Abstract
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。
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
