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.

Autor:	John T; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia. Electronic address: Tom.John@petermac.org., Grohé C; Klinik für Pneumologie - Evangelische Lungenklinik Berlin Buch, Berlin, Germany., Goldman JW; David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California., Shepherd FA; Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada., de Marinis F; Thoracic Oncology Division, European Institute of Oncology (IEO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy., Kato T; Department of Thoracic Oncology, Kanagawa Cancer Center, Asahi Ward, Yokohama, Japan., Wang Q; Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China., Su WC; Department of Oncology, National Cheng Kung University, Tainan, Taiwan., Choi JH; Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea., Sriuranpong V; Division of Medical Oncology, Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand., Melotti B; Division of Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Fidler MJ; Hematology, Oncology and Cell Therapy, Department of Medicine, Rush University Medical Center, Chicago, Illinois., Chen J; Department of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, People's Republic of China., Albayaty M; Oncology Research & Development, AstraZeneca, Cambridge, United Kingdom., Stachowiak M; Late Oncology Research & Development, AstraZeneca, Warsaw, Poland., Taggart S; Oncology Biometrics, AstraZeneca, Cambridge, United Kingdom., Wu YL; Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, People's Republic of China., Tsuboi M; Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan., Herbst RS; Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut., Majem M; Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Jazyk:	angličtina
Zdroj:	Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] 2023 Sep; Vol. 18 (9), pp. 1209-1221. Date of Electronic Publication: 2023 May 24.
DOI:	10.1016/j.jtho.2023.05.015
Abstrakt:	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. (Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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