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Icotinib, an EGFR tyrosine kinase inhibitor, as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma: a multicenter, open-label, single-arm, phase II study (ICAPE)

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机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Thorac Surg, 45 Changchun St, Beijing 100053, Peoples R China [2]Capital Med Univ, Dept Thorac Surg, Beijing Inst Resp Med, Beijing, Peoples R China [3]Capital Med Univ, Beijing Chao Yang Hosp, Beijing, Peoples R China [4]Hebei Med Univ, Dept Thorac Surg, Hosp 4, Shijiazhuang, Hebei, Peoples R China [5]Capital Med Univ, Beijing Chest Hosp, Dept Thorac Surg, Beijing, Peoples R China [6]Handan Cent Hosp, Dept Thorac Surg 2, Handan, Hebei, Peoples R China [7]First Hosp Qinhuangdao, Dept Thorac Surg, Qinhuangdao, Hebei, Peoples R China [8]Chifeng Univ, Dept Thorac Surg, Affiliated Hosp, Chifeng, Neimenggu, Peoples R China [9]Peking Union Med Coll Hosp, Dept Thorac Surg, Beijing, Peoples R China [10]Hebei Prov Peoples Hosp, Dept Thorac Surg, Shijiazhuang, Hebei, Peoples R China
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关键词: Adenocarcinoma Adjuvant therapy Epidermal growth factor receptor mutation Icotinib Non-small-cell lung cancer

摘要:
The survival benefit of icotinib (an oral epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor) in patients with advanced lung cancer has been confirmed in several studies. This study (ICAPE) evaluated the efficacy of icotinib as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma. Patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma were enrolled in the multicenter, open-label, single-arm, phase II study. Eligible patients received oral icotinib 125 mg thrice daily for 1.5 years after complete surgical resection. The primary endpoint was disease-free survival (DFS). Between March 2014 and January 2018, 79 patients were enrolled. The median follow-up time was 39.7 months with a median DFS and overall survival (OS) of 41.4 months (95% CI: 33.6-51.8) and 67.0 months (95% CI: 21.2-not reached [NR]), respectively. The 1-year, 3-year, and 5-year OS rates were 100%, 83.3%, and 61.7%, respectively. No significant difference was found in the median DFS between patients with Bcl-2 interacting mediator of cell death (BIM) mutant-type and wild-type (NR vs. 41.7 months; p = 0.75). No significant difference was found in the median DFS according to EGFR mutation types. Icotinib as adjuvant therapy demonstrated a favorable survival benefit in patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma, indicating that icotinib might be a promising treatment option for this patient population. The optimal adjuvant duration of icotinib is still not clear and needs more incoming data to answer.

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出版当年[2022]版:
大类 | 3 区 医学
小类 | 3 区 药学 4 区 肿瘤学
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 药学 4 区 肿瘤学
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出版当年[2021]版:
Q2 PHARMACOLOGY & PHARMACY Q3 ONCOLOGY
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Q2 ONCOLOGY Q2 PHARMACOLOGY & PHARMACY

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第一作者机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Thorac Surg, 45 Changchun St, Beijing 100053, Peoples R China
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