Newly Developed Drugs for Hepatocellular Carcinoma Expanded the Use of Systemic Therapy: An Interrupted Time Series Analysis Using an Electronic Medical Record in Japan.

IF 1.8 3区医学 Q3 ONCOLOGY

Oncology Pub Date : 2025-08-11 DOI:10.1159/000547883

Sachiyo Shirakawa, Takanori Yanai, Koji Kawakami

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引用次数: 0

Abstract

Introduction: Systemic therapy options for hepatocellular carcinoma (HCC) have rapidly expanded, transforming the treatment landscape. However, real-world changes in treatment choices remain unclear. This study aimed to determine the current treatment choices for HCC in Japan, considering age and liver functional reserves.

Methods: We conducted an interrupted time series analysis using electronic medical records in Japan to assess the overall changes in the proportions of systemic therapy among the initial treatments for HCC following the approval of lenvatinib in 2018 and atezolizumab plus bevacizumab (atezo/bev) in 2020, stratified by age and modified albumin-bilirubin (mALBI) grade. This study included patients who were diagnosed with HCC between 2015 and 2022. We also assessed 2-year survival rates.

Results: In the interrupted time series analysis, the proportions of systemic therapy among the initial treatments for HCC increased by 3.96% (95% confidence interval: 2.75, 5.17, p < 0.001) following lenvatinib approval, with a 1.00% (0.45, 1.55, p = 0.002) slope change per 6 months. There was a 4.27% (1.69, 6.86, p = 0.004) increase in systemic therapy use following atezo/bev approval and a 0.27% (-0.66, 1.20, p = 0.53) slope change. In age subgroups with a cutoff of 75 years, the largest increase in systemic therapy use was 6.94% (4.46, 9.42) in the elderly group following atezo/bev approval (p = 0.189). Increases in systemic therapy use following lenvatinib approval in patients with mALBI grades 2b or 3 and 1 or 2 were 10.0% (6.70, 13.42) and 0.80% (-1.16, 2.77), respectively (p < 0.001). There was no apparent change in the overall 2-year survival or in any subgroup before and after approval.

Conclusion: Newly developed drugs for HCC would expand the population for systemic therapy. The optimal population for systemic therapy should be explored based on long-term survival considering age and liver functional reserve heterogeneity.

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新开发的肝细胞癌药物扩大了全身治疗的使用：日本使用电子病历进行的中断时间序列分析。

导读：肝细胞癌（HCC）的全身治疗选择迅速扩大，改变了治疗前景。然而，现实世界中治疗选择的变化仍不清楚。本研究旨在考虑年龄和肝功能储备，确定目前日本HCC的治疗选择。方法：我们使用日本的电子医疗记录进行了中断时间序列分析，以评估2018年lenvatinib和2020年atezolizumab加贝伐单抗（atezo/bev）获批后HCC初始治疗中全身治疗比例的总体变化，并按年龄和修改的白蛋白胆红素（mALBI）等级分层。该研究纳入了2015年至2022年间被诊断为HCC的患者。我们还评估了2年生存率。结果：在中断时间序列分析中，lenvatinib批准后，全身治疗在HCC初始治疗中的比例增加了3.96%(95%可信区间：2.75,5.17,p < 0.001)，每6个月斜率变化为1.00% （0.45,1.55,p = 0.002）。atezo/bev批准后，全身治疗的使用增加了4.27% (1.69,6.86,p = 0.004)，斜率变化为0.27% （-0.66,1.20,p = 0.53）。在75岁的年龄亚组中，atezo/bev批准后，老年组的全身治疗使用增幅最大，为6.94% (4.46%,9.42%)（p = 0.189）。lenvatinib批准后，mALBI 2b或3级和1或2级患者的全身治疗使用分别增加了10.0%（6.70,13.42）和0.80% (-1.16,2.77)（p < 0.001）。在批准前后，总2年生存率或任何亚组均无明显变化。结论：新开发的肝癌药物将扩大全身治疗人群。在考虑年龄和肝功能储备异质性的基础上，寻找适合全身治疗的最佳人群。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncology 医学-肿瘤学

CiteScore

6.00

自引率

2.90%

发文量

审稿时长

6-12 weeks

期刊介绍： Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.