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

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. Patients were randomized 1:1 to osimert...

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Detalles Bibliográficos
Autores: John, Thomas|||0000-0003-3399-5342, Grohé, Christian, Goldman, Jonathan W., Shepherd, Frances A., De Marinis, Filippo, Kato, Terufumi, Wang, Qun, Su, Wu-Chou, Choi, Jin Hyuk, Sriuranpong, Virote, Melotti, Barbara, Fidler, Mary J., Chen, Jun, Albayaty, Muna, Stachowiak, Marta, Taggart, Sarah, Wu, Yi-Long|||0000-0002-3611-0258, Tsuboi, Masahiro, Herbst, Roy S.|||0000-0003-2535-5847, Majem Tarruella, Margarita|||0000-0002-9919-7485
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:303869
Acceso en línea:https://ddd.uab.cat/record/303869
https://dx.doi.org/urn:doi:10.1016/j.jtho.2023.05.015
Access Level:acceso abierto
Palabra clave:Adjuvant
EGFR
Non-small cell lung cancer
Osimertinib
Safety
Descripción
Sumario: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. 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. 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. 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.

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