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Camidge, D Ross; Kim, Hye Ryun; Ahn, Myung-Ju; Yang, James Chih-Hsin; 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, Frank; Morabito, Alessandro; Felip, Enriqueta; Califano, Raffaele; Ghosh, Sharmistha; Spira, Alexander; Gettinger, Scott N; Tiseo, Marcello; Gupta, Neeraj; Haney, Jeff; Kerstein, David; Popat, Sanjay
The New England journal of medicine, 11/2018, Letnik: 379, Številka: 21Journal Article
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. 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. 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 follow-up 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. 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. (Funded by Ariad Pharmaceuticals; ALTA-1L ClinicalTrials.gov number, NCT02737501 .).
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Dostop do baze podatkov JCR je dovoljen samo uporabnikom iz Slovenije. Vaš trenutni IP-naslov ni na seznamu dovoljenih za dostop, zato je potrebna avtentikacija z ustreznim računom AAI.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Vir: Osebne bibliografije
in: SICRIS
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