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Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study)

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收录情况： ◇ SCIE

作者：
Lv C[1] * ; Wang R[2] * ; Li S[1] ; Yan S[1] ; Wang Y[1] ; Chen J[1] ; Wang L[1] ; Liu Y[1] ; Guo Z[3] ; Wang J[1] ; Pei Y[1] ; Yu L[4] ; Wu N[1] ; Lu F[1] ; Gao F[2] ; Chen J[5] ; Liu Y[6] ; Wang X[1] ; Li S[7] ; Han B[8] ; Zhang L[1] ; Ma Y[1] ; Ding L[9] ; Wang Y[9] ; Yuan X[9] ; Yang Y[1,*1] ;
机构： [1]Department of Thoracic Surgery II, Beijing Cancer Hospital, Beijing [2]Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Hebi [3]Department of Thoracic Surgery, The Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia [4]Department of Thoracic Surgery, Beijing TongrenHospital, CMU, Beijing [5]Thoracic Neoplasms Surgical Department, Tianjing Medical University General Hospital, Tianjing [6]Thoracic Neoplasms Surgical Department,Inner Mongolia People’s Hospital, Inner Mongolia [7]Department of Thoracic Surgery, Peking Union Medical College Hospital, Beijing [8]Department of Thoracic Surgery,PLA Pocket Force Characteristic Medical Center, Beijing [9]Betta Pharmaceuticals Co., Ltd, Hangzhou, China
出处：
DOI： 10.1016/j.esmoop.2023.101565
ISSN：

关键词： non-small-cell lung cancer adjuvant targeted therapy EGFR mutations icotinib disease-free survival

摘要：
Despite the prolonged median disease-free survival (DFS) by adjuvant targeted therapy in non-small-cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations, the relationship between the treatment duration and the survival benefits in patients remains unknown.In this multicenter, randomized, open-label, phase II trial, eligible patients aged 18-75 years with EGFR-mutant, stage II-IIIA lung adenocarcinoma and who had not received adjuvant chemotherapy after complete tumor resection were enrolled from eight centers in China. Patients were randomly assigned (1 : 1) to receive either 1-year or 2-year icotinib (125 mg thrice daily). The primary endpoint was DFS assessed by investigator. The secondary endpoints were overall survival (OS) and safety. This study was registered at ClinicalTrials.gov (NCT01929200).Between September 2013 and October 2018, 109 patients were enrolled (1-year group, n = 55; 2-year group, n = 54). Median DFS was 48.9 months [95% confidence interval (CI) 33.1-70.1 months] in the 2-year group and 32.9 months (95% CI 26.6-44.8 months) in the 1-year group [hazard ratio (HR) 0.51; 95% CI 0.28-0.94; P = 0.0290]. Median OS for patients was 75.8 months [95% CI 64.4 months-not evaluable (NE)] in the 2-year group and NE (95% CI 66.3 months-NE) in the 1-year group (HR 0.34; 95% CI 0.13-0.95; P = 0.0317). Treatment-related adverse events (TRAEs) were observed in 41 of 55 (75%) patients in the 1-year group and in 36 of 54 (67%) patients in the 2-year group. Grade 3-4 TRAEs occurred in 4 of 55 (7%) patients in the 1-year group and in 3 of 54 (6%) patients in the 2-year group. No treatment-related deaths or interstitial lung disease was reported.Two-year adjuvant icotinib was shown to significantly improve DFS and provide an OS benefit in EGFR-mutant, stage II-IIIA lung adenocarcinoma patients compared with 1-year treatment in this exploratory phase II study.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

基金：
Betta Pharmaceuticals Co., Ltd (no grant number).
语种：
外文
被引次数：
WOS：
PubmedID：
中科院分区：
出版当年[2023]版：
大类 | 2 区 医学
小类 | 2 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
JCR分区：
出版当年[2023]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Thoracic Surgery II, Beijing Cancer Hospital, Beijing
共同第一作者：
通讯作者：
通讯机构： [1]Department of Thoracic Surgery II, Beijing Cancer Hospital, Beijing [*1]Department of Thoracic Surgery II, Beijing Cancer Hospital, No. 52 Fucheng Road, Haidian District, Beijing 100142,China
推荐引用方式(GB/T 7714)：
Lv C,Wang R,Li S,et al.Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study)[J].ESMO OPEN.2023,8(4):doi:10.1016/j.esmoop.2023.101565.
APA：
Lv C,Wang R,Li S,Yan S,Wang Y...&Yang Y.(2023).Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study).ESMO OPEN,8,(4)
MLA：
Lv C,et al."Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study)".ESMO OPEN 8..4(2023)

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