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A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer – The FALUCA study

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作者：
Shun Lu[1,*1] * ; Gongyan Chen[2] ; Yuping Sun[3] ; Sanyuan Sun[4] ; Jianhua Chang[5] ; Yu Yao[6] ; Zhendong Chen[7] ; Feng Ye[8] ; Junguo Lu[9] ; Jianhua Shi[10] ; Jianxing He[11] ; Xiaoqing Liu[12] ; Yiping Zhang[13] ; Zhihua Liu[14] ; Jian Fang[15] ; Ying Cheng[16] ; Chunhong Hu[17] ; Weidong Mao[18] ; Yanping Hu[19] ; Youling Gong[20] ; Li Shan[21] ; Zhixiong Yang[22] ; Yong Song[23] ; Wei Li[24] ; Chong Bai[25] ; Buhai Wang[26] ; Rui Ma[27] ; Zhendong Zheng[28] ; Mingfang Liu[29] ; Zhijun Jie[30] ; Lejie Cao[31] ; Wangjun Liao[32] ; Hongming Pan[33] ; Dongning Huang[34] ; Yuan Chen[35] ; Jinji Yang[36] ; Shukui Qin[37] ; Shenglin Ma[38] ; Li Liang[39] ; Zhe Liu[40] ; Jianying Zhou[41] ; Min Tao[42] ; Yijiang Huang[43] ; Feng Qiu[44] ; Yunchao Huang[45] ; Sha Guan[46] ; Mengye Peng[46] ; Weiguo Su[46] ;
机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University [2]Harbin Medical University Cancer Hospital [3]Jinnan Central Hospital [4]XuZhou Central Hospital [5]Fudan University Shanghai Cancer Center [6]The First Affiliated Hospital of Xi'an Jiaotong University [7]The Second Hospital of Anhui Medical University [8]Xiamen Key Laboratory of Antitumor Drug Transformation Research, The First Affiliated Hospital of Xiamen University [9]Nantong Tumor Hospital [10]Linyi Cancer Hospital [11]The First Affiliated Hospital of Guanzhou Medical University [12]The Fifth Medical Center, General Hospital of the People's Liberation Army [13]Zhejiang Cancer Hospital [14]Jiangxi Cancer Hospital [15]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute [16]Jilin Cancer Hospital [17]The Second Xiangya Hospital of Central South University [18]Jiangyin People’s Hospital [19]Hubei Cancer Hospital [20]West China Hospital of Sichuan University [21]Xinjiang Cancer Hospital [22]Affiliated Hospital of Guangdong Medical University [23]Jinling Hospital, Nanjing University School of Medicine [24]The First Hospital of Jilin University [25]Shanghai Changhai Hospital [26]Northern Jiangsu People's Hospital [27]Liaoning Cancer Hospital [28]General Hospital of Northern Theater Command [29]General Hospital of Ningxia Medical University [30]The Fifth People's Hospital of Shanghai [31]The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China [32]Nanfang Hospital of Southern Medical University [33]Sir Run Run Shaw Hospital Affiliated with School of Medicine, Zhe Jiang University [34]The Fourth Affiliated Hospital of Guangxi Medical University [35]Tongji Hospital, Tongji Medical College of Hust [36]Guandong Provincial People's Hospital [37]People’s Liberation Army Cancer Center of Nanjing Jinling Hospital [38]Hangzhou First People's Hospital [39]Peking University Third Hospital [40]Beijing Chest Hospital, Capital Medical University [41]The First Affiliated Hospital, Zhejiang University [42]The First Affiliated Hospital of Soochow University [43]Hainan General Hospital [44]The First Affiliated Hospital of Nanchang University [45]Yunnan Cancer Hospital [46]Hutchison MediPharma, Shanghai, China
出处：
DOI： 10.1016/j.lungcan.2020.06.016
ISSN：

关键词： Fruquintinib Non-small-cell lung cancer VEGFR-TKI

摘要：
Objectives: Fruquintinib is an orally active kinase inhibitor that selectively targets the vascular endothelial growth factor (VEGF) receptor. A Phase II trial has demonstrated a significant benefit in progression-free survival (PFS) for fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy. This Phase III trial is a randomized, double-blind, multicenter trial to confirm fruquintinib's efficacy in the same patient population. Materials and methods: From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study. Participants were randomized 2:1 to receive fruquintinib (n = 354) or placebo (n = 173) once daily for 3 weeks on-treatment, and 1 week off-treatment. Patients were stratified according to epidermal growth factor receptor mutation status and prior use of VEGF inhibitors. Primary endpoint was overall survival (OS). Results: Median OS was 8.9 months for the fruquintinib group and 10.4 months for placebo group (hazard ratio [HR] 1.02; 95 % confidence interval [CI], 0.82–1.28; P = 0.841), with median PFS of 3.7 months and 1.0 months, respectively (HR 0.34; 95 % CI, 0.28–0.43; P < 0.001). Objective response rate and disease control rate were 13.8 % and 66.7 % for fruquintinib, and 0.6 % and 24.9 % for placebo, respectively (P < 0.001). Hypertension was the most frequent treatment-emergent adverse event (≥grade 3) observed in fruquintinib-treated patients (21.0 %). Post hoc analysis revealed that fruquintinib prolonged the median OS for patients who did not receive subsequent antitumor therapy: 7.0 months versus 5.1 months for placebo (HR 0.65; 95 % CI, 0.46–0.91; P = 0.012). Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires. Conclusion: Although the study did not meet its primary endpoint, fruquintinib could be effective in combination with other agents for the treatment of patients with NSCLC who have failed second-line chemotherapy. © 2020 Elsevier B.V.

基金：
This study was funded by Hutchison MediPharma (Shanghai), Eli Lilly and the Shanghai International Science and Technology Cooperation Fund Project. The sponsors were involved in the decision to submit the report for publication.
语种：
外文
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WOS：
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中科院(CAS)分区：
出版当年[2020]版：
大类 | 2 区 医学
小类 | 2 区 肿瘤学 2 区 呼吸系统
最新[2023]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
JCR分区：
出版当年[2020]版：
Q1 RESPIRATORY SYSTEM Q2 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University [*1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University. #241 Huai Hai Rd (West), Shanghai, China, 200030
通讯作者：
通讯机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University [*1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University. #241 Huai Hai Rd (West), Shanghai, China, 200030
推荐引用方式(GB/T 7714)：
Shun Lu,Gongyan Chen,Yuping Sun,et al.A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer – The FALUCA study[J].LUNG CANCER.2020,146:252-262.doi:10.1016/j.lungcan.2020.06.016.
APA：
Shun Lu,Gongyan Chen,Yuping Sun,Sanyuan Sun,Jianhua Chang...&Weiguo Su.(2020).A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer – The FALUCA study.LUNG CANCER,146,
MLA：
Shun Lu,et al."A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer – The FALUCA study".LUNG CANCER 146.(2020):252-262

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