A Newly Launched Nationwide Database Revealed Real-World Evidence on Systemic Therapy for Unresectable Hepatocellular Carcinoma in Japan: Hepatoma Registry of Integrating and Aggregating Electronic Health Record (HERITAGE)

作者：Yoshinari Asaoka, Ryosuke Tateishi, Yasuhide Yamada, Takashi Kokudo, Akiko Saito, Kiyoshi Hasegawa, Hiroko Iijima, Naoya Kato, Mitsuo Shimada, Etsuro Hatano, Takumi Fukumoto, Takamichi Murakami, Hirohisa Yano, Kengo Yoshimitsu, Masayuki Kurosaki, Michiie Sakamoto, Yutaka Matsuyama, Masatoshi Kudo, Hiroaki Miyata, Norihiro Kokudo · 发表于：Liver Cancer · 年份：2025 · DOI：10.1159/000546862 · 被引用次数：9 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cholangiocarcinoma and Gallbladder Cancer Studies、Gastric Cancer Management and Outcomes

Background and Aims: As systemic therapy for hepatocellular carcinoma (HCC) rapidly advances, eight treatment regimens are currently approved in Japan. However, the limited settings of phase III clinical trials necessitate large-scale real-world data to evaluate effective treatment sequences. To address this, we established a nationwide registry called the Hepatoma Registry of Integrating and Aggregating Electronic Health Record (HERITAGE). Approach and Results: HERITAGE, associated with a nationwide follow-up survey by the Japan Liver Cancer Association, included cases where first-line systemic therapy commenced between April 2015 and December 2022. We collected data on treatment regimens, patient demographics, effectiveness, and duration and assessed changes in regimens, trends in patient characteristics, efficacy per regimen, and cross-resistance in combinations of first- and second-line treatments. The study enrolled over 8,000 treatment lines from 5,525 cases. Chronological analysis revealed a progression in first-line treatments from sorafenib to lenvatinib and then to atezolizumab plus bevacizumab. These regimens were frequently reused in second and subsequent lines. There was an increase in older patients and those with nonviral etiologies and robust liver function. Treatments were generally initiated at earlier disease stages. Cross-resistance studies indicated that responses to second-line treatments were significantly influenced by the efficacy of first-line therap...