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Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial

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单位: [1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Canc Ctr, Shanghai, Peoples R China [2]Cent S Univ, Xiangya Hosp, Dept Resp, Changsha, Hunan, Peoples R China [3]Fourth Mil Univ, Xijing Hosp, Affiliated Hosp 1, Dept Resp, Xian, Shaanxi, Peoples R China [4]Huazhong Univ Sci & Technol, Tongji Hosp, Div Thorac Tumor, Tongji Med Coll, Wuhan, Hubei, Peoples R China [5]Nanjing Mil Gen Hosp, Dept Resp, Nanjing, Jiangsu, Peoples R China [6]Zhejiang Univ, Affiliated Hosp 1, Div Thorac Tumor, Hangzhou, Zhejiang, Peoples R China [7]Zhejiang Canc Hosp, Dept Med Oncol, Hangzhou, Zhejiang, Peoples R China [8]Huazhong Univ Sci & Technol, Dept Med Oncol, Union Hosp, Tongji Med Coll, Wuhan, Hubei, Peoples R China [9]Zhengzhou Univ, Henan Canc Hosp, Div Thorac Tumor, Zhengzhou, Henan, Peoples R China [10]Beijing Univ, Beijing Canc Hosp, Div Thorac Tumor, Beijing, Peoples R China [11]Guangxi Canc Hosp, Div Thorac Tumor, Nanning, Peoples R China [12]Capital Med Univ, Beijing Chest Hosp, Div Thorac Tumor, Beijing, Peoples R China
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关键词: Cisplatin Docetaxel Nedaplatin Randomized controlled trial Phase III Squamous cell lung carcinoma

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Introduction: This study aimed to compare the efficacy of first-line nedaplatin (80 mg/m(2)) plus docetaxel (75 mg/m(2)) (ND) versus cisplatin (75 mg/m(2)) plus docetaxel (75 mg/ m(2)) (CD) in patients with advanced squamous cell lung carcinoma. Methods: This open-label randomized controlled phase III trial was performed at 12 hospitals in China. Patients with squamous cell lung carcinoma were randomized to four cycles of ND or CD. The primary endpoint was progressionfree survival (PFS). Secondary endpoints included time to progression, best overall response, and adverse events. Results: In the intent-to-treat analysis set (ND: n = 141; CD: n = 139), median PFS was 4.63 months (95% confidence interval: 4.43-5.10) for the ND and 4.23 months (95% confidence interval: 3.37-4.53) for CD groups (p = 0.056). No significant difference in time to progression was observed between the two groups. Best overall responses and disease control rate were better with ND 51.5%, than with CD 38.1% (p = 0.033 and p = 0.0004, respectively). Grade III or IV adverse events and grade 3-4 nausea and fatigue were more frequent in the CD group compared with the ND group (all p < 0.05). Conclusions: There is no improvement in PFS with the nedaplatin and docetaxel combination in the intent-to-treat analysis. More hematologic toxicities were observed in the ND group (compared with CD), whereas more nonhematologic toxicities were observed in the CD group. ND could be a new treatment option for advanced or relapsed squamous cell lung cancer. (C) 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

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出版当年[2017]版:
大类 | 2 区 医学
小类 | 2 区 肿瘤学 2 区 呼吸系统
最新[2025]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
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出版当年[2016]版:
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM
最新[2023]版:
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

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第一作者单位: [1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Canc Ctr, Shanghai, Peoples R China [*1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Tumor Clin Med Ctr, 241 Huai Hai Rd West, Shanghai, Peoples R China
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通讯机构: [1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Canc Ctr, Shanghai, Peoples R China [*1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Tumor Clin Med Ctr, 241 Huai Hai Rd West, Shanghai, Peoples R China
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