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Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A retrospective multicenter study
Liver Cancer ( IF 13.8 ) Pub Date : 2022-01-14 , DOI: 10.1159/000521746 Sabrina Welland 1 , Catherine Leyh 2 , Fabian Finkelmeier 3 , André Jefremow 4, 5 , Kateryna Shmanko 6 , Maria A Gonzalez-Carmona 7 , Arne Kandulski 8 , Petia Jeliazkova 9 , Jan Best 10 , Thorben W Fründt 11 , Angela Djanani 12 , Maria Pangerl 13 , Andreas Maieron 14 , Richard Greil 15 , Christina Fricke 14 , Disorn Sookthai 16 , Rainer Günther 13 , Andreas Schmiderer 12 , Henning Wege 11 , Marino Venerito 17 , Ursula Ehmer 9 , Martina Müller 8 , Christian P Strassburg 7 , Arndt Weinmann 6 , Jürgen Siebler 5, 18 , Oliver Waidmann 3 , Christian M Lange 2 , Anna Saborowski 1 , Arndt Vogel 1
Liver Cancer ( IF 13.8 ) Pub Date : 2022-01-14 , DOI: 10.1159/000521746 Sabrina Welland 1 , Catherine Leyh 2 , Fabian Finkelmeier 3 , André Jefremow 4, 5 , Kateryna Shmanko 6 , Maria A Gonzalez-Carmona 7 , Arne Kandulski 8 , Petia Jeliazkova 9 , Jan Best 10 , Thorben W Fründt 11 , Angela Djanani 12 , Maria Pangerl 13 , Andreas Maieron 14 , Richard Greil 15 , Christina Fricke 14 , Disorn Sookthai 16 , Rainer Günther 13 , Andreas Schmiderer 12 , Henning Wege 11 , Marino Venerito 17 , Ursula Ehmer 9 , Martina Müller 8 , Christian P Strassburg 7 , Arndt Weinmann 6 , Jürgen Siebler 5, 18 , Oliver Waidmann 3 , Christian M Lange 2 , Anna Saborowski 1 , Arndt Vogel 1
Affiliation
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.
中文翻译:
Lenvatinib 治疗肝细胞癌 (ELEVATOR) 的真实数据:一项回顾性多中心研究
背景 Lenvatinib 被批准作为晚期肝细胞癌 (HCC) 患者的一线治疗药物。lenvatinib 在高加索真实世界患者中的疗效尚不明确。本研究的目的是评估 lenvatinib 在来自德国和奥地利的多中心队列 (ELEVATOR) 中的疗效。方法对 14 个不同部位接受一线全身性乐伐替尼治疗的 205 例患者进行回顾性数据分析。评估和分析总生存期、无进展生存期、总反应率和不良事件发生率。结果 在现实世界中接受乐伐替尼的患者中位总生存期达到 12.8 个月,这与 REFLECT 研究报告的结果相当。与不符合纳入标准的患者相比,符合 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) 更优(mOS 15.6 个月 vs 10.2 个月,HR 0.55,95% CI 0.38-0.81,p=0.002;mPFS 8.1 vs 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) 分级显示肝功能受损或 ECOG 体能状态降低≥2 的患者,与肝功能持续(ALBI 1 级)和体能状态良好(ECOG 体能状态)的患者相比,生存期显着缩短0) 分别为 (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,大血管侵犯 (HR 1.55, 95% CI 1.02-2.37, p=0.041) 和 AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0. 034)在我们的晚期 HCC 患者队列中被确认为独立的负面预后因素。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现实世界队列中没有发现新的或意外的副作用,支持使用乐伐替尼作为无法接受 IO 治疗的患者的有意义的替代方案一线 HCC 中的基于组合。
更新日期:2022-01-14
中文翻译:
Lenvatinib 治疗肝细胞癌 (ELEVATOR) 的真实数据:一项回顾性多中心研究
背景 Lenvatinib 被批准作为晚期肝细胞癌 (HCC) 患者的一线治疗药物。lenvatinib 在高加索真实世界患者中的疗效尚不明确。本研究的目的是评估 lenvatinib 在来自德国和奥地利的多中心队列 (ELEVATOR) 中的疗效。方法对 14 个不同部位接受一线全身性乐伐替尼治疗的 205 例患者进行回顾性数据分析。评估和分析总生存期、无进展生存期、总反应率和不良事件发生率。结果 在现实世界中接受乐伐替尼的患者中位总生存期达到 12.8 个月,这与 REFLECT 研究报告的结果相当。与不符合纳入标准的患者相比,符合 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) 更优(mOS 15.6 个月 vs 10.2 个月,HR 0.55,95% CI 0.38-0.81,p=0.002;mPFS 8.1 vs 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) 分级显示肝功能受损或 ECOG 体能状态降低≥2 的患者,与肝功能持续(ALBI 1 级)和体能状态良好(ECOG 体能状态)的患者相比,生存期显着缩短0) 分别为 (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,大血管侵犯 (HR 1.55, 95% CI 1.02-2.37, p=0.041) 和 AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0. 034)在我们的晚期 HCC 患者队列中被确认为独立的负面预后因素。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现实世界队列中没有发现新的或意外的副作用,支持使用乐伐替尼作为无法接受 IO 治疗的患者的有意义的替代方案一线 HCC 中的基于组合。