| Autor: |
Caicun Zhou, MD, PhD, You Lu, MD, Sang-We Kim, MD, PhD, Thanyanan Reungwetwattana, MD, Jianying Zhou, MD, Yiping Zhang, MD, Jianxing He, MD, PhD, Jin-Ji Yang, MD, Ying Cheng, MD, Se-Hoon Lee, MD, PhD, Jianhua Chang, MD, Jian Fang, MD, Zhe Liu, PhD, Lilian Bu, MSc, Li Qian, MD, Tingting Xu, MD, Venice Archer, MB ChB, MSc, Magalie Hilton, MSc, Mingzhu Zhou, MSc, Li Zhang, MD |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
JTO Clinical and Research Reports, Vol 5, Iss 9, Pp 100700- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2666-3643 |
| DOI: |
10.1016/j.jtocrr.2024.100700 |
| Popis: |
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-naïve 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-naïve, 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 overall 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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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