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Erlotinib vs etoposide/cisplatin with radiotherapy in unresectable stage III epidermal growth factor receptor mutation-positive non-small-cell lung cancer: A multicenter, randomized, open-label, phase 2 trial.

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收录情况： ◇ SCIE ◇ EI

作者：
Ligang Xing[1] * ; Gang Wu[2] ; Luhua Wang[3] ; Jiancheng Li[4] ; Jianhua Wang[5] ; Zhiyong Yuan[6] ; Ming Chen[7] ; Yaping Xu[7,19] ; Xiaolong Fu[8,20] ; Zhengfei Zhu[8] ; You Lu[9] ; Chun Han[10] ; Tingyi Xia[11] ; Conghua Xie[12] ; Guang Li[13] ; Shenglin Ma[14] ; Bing Lu[15] ; Qin Lin[16] ; Guangying Zhu[17,21] ; Baolin Qu[18] ; Wanqi Zhu[1] ; Jinming Yu[1] ;
机构： [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 [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 [8]Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [9]Department of Thoracic Oncology, Huaxi Hospital, Sichuan University, Chengdu, China [10]Department of Thoracic Oncology, Fourth Hospital of Hebei Medical University, Shijiazhuang, China [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.
出处：
DOI： 10.1016/j.ijrobp.2020.11.026
ISSN：

摘要：
This study aimed to compare erlotinib (E) and etoposide/cisplatin (EP) with concurrent radiotherapy (RT) for patients with stage IIIA/B unresectable advanced non-small-cell lung cancer (NSCLC) with activating epidermal growth factor receptor mutation (EGFRm+). 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/day for 2 years or until disease progression or intolerable toxicity and RT 200 cGy/day, 5 days/week for 6 weeks from the first day of erlotinib) or EP+RT (etoposide 50 mg/m2 intravenously on days 1-5 and 29-33; cisplatin 50 mg/m2 intravenously on days 1, 8, 29 and 36; and RT as above). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and safety. A total of 252 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 < 0.001]). ORR in the E+RT and EP+RT groups was 70% and 61.9%, respectively (P = 0.744). The incidence of adverse events (any grade) was similar between E+RT and EP+RT groups (88.9% and 84.2%). 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 NSCLC with activating EGFRm+ cannot be made, and slow patient accrual will likely make it infeasible to conduct a phase 3 study. Copyright © 2020. Published by Elsevier Inc.

基金：
This work was funded by Shanghai Roche Pharmaceuticals Ltd, the National Key Research and Development Projects of China (2016YFC0904700) and the Key Research and Development Program of Shandong Province (2016CYJS01A03).
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外文
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出版当年[2021]版：
Q1 ONCOLOGY Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
最新[2024]版：
Q1 ONCOLOGY Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

影响因子： 最新[2024版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [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 vs etoposide/cisplatin with radiotherapy 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 vs etoposide/cisplatin with radiotherapy 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 vs etoposide/cisplatin with radiotherapy 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

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