Author(s): Shaw AT, Yeap BY, Solomon BJ, Riely GJ, Gainor J,et al.
Background: ALK gene rearrangement defines a new molecular subtype of non-small-cell lung cancer (NSCLC). In a recent phase 1 clinical trial, the ALK tyrosine-kinase inhibitor (TKI) crizotinib showed marked antitumour activity in patients with advanced, ALK-positive NSCLC. To assess whether crizotinib affects overall survival in these patients, we did a retrospective study comparing survival outcomes in crizotinib-treated patients in the trial and crizotinib-naive controls screened during the same time period.
Methods: We examined overall survival in patients with advanced, ALK-positive NSCLC who enrolled in the phase 1 clinical trial of crizotinib, focusing on the cohort of 82 patients who had enrolled through Feb 10, 2010. For comparators, we identified 36 ALK-positive patients from trial sites who were not given crizotinib (ALK-positive controls), 67 patients without ALK rearrangement but positive for EGFR mutation, and 253 wild-type patients lacking either ALK rearrangement or EGFR mutation. To assess differences in overall survival, we assessed subsets of clinically comparable ALK-positive and ALK-negative patients.
Author(s): Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y,et al.
Author(s): Soda M, Takada S, Takeuchi K, Choi YL, Enomoto M,et al.
Author(s): Koivunen JP, Mermel C, Zejnullahu K, Murphy C, Lifshits E,et al.
Author(s): Kwak EL, Bang YJ, CamidgeDaR, Shaw AT, Solomon B,et al.
Author(s): Lee JK, Park HS, Kim DW, Kulig K, Kim TM,et al.