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Platinum-based chemotherapy plus cetuximab first-line for Asian patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Results of an open-label, single-arm, multicenter trial

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单位: [1]Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, Shanghai 200433, Peoples R China [2]Fourth Mil Med Univ, Dept Radiat Oncol, Xijing Hosp, Affiliated Hosp 1, Xian, Shanxi Province, Peoples R China [3]Sun Yat Sen Univ, Head & Neck Dept, Ctr Canc, Guangzhou 510275, Guangdong, Peoples R China [4]Jiangsu Canc Hosp, Dept Med Oncol, Nanjing, Jiangsu, Peoples R China [5]Guangxi Med Univ, Affiliated Canc Hosp, Dept Radiotherapy, Nanning, Guangxi Provinc, Peoples R China [6]Pusan Natl Univ Hosp, Dept Med Oncol, Busan, South Korea [7]Huazhong Univ Sci & Technol, Canc Dept, Tongji Hosp, Tongji Med Coll, Wuhan 430074, Peoples R China [8]Fujian Prov Canc Hosp, Dept Radiat Oncol, Fuzhou, Peoples R China [9]Cent S Univ, Dept Oncol, Xiangya Hosp 2, Changsha, Hunan, Peoples R China [10]Nanfang Hosp, Dept Canc Med, Guangzhou, Guangdong, Peoples R China [11]Zhejiang Canc Hosp, Chemotherapy Ctr, Hangzhou, Zhejiang, Peoples R China [12]Fudan Univ, Head & Neck Surg Dept, Eye & Ear Nose & Throat Hosp, Shanghai 200433, Peoples R China [13]Jilin Canc Hosp, Dept Med Oncol, Changchun, Jilin, Peoples R China [14]Merck KGaA, Darmstadt, Germany [15]Merck Serono Beijing Pharmaceut R&D Co, Ctr, Shanghai, Peoples R China [16]Chinese Acad Med Sci, Dept Med Oncol, Inst Canc Hosp, Beijing 100730, Peoples R China [17]Peking Union Med Coll, Beijing Key Lab Clin Study Anticancer Mol Targete, Beijing 100021, Peoples R China
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关键词: cetuximab Chinese EXTREME trial head and neck cancer recurrent and metastatic squamous cell carcinoma

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BackgroundThe purpose of this study was to assess the efficacy, safety, and pharmacokinetics of cisplatin-based chemotherapy plus cetuximab as first-line treatment in Chinese and Korean patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). MethodsPatients (n = 68) received cetuximab weekly plus 3-week cycles of cisplatin/5-fluorouracil (5-FU) chemotherapy for up to 6 cycles. The primary endpoint was overall response rate. ResultsThe overall response rate was 55.9%, including 2 complete responses (CRs). Median overall survival (OS) was 12.6 months and median progression-free survival (PFS) was 6.6 months. Grade 3/4 adverse events (AEs) were reported in 41 (60.3%) patients. The safety profile was in line with previous clinical experience. The pharmacokinetic profile was in line with that observed with cetuximab in white and Japanese patients. ConclusionThe efficacy, safety, and pharmacokinetic findings from this study support the use of first-line platinum-based chemotherapy plus cetuximab in Chinese and Korean patients with recurrent and/or metastatic SCCHN ( NCT01177956). (c) 2014 Wiley Periodicals, Inc. Head Neck37: 1081-1087, 2015

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出版当年[2014]版:
大类 | 3 区 医学
小类 | 2 区 耳鼻喉科学 2 区 外科
最新[2025]版:
大类 | 3 区 医学
小类 | 2 区 耳鼻喉科学 3 区 外科
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出版当年[2013]版:
Q1 SURGERY Q1 OTORHINOLARYNGOLOGY
最新[2023]版:
Q1 OTORHINOLARYNGOLOGY Q1 SURGERY

影响因子: 最新[2023版] 最新五年平均 出版当年[2013版] 出版当年五年平均 出版前一年[2012版] 出版后一年[2014版]

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第一作者单位: [1]Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, Shanghai 200433, Peoples R China
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通讯机构: [16]Chinese Acad Med Sci, Dept Med Oncol, Inst Canc Hosp, Beijing 100730, Peoples R China [17]Peking Union Med Coll, Beijing Key Lab Clin Study Anticancer Mol Targete, Beijing 100021, Peoples R China [*1]Chinese Acad Med Sci, Dept Med Oncol, Inst Canc Hosp, 17 Panjiayuannanli, Beijing 100730, Peoples R China
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