Adjuvant Lenvatinib for High-Risk CNLC IIb/IIIa Hepatocellular Carcinoma After Curative Hepatectomy: A Prospective Exploratory Study.

IF 4.2 3区 医学 Q2 ONCOLOGY
Journal of Hepatocellular Carcinoma Pub Date : 2025-05-22 eCollection Date: 2025-01-01 DOI:10.2147/JHC.S516478
Hui-Chuan Sun, Zhi-Yong Huang, Tianfu Wen, Lianxin Liu, Xiao-Dong Zhu, Erlei Zhang, Chuan Li, Xiaoyun Zhang, Jiabei Wang, Jia Fan, Jian Zhou
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Abstract

Objective: The risk of hepatocellular carcinoma (HCC) recurrence following surgical resection remains high, approaching 50%-70% at 5 years, with the highest risk occurring in the first year after resection. This study aimed to evaluate the efficacy and safety of lenvatinib as adjuvant therapy for HCC.

Methods: In this open-label, single-arm, prospective, multicenter Phase II clinical study, a total of 51 hCC patients with China Liver Cancer (CNLC) stage IIb/IIIa (ie tumor number ≥ 4 or vascular invasion, equivalent to BCLC B/C) who underwent R0 resection 4-6 weeks after curative surgery were enrolled. Patients received lenvatinib for up to 12 months, at a dose of 8 mg/day for body weight < 60 kg, or 12 mg/day for ≥ 60 kg. Patients were followed up every 2 months for a median of 24.1 months.

Results: The median recurrence-free survival (RFS) was 16.1 months, with a 12-month RFS rate of 60.4%, exceeding the historical rate of under 50% in similar high-risk populations. The 12-month overall survival (OS) rate was 93.6%, while median OS was not reached. Treatment-related adverse events (TRAEs) occurred in 88.0% of patients, with ≥ grade 3 TRAEs in 14.0%, including thrombocytopenia and proteinuria in 6.0% of patients each, and leukopenia, neutropenia, elevated aspartate aminotransferase, and elevated alanine aminotransferase in 2.0% of patients each. AEs leading to the interruption of lenvatinib occurred in 6.0% of patients, and dose reduction was required in 18% of patients. No deaths were observed.

Conclusion: Lenvatinib may be an effective adjuvant therapy for patients with CNLC stage IIb/IIIa HCC after R0 hepatectomy. However, the findings are limited by the single-arm design and small patient cohort, necessitating larger randomized controlled trials for validation.

Lenvatinib辅助治疗高危CNLC IIb/IIIa型肝细胞癌:一项前瞻性探索性研究
目的:肝细胞癌(HCC)手术切除后复发率仍然很高,5年复发率接近50%-70%,其中术后第一年复发率最高。本研究旨在评价lenvatinib作为HCC辅助治疗的有效性和安全性。方法:在这项开放标签、单臂、前瞻性、多中心II期临床研究中,共纳入51例中国肝癌(CNLC) IIb/IIIa期(即肿瘤数≥4或血管侵犯,相当于BCLC B/C) hCC患者,这些患者在治愈性手术后4-6周行R0切除术。患者接受lenvatinib治疗长达12个月,体重< 60kg的患者剂量为8mg /天,体重≥60kg的患者剂量为12mg /天。患者每2个月随访一次,中位随访24.1个月。结果:中位无复发生存期(RFS)为16.1个月,12个月RFS率为60.4%,超过了类似高危人群50%以下的历史水平。12个月总生存率(OS)为93.6%,中位OS未达到。治疗相关不良事件(TRAEs)发生率为88.0%,TRAEs≥3级发生率为14.0%,包括血小板减少症和蛋白尿各占6.0%,白细胞减少症、中性粒细胞减少症、天冬氨酸转氨酶升高、丙氨酸转氨酶升高各占2.0%。6.0%的患者发生了导致lenvatinib中断的不良事件,18%的患者需要减少剂量。没有观察到死亡。结论:Lenvatinib可能是CNLC IIb/IIIa期肝癌R0肝切除术后有效的辅助治疗方法。然而,研究结果受到单臂设计和小患者队列的限制,需要更大规模的随机对照试验来验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
0.50
自引率
2.40%
发文量
108
审稿时长
16 weeks
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