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

医学 奥西默替尼 中止 耐受性 安慰剂 内科学 不利影响 肿瘤科 外科 癌症 腺癌 病理 替代医学 ROS1型
作者
Thomas John,Christian Grohé,Jonathan W. Goldman,Frances A. Shepherd,Filippo de Marinis,Terufumi Kato,Qun Wang,Wu‐Chou Su,Jin-Hyuk Choi,Virote Sriuranpong,Barbara Melotti,Mary J. Fidler,Jun Chen,Muna Albayaty,Marta Stachowiak,Sarah C. Taggart,Yi‐Long Wu,Masahiro Tsuboi,Roy S. Herbst,Margarita Majem
出处
期刊:Journal of Thoracic Oncology [Elsevier]
卷期号:18 (9): 1209-1221 被引量:7
标识
DOI:10.1016/j.jtho.2023.05.015
摘要

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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