单位：[1]Department of Radiation Oncology and Shandong Key Laboratory of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, China[2]Cancer Center, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[3]Department of Radiation Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China[4]Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Clinical College of Fujian Medical University, Fuzhou, China[5]Department of Radiation Oncology, Zhengzhou University Cancer Hospital, Zhengzhou, China[6]Department of Radiation Oncology, CyberKnife Center, Tianjin Medical University Cancer Institute and Hospital, Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin’s Clinical Research Center for Cancer, Tianjin, China[7]Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China浙江省肿瘤医院[8]Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China[9]Department of Thoracic Oncology, Huaxi Hospital, Sichuan University, Chengdu, China四川大学华西医院[10]Department of Thoracic Oncology, Fourth Hospital of Hebei Medical University, Shijiazhuang, China河北医科大学第四医院[11]Department of Radiation Oncology, Air Force General Hospital, Beijing, China[12]Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China[13]Department of Radiation Oncology, First Hospital of China Medical University, Shenyang, China[14]Department of Oncology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China[15]Department of Radiation Oncology, Guizhou Cancer Hospital, Guiyang, China[16]Department of Radiation Oncology, First Affiliated Hospital of Xiamen University, Xiamen, China[17]Department of Radiation Oncology, Beijing Cancer Hospital, Beijing, China[18]Department of Radiation Oncology, PLA General Hospital, Beijing, China[19]Department of Radiation Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.[20]Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai, China.[21]Department of Radiation Oncology, China-Japan Friendship Hospital, Beijing, China.
Purpose: This study aimed to compare erlotinib (E) and etoposide/ cisplatin (EP) with concurrent radiation therapy (RT) for patients with stage IIIA/B unresectable advanced non-small cell lung cancer with activating epidermal growth factor receptor mutation ( EGFRm+). Methods and Patients: This was a multicenter, randomized, open-label, phase 2 trial conducted across 19 institutions in China (December 2012 to January 2016). Enrolled patients were randomized (1:1) to E + RT (oral erlotinib 150 mg/d for 2 years or until disease progression or intolerable toxicity and RT 200 cGy/d, 5 d/wk for 6 weeks from the first day of erlotinib) or EP + RT (etoposide 50 mg/m(2) intravenously on days 1-5 and 29-33; cisplatin 50 mg/m2 intravenously on days 1, 8, 29 and 36; and RT as for E + RT). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate and safety. Results: Two hundred fifty-two patients were screened, and 20 patients with EGFRm+ in each group received the allocated E + RT or EP + RT treatment. Patient characteristics were well balanced between groups. Compared with EP + RT, median PFS with E + RT was significantly longer (24.5 vs 9.0 months [hazard ratio, 0.104; 95% confidence interval, 0.028-0.389; P<.001]). Objective response rate in the E + RT and EP + RT groups was 70% and 61.9%, respectively (P=.744). The incidence of adverse events (any grade) was similar between E + RT and EP + RT groups (88.9% and 84.2%). Conclusions: The primary endpoint of PFS was met, and the data showed that E + RT might provide PFS improvement compared with EP + RT, with similar tolerability. However, definitive statements regarding the efficacy of concurrent E + RT in patients with unresectable stage III non-small cell lung cancer with activating EGFRm+ cannot be made, and slow patient accrual will likely make it infeasible to conduct a phase 3 study. (C) 2020 Elsevier Inc. All rights reserved.
基金：
Shanghai Roche Pharmaceuticals Ltd; National Key Research and Development Projects of China [2016YFC0904700]; Key Research and Development Program of Shandong Province [2016CYJS01A03]
语种：
外文
被引次数：
WOS：
中科院(CAS)分区：
出版当年[2020]版：
大类|2 区医学
小类|2 区肿瘤学2 区核医学
最新[2025]版：
大类|1 区医学
小类|2 区肿瘤学2 区核医学
JCR分区：
出版当年[2019]版：
Q1ONCOLOGYQ1RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
最新[2023]版：
Q1ONCOLOGYQ1RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
第一作者单位：[1]Department of Radiation Oncology and Shandong Key Laboratory of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, China
通讯作者：
推荐引用方式(GB/T 7714)：
Ligang Xing,Gang Wu,Luhua Wang,et al.Erlotinib Versus Etoposide/Cisplatin With Radiation Therapy in Unresectable Stage III Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer: A Multicenter, Randomized, Open-Label, Phase 2 Trial[J].INTERNATIONAL JOURNAL of RADIATION ONCOLOGY BIOLOGY PHYSICS.2021,109(5):1349-1358.doi:10.1016/j.ijrobp.2020.11.026.
APA：
Ligang Xing,Gang Wu,Luhua Wang,Jiancheng Li,Jianhua Wang...&Jinming Yu.(2021).Erlotinib Versus Etoposide/Cisplatin With Radiation Therapy in Unresectable Stage III Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer: A Multicenter, Randomized, Open-Label, Phase 2 Trial.INTERNATIONAL JOURNAL of RADIATION ONCOLOGY BIOLOGY PHYSICS,109,(5)
MLA：
Ligang Xing,et al."Erlotinib Versus Etoposide/Cisplatin With Radiation Therapy in Unresectable Stage III Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer: A Multicenter, Randomized, Open-Label, Phase 2 Trial".INTERNATIONAL JOURNAL of RADIATION ONCOLOGY BIOLOGY PHYSICS 109..5(2021):1349-1358
医学