Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer
- Author(s)
- Wu, YL; Dziadziuszko, R; Ahn, JS; Barlesi, F; Nishio, M; Lee, DH; Lee, JS; Zhong, W; Horinouchi, H; Mao, W; Hochmair, M; de Marinis, F; Migliorino, MR; Bondarenko, I; Lu, S; Wang, Q; Ochi Lohmann, T; Xu, T; Cardona, A; Ruf, T; Noe, J; Solomon, BJ; ALINA Investigators;
- Details
- Publication Year 2024-04-11,Volume 390,Issue #14,Page 1265-1276
- Journal Title
- New England Journal of Medicine
- Publication Type
- Research article
- Abstract
- BACKGROUND: Platinum-based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK-positive non-small-cell lung cancer (NSCLC). Data on the efficacy and safety of adjuvant alectinib as compared with chemotherapy in patients with resected ALK-positive NSCLC are lacking. METHODS: We conducted a global, phase 3, open-label, randomized trial in which patients with completely resected, ALK-positive NSCLC of stage IB (tumors ≥4 cm), II, or IIIA (as classified according to the seventh edition of the Cancer Staging Manual 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: Among patients with resected ALK-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.).
- Publisher
- Massachusetts Medical Society
- Keywords
- Humans; Carbazoles/therapeutic use; *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics/surgery; *Lung Neoplasms/drug therapy/genetics/surgery; Neoplasm Recurrence, Local/drug therapy; Piperidines/therapeutic use; Receptor Protein-Tyrosine Kinases; *Tyrosine Kinase Inhibitors/therapeutic use; Treatment Outcome; Administration, Oral; Administration, Intravenous; *Platinum Compounds/therapeutic use; *Antineoplastic Agents/therapeutic use
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1056/NEJMoa2310532
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-07-25 05:42:28
Last Modified: 2024-07-25 05:52:23