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西班牙接受系统治疗的肝细胞癌患者的真实世界管理与结局:来自RETUD胃肠病登记处的患者队列

Real-world management and outcomes of patients with hepatocellular carcinoma treated with systemic therapy in Spain: a patient cohort from the RETUD gastrointestinal registry.

作者信息

López-López Carlos, de Castro Eva Martínez, Montes Ana Fernández, Orozco Encarnación Jiménez, Peraita Sandra López, Vera Ruth, Cerdá Paula, Calvo Mariona, Paredes Beatriz García, de Mena Miriam Lobo, La Casta Adelaida, Gallego Javier, Adeva Jorge, Cano Juana Mª Cano, Ruiz-Casado Ana, Vidal-Tocino Rosario, García-García Teresa, Pazo-Cid Roberto, Garrote Mercedes Rodríguez, Sastre Javier

机构信息

Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, UNICAN, Santander, Spain.

Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.

出版信息

Clin Transl Oncol. 2025 Aug 9. doi: 10.1007/s12094-025-04010-z.

Abstract

PURPOSE

Characterization of the management and outcomes of patients diagnosed with hepatocellular carcinoma (HCC) and treated with systemic therapy who were included in the Spanish gastrointestinal RETUD registry.

METHODS/PATIENTS: This is a retrospective, registry-based, non-interventional, multicenter study conducted in Spain (NCT06711211, retrospectively registered in Dec-2024). This cohort from the RETUD registry includes adult patients diagnosed with HCC and treated with systemic therapy between Jan-2017 and Feb-2024. Sociodemographic, clinical, therapeutic and survival data are analyzed descriptively.

RESULTS

Four hundred and sixty nine patients were included (median age: 65.8 years; 90.2% males; 98.1% Caucasian). At diagnosis, 51.8% presented a clinical stage of Barcelona Clinic Liver Cancer (BCLC)-C. At the start of systemic treatment, 34.5% and 30.3% of the patients showed extrahepatic spread of the disease and main portal vein invasion, respectively. The most frequently administered first-line systemic therapies were sorafenib (57.1%), atezolizumab/bevacizumab (27.7%) and lenvatinib (7.5%). More than a third of the cohort (37.1%) received locoregional treatment at any time (before, concurrent and/or after systemic treatment). Overall, the median progression-free survival (PFS) and overall survival (OS) were 5.1 and 9.8 months, respectively. Patients receiving atezolizumab/bevacizumab showed the longest PFS (10.6 months) and OS (14.0 months) of all treatment groups and a numerically higher objective response rate (ORR) compared to the overall population (31.0% vs 12.5%).

CONCLUSIONS

This study offers valuable insights into the clinical characteristics, management, and outcomes of HCC patients in Spain in a real-world setting. Our results suggest potential benefits of immunotherapy-based combinations over other available alternatives, supporting findings from interventional and real-world studies.

摘要

目的

对纳入西班牙胃肠道RETUD注册研究的肝细胞癌(HCC)患者进行系统治疗的管理及结局特征分析。

方法/患者:这是一项在西班牙开展的回顾性、基于注册研究、非干预性多中心研究(NCT06711211,于2024年12月进行回顾性注册)。RETUD注册研究中的这一队列包括2017年1月至2024年2月期间被诊断为HCC并接受系统治疗的成年患者。对社会人口统计学、临床、治疗及生存数据进行描述性分析。

结果

共纳入469例患者(中位年龄:65.8岁;90.2%为男性;98.1%为白种人)。诊断时,51.8%的患者临床分期为巴塞罗那临床肝癌(BCLC)-C期。在开始系统治疗时,分别有34.5%和30.3%的患者出现肝外转移和主要门静脉侵犯。最常用的一线系统治疗药物为索拉非尼(57.1%)、阿替利珠单抗/贝伐珠单抗(27.7%)和仑伐替尼(7.5%)。超过三分之一的队列患者(37.1%)在任何时间(在系统治疗之前、同时或之后)接受了局部区域治疗。总体而言,中位无进展生存期(PFS)和总生存期(OS)分别为5.1个月和9.8个月。在所有治疗组中,接受阿替利珠单抗/贝伐珠单抗治疗的患者PFS最长(10.6个月),OS最长(14.个月),且客观缓解率(ORR)在数值上高于总体人群(31.0%对12.5%)。

结论

本研究为西班牙HCC患者在真实世界中的临床特征、管理及结局提供了有价值的见解。我们的结果表明,基于免疫疗法的联合治疗相较于其他可用方案具有潜在益处,这支持了干预性研究和真实世界研究的结果。

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