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Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial

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机构: [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [2]Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, Shanghai, China [3]Department of Medical Oncology, Jilin Province Cancer Hospital, Changchun, China [4]Department of Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China [5]Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China [6]Department of Medical Oncology, 307 Hospital of the People’s Liberation Army (PLA), Beijing, China [7]Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, China [8]Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, China [9]Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China [10]Department of Medical Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China [11]Department of Medical Oncology, Beijing Hospital, Beijing, China [12]Department of Medical Oncology, Fujian Province Tumor Hospital, Fuzhou, China [13]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China [14]Department of Medical Oncology, Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, China [15]Department of Medical Oncology, Chinese People’s Liberation Army General Hospital, Beijing, China [16]Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai, China
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关键词: Non-small cell lung cancer (NSCLC) docetaxel continuation maintenance therapy chemotherapy

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Background: Maintenance therapy is important in the management of advanced non-small cell lung cancer (NSCLC). The present TFINE study assessed the efficacy and safety of docetaxel continuation maintenance (DCM) therapy after first-line treatment with different doses of docetaxel plus cisplatin. Methods: In this open-label, randomized, phase III study, newly diagnosed patients with advanced NSCLC were initially randomized (R1, 1:1) to receive first-line treatment with cisplatin 75 mg/m(2) plus docetaxel 75 mg/m(2) (DC75) or 60 mg/m(2) (DC60) for up to 4 cycles. Patients without progression were further randomized (R2, 1:2) to best supportive care (BSC) or DCM (60 mg/m(2)) for up to 6 cycles. The primary endpoint was progression-free survival (PFS) after R2, and the secondary endpoints included best response rate in first-line treatment, overall survival (OS), time to progression (TTP), and toxicities. Results: A total of 375 patients were enrolled in R1 and 184 of these patients continued in R2. DCM significantly prolonged PFS compared to BSC (HR =0.57, median PFS =5.8 vs. 3.0 months, P=0.002). The response rates were 30.2% and 23.9% in the DC75 and DC60 groups, respectively (P=0.17). There was no significant difference in OS (12.3 vs. 13.7 months, P=0.77). Additionally, 47.8% and 45.7% of patients reported AEs in the DC75 and DC60 groups, respectively. Diarrhea was more frequent with DC75 than with DC60 (8.6% vs. 3.2%, P=0.029). Other toxicities were comparable between the 2 docetaxel dose groups. Conclusions: Continuation maintenance treatment with docetaxel is well tolerated and improves PFS in patients with NSCLC. The docetaxel dose of 60 mg/m(2) may be preferred due to similar efficacy and less diarrhea. Trial registration: NCT01038661.

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出版当年[2021]版:
大类 | 4 区 医学
小类 | 4 区 肿瘤学 4 区 医学:研究与实验
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Q3 MEDICINE, RESEARCH & EXPERIMENTAL Q3 ONCOLOGY
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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]

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第一作者机构: [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [*1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
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通讯机构: [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [2]Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, Shanghai, China [*1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [*2]Department of Oncology, Shanghai Lung Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China
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