索拉非尼作为阿特珠单抗-贝伐单抗治疗不可切除性肝细胞癌后的二线治疗方案的次优疗效。

IF 4 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease Pub Date : 2024-08-20 DOI:10.1016/j.dld.2024.07.035

Francesco Tovoli, Dante Pio Pallotta, Caterina Vivaldi, Claudia Campani, Piera Federico, Andrea Palloni, Andrea Dalbeni, Caterina Soldà, Lorenzo Lani, Gianluca Svegliati-Baroni, Ingrid Garajova, Luca Ielasi, Stefania De Lorenzo, Alessandro Granito, Bernardo Stefanini, Gianluca Masi, Fabio Marra, Sara Lonardi, Giovanni Brandi, Bruno Daniele, Alessandra Auriemma, Laura Schiadà, Rusi Chen, Fabio Piscaglia

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引用次数: 0

摘要

背景：大多数接受阿特珠单抗-贝伐单抗（AB）治疗肝细胞癌的患者最终会出现疾病进展。目前正在进行随机临床试验 (RCT)，以确定二线治疗方案。在没有随机临床试验或患者不符合条件的情况下，通常会根据批准和报销政策处方索拉非尼。然而，支持这种方法的证据却很少：评估索拉非尼对永久停用 AB 的患者的疗效和安全性：ARTE数据库前瞻性地收集了现实生活中接受AB治疗的患者。我们分析了接受索拉非尼二线治疗的患者的疗效：在213名患者中，有130人（61.0%）永久中断了AB治疗。其中 54 人接受了二线治疗，40 人接受了索拉非尼治疗。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%置信区间[CI] 2.7-11.1）：索拉非尼对AB进展期患者的疗效有限。

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

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.

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来源期刊

Digestive and Liver Disease 医学-胃肠肝病学

CiteScore

6.10

自引率

2.20%

发文量

632

审稿时长

19 days

期刊介绍： Digestive and Liver Disease is an international journal of Gastroenterology and Hepatology. It is the official journal of Italian Association for the Study of the Liver (AISF); Italian Association for the Study of the Pancreas (AISP); Italian Association for Digestive Endoscopy (SIED); Italian Association for Hospital Gastroenterologists and Digestive Endoscopists (AIGO); Italian Society of Gastroenterology (SIGE); Italian Society of Pediatric Gastroenterology and Hepatology (SIGENP) and Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Digestive and Liver Disease publishes papers on basic and clinical research in the field of gastroenterology and hepatology. Contributions consist of: Original Papers Correspondence to the Editor Editorials, Reviews and Special Articles Progress Reports Image of the Month Congress Proceedings Symposia and Mini-symposia.