Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial

John, T; Grohe, C; Goldman, JW; Shepherd, FA; de Marinis, F; Kato, T; Wang, Q; Su, WC; Choi, JH; Sriuranpong, V; Melotti, B; Fidler, MJ; Chen, J; Albayaty, M; Stachowiak, M; Taggart, S; Wu, YL; Tsuboi, M; Herbst, RS; Majem, M

Author(s): John, T; Grohe, C; Goldman, JW; Shepherd, FA; de Marinis, F; Kato, T; Wang, Q; Su, WC; Choi, JH; Sriuranpong, V; Melotti, B; Fidler, MJ; Chen, J; Albayaty, M; Stachowiak, M; Taggart, S; Wu, YL; Tsuboi, M; Herbst, RS; Majem, M;
Details: Publication Year 2023-09,Volume 18,Issue #9,Page 1209-1221
Journal Title: Journal of Thoracic Oncology
Publication Type: Research article
Abstract: INTRODUCTION: In ADAURA, adjuvant osimertinib significantly improved disease-free survival versus placebo in resected stage IB to IIIA EGFR-mutated NSCLC. We report in-depth analyses of three-year safety, tolerability, and health-related quality of life (HRQoL) from ADAURA. METHODS: Patients were randomized 1:1 to osimertinib 80 mg or placebo once daily for up to 3 years. Safety assessments were performed at baseline, week 2, week 4, week 12, and every 12 weeks until treatment completion or discontinuation, and 28 days after treatment was stopped. The SF-36 survey measured HRQoL at baseline, week 12, week 24, and every 24 weeks until recurrence, treatment completion or discontinuation. Data cutoff: April 11, 2022. RESULTS: Safety and HRQoL analysis sets: osimertinib, n = 337 and n = 339; placebo, n = 343 each. Median (range) total exposure duration was longer with osimertinib versus placebo: 35.8 (0-38) versus 25.1 (0-39) months. Most adverse events (AEs) were first reported within 12 months of starting treatment (osimertinib 97%, placebo 86%). AEs leading to dose reduction, interruption or discontinuation were reported in 12%, 27% and 13% respectively of patients with osimertinib; 1%, 13% and 3% with placebo. Stomatitis and diarrhea were the most common AEs leading to osimertinib dose reduction or interruption; interstitial lung disease was the most common leading to osimertinib discontinuation (per protocol). There were no differences in time to deterioration for SF-36 physical, mental component summaries between osimertinib and placebo. CONCLUSIONS: No new safety signals were reported and HRQoL was maintained with 3 years of adjuvant osimertinib treatment. Combined with significant efficacy benefit, these data further support adjuvant osimertinib in stage IB to IIIA EGFR-mutated NSCLC.
Publisher: Elsevier
Keywords: Humans; Aniline Compounds/adverse effects; *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics/chemically induced; ErbB Receptors/genetics/therapeutic use; *Lung Neoplasms/drug therapy/genetics/chemically induced; Mutation; Protein Kinase Inhibitors/therapeutic use; Quality of Life; Adjuvant; Egfr; Non-small cell lung cancer; Osimertinib; Safety
Department(s): Medical Oncology
PubMed ID: 37236398
Publisher's Version: https://doi.org/10.1016/j.jtho.2023.05.015
Open Access at Publisher's Site: https://doi.org/10.1016/j.jtho.2023.05.015
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-11-21 05:54:17

Last Modified: 2023-11-21 05:55:40