First-line osimertinib in patients with epidermal growth factor receptor–mutant non–small-cell lung cancer and with a coexisting low allelic fraction of Thr790Met

奥西默替尼 医学 内科学 肺癌 肿瘤科 四分位间距 临床终点 表皮生长因子受体 临床研究阶段 无进展生存期 置信区间 胃肠病学 外科 癌症 临床试验 化疗 埃罗替尼
作者
Margarita Majem,Ivanna Sullivan,Santiago Viteri,Guillermo López-Vivanco,Manuel Cobo,José Miguel Sánchez,Jorge García,J. Garde,Miguel Sampayo,Griselda Martrat,Andrea Malfettone,Niki Karachaliou,Miguel Ángel Molina‐Vila,Rafael Rosell
出处
期刊:European Journal of Cancer [Elsevier BV]
卷期号:159: 174-181 被引量:7
标识
DOI:10.1016/j.ejca.2021.09.039
摘要

The AZENT (NCT02841579) study aimed to assess the efficacy and safety of first-line osimertinib in patients with epidermal growth factor receptor(EGFR)mutation-positive advanced non-small-cell lung cancer (NSCLC) and with a coexisting low allelic fraction of Thr790Met.In this multicentre, single-arm, open-label, phase IIa study, patients with locally advanced or metastatic NSCLC harbouring centrally confirmedEGFR Thr790Met mutation received 80 mg osimertinib daily. The primary end-point was objective response rate (ORR). The secondary end-points included disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Efficacy was assessed as per Response Evaluation Criteria in Solid Tumours, version 1.1. Blood samples collected at baseline, end of week 2 and disease progression were analysed using next-generation sequencing. As osimertinib was approved as a first-line therapy during the trial, this led to early termination of phase II; thus, analysis is considered exploratory.Twenty-two patients were enrolled and received osimertinib. All 22 patients were included in the efficacy and safety analysis. At the data cutoff, 10 (50%) patients remained on treatment. The median duration of follow-up was 24.4 months (interquartile range 12.9 to 26.0). The ORR was 77.3% (17/22 [95% confidence interval {CI} 54.6 to 89.3]). The DCR was 86.4% (19/22, [95% CI 65.1 to 97.1]). The median PFS was 23.1 months (95% CI 14.1 to NE). The median OS was 28·4 months (95% CI 25.6 to NE).Despite early study termination, osimertinib first-line therapy yields an overall PFS of 23.1 months in EGFR-mutant patients harbouring a coexisting low allelic fraction of EGFR Thr790Met mutation.
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