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Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer

Cited 174 time in Web of Science Cited 194 time in Scopus
Authors
Camidge, D. Ross; Kim, Hye Ryun; Ahn, Myung-Ju; Yang, James Chih-Hsin -H.; Han, Ji-Youn; Lee, Jong Seok; Hochmair, Maximilian J.; Li, Jacky Yu-Chung; Chang, Gee-Chen; Lee, Ki Hyeong; Gridelli, Cesare; Delmonte, Angelo; Garcia Campelo, Rosario; Kim, Dong-Wan; Bearz, Alessandra; Griesinger, Ffrank; Morabito, Alessandro; Felip, Enriqueta; Califano, Raffaele; Ghosh, Sharmistha; Spira, Alexander; Gettinger, Scott N.; Tiseo, Marcello; Gupta, Neeraj; Haney, Jeff; Kerstein, David; Popat, Sanjay
Issue Date
2018-11
Citation
New England Journal of Medicine, Vol.379 No.21, pp.2027-2039
Abstract
BACKGROUND Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, has robust efficacy in patients with ALK-positive non-small-cell lung cancer (NSCLC) that is refractory to crizotinib. The efficacy of brigatinib, as compared with crizotinib, in patients with advanced ALK-positive NSCLC who have not previously received an ALK inhibitor is unclear. METHODS In an open-label, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with advanced ALK-positive NSCLC who had not previously received ALK inhibitors to receive brigatinib at a dose of 180 mg once daily (with a 7-day lead-in period at 90 mg) or crizotinib at a dose of 250 mg twice daily. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included the objective response rate and intracranial response. The first interim analysis was planned when approximately 50% of 198 expected events of disease progression or death had occurred. RESULTS A total of 275 patients underwent randomization; 137 were assigned to brigatinib and 138 to crizotinib. At the first interim analysis (99 events), the median followup was 11.0 months in the brigatinib group and 9.3 months in the crizotinib group. The rate of progression-free survival was higher with brigatinib than with crizotinib (estimated 12-month progression-free survival, 67% (95% confidence interval {CI}, 56 to 75) vs. 43% [95% CI, 32 to 53); hazard ratio for disease progression or death, 0.49 (95% CI, 0.33 to 0.74); P<0.001 by the log-rank test). The confirmed objective response rate was 71% (95% CI, 62 to 78) with brigatinib and 60% (95% CI, 51 to 68) with crizotinib; the confirmed rate of intracranial response among patients with measurable lesions was 78% (95% CI, 52 to 94) and 29% (95% CI, 11 to 52), respectively. No new safety concerns were noted. CONCLUSIONS Among patients with ALK-positive NSCLC who had not previously received an ALK inhibitor, progression-free survival was significantly longer among patients who received brigatinib than among those who received crizotinib.
ISSN
0028-4793
URI
http://hdl.handle.net/10371/165234
DOI
https://doi.org/10.1056/NEJMoa1810171
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College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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