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)

被引：6

作者：

Lv, C. ^{[1
]}

Wang, R. ^{[2
]}

Li, S. ^{[1
,7
]}

Yan, S. ^{[1
]}

Wang, Y. ^{[1
,9
]}

Chen, J. ^{[1
,2
,5
]}

Wang, L. ^{[1
]}

Liu, Y. ^{[1
,6
]}

Guo, Z. ^{[3
]}

Wang, J. ^{[1
]}

Pei, Y.

Yu, L. ^{[4
]}

Wu, N. ^{[1
]}

Lu, F. ^{[1
]}

Gao, F. ^{[2
]}

Chen, J. ^{[1
,2
,5
]}

Liu, Y. ^{[1
,6
]}

Wang, X. ^{[1
]}

Li, S. ^{[1
,7
]}

Han, B. ^{[8
]}

Zhang, L. ^{[1
]}

Ma, Y. ^{[1
]}

Ding, L. ^{[9
]}

Wang, Y. ^{[1
,9
]}

Yuan, X. ^{[9
]}

Yang, Y. ^{[1
]}

机构：

[1] Beijing Canc Hosp, Dept Thorac Surg 2, 52 Fucheng Rd, Beijing 100142, Peoples R China

[2] Hebei Med Univ, Dept Thorac Surg, Hosp 4, Hebi, Peoples R China

[3] Inner Mongolia Med Univ, Dept Thorac Surg, Affiliated Hosp, Hohhot, Inner Mongolia, Peoples R China

[4] CMU, Beijing Tongren Hosp, Dept Thorac Surg, Beijing, Peoples R China

[5] Tianjing Med Univ Gen Hosp, Thorac Neoplasms Surg Dept, Tianjin, Peoples R China

[6] Inner Mongolia Peoples Hosp, Thorac Neoplasms Surg Dept, Hohhot, Inner Mongolia, Peoples R China

[7] Peking Union Med Coll Hosp, Dept Thorac Surg, Beijing, Peoples R China

[8] PLA Pocket Force Characterist Med Ctr, Dept Thorac Surg, Beijing, Peoples R China

[9] Betta Pharmaceut Co Ltd, Hangzhou, Peoples R China

来源：

ESMO OPEN | 2023年 / 8卷 / 04期

关键词：

non-small-cell lung cancer; adjuvant targeted therapy; EGFR mutations; icotinib; disease-free survival; OPEN-LABEL; 1ST-LINE TREATMENT; CANCER; CHEMOTHERAPY; GEFITINIB; MUTATIONS; CISPLATIN; MULTICENTER; ERLOTINIB; THERAPY;

D O I：

10.1016/j.esmoop.2023.101565

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: 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.Patients and methods: 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).Results: 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. Conclusions: 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.

引用

页数：10

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