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作者：SCI天天读
SCI
8 June 2023
Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients with Resected Stage IB–IIIA EGFR-Mutated Non- Small Cell Lung Cancer: Updated Analysis from the Phase 3 ADAURA Trial
(IF: JTO., 20.121)
John T, Grohé C, Goldman JW, Shepherd FA, de Marinis F, Kato T, Wang Q, Su W-C, Choi JH, Sriuranpong V, Melotti B, Fidler MJ, Chen J, Albayaty M, Stachowiak M, Taggart S, Wu Y-L, Tsuboi M, Herbst RS, Majem M, Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients with Resected Stage IB–IIIA EGFR-Mutated Non-Small Cell Lung Cancer: Updated Analysis from the Phase 3 ADAURA Trial, Journal of Thoracic Oncology (2023)
Corresponding author: Thomas John, MBBS, PhD, Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, Victoria, 3000, Australia. Email: Tom.John@petermac.org.
Introduction 介绍
In ADAURA, adjuvant osimertinib significantly improved disease-free survival versus placebo in resected stage IB–IIIA EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We report in-depth analyses of three-year safety, tolerability, and health-related quality of life (HRQoL) from ADAURA.
ADAURA研究表明，在已手术切除的IB期到IIIA期EGFR突变（EGFRm）非小细胞肺癌（NSCLC）患者中，与安慰剂相比，使用奥希替尼显辅助治疗可显著改善无病生存期。我们报告了ADAURA研究三年安全性、耐受性和健康相关生活质量（HRQoL）的深入分析。
Methods 方法
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, 4, 12, and every 12 weeks until treatment completion/discontinuation, and 28 days after treatment stopped. The Short Form-36 (SF-36) survey measured HRQoL at baseline, week 12, 24, and every 24 weeks until recurrence/treatment completion/discontinuation. Data cut-off: April 11, 2022.
患者以1：1的比例被随机分配接受每日一次的奥希替尼80毫克组或安慰剂组，持续长达3年。在基线、第2周、第4周、第12周和每12周进行一次安全性评估，直到治疗完成/停止，以及在治疗停止后28天进行一次。使用简表-36（SF-36）测量患者的HRQoL，分别在基线、第12周、第24周以及每每24周测量一次，直到复发/治疗完成/停药。数据截止日期为2022年4月11日。
Results 结果
Safety and HRQoL analysis sets: osimertinib, n = 337 and n = 339; placebo, 12 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/discontinuation were reported in 12/27/13% of patients with osimertinib; 1/13/3% with placebo. Stomatitis/diarrhea were the most common AEs leading to osimertinib dose reduction/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.
安全性和HRQoL分析集：奥希替尼组（n=337和n=339）；安慰剂组（n=343）。奥希替尼组的中位（范围）总暴露时间比安慰剂组更长：35.8（0–38）个月对比25.1（0–39）个月。大多数不良事件（AEs）在治疗开始后12个月内被首次报告（奥希替尼97％，安慰剂86％）。导致剂量减少/中断/停药的不良事件分别占奥希替尼组患者的12/27/13％，占安慰剂组患者的1/13/3％。口腔炎/腹泻是导致奥希替尼剂量减少/中断最常见的AE；间质性肺病是导致停用奥希替尼最常见的疾病（根据方案）。在SF-36身体/精神成分总结方面，奥希替尼和安慰剂组的恶化时间没有差异。
Conclusions 结论
No new safety signals were reported and HRQoL was maintained over 3 years of adjuvant osimertinib treatment. Combined with significant efficacy benefit, these data further support adjuvant osimertinib in stage IB–IIIA EGFRm NSCLC.
没有报告新的安全信号，并且在奥希替尼辅助治疗期间，患者的HRQoL得以维持三年以上。结合显著的疗效优势，这些数据进一步支持在IB期到IIIA期EGFRm NSCLC患者中应用奥希替尼进行辅助治疗。
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原文地址：http://mp.weixin.qq.com/s?src=11×tamp=1686242656&ver=4578&signature=wFMxJo4rDtOxK7Jgq0rPSUwee78pYYu9QoL4vjGoQ9690sS4VuV-A3Jef0sV5sW*S5mg*18O6A87trT7ZZYtptPyIl84g*pkkdkcYz3He4AD6wN0QmdUqXte4Oqo9QR-&new=1 |
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