Hiraoka Atsushi, Tanizawa Yoshinori, Huang Yu-Jing, Cai Zhihong, Sakaguchi Sachi
Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Medicines Development Unit, Eli Lilly Japan K.K., Lilly Plaza One Bldg, 5-1-28 Isogamidori, Chuo-Ku, Kobe, 651-0086, Japan.
Drugs Real World Outcomes. 2021 Sep;8(3):301-314. doi: 10.1007/s40801-021-00245-8. Epub 2021 Apr 1.
Evidence about the relationship between albumin-bilirubin (ALBI) grade and sequential systemic therapy for advanced hepatocellular carcinoma in real-world Japanese clinical practice is limited.
The objective of this study was to investigate ALBI grades and sequential treatment for advanced hepatocellular carcinoma in Japanese clinical practice.
We conducted a retrospective cohort study using a Japanese hospital-based administration database to assess treatment sequence in patients with confirmed advanced hepatocellular carcinoma and first prescription (index line) of lenvatinib (July 2014-June 2019; N = 1558) or sorafenib (July 2014-June 2016 [sorafenib-A; N = 1511] or June 2017-June 2019 [sorafenib-B; N = 1276]). Transition to subsequent line was assessed in patients who completed the index line without transarterial chemoembolization. The ALBI grade and sequential treatment relationships were analyzed in patients with baseline and/or end of index line ALBI scores.
Transition to a subsequent line was low (sorafenib-A [n = 1320]: 12.6%; sorafenib-B [n = 1049]: 40.7%; lenvatinib [n = 786]: 27.2%). In patients with baseline ALBI data (combined cohorts; n = 385), overall treatment duration was shorter in those with baseline ALBI grade 2b or 3 vs grade 1 or 2a (median: 7.1, 6.7, 4.5, and 3.0 months for grades 1, 2a, 2b, and 3, respectively). In patients with baseline and end of index line ALBI data (combined cohorts; n = 222), ALBI grade worsened during index line regardless of baseline grade. Of these patients in the sorafenib-B or lenvatinib cohorts who completed the index line without transarterial chemoembolization (n = 120), transition to a subsequent line was higher with the end of index line grade 1/2a (66.7/68.4%) than with grade 2b/3 (34.0/11.1%).
Adequate liver function, indicated by ALBI grade, at the start and end of first-line treatment is associated with successful sequential therapy in Japanese clinical practice.
在日本实际临床实践中，关于白蛋白-胆红素（ALBI）分级与晚期肝细胞癌序贯全身治疗之间关系的证据有限。
本研究的目的是调查日本临床实践中晚期肝细胞癌的ALBI分级和序贯治疗情况。
我们进行了一项回顾性队列研究，使用基于日本医院的管理数据库来评估确诊为晚期肝细胞癌且首次处方（索引线）为乐伐替尼（2014年7月至2019年6月；N = 1558）或索拉非尼（2014年7月至2016年6月[索拉非尼-A；N = 1511]或2017年6月至2019年6月[索拉非尼-B；N = 1276]）的患者的治疗顺序。在未接受经动脉化疗栓塞而完成索引线治疗的患者中评估向后续治疗线的转换。对具有基线和/或索引线结束时ALBI评分的患者分析ALBI分级与序贯治疗的关系。
向后续治疗线的转换率较低（索拉非尼-A [n = 1320]：12.6%；索拉非尼-B [n = 1049]：40.7%；乐伐替尼 [n = 786]：27.2%）。在具有基线ALBI数据的患者（合并队列；n = 385）中，基线ALBI 2b或3级患者的总体治疗持续时间短于1级或2a级患者（1、2a、2b和3级的中位数分别为7.1、6.7、4.5和3.0个月）。在具有基线和索引线结束时ALBI数据的患者（合并队列；n = 222）中，无论基线分级如何，索引线治疗期间ALBI分级均恶化。在索拉非尼-B或乐伐替尼队列中未接受经动脉化疗栓塞而完成索引线治疗的这些患者（n = 120）中，索引线结束时1/2a级患者向后续治疗线的转换率高于2b/3级患者（66.7/68.4%对34.0/11.1%）。
在日本临床实践中，一线治疗开始和结束时由ALBI分级所表明的足够肝功能与成功的序贯治疗相关。
