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乐伐替尼作为晚期肝硬化肝功能受损患者肝细胞癌一线治疗:三级肝胆中心的真实世界数据与经验

Lenvatinib as First-line Treatment of Hepatocellular Carcinoma in Patients with Impaired Liver Function in Advanced Liver Cirrhosis: Real World Data and Experience of a Tertiary Hepatobiliary Center.

作者信息

Cosma Lidia-Sabina, Weigand Kilian, Müller-Schilling Martina, Kandulski Arne

机构信息

Department and Outpatients Department of Internal Medicine I, University Hospital Regensburg, Regensburg, Germany. .

Department and Outpatients Department of Internal Medicine I, University Hospital Regensburg, Regensburg, Germany.

出版信息

J Gastrointestin Liver Dis. 2021 Jun 18;30(2):247-253. doi: 10.15403/jgld-3345.

DOI:10.15403/jgld-3345
PMID:33951122
Abstract

BACKGROUND AND AIMS

Lenvatinib is a multikinase inhibitor approved for systemic first line treatment of hepatocellular cancer (HCC) in patients with compensated liver cirrhosis (LC) and unaltered liver function. We aimed to evaluate the efficiency and tolerability of lenvatinib in patients with HCC in a real world setting, also including patients with advanced LC and impaired liver function.

METHODS

Retrospectively, 35 patients with HCC BCLC stages B, C and D were screened. After drop-out and exclusion of patients not receiving active treatment for > 2 weeks, 28 patients (27 male; median age 64.7) with advanced HCC and LC were included in the analysis.

RESULTS

Fourteen patients (male, median age 62.7) treated had Child-Pugh class B LC, while the other 12 patients had a good liver function Child-Pugh class A (male, median age 68.8). Two patients had advanced Child-Pugh class C LC. The patients received an escalating dosing scheme of lenvatinib up to 12 mg/d. The tolerability of lenvatinib was similar in most of the patients, with no significant difference between the subgroups. Median survival was better in patients with Child-Pugh A LC (p=0.003). More than 60% of the patients with Child-Pugh A were still on treatment at the time of data analysis with a median follow-up of 274 ± 117.5 days compared with 153 days (95%CI: 88.3 - 217.7) in patients with Child-Pugh B and 30 days in Child-Pugh C. The survival benefit correlated significantly with less impaired liver function (p=0.003).

CONCLUSION

Tolerability and toxicity of lenvatinib are similar in patients withChild-Pugh class A and class B LC, but patients with less impaired liver function have a better survival benefit.

摘要

背景与目的

乐伐替尼是一种多激酶抑制剂,已被批准用于肝功能代偿性肝硬化(LC)且肝功能未改变的肝细胞癌(HCC)患者的一线全身治疗。我们旨在评估乐伐替尼在真实世界环境中对HCC患者的疗效和耐受性,其中也包括晚期LC和肝功能受损的患者。

方法

回顾性筛选了35例BCLC分期为B、C和D期的HCC患者。在剔除和排除未接受积极治疗超过2周的患者后,纳入28例晚期HCC和LC患者(27例男性;中位年龄64.7岁)进行分析。

结果

接受治疗的14例患者(男性,中位年龄62.7岁)为Child-Pugh B级LC,另外12例患者肝功能良好,为Child-Pugh A级(男性,中位年龄68.8岁)。2例患者为晚期Child-Pugh C级LC。患者接受了剂量递增的乐伐替尼给药方案,最高剂量达12mg/d。大多数患者中乐伐替尼的耐受性相似,各亚组之间无显著差异。Child-Pugh A级LC患者的中位生存期更好(p=0.003)。在数据分析时,超过60%的Child-Pugh A级患者仍在接受治疗,中位随访时间为274±117.5天,而Child-Pugh B级患者为153天(95%CI:88.3 - 217.7),Child-Pugh C级患者为30天。生存获益与肝功能损害较轻显著相关(p=0.003)。

结论

乐伐替尼在Child-Pugh A级和B级LC患者中的耐受性和毒性相似,但肝功能损害较轻的患者生存获益更好。

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