索拉非尼作为阿替利珠单抗-贝伐珠单抗二线治疗不可切除肝细胞癌的疗效不佳。

Suboptimal outcomes of sorafenib as a second-line treatment after atezolizumab-bevacizumab for unresectable hepatocellular carcinoma.

机构信息

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; Unit of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

出版信息

Dig Liver Dis. 2024 Dec;56(12):2079-2084. doi: 10.1016/j.dld.2024.07.035. Epub 2024 Aug 20.

DOI:10.1016/j.dld.2024.07.035

PMID:39168753

Abstract

BACKGROUND

Most patients receiving atezolizumab-bevacizumab (AB) for hepatocellular carcinoma will eventually experience disease progression. Randomized clinical trials (RCTs) are undergoing to identify second-line treatments. Where RCTs are unavailable or patients are non-eligible, sorafenib is often prescribed based on approval and reimbursement policies. However, evidence supporting this approach is minimal.

OBJECTIVE

To assess the efficacy and safety of sorafenib in patients who permanently discontinued AB.

METHODS

The ARTE database prospectively collects patients treated with AB in a real-life setting. We analysed the outcome of patients who received sorafenib as second-line treatment.

RESULTS

Amongst 213 patients, 130 (61.0 %) permanently discontinued AB. Of them, 54 received second- line treatments, and sorafenib was prescribed in 40 patients. The disease control rate (DCR) was 10.0 %. The median progression-free (PFS) and overall survival were 3.3 (95 % confidence interval [CI] 2.7-3.9) and 6.9 months (95 % CI 2.7-11.1), respectively.

CONCLUSIONS

In patients progressing under AB, the efficacy of sorafenib on different outcomes is limited.

摘要

背景

大多数接受阿特珠单抗-贝伐珠单抗（AB）治疗肝细胞癌的患者最终会出现疾病进展。正在进行随机临床试验（RCT）以确定二线治疗方法。在 RCT 不可用或患者不符合条件的情况下，根据批准和报销政策，通常会开索拉非尼。然而，支持这种方法的证据很少。

目的

评估索拉非尼在永久性停用 AB 的患者中的疗效和安全性。

方法

ARTE 数据库前瞻性地收集了真实环境中接受 AB 治疗的患者的数据。我们分析了接受索拉非尼作为二线治疗的患者的结局。

结果

在 213 名患者中，有 130 名（61.0%）永久性停用 AB。其中，54 名患者接受了二线治疗，40 名患者开了索拉非尼。疾病控制率（DCR）为 10.0%。中位无进展生存期（PFS）和总生存期分别为 3.3 个月（95%置信区间 [CI] 2.7-3.9）和 6.9 个月（95%CI 2.7-11.1）。