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Whole Brain Radiotherapy With and Without Concurrent Erlotinib in NSCLC with Brain Metastases: a multicentre, open-label, randomized, controlled phase 3 Trial.

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机构: [1]Cancer Center, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. [2]Cancer Center, Research Institute of Surgery, Daping Hospital, Chongqing, China. [3]Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China. [4]Department of Radiation Oncology, The First Affiliated Hospital of Kunming Medical University, Kunming, China. [5]Department of Radiotherapy of the Chest and Abdomen, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China. [6]Institute for Cancer Prevention and Treatment, Chongqing Sanxia Central Hospital, Chongqing, China. [7]Department of Medical Oncology, Xinqiao Hospital, Chongqing, China. [8]Department of Oncology, Southwest Hospital, Chongqing, China. [9]Department of Radiation Oncology, Cancer Hospital, Guangxi Medical University, Nanning, China. [10]Department of Radiotherapy, General Hospital of Ningxia Medical University, Yinchuan, China. [11]Department of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China. [12]GenePlus-Beijing Institute, Peking University Medical Industrial Park, Zhongguancun Life Science Park, Beijing, China. [13]Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA. [14]Department of Internal Medicine, Division of Medical Oncology, The Ohio State University Medical Center, Columbus, USA.
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关键词: Whole brain radiation therapy Erlotinib Brain metastases Non-small cell lung cancer Epidermal growth factor receptor

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Erlotinib combined with whole brain radiotherapy (WBRT) demonstrated a favorable objective response rate in a phase 2 single-arm trial of non-small cell lung cancer (NSCLC) patients with brain metastases. We assessed whether concurrent erlotinib with WBRT is safe and benefits patients in a phase 3, randomized trial. NSCLC patients with two or more brain metastases were enrolled and randomly assigned (1:1) to WBRT (n=115) or WBRT combined with erlotinib arms (n=109). The primary endpoint was intracranial progression-free survival (iPFS) and cognitive function (CF) was assessed by Mini-Mental State Examination (MMSE). A total of 224 patients from 10 centers across China were randomized to treatments. Median follow-up was 11.2 months. Median iPFS for WBRT concurrent erlotinib was 11.2 months versus 9.2 months for WBRT-alone (p=0.601). Median PFS and overall survival (OS) of combination group were 5.3 versus 4.0 months (p=0.825) and 12.9 versus 10.0 months (p=0.545), respectively, compared with WBRT-alone. In EGFR-mutant patients, iPFS (14.6 versus 12.8 months; p=0.164), PFS (8.8 versus 6.4 months; p=0.702) and OS (17.5 versus 16.9 months; p=0.221) were not significantly improved in combination group over WBRT-alone. Moreover, there were no significant differences in patients experiencing MMSE score change between the treatments. Concurrent erlotinib with WBRT didn't improve iPFS and excessive CF detriment either in the intent-to-treat (ITT) population or in EGFR-mutant patients compared with WBRT-alone, suggesting that while safe for patients already taking the drug, there is no justification for adding concurrent EGFR-TKI with WBRT for the treatment of brain metastases. © The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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出版当年[2021]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 临床神经病学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 临床神经病学 1 区 肿瘤学
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出版当年[2021]版:
Q1 CLINICAL NEUROLOGY Q1 ONCOLOGY
最新[2023]版:
Q1 CLINICAL NEUROLOGY Q1 ONCOLOGY

影响因子: 最新[2023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]

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第一作者机构: [1]Cancer Center, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. [2]Cancer Center, Research Institute of Surgery, Daping Hospital, Chongqing, China. [*1]No.288 Tianwen Road, Nan’an District, Chongqing, China 400000
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通讯机构: [1]Cancer Center, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. [2]Cancer Center, Research Institute of Surgery, Daping Hospital, Chongqing, China. [13]Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA. [14]Department of Internal Medicine, Division of Medical Oncology, The Ohio State University Medical Center, Columbus, USA. [*1]No.288 Tianwen Road, Nan’an District, Chongqing, China 400000 [*2]Department of Radiation Oncology, Unit 1422, The University of Texas MD [*3]The Ohio State University Medical Center, 488 Biomedical Research Tower, 460 W. 12th Ave., Columbus, OH, 43210, USA
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