Yukimoto Atsushi, Hirooka Masashi, Hiraoka Atsushi, Michitaka Kojiro, Ochi Hironori, Joko Kouji, Imai Yusuke, Watanabe Takao, Koizumi Yohei, Yoshida Osamu, Abe Masanori, Hiasa Yoichi
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Japan.
Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Jpn J Clin Oncol. 2019 Jan 1;49(1):42-47. doi: 10.1093/jjco/hyy153.
Although sorafenib-regorafenib sequential therapy improves the prognosis of patients with hepatocellular carcinoma (HCC), many patients abandon sequential therapy due to worsening hepatic reserve function. Thus, it is important to clarify which patients can be treated using regorafenib. The albumin-bilirubin score is a good biomarker for hepatic reserve function. The aim of this study was to determine whether patient albumin-bilirubin scores at the start of sorafenib treatment could be used to identify candidates for subsequent regorafenib therapy.
This is a retrospective cohort study. From 2009 to 2017, 267 hepatocellular carcinoma patients treated with sorafenib were enrolled. After sorafenib therapy, 138 progressive disease patients were analyzed. The patients were divided in two groups: (i) regorafenib candidate group (Child-Pugh class A, Eastern Cooperative Oncology Group Performance Status ≤1, and maintained sorafenib tolerance); and (ii) regorafenib non-candidate group. The primary endpoint was the albumin-bilirubin score. We assessed retrospectively whether albumin-bilirubin scores were useful for predicting regorafenib treatment regimen candidacy.
For the 138 analyzed patients, the median overall survival duration was 15.6 months in the regorafenib candidate group and 6.8 months in the regorafenib non-candidate group (P < 0.01). Using univariate analysis, etiology, aspartate aminotransferase ≥40 IU/L, prothrombin time ≥85% and albumin-bilirubin score <-2.53 at the start of sorafenib treatment were identified as predictors. Using multivariate analysis, albumin-bilirubin score <-2.53 was the only significant predictor.
Based on the multivariate analysis results, albumin-bilirubin score at the start of sorafenib therapy is a useful marker for identifying candidate patients for starting regorafenib therapy.
尽管索拉非尼-瑞戈非尼序贯疗法可改善肝细胞癌(HCC)患者的预后,但许多患者因肝储备功能恶化而放弃序贯治疗。因此,明确哪些患者可以使用瑞戈非尼进行治疗非常重要。白蛋白-胆红素评分是肝储备功能的良好生物标志物。本研究的目的是确定索拉非尼治疗开始时患者的白蛋白-胆红素评分是否可用于识别后续瑞戈非尼治疗的候选者。
这是一项回顾性队列研究。2009年至2017年,纳入了267例接受索拉非尼治疗的肝细胞癌患者。索拉非尼治疗后,对138例疾病进展患者进行分析。患者分为两组:(i)瑞戈非尼候选组(Child-Pugh A级,东部肿瘤协作组体能状态≤1,且维持索拉非尼耐受性);(ii)瑞戈非尼非候选组。主要终点是白蛋白-胆红素评分。我们回顾性评估白蛋白-胆红素评分是否有助于预测瑞戈非尼治疗方案的候选资格。
对于138例分析患者,瑞戈非尼候选组的中位总生存时间为15.6个月,瑞戈非尼非候选组为6.8个月(P<0.01)。单因素分析显示,病因、索拉非尼治疗开始时天冬氨酸转氨酶≥40 IU/L、凝血酶原时间≥85%以及白蛋白-胆红素评分<-2.53被确定为预测因素。多因素分析显示,白蛋白-胆红素评分<-2.53是唯一显著的预测因素。
基于多因素分析结果,索拉非尼治疗开始时的白蛋白-胆红素评分是识别开始瑞戈非尼治疗候选患者的有用标志物。