阿雷替尼被推荐用于阳性Anaplastic淋巴瘤激酶融合基因的非小细胞肺癌。我们在真实世界的经验中已经发现了早期因疾病进展和不良反应而停用阿雷替尼的情况。因为阿雷替尼的蛋白结合率高达99%以上，低血清白蛋白可能会增加游离药物的浓度并影响疗效和不良事件。然而，目前尚无报道血清白蛋白与阿雷替尼的临床影响之间的关联。本研究旨在确定血清白蛋白对阿雷替尼治疗失败时间（TTF）的影响。回顾性评估了2014年10月至2020年9月期间入住于北海道癌症中心、札幌南三条医院、KKR札幌医疗中心和小樽综合医院的四家医院的56名接受阿雷替尼治疗的患者。多元分析显示，与开始使用阿雷替尼时血清白蛋白≥3.6 g/dl相比，血清白蛋白<3.6 g/dl时停药风险显著增加（风险比=3.00；95%置信区间=1.36-6.66；p<0.01）。Kaplan-Meier曲线显示，血清白蛋白<3.6时的TTF明显短于≥3.6（中位TTF：12.1个月 vs. 未达到，p<0.01）。据我们所知，该研究是首次报道，血清白蛋白<3.6 g/dl在阿雷替尼治疗初始阶段与较差的TTF有关。低血清白蛋白是癌症患者的不良预后因素。因此，治疗前必须测量血清白蛋白水平。 版权所有 © 2023，国际抗癌研究学会（George J. Delinasios博士），保留所有权利。

Alectinib is recommended for anaplastic lymphoma kinase fusion gene-positive non-small cell lung cancer. We have experienced early alectinib discontinuation due to disease progression and adverse effects in real world. Because alectinib has a high protein-binding rate of >99%, low serum albumin may increase the concentration of free drug and affect efficacy and adverse events. However, no association between serum albumin and the clinical impact of alectinib has been reported. The purpose of this study was to determine the effect of serum albumin on time-to-treatment failure (TTF) in alectinib.Fifty-six patients who were admitted to four hospitals (National Hospital Organization Hokkaido Cancer Center, Sapporo Minami-Sanjo Hospital, KKR Sapporo Medical Center, Otaru General Hospital) between October 2014 and September 2020 were retrospectively evaluated to identify those treated with alectinib.The multivariate analysis showed that the risk of discontinuation was significantly higher with serum albumin <3.6 g/dl compared to ≥3.6 g/dl at the start of alectinib administration (hazard ratio=3.00; 95% confidence interval=1.36-6.66; p<0.01). On Kaplan-Meier curves, TTF for serum albumin <3.6 was significantly shorter than that for ≥3.6. (median TTF: 12.1 months vs. not reach, p<0.01).To the best of our knowledge, this study is the first to report that serum albumin <3.6 g/dl at alectinib induction is associated with poor TTF. Low serum albumin is a poor prognostic factor in cancer patients. Thus, serum albumin levels must be measured before treatment.Copyright © 2023, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.