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
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广东省人民医院[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四川大学华西医院[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
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.
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
共同第一作者：
通讯作者：
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
推荐引用方式(GB/T 7714)：
Zhang Li,Lu Shun,Cheng Ying,et al.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[J].ANNALS OF TRANSLATIONAL MEDICINE.2021,9(4):doi:10.21037/atm-20-8078.
APA：
Zhang, Li,Lu, Shun,Cheng, Ying,Hu, Zhihuang,Wu, Yi-Long...&Sun, Yuping.(2021).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.ANNALS OF TRANSLATIONAL MEDICINE,9,(4)
MLA：
Zhang, Li,et al."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".ANNALS OF TRANSLATIONAL MEDICINE 9..4(2021)
