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, Thomas (The University of Melbourne)
Grohé, Christian (Evangelische Lungenklinik Berlin Buch)
Goldman, Jonathan W. (University of California Los Angeles)
Shepherd, Frances A. (University of Toronto)
De Marinis, Filippo (Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS))
Kato, Terufumi (Kanagawa Cancer Center. Asahi Ward)
Wang, Qun (Zhongshan Hospital)
Su, Wu-Chou (National Cheng Kung University)
Choi, Jin Hyuk (Ajou University School of Medicine)
Sriuranpong, Virote (the King Chulalongkorn Memorial Hospital)
Melotti, Barbara (Università di Bologna)
Fidler, Mary J. (Rush University Medical Center)
Chen, Jun (Tianjin Medical University General Hospital)
Albayaty, Muna (AstraZeneca)
Stachowiak, Marta (AstraZeneca)
Taggart, Sarah (AstraZeneca)
Wu, Yi-Long (Southern Medical University)
Tsuboi, Masahiro (National Cancer Center Hospital East)
Herbst, Roy S. (Yale Cancer Center)
Majem, Margarita (Institut d'Investigació Biomèdica Sant Pau)
Universitat Autònoma de Barcelona

Data:	2023
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Adjuvant ; EGFR ; Non-small cell lung cancer ; Osimertinib ; Safety
Publicat a:	Journal of thoracic oncology, Vol. 18 Núm. 9 (september 2023) , p. 1209-1221, ISSN 1556-1380

DOI: 10.1016/j.jtho.2023.05.015
PMID: 37236398

13 p, 448.6 KB

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