乐伐替尼治疗肝细胞癌的真实世界数据（ELEVATOR）：一项回顾性多中心研究。
Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study.
作者信息
Welland Sabrina, Leyh Catherine, Finkelmeier Fabian, Jefremow André, Shmanko Kateryna, Gonzalez-Carmona Maria A, Kandulski Arne, Jeliazkova Petia, Best Jan, Fründt Thorben W, Djanani Angela, Pangerl Maria, Maieron Andreas, Greil Richard, Fricke Christina, Sookthai Disorn, Günther Rainer, Schmiderer Andreas, Wege Henning, Venerito Marino, Ehmer Ursula, Müller Martina, Strassburg Christian P, Weinmann Arndt, Siebler Jürgen, Waidmann Oliver, Lange Christian M, Saborowski Anna, Vogel Arndt
机构信息
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
Department of Gastroenterology and Hepatology, University Hospital and University of Duisburg-Essen, Essen, Germany.
出版信息
Liver Cancer. 2022 Jan 14;11(3):219-232. doi: 10.1159/000521746. eCollection 2022 Jun.
BACKGROUND
Lenvatinib is approved as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The efficacy of lenvatinib in Caucasian real-world patients is insufficiently defined. The purpose of this study was to evaluate the efficacy of lenvatinib in a multi-center cohort (ELEVATOR) from Germany and Austria.
METHODS
A retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites was conducted. Overall survival, progression free survival, overall response rate and adverse event rates were assessed and analyzed.
RESULTS
Patients receiving lenvatinib in the real-world setting reached a median overall survival of 12.8 months, which was comparable to the results reported from the REFLECT study. Median overall survival (mOS) and progression free survival (mPFS) was superior in those patients who met the inclusion criteria of the REFLECT study compared to patients who failed to meet the inclusion criteria (mOS 15.6 vs 10.2 months, HR 0.55, 95% CI 0.38-0.81, p=0.002; mPFS 8.1 vs 4.8 months HR 0.65, 95% CI 0.46-0.91, p=0.0015). For patients with an impaired liver function according to the Albumin-Bilirubin (ALBI) grade, or reduced ECOG performance status ≥2, survival was significantly shorter compared to patients with sustained liver function (ALBI grade 1) and good performance status (ECOG performance status 0), respectively (HR 1.69, 95% CI 1.07-2.66, p=0.023; HR 2.25, 95% CI 1.19-4.23, p=0.012). Additionally, macrovascular invasion (HR 1.55, 95% CI 1.02-2.37, p=0.041) and an AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0.034) were confirmed as independent negative prognostic factors in our cohort of patients with advanced HCC.
CONCLUSION
Overall, our data confirm the efficacy of lenvatinib as first-line treatment and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC.
背景
乐伐替尼被批准作为晚期肝细胞癌（HCC）患者的一线治疗药物。乐伐替尼在高加索地区真实世界患者中的疗效尚未得到充分明确。本研究的目的是评估乐伐替尼在来自德国和奥地利的多中心队列（ELEVATOR）中的疗效。
方法
对在14个不同地点接受一线系统性乐伐替尼治疗的205例患者进行回顾性数据分析。评估并分析总生存期、无进展生存期、总缓解率和不良事件发生率。
结果
在真实世界中接受乐伐替尼治疗的患者中位总生存期为12.8个月，这与REFLECT研究报告的结果相当。与未达到纳入标准的患者相比，达到REFLECT研究纳入标准的患者的中位总生存期（mOS）和无进展生存期（mPFS）更长（mOS 15.6个月对10.2个月，HR 0.55，95%CI 0.38 - 0.81，p = 0.002；mPFS 8.1个月对4.8个月，HR 0.65，95%CI 0.46 - 0.91，p = 0.0015）。对于根据白蛋白 - 胆红素（ALBI）分级肝功能受损或东部肿瘤协作组（ECOG）体能状态降低≥2的患者，其生存期分别显著短于肝功能持续正常（ALBI 1级）和体能状态良好（ECOG体能状态0）的患者（HR 1.69，95%CI 1.07 - 2.66，p = 0.023；HR 2.25，95%CI 1.19 - 4.23，p = 0.012）。此外，在我们的晚期HCC患者队列中，大血管侵犯（HR 1.55，95%CI 1.02 - 2.37，p = 0.041）和甲胎蛋白（AFP）≥200 ng/mL（HR 1.56，95%CI 1.03 - 2.34，p = 0.034）被确认为独立的不良预后因素。
结论
总体而言，我们的数据证实了乐伐替尼作为一线治疗的疗效，并且在大型回顾性高加索真实世界队列中未发现新的或意外的副作用，支持乐伐替尼作为一线HCC中无法接受基于免疫肿瘤学（IO）联合治疗的患者的有效替代方案。
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