Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California.
Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.
In the phase III ADAURA trial, adjuvant treatment with osimertinib versus placebo, with/without prior adjuvant chemotherapy, resulted in a statistically significant and clinically meaningful disease-free survival benefit in completely resected stage IB-IIIA EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQoL) outcomes from ADAURA.
Patients randomized 1:1 received oral osimertinib 80 mg or placebo for 3 years or until recurrence/discontinuation. HRQoL (secondary endpoint) was measured using the Short Form-36 (SF-36) health survey at baseline, 12, and 24 weeks, then every 24 weeks until recurrence or treatment completion/discontinuation. Exploratory analyses of SF-36 score changes from baseline until week 96 and time to deterioration (TTD) were performed in the overall population (stage IB-IIIA; N = 682). Clinically meaningful changes were defined using the SF-36 manual.
Baseline physical/mental component summary (PCS/MCS) scores were comparable between osimertinib and placebo (range, 46-47) and maintained to Week 96, with no clinically meaningful differences between arms; difference in adjusted least squares (LS) mean [95% confidence intervals (CI), -1.18 (-2.02 to -0.34) and -1.34 (-2.40 to -0.28), for PCS and MCS, respectively. There were no differences between arms for TTD of PCS and MCS; HR, 1.17 (95% CI, 0.82-1.67) and HR, 0.98 (95% CI, 0.70-1.39), respectively.
HRQoL was maintained with adjuvant osimertinib in patients with stage IB-IIIA EGFRm NSCLC, who were disease-free after complete resection, with no clinically meaningful differences versus placebo, further supporting adjuvant osimertinib as a new treatment in this setting. See related commentary by Patil and Bunn, p. 2204.
在 III 期 ADAURA 试验中，与安慰剂相比，在接受过或未接受过辅助化疗的情况下，完全切除的 IB 期-IIIA 期表皮生长因子受体突变（EGFRm）非小细胞肺癌（NSCLC）患者接受奥希替尼辅助治疗，在无病生存期方面取得了具有统计学意义和临床意义的获益。我们报告 ADAURA 试验的健康相关生活质量（HRQoL）结果。
患者以 1:1 的比例随机接受奥希替尼 80mg 或安慰剂治疗 3 年或直至复发/停药。使用健康调查简表 36 项（SF-36）在基线、12 周和 24 周时测量 HRQoL（次要终点），然后在复发或治疗完成/停药之前每 24 周测量一次。在总体人群（IB 期-IIIA 期；N=682）中进行了 SF-36 评分从基线到第 96 周的变化和恶化时间（TTD）的探索性分析。使用 SF-36 手册定义了有临床意义的变化。
奥希替尼和安慰剂组的基线生理/心理综合评分（PCS/MCS）（范围为 46-47）相似，且在第 96 周时保持不变，两组之间无临床意义的差异；调整后的最小二乘（LS）平均值的差异[95%置信区间（CI），-1.18（-2.02 至-0.34）和-1.34（-2.40 至-0.28），分别用于 PCS 和 MCS。PCS 和 MCS 的 TTD 无组间差异；HR，1.17（95%CI，0.82-1.67）和 HR，0.98（95%CI，0.70-1.39）。
在完全切除的 IB 期-IIIA 期 EGFRm NSCLC 患者中，辅助奥希替尼治疗可维持 HRQoL，且无疾病复发，与安慰剂相比，无临床意义的差异，进一步支持辅助奥希替尼作为该治疗环境下的新治疗方法。见 Patil 和 Bunn 的相关评论，第 2204 页。
