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Etoposide and cisplatin versus paclitaxel and carboplatin with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer: a multicenter randomized phase III trial

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机构: [1]Chinese Acad Med Sci, Canc Hosp, Natl Canc Ctr, Dept Radiat Oncol, Beijing, Peoples R China; [2]Peking Union Med Coll, Beijing, Peoples R China; [3]Wenzhou Med Univ, Affiliated Hosp 1, Dept Radiat Oncol, Wenzhou, Peoples R China; [4]Sun Yat Sen Univ, Ctr Canc, Dept Radiat Oncol, Guangzhou, Peoples R China; [5]Shanghai Chest Hosp, Dept Radiat Oncol, Shanghai, Peoples R China; [6]Tianjin Canc Hosp, Dept Radiat Oncol, Tianjin, Peoples R China; [7]Beijing Canc Hosp, Dept Radiat Oncol, Beijing, Peoples R China; [8]Fudan Univ, Zhongshan Hosp, Dept Radiat Oncol, Shanghai, Peoples R China; [9]Zhejiang Canc Hosp, Dept Radiat Oncol, Hangzhou, Zhejiang, Peoples R China; [10]Vanderbilt Univ, Ctr Quantitat Sci, 221 Kirkland Hall, Nashville, TN 37235 USA; [11]Chinese Acad Med Sci, Canc Hosp, Thorac Surg Natl Canc Center, Epidem Res Lab, Beijing, Peoples R China; [12]Chinese Acad Med Sci, Natl Canc Ctr, Dept Med Oncol, Beijing, Peoples R China; [13]Chinese Acad Med Sci, Natl Canc Ctr, Dept Thorac Surg, Beijing, Peoples R China
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关键词: non-small cell lung cancer locally advanced chemoradiotherapy cisplatin and etoposide carboplatin and paclitaxel

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Background: The optimal chemotherapy regimen administered currently with radiation in patients with stage III non-small cell lung cancer (NSCLC) remains unclear. A multicenter phase III trial was conducted to compare the efficacy of concurrent thoracic radiation therapy with either etoposide/cisplatin (EP) or carboplatin/paclitaxel (PC) in patients with stage III NSCLC. Patients and methods: Patients were randomly received 60-66 Gy of thoracic radiation therapy concurrent with either etoposide 50 mg/m(2) on days 1-5 and cisplatin 50 mg/m(2) on days 1 and 8 every 4 weeks for two cycles (EP arm), or paclitaxel 45 mg/m(2) and carboplatin (AUC 2) on day 1 weekly (PC arm). The primary end point was overall survival (OS). The study was designed with 80% power to detect a 17% superiority in 3-year OS with a type I error rate of 0.05. Results: A total of 200 patients were randomized and 191 patients were treated (95 in the EP arm and 96 in the PC arm). With a median follow-up time of 73 months, the 3-year OS was significantly higher in the EP arm than that of the PC arm. The estimated difference was 15.0% (95%CI 2.0%-28.0%) and P value of 0.024. Median survival times were 23.3 months in the EP arm and 20.7 months in the PC arm (log-rank test P = 0.095, HR 0.76, 95%CI 0.55-1.05). The incidence of Grade >= 2 radiation pneumonitis was higher in the PC arm (33.3% versus 18.9%, P = 0.036), while the incidence of Grade >= 3 esophagitis was higher in the EP arm (20.0% versus 6.3%, P = 0.009). Conclusion: EP might be superior to weekly PC in terms of OS in the setting of concurrent chemoradiation for unresectable stage III NSCLC.

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出版当年[2017]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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第一作者机构: [1]Chinese Acad Med Sci, Canc Hosp, Natl Canc Ctr, Dept Radiat Oncol, Beijing, Peoples R China; [2]Peking Union Med Coll, Beijing, Peoples R China;
通讯机构: [1]Chinese Acad Med Sci, Canc Hosp, Natl Canc Ctr, Dept Radiat Oncol, Beijing, Peoples R China; [2]Peking Union Med Coll, Beijing, Peoples R China;
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