白蛋白-胆红素评分在预测接受雷莫芦单抗治疗的日本晚期肝细胞癌患者结局中的作用：一项真实世界研究。

The Role of the Albumin-Bilirubin Score for Predicting the Outcomes in Japanese Patients with Advanced Hepatocellular Carcinoma Treated with Ramucirumab: A Real-World Study.

机构信息

Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan,

Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan.

出版信息

Oncology. 2021;99(4):203-214. doi: 10.1159/000511734. Epub 2020 Dec 4.

DOI:10.1159/000511734

PMID:33279908

Abstract

AIM

The aim of this retrospective study was to investigate the efficacy and safety of ramucirumab treatment under real-world conditions and to clarify the role of albumin-bilirubin (ALBI) score in predicting outcomes.

METHODS

Between June 2019 and May 2020, a total of 16 patients with advanced hepatocellular carcinoma (HCC) treated with ramucirumab in Gunma Saiseikai Maebashi Hospital and its affiliated hospitals was included.

RESULTS

The median age was 71 (interquartile range [IQR] 65-74) years old, and 12 patients (75.0%) were male. The modified ALBI (mALBI) grade was 1, 2a, and 2b at baseline in 4 (25.0%), 3 (18.8%), and 9 patients (56.3%), respectively. The Barcelona Clinic Liver Cancer stage was intermediate and advanced stage in 1 (6.3%) and 15 patients (93.8%), respectively. The serum α-fetoprotein at baseline was 4,911 (IQR 2,091-17,377) ng/mL. The disease control rate in patients with mALBI grade1 + 2a was significantly higher than in those with mALBI grade 2b (100 vs. 28.6%, p = 0.028). The patients with mALBI grade 1 + 2a had a significantly better overall survival (OS) and longer progression-free survival (PFS) than those with mALBI grade 2b (median OS 6.7 vs. 3.0 months; p = 0.036, median PFS 7.5 vs. 1.4 months; p = 0.002). The number of cycles of ramucirumab treatment was significantly correlated with the ALBI score (r = -0.452, p = 0.030). The patients with mALBI grade 1 + 2a showed a low incidence of adverse events (AEs) and discontinuation due to AEs.

CONCLUSIONS

Advanced HCC patients with mALBI grade 1 + 2a may be a good indication for ramucirumab treatment.

摘要

目的

本回顾性研究旨在探讨真实世界环境下雷莫芦单抗治疗的疗效和安全性，并阐明白蛋白-胆红素（ALBI）评分在预测结局中的作用。

方法

2019 年 6 月至 2020 年 5 月，共纳入在群马县立癌症中心前桥医院及其附属医院接受雷莫芦单抗治疗的 16 例晚期肝细胞癌（HCC）患者。

结果

中位年龄为 71（四分位距[IQR]65-74）岁，12 例（75.0%）为男性。基线时改良 ALBI（mALBI）分级为 1、2a 和 2b 的患者分别为 4 例（25.0%）、3 例（18.8%）和 9 例（56.3%）。巴塞罗那临床肝癌分期为中晚期的患者分别为 1 例（6.3%）和 15 例（93.8%）。基线时血清甲胎蛋白为 4911（IQR 2091-17377）ng/ml。mALBI 分级 1+2a 的患者疾病控制率明显高于 mALBI 分级 2b 的患者（100% vs. 28.6%，p=0.028）。mALBI 分级 1+2a 的患者总生存期（OS）和无进展生存期（PFS）明显优于 mALBI 分级 2b 的患者（中位 OS 6.7 个月 vs. 3.0 个月；p=0.036，中位 PFS 7.5 个月 vs. 1.4 个月；p=0.002）。雷莫芦单抗治疗的周期数与 ALBI 评分显著相关（r=-0.452，p=0.030）。mALBI 分级 1+2a 的患者不良事件（AE）发生率低，AE 导致停药率低。