机构：[1]Tongji Univ, Shanghai Pulm Hosp, Dept Med Oncol, Shanghai, Peoples R China[2]Sichuan Univ, West China Hosp, Dept Thorac Oncol, Chengdu, Peoples R China四川大学华西医院[3]Univ Ulsan, Coll Med, Asan Med Ctr, Dept Oncol, Seoul, South Korea[4]Mahidol Univ, Dept Med, Div Med Oncol, Fac Med,Ramathibodi Hosp, Bangkok, Thailand[5]Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dept Resp Dis, Hangzhou, Peoples R China浙江大学医学院附属第一医院[6]Zhejiang Canc Hosp, Dept Thorac Oncol, Hangzhou, Peoples R China浙江省肿瘤医院[7]Guangzhou Med Univ, Affiliated Hosp 1, Dept Thorac Surg, Guangzhou, Peoples R China[8]Guangdong Gen Hosp, Guangdong Lung Canc Inst, Guangzhou, Peoples R China广东省人民医院[9]Jilin Canc Hosp, Dept Oncol, Changchun, Peoples R China[10]Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, Seoul, South Korea[11]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Shenzhen, Peoples R China[12]Chinese Acad Med Sci & Peking Union Med Coll, Shenzhen Hosp, Shenzhen, Peoples R China[13]Beijing Canc Hosp, Dept Thorac Oncol, Beijing, Peoples R China[14]Capital Med Univ, Beijing Chest Hosp, Dept Oncol, Beijing, Peoples R China[15]Roche China Holding Ltd, Dept Data Sci, Shanghai, Peoples R China[16]Roche China Holding Ltd, Dept Clin Sci, Shanghai, Peoples R China[17]Roche Prod Ltd, Prod Dev, Welwyn Garden City, England[18]F Hoffmann La Roche Ltd, Prod Dev Data Sci, Basel, Switzerland[19]Roche China Holding Ltd, Dept Safety, Shanghai, Peoples R China[20]Sun Yat Sen Univ, Canc Ctr, Collaborat Innovat Ctr Canc Med, State Key Lab Oncol South China, Guangzhou 510060, Peoples R China
Introduction: Previous results from the phase 3 ALESIA study (NCT02838420) revealed that alectinib (a central nervous system [CNS]-active, ALK inhibitor) had clinical benefits in treatment-na & iuml;ve Asian patients with advanced ALK-positive NSCLC, consistent with the global ALEX study. We present updated data after more than or equal to 5 years of follow-up from the "last patient in" date. Methods: Adult patients with treatment-na & iuml;ve, advanced ALK-positive NSCLC from mainland China, South Korea, and Thailand were randomized 2:1 to receive twice-daily 600 mg alectinib (n = 125) or 250 mg crizotinib (n = 62). The primary endpoint was investigator-assessed progression-free survival. Secondary or exploratory endpoints included over- all survival, objective response rate, time to CNS progression, and safety. Results: At the data cutoff (May 16, 2022), the median survival follow-up was 61 and 51 months in the alectinib and crizotinib arms, respectively. Median progression-free survival was 41.6 months with alectinib versus 11.1 months with crizotinib (stratified hazard ratio = 0.33, 95% confidence interval: 0.23-0.49). Overall survival data remain immature; 5-year overall survival rates were 66.4% (alectinib arm) versus 56.1% (crizotinib arm). Objective response rate was 91.2% versus 77.4% with alectinib and crizotinib, respectively. CNS progression was delayed with alectinib versus crizotinib (cause-specific hazard ratio = 0.16, 95% confidence interval: 0.08-0.32). Median treatment duration was longer with alectinib versus crizotinib (42.3 versus 12.6 mo). No new safety signals were observed. Conclusions: With four additional years of follow-up, these updated results confirm the clinical benefit and manageable safety of alectinib in Asian patients with advanced ALK-- positive NSCLC, and confirm alectinib as a standard-of-care treatment for patients with advanced ALK-positive NSCLC. (c) 2024 The Authors. Published by Elsevier Inc. on behalf of the International Association for the Study of Lung Cancer. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
第一作者机构：[1]Tongji Univ, Shanghai Pulm Hosp, Dept Med Oncol, Shanghai, Peoples R China
通讯作者：
推荐引用方式(GB/T 7714)：
Zhou Caicun,Lu You,Kim Sang-We,et al.Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC : Five-Year Update From the Phase 3 ALESIA Study[J].JTO CLINICAL AND RESEARCH REPORTS.2024,5(9):doi:10.1016/j.jtocrr.2024.100700.
APA：
Zhou, Caicun,Lu, You,Kim, Sang-We,Reungwetwattana, Thanyanan,Zhou, Jianying...&Zhang, Li.(2024).Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC : Five-Year Update From the Phase 3 ALESIA Study.JTO CLINICAL AND RESEARCH REPORTS,5,(9)
MLA：
Zhou, Caicun,et al."Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC : Five-Year Update From the Phase 3 ALESIA Study".JTO CLINICAL AND RESEARCH REPORTS 5..9(2024)
