Alectinib in Resected <i>ALK</i> -Positive Non–Small-Cell Lung Cancer
Yi‐Long Wu, Rafał Dziadziuszko, Jin Seok Ahn, Fabrice Barlési, Makoto Nishio, Ki Hyeong Lee, Jong Seok Lee, Wen‐Zhao Zhong, Hidehito Horinouchi, Weimin Mao, Maximilian J. Hochmair, Filippo de Marinis, M.R. Migliorino, Igor Bondarenko, Shun Lü, Qun Wang, Tania Ochi Lohmann, Tingting Xu, Andrés F. Cardona, Thorsten Ruf, Johannes Noé, Benjamin Solomon
Abstract
BACKGROUND: -positive NSCLC are lacking. METHODS: of the American Joint Committee on Cancer and Union for International Cancer Control) were randomly assigned in a 1:1 ratio to receive oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was disease-free survival, tested hierarchically among patients with stage II or IIIA disease and then in the intention-to-treat population. Other end points included central nervous system (CNS) disease-free survival, overall survival, and safety. RESULTS: In total, 257 patients were randomly assigned to receive alectinib (130 patients) or chemotherapy (127 patients). The percentage of patients alive and disease-free at 2 years was 93.8% in the alectinib group and 63.0% in the chemotherapy group among patients with stage II or IIIA disease (hazard ratio for disease recurrence or death, 0.24; 95% confidence interval [CI], 0.13 to 0.45; P<0.001) and 93.6% and 63.7%, respectively, in the intention-to-treat population (hazard ratio, 0.24; 95% CI, 0.13 to 0.43; P<0.001). Alectinib was associated with a clinically meaningful benefit with respect to CNS disease-free survival as compared with chemotherapy (hazard ratio for CNS disease recurrence or death, 0.22; 95% CI, 0.08 to 0.58). Data for overall survival were immature. No unexpected safety findings were observed. CONCLUSIONS: -positive NSCLC of stage IB, II, or IIIA, adjuvant alectinib significantly improved disease-free survival as compared with platinum-based chemotherapy. (Funded by F. Hoffmann-La Roche; ALINA ClinicalTrials.gov number, NCT03456076.).