Department of Pharmacy, Gifu University Hospital, Yanagido 1-1, Gifu, 501-1194, Japan.
Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.
Int J Clin Oncol. 2021 Jul;26(7):1257-1263. doi: 10.1007/s10147-021-01910-2. Epub 2021 Apr 11.
Regorafenib is recognized as a later-line standard treatment in patients with metastatic colorectal cancer (mCRC). In this study, we examined the association of the albumin-bilirubin (ALBI) score in patients with mCRC receiving later-line chemotherapy with regorafenib.
We retrospectively analyzed data from patients with mCRC treated with regorafenib in a later line between January 2013 and December 2019. Patients were divided into a Normal-ALBI group (ALBI grade 1) and a High-ALBI group (ALBI grades 2 and 3). Primary endpoint was median overall survival (OS) and secondary endpoints were median time to treatment failure (TTF) and incidence of adverse events (AEs).
Data from 60 patients were analyzed (Normal-ALBI group: 32 patients and High-ALBI group: 28 patients). Median OS [10.23 vs. 3.70 months, hazard ratio (HR): 1.79, 95% confidence interval (CI) 1.02-3.13, p = 0.041] and median TTF (2.27 vs. 1.78 months, HR: 1.78, 95%CI 1.02-3.09, p = 0.042) were significantly longer in the Normal-ALBI group than High-ALBI group. On Cox proportional hazard analysis, ALBI score was significantly correlated with OS. The incidence of liver dysfunction (grade ≥ 2) was significantly higher in the High-ALBI than the Normal-ALBI group (42.9% vs. 15.6%, p = 0.041), whereas other AEs were comparable between the two groups.
ALBI was strongly associated with the prognosis of patients with mCRC treated with regorafenib and with the occurrence of liver-related adverse events. These findings may imply that patients with a high ALBI score should not be treated with regorafenib.
瑞戈非尼被认为是转移性结直肠癌（mCRC）患者的三线标准治疗药物。在这项研究中，我们研究了 mCRC 患者接受三线化疗联合瑞戈非尼治疗时的白蛋白-胆红素（ALBI）评分与预后的关系。
我们回顾性分析了 2013 年 1 月至 2019 年 12 月期间接受三线瑞戈非尼治疗的 mCRC 患者的数据。患者分为正常 ALBI 组（ALBI 分级 1）和高 ALBI 组（ALBI 分级 2 和 3）。主要终点为中位总生存期（OS），次要终点为中位无进展生存期（TTF）和不良反应（AE）发生率。
共分析了 60 例患者的数据（正常 ALBI 组 32 例，高 ALBI 组 28 例）。正常 ALBI 组的中位 OS [10.23 个月与 3.70 个月，风险比（HR）：1.79，95%置信区间（CI）：1.02-3.13，p=0.041]和中位 TTF（2.27 个月与 1.78 个月，HR：1.78，95%CI：1.02-3.09，p=0.042）明显长于高 ALBI 组。Cox 比例风险分析显示，ALBI 评分与 OS 显著相关。高 ALBI 组肝功能不全（≥2 级）的发生率明显高于正常 ALBI 组（42.9%与 15.6%，p=0.041），而两组其他 AE 发生率相似。
ALBI 与接受瑞戈非尼治疗的 mCRC 患者的预后和肝相关不良事件的发生密切相关。这些发现可能表明，ALBI 评分较高的患者不应接受瑞戈非尼治疗。
