Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC

Tsuboi, M; Herbst, RS; John, T; Kato, T; Majem, M; Grohe, C; Wang, J; Goldman, JW; Lu, S; Su, WC; de Marinis, F; Shepherd, FA; Lee, KH; Le, NT; Dechaphunkul, A; Kowalski, D; Poole, L; Bolanos, A; Rukazenkov, Y; Wu, YL; ADAURA Investigators

Author(s): Tsuboi, M; Herbst, RS; John, T; Kato, T; Majem, M; Grohe, C; Wang, J; Goldman, JW; Lu, S; Su, WC; de Marinis, F; Shepherd, FA; Lee, KH; Le, NT; Dechaphunkul, A; Kowalski, D; Poole, L; Bolanos, A; Rukazenkov, Y; Wu, YL; ADAURA Investigators;
Details: Publication Year 2023-07-13,Volume 389,Issue #2,Page 137-147
Journal Title: New England Journal of Medicine
Publication Type: Research article
Abstract: BACKGROUND: Among patients with resected, epidermal growth factor receptor (EGFR)-mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), adjuvant osimertinib therapy, with or without previous adjuvant chemotherapy, resulted in significantly longer disease-free survival than placebo in the ADAURA trial. We report the results of the planned final analysis of overall survival. METHODS: In this phase 3, double-blind trial, we randomly assigned eligible patients in a 1:1 ratio to receive osimertinib (80 mg once daily) or placebo until disease recurrence was observed, the trial regimen was completed (3 years), or a discontinuation criterion was met. The primary end point was investigator-assessed disease-free survival among patients with stage II to IIIA disease. Secondary end points included disease-free survival among patients with stage IB to IIIA disease, overall survival, and safety. RESULTS: Of 682 patients who underwent randomization, 339 received osimertinib and 343 received placebo. Among patients with stage II to IIIA disease, the 5-year overall survival was 85% in the osimertinib group and 73% in the placebo group (overall hazard ratio for death, 0.49; 95.03% confidence interval [CI], 0.33 to 0.73; P<0.001). In the overall population (patients with stage IB to IIIA disease), the 5-year overall survival was 88% in the osimertinib group and 78% in the placebo group (overall hazard ratio for death, 0.49; 95.03% CI, 0.34 to 0.70; P<0.001). One new serious adverse event, pneumonia related to coronavirus disease 2019, was reported after the previously published data-cutoff date (the event was not considered by the investigator to be related to the trial regimen, and the patient fully recovered). Adjuvant osimertinib had a safety profile consistent with that in the primary analysis. CONCLUSIONS: Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected, EGFR-mutated, stage IB to IIIA NSCLC. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.).
Publisher: Massachusetts Medical Society
Keywords: Humans; Antineoplastic Combined Chemotherapy Protocols/therapeutic use; *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics/mortality/surgery; *COVID-19/etiology; ErbB Receptors/genetics; *Lung Neoplasms/drug therapy/genetics/mortality/surgery; Mutation; Neoplasm Recurrence, Local/drug therapy; Survival Analysis
Department(s): Medical Oncology
PubMed ID: 37272535
Publisher's Version: https://doi.org/10.1056/NEJMoa2304594
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-10-12 07:16:45

Last Modified: 2024-07-30 01:46:58