Introduction: In the REFLECT trial, lenvatinib was found to be non-inferior 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 to identify clinical factors that could be significantly associated with survival outcomes. Methods: The study population derived from retrospectively collected data of HCC patients treated with lenvatinib. The overall cohort included Western and Eastern populations from 23 centres in five countries. Results: We included 1325 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 aetiology 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 as 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 that the appearance of decreased appetite Grade ≥ 2 versus Grade 0-1 as an independent prognostic factor for worse Progression Free Survival. 924 patients on 1325 progressed during lenvatinib (69.7%), and 827 of them had a follow-up over two-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). Conclusions: Our study confirms in a large and global population of patients with advanced HCC not candidate to locoregional treatment the OS reported in the registration study and a high response rate with lenvatinib.


中文翻译：

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LEnVAtiNib 治疗肝细胞癌的真实生活研究：相关研究


简介：在 REFLECT 试验中，发现乐伐替尼在总生存期方面并不劣于索拉非尼。在这里，我们分析了乐伐替尼在世界各地多个中心的现实生活中的效果，并确定可能与生存结果显着相关的临床因素。 方法：研究人群来源于回顾性收集的接受乐伐替尼治疗的 HCC 患者的数据。整个队列包括来自五个国家 23 个中心的西方和东方人群。 结果：我们的分析中纳入了 1325 名接受乐伐替尼治疗的 HCC 患者。中位 OS 为 16.1 个月。总体回应率为 38.5%。 OS 的多变量分析强调，在所有模型中，HBsAg 阳性、NLR >3 和 AST >38 与不良预后独立相关。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。无进展生存期的多变量分析显示，NAFLD/NASH、BCLC、NLR 和 AST 是无进展生存期的独立预后因素。 75.2% 的患者在研究期间遭受至少一种不良反应。多变量分析表明，与 0-1 级相比，≥ 2 级食欲下降的出现是无进展生存期较差的独立预后因素。 1325 名患者中，有 924 名患者在乐伐替尼期间病情出现进展（69.7%），其中 827 名患者从二线治疗开始后进行了两个月以上的随访。从一线治疗中，乐伐替尼和免疫治疗序列获得最长的中位 OS（47.0 个月），其次是 TACE（24.7 个月）、雷莫芦单抗（21.2 个月）、索拉非尼（15.7 个月）、瑞戈非尼（12.7 个月）和最佳支持治疗（10.8 个月）。结论：我们的研究在全球大量不适合局部治疗的晚期 HCC 患者中证实了注册研究中报告的 OS 以及乐伐替尼的高缓解率。