机、双盲、安慰剂对照试验
影响因子：
51.1
作者：
Cheng, Ann-Lii;Kang, Yoon-Koo;Guan, Zhongzhen
通讯作者：
Guan, Zhongzhen