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 |
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| Institution: | 1. Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia;2. Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia;3. Klinik für Pneumologie - Evangelische Lungenklinik Berlin Buch, Berlin, Germany;4. David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California;5. Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada;6. Thoracic Oncology Division, European Institute of Oncology (IEO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy;7. Department of Thoracic Oncology, Kanagawa Cancer Center, Asahi Ward, Yokohama, Japan;8. Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China;9. Department of Oncology, National Cheng Kung University, Tainan, Taiwan;10. Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea;11. Division of Medical Oncology, Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand;12. Division of Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy;13. Hematology, Oncology and Cell Therapy, Department of Medicine, Rush University Medical Center, Chicago, Illinois;14. Department of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China;15. Oncology Research & Development, AstraZeneca, Cambridge, United Kingdom;p. Late Oncology Research & Development, AstraZeneca, Warsaw, Poland;q. Oncology Biometrics, AstraZeneca, Cambridge, United Kingdom;r. Guangdong Lung Cancer Institute, Guangdong Provincial People''s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, People’s Republic of China;s. Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan;t. Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut;u. Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain |
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| Abstract: | IntroductionIn 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.MethodsPatients 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.ResultsSafety 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.ConclusionsNo 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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| Keywords: | Osimertinib Adjuvant EGFR Non–small cell lung cancer Safety |
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