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Paclitaxel and cisplatin with or without cetuximab in metastatic esophageal squamous cell carcinoma: a randomized, multicenter phase II trial.

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收录情况： ◇ ESCI

作者：
Lu Zhihao[1] * ; Zhang Yanqiao[2] * ; Fan Qingxia[3] * ; Pan Yueyin[4] ; Jiang Da[5] ; Lu Ping[6] ; Zhang Jingdong[7] ; Yuan Xianglin[8] ; Feng Jifeng[9] ; Yang Shujun[10] ; Yue Wenbin[11] ; Zhao Lin[12] ; Xu Yunhua[13] ; Luo Jinhua[14] ; Shen Lin[1] ;
机构： [1]Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China. [2]Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China. [3]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China. [4]Department of Oncology, Anhui Province Hospital, Hefei, Anhui 230088, China. [5]Department of Medical Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei Province 050011, China. [6]Department of Medical Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan 453199, China. [7]Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang 110042, China. [8]Department of Oncology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China. [9]Department of Oncology, Jiangsu Cancer Hospital, Nanjing, Jiangsu 210009, China. [10]Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan 450003, China. [11]Department of Oncology, Puyang Oilfield General Hospital Puyang, Henan, China. [12]Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China. [13]Department of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China. [14]Department of Thoracic Surgery, Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
出处：
DOI： 10.1016/j.xinn.2022.100239
ISSN：

摘要：
Lack of effective targeted therapy in metastatic esophageal squamous cell carcinoma (ESCC) underscores the urgent need for identifying new treatment approaches for this challenging disease. We sought to assess the addition of cetuximab to paclitaxel-cisplatin chemotherapy for first-line treatment in patients with metastatic ESCC. In this randomized, multicenter, open-label, phase II clinical trial, patients were randomized to receive paclitaxel-cisplatin (TP) (paclitaxel [175 mg/m2 intravenously (i.v.) on day 1 of every 3-week cycle] and cisplatin [75 mg/m2 i.v. on day 1 of every 3-week cycle]) and TP plus cetuximab (CTP) (cetuximab, 400 mg/m2 i.v. on day 1 of week 1, followed by 250 mg/m2 weekly), respectively. Targeted next-generation sequencing (NGS) was performed on 89 tumor samples for biomarker exploration. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. With a median follow-up of 22.6 months, median PFS was 5.7 months (95% confidence interval [CI]: 4.8-7.0) in patients administered CTP versus 4.2 months (95% CI: 3.0-5.3) in the TP group (hazard ratio [HR] = 0.61; 95% CI: 0.40-0.93; p = 0.02). Median overall survival was 11.5 months (95% CI: 7.9-13.1) in the CTP group and 10.5 months (95% CI: 9.0-13.2) in the TP arm (HR = 0.98; 95% CI: 0.67-1.44; p = 0.91). The most common reported greater than or equal to grade 3 adverse events were neutropenia (35.2% versus 22.4%) and leukopenia (25.4% versus 13.2%). In patients with epidermal growth factor receptor (EGFR) amplification tumors (15.7%), PFS was improved with CTP compared with TP treatment (HR = 0.11; 95% CI: 0.01-0.98; p = 0.018). First-line CTP significantly improves PFS, with a manageable safety profile in patients with metastatic ESCC.© 2022.

基金：
Merck Serono, Co. Ltd., Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany, the Clinical Medicine Plus X - Young Scholars Project of Peking University (PKU2020LCXQ008), the Digestive Medical Coordinated Development Center of Beijing Hospitals Authority (no. XXT19), and Beijing Hospitals Authority Youth Programme (QML20191102)
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外文
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大类 | 1 区 综合性期刊
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Q1 MULTIDISCIPLINARY SCIENCES

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
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推荐引用方式(GB/T 7714)：
Lu Zhihao,Zhang Yanqiao,Fan Qingxia,et al.Paclitaxel and cisplatin with or without cetuximab in metastatic esophageal squamous cell carcinoma: a randomized, multicenter phase II trial.[J].INNOVATION.2022,3(3):doi:10.1016/j.xinn.2022.100239.
APA：
Lu Zhihao,Zhang Yanqiao,Fan Qingxia,Pan Yueyin,Jiang Da...&Shen Lin.(2022).Paclitaxel and cisplatin with or without cetuximab in metastatic esophageal squamous cell carcinoma: a randomized, multicenter phase II trial..INNOVATION,3,(3)
MLA：
Lu Zhihao,et al."Paclitaxel and cisplatin with or without cetuximab in metastatic esophageal squamous cell carcinoma: a randomized, multicenter phase II trial.".INNOVATION 3..3(2022)

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