Lenvatinib plus immunotherapy versus lenvatinib monotherapy in lenvatinib-insensitive patients with unresectable hepatocellular carcinoma: a retrospective study.

IF 3 3区医学 Q2 ONCOLOGY

Investigational New Drugs Pub Date : 2025-02-01 Epub Date: 2025-01-07 DOI:10.1007/s10637-024-01502-7

Zeyu Yu, Bin Leng, Ran You, Chendong Wang, Lingfeng Diao, Qingyu Xu, Guowen Yin

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引用次数: 0

Abstract

Purpose: The combination therapy of lenvatinib and immunotherapy as first-line treatment remains controversial in unresectable hepatocellular carcinoma (uHCC). This research aimed to compare the efficacy and safety of lenvatinib monotherapy (L) and combination therapy of lenvatinib and immune checkpoint inhibitor (LI) in lenvatinib-insensitive patients with uHCC.

Methods: Two hundred fifty-five uHCC patients were enrolled in this study. Patients were classified into two groups: (1) Lenvatinib monotherapy (L); (2) Combination therapy (LI). Patients who remained stable disease (SD) but did not achieve complete response (CR) or partial response (PR) or progression disease (PD) for at least 3 months after receiving lenvatinib monotherapy were defined as lenvatinib-insensitive. Overall survival (OS) and progression-free survival (PFS), baseline characteristics, and safety were compared between groups.

Results: The LI group had longer OS (15.9 months vs. 11.9 months, P = 0.001) and PFS (12.6 months vs. 7.3 months, P < 0.001) than the L group. ECOG PS was an independent prognostic factor affecting OS and Up-to-seven was an independent prognostic factor affecting PFS. The frequency of grade ≥ 3 treatment-related adverse events (TRAEs) was not significantly different.

Conclusions: Our study demonstrated that the combination therapy (LI) had longer OS and PFS than the lenvatinib monotherapy (L) in lenvatinib-insensitive patients with uHCC.

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目的：在不可切除肝细胞癌（uHCC）的一线治疗中，来伐替尼和免疫疗法的联合治疗仍存在争议。本研究旨在比较来伐替尼单药治疗（L）和来伐替尼与免疫检查点抑制剂联合治疗（LI）对来伐替尼不敏感的uHCC患者的疗效和安全性：本研究共招募了255名uHCC患者。患者分为两组：（1）来伐替尼单药治疗组（L）；（2）联合治疗组（LI）。接受来伐替尼单药治疗至少3个月后病情仍保持稳定（SD）但未获得完全应答（CR）或部分应答（PR）或病情进展（PD）的患者被定义为来伐替尼不敏感患者。比较各组的总生存期（OS）和无进展生存期（PFS）、基线特征和安全性：结果：来伐替尼组的OS（15.9个月 vs. 11.9个月，P = 0.001）和PFS（12.6个月 vs. 7.3个月，P我们的研究表明，对于来伐替尼不敏感的uHCC患者，联合疗法（LI）的OS和PFS均长于来伐替尼单药疗法（L）。

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

Investigational New Drugs 医学-药学

CiteScore

7.60

自引率

0.00%

发文量

121

审稿时长

1 months

期刊介绍： The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.