Background: Anaplastic lymphoma kinase (ALK) rearrangement is a common driver gene of non-small cell lung cancer (NSCLC). Ceritinib is a second-generation ALK inhibitor, which can bring survival benefits to ALK-positive metastatic NSCLC. However, few studies focus on the safety and efficacy of ceritinib in China. Therefore, this study intends to investigate the safety and preliminary efficacy of ceritinib 450 mg with meals in Chinese patients with ALK-positive NSCLC through a real world study.
Methods: From October 2018 to December 2019, patients with ALK-positive NSCLC from 8 medical centers in Sichuan province were recruited in this study. All of these participants received ceritinib 450 mg/d with food. The basic characteristics, adverse effects (AEs) and responses were collected and analyzed in order to evaluate the safety and efficacy of ceritinib.
Results: A total of 109 patients were included in this study. Data cutoff was January 23, 2020. The median duration of treatment exposure was 5.87 mon (range: 0.4 mon-15.7 mon). Total AEs were reported in 98 (89.9%) of 109 patients and grade 3 or 4 AEs were reported in 22.9% of patients. Most common AEs (mainly grade 1 or 2) were diarrhea (60.6%), elevated alanine aminotransferase (ALT)(38.5%) and aspartate aminotransferase (AST)(37.6%). As of data cutoff, 45 patients discontinued ceritinib. The overall response rate (ORR) was 37.6% (95%CI: 28.5%-47.4%) and disease control rate (DCR) was 86.2% (95%CI: 78.3%-92.1%).
Conclusions: The treatment of ceritinib 450 mg with food for Chinese ALK-positive NSCLC patients had a good safety profile and favorable DCR in real-world setting. However, this conclusion needs to be further verified by large sample, prospective trials.
【中文题目：塞瑞替尼450 mg随餐服用治疗中国ALK阳性非小细胞肺癌患者的安全性及近期疗效分析】 【中文摘要：背景与目的 间变性淋巴瘤激酶（anaplastic lymphoma kinase, ALK）染色体易位为非小细胞肺癌（non-small cell lung cancer, NSCLC）常见的驱动基因。塞瑞替尼为第二代的ALK抑制剂，可为ALK阳性转移性NSCLC患者带来生存获益，但国内尚无塞瑞替尼用药安全性及疗效的研究报道。因此本研究拟通过真实世界研究来探讨塞瑞替尼450 mg随餐服用治疗中国ALK阳性NSCLC患者的安全性及近期疗效。方法 回顾性分析2018年10月-2019年12月期间就诊于四川省8家医疗机构口服塞瑞替尼450 mg/d随餐治疗的ALK阳性NSCLC患者，收集患者基本信息、治疗期间不良事件（adverse effects, AEs）及疗效数据等资料，评价其安全性及初步疗效。结果 研究共纳入109例患者，随访至2020年1月23日，中位服药时间为5.87个月（范围：0.4个月-15.7个月），总体不良事件发生率为89.9%，3级-4级不良事件发生率为22.9%。最常见AEs（主要为1级-2级）为腹泻（60.6%）、丙氨酸氨基转移酶（alanine aminotransferase, ALT）升高（38.5%）及门冬氨酸氨基转移酶（aspartate aminotransferase, AST）升高（37.6%）。至随访截止，共45例患者停药，总体客观缓解率（objective response rate, ORR）为37.6%（95%CI: 28.5%-47.4%），疾病控制率（disease control rate, DCR）为 86.2%（95%CI: 78.3%-92.1%）。结论 真实世界中，塞瑞替尼450 mg随餐服用的给药方式在中国ALK阳性NSCLC患者中具有良好的安全性及疾病控制率，但需要更大样本量的前瞻性研究来进一步验证。】 【中文关键词：塞瑞替尼；间变性淋巴瘤激酶；肺肿瘤；安全性；疗效】.
Keywords: Anaplastic lymphoma kinase; Ceritinib; Efficacy; Lung neoplasms; Safety.