Remon Jordi, Menis Jessica, Hasan Baktiar, Peric Aleksandra, De Maio Eleonora, Novello Silvia, Reck Martin, Berghmans Thierry, Wasag Bartosz, Besse Benjamin, Dziadziuszko Rafal
Department of Oncology Medicine, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Clin Lung Cancer. 2017 Sep;18(5):583-588. doi: 10.1016/j.cllc.2017.02.005. Epub 2017 Mar 1.
The AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR-mutant NSCLC Patients (APPLE) trial is a randomized, open-label, multicenter, 3-arm, phase II study in advanced, epidermal growth factor receptor (EGFR)-mutant and EGFR tyrosine kinase inhibitor (TKI)-naive non-small-cell lung cancer (NSCLC) patients, to evaluate the best strategy for sequencing gefitinib and osimertinib treatment. Advanced EGFR-mutant NSCLC patients, with World Health Organization performance status 0-2 who are EGFR TKI treatment-naive and eligible to receive first-line treatment with EGFR TKI will be randomized to: In all arms, a plasmatic ctDNA T790M test will be performed by a central laboratory at the Medical University of Gdansk (Poland) but will be applied as a predictive marker for making treatment decisions only in arm B. The primary objective is to evaluate the best strategy for sequencing of treatment with gefitinib and osimertinib in advanced NSCLC patients with common EGFR mutations, and to understand the value of liquid biopsy for the decision-making process. The progression-free survival rate at 18 months is the primary end point of the trial. The activity of osimertinib versus gefitinib to prevent brain metastases will be evaluated.
AZD9291（奥希替尼）治疗EGFR突变的非小细胞肺癌患者血浆T790M阳性（APPLE）试验是一项针对晚期、表皮生长因子受体（EGFR）突变且未接受过EGFR酪氨酸激酶抑制剂（TKI）治疗的非小细胞肺癌（NSCLC）患者的随机、开放标签、多中心、三臂II期研究，旨在评估吉非替尼和奥希替尼序贯治疗的最佳策略。符合条件的晚期EGFR突变NSCLC患者，世界卫生组织体能状态为0 - 2，未接受过EGFR TKI治疗且有资格接受EGFR TKI一线治疗，将被随机分组：在所有组中，血浆循环肿瘤DNA（ctDNA）T790M检测将由波兰格但斯克医科大学的中央实验室进行，但仅在B组用作治疗决策的预测标志物。主要目的是评估晚期常见EGFR突变NSCLC患者中吉非替尼和奥希替尼序贯治疗的最佳策略，并了解液体活检在决策过程中的价值。18个月时的无进展生存率是该试验的主要终点。将评估奥希替尼与吉非替尼预防脑转移的活性。
