评估索拉非尼（SORA-2）作为不可切除肝细胞癌二线治疗的疗效：一项欧洲回顾性多中心研究。
Evaluating Sorafenib (SORA-2) as Second-Line Treatment for Unresectable Hepatocellular Carcinoma: A European Retrospective Multicenter Study.
作者信息
Möhring Christian, Berger Moritz, Sadeghlar Farsaneh, Zhou Xin, Zhou Taotao, Monin Malte Benedikt, Shmanko Kateryna, Welland Sabrina, Sinner Friedrich, Schwacha-Eipper Birgit, Bauer Ulrike, Roderburg Christoph, Pirozzi Angelo, Ben Khaled Najib, Schrammen Peter, Balcar Lorenz, Pinter Matthias, Ettrich Thomas J, Saborowski Anna, Berres Marie-Luise, De Toni Enrico N, Lüdde Tom, Rimassa Lorenza, Ehmer Ursula, Venerito Marino, Radu Iuliana-Pompilia, Schmidt-Wolf Ingo G H, Weinmann Arndt, Vogel Arndt, Schmid Matthias, Kalff Jörg C, Strassburg Christian P, Gonzalez-Carmona Maria A
机构信息
Department of Medicine I, University Hospital of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.
Department IB of Internal Medicine, German Armed Forces Central Hospital, 56072 Koblenz, Germany.
出版信息
Cancers (Basel). 2025 Mar 13;17(6):972. doi: 10.3390/cancers17060972.
BACKGROUND/OBJECTIVES: Systemic treatment for unresectable hepatocellular carcinoma (HCC) has rapidly advanced, with immune checkpoint inhibitors now the preferred first-line option. However, with multiple agents available and no established treatment sequence, selecting the most suitable second-line (2L) therapy remains challenging. While sorafenib is frequently chosen for 2L treatment, comprehensive data supporting its use is limited. This study evaluates the effectiveness of sorafenib as 2L therapy and factors influencing outcomes following first-line treatment failure in advanced HCC patients.
METHODS
This is a retrospective, multicenter study, including 81 patients with unresectable HCC from 12 European centers who received sorafenib as 2L treatment. Median overall survival (mOS), median progression-free survival (mPFS), radiological response to treatment, and toxicity were evaluated. Univariable and multivariable analyses were performed to identify potential predictors of clinical benefit.
RESULTS
In this cohort, some patients were treated with 2L sorafenib mOS for 7.4 months (95% CI: 6.6-13.6) and other patients were treated with mPFS for 3.7 months (95% CI: 3.0-4.8). Multivariable analysis revealed the best median OS for patients with CP A and AFP levels < 400 ng/mL (15.5 months). Adverse events (AE) of grade ≥ 3 were reported in 59.4% of patients.
CONCLUSIONS
In this real-world cohort of European patients with unresectable HCC, the outcome of sorafenib treatment in the 2L setting was comparable to that of the other established 2L treatment options in patients with preserved liver function and good performance status. This study contributes to the understanding of the role of sorafenib in the 2L setting and underscores the need for further research to identify predictive factors for response and survival in order to optimize treatment algorithms for advanced HCC.
背景/目的：不可切除肝细胞癌（HCC）的系统治疗进展迅速，免疫检查点抑制剂现已成为首选的一线治疗方案。然而，由于有多种药物可供选择且尚无既定的治疗顺序，选择最合适的二线（2L）治疗仍然具有挑战性。虽然索拉非尼常被选作2L治疗药物，但支持其使用的全面数据有限。本研究评估了索拉非尼作为2L治疗的有效性以及影响晚期HCC患者一线治疗失败后预后的因素。
方法
这是一项回顾性多中心研究，纳入了来自12个欧洲中心的81例不可切除HCC患者，这些患者接受索拉非尼作为2L治疗。评估了中位总生存期（mOS）、中位无进展生存期（mPFS）、治疗的放射学反应和毒性。进行单变量和多变量分析以确定临床获益的潜在预测因素。
结果
在该队列中，部分患者接受2L索拉非尼治疗的mOS为7.4个月（95%CI：6.6 - 13.6），其他患者的mPFS为3.7个月（95%CI：3.0 - 4.8）。多变量分析显示，Child-Pugh A级且甲胎蛋白（AFP）水平<400 ng/mL的患者中位OS最佳（15.5个月）。59.4%的患者报告了≥3级不良事件（AE）。
结论
在这个欧洲不可切除HCC患者的真实世界队列中，索拉非尼在2L治疗中的疗效与其他既定的2L治疗方案在肝功能良好和体能状态良好的患者中相当。本研究有助于理解索拉非尼在2L治疗中的作用，并强调需要进一步研究以确定反应和生存的预测因素，从而优化晚期HCC的治疗方案。
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