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Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study.

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作者：
Jie Zhang[1] * ; Yueyin Pan[2] * ; Qin Shi[3] * ; Guojun Zhang[4] * ; Liyan Jiang[5] ; Xiaorong Dong[6] ; Kangsheng Gu[7] ; Huijuan Wang[8] ; Xiaochun Zhang[9] ; Nong Yang[10] ; Yuping Li[11] ; Jianping Xiong[12] ; Tienan Yi[13] ; Min Peng[14] ; Yong Song[15] ; Yun Fan[16] ; Jiuwei Cui[17] ; Gongyan Chen[18] ; Wei Tan[19] ; Aimin Zang[20] ; Qisen Guo[21] ; Guangqiang Zhao[22] ; Ziping Wang[23] ; Jianxing He[24] ; Wenxiu Yao[25] ; Xiaohong Wu[26] ; Kai Chen[27] ; Xiaohua Hu[28] ; Chunhong Hu[29] ; Lu Yue[30] ; Da Jiang[31] ; Guangfa Wang[32] ; Junfeng Liu[33] ; Guohua Yu[34] ; Junling Li[35] ; Jianling Bai[36] ; Wenmin Xie[37] ; Weihong Zhao[37] ; Lihong Wu[38] ; Caicun Zhou[1,*1] ;
机构： [1]Department of Medical Oncology, Shanghai Pulmonary Hospital & Thoracic Cancer InstituteTongji University School of Medicine, Shanghai 200433,P. R. China [2]Department of Chemotherapy, Anhui Provincial Hospital, Hefei, Anhui 230001, P. R. China [3]Department of Oncology, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, Fujian 350008, P. R. China [4]Department of Respiratory Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, P. R. China [5]Department of Respiration, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, P. R. China [6]Cancer Center, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430022, P. R. China [7]Department of Medical Oncology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230032, P. R. China [8]Department of Respiration, Henan Cancer Hospital, Zhengzhou, Henan 450008, P. R. China [9]Department of Medical Oncology, the Affiliated Hospital of Qingdao University, Qingdao, Shandong 266000, P. R. China [10]Department of Medical Oncology, Hunan Cancer Hospital, Changsha, Hunan 410013, P. R. China [11]Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of Wenzhou Medical College, Shangcai village, Wenzhou,Zhejiang 325000, P. R. China [12]Department of Medical Oncology, the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, P. R. China [13]Department of Medical Oncology, Xiang Yang Central Hospital, Xiangyang, Hubei 441021, P. R. China [14]Department of Medical Oncology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, P. R. China [15]Department of Respiration, General Hospital of Eastern Theater Command of Chinese People’s Liberation Army, Nanjing, Jiangsu 210002, P. R.China [16]Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, P. R. China [17]Cancer Center, the First Bethune Hospital of Jilin University, Changchun, Jilin 130021, P. R. China [18]Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang 150081, P. R. China [19]Department of Respiratory Medicine, Weifang People’s Hospital, Weifang, Shandong 261000, P. R. China [20]Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, Hebei 071030, P. R. China [21]Department of Internal Medicine, Shandong Cancer Hospital & Institute, Jinan, Shandong 250117, P. R. China [22]Department of Thoracic Surgery, the Third Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 650118, P. R. China [23]Department of Medical Oncology, Beijing Cancer Hospital, Beijing 100142, P. R. China [24]Department of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120,P. R. China [25]Department of Chemotherapy, Sichuan Cancer Hospital & Institute, Chengdu, Sichuan 610041, P. R. China [26]Department of Medical Oncology, the Fourth People’s Hospital of Wuxi, Wuxi, Jiangsu 214062, P. R. China [27]Department of Medical Oncology, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, P. R. China [28]Department of Medical Oncology, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P. R. China [29]Department of Medical Oncology, the Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, P. R. China [30]Department of Medical Oncology, Qingdao Municipal Hospital, Qingdao, Shandong 266071, P. R. China [31]Department of Medical Oncology, the 4th Hospital of Hebei Medical University, Shijiazhuang, Hebei 050010, P. R. China [32]Department of Respiratory Medicine, Peking University First Hospital, Beijing 100034, P. R. China [33]Department of Thoracic Surgery, the 4th Hospital of Hebei Medical University, Shijiazhuang, Hebei 050010, P. R. China [34]Department of Medical Oncology, Weifang People’s Hospital, Weifang, Shandong 261000, P. R. China [35]Cancer Hospital Chinese Academy of Medical Sciences, Beijing 100021, P. R. China [36]Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu 211166, P. R. China [37]Nanjing Luye Pharmaceutical Co., Ltd, Nanjing, Jiangsu 210061, P. R. China [38]Genecast Biotechnology Co., Ltd, Wuxi, Jiangsu 214104, P. R. China
出处：
DOI： 10.1002/cac2.12225
ISSN：

关键词： chemotherapy cisplatin clinical trial gemcitabine liposomal paclitaxel (Lipusu) locally advanced lung squamous cell carcinoma metastatic multicenter plasma cytokines

摘要：
Lipusu is the first commercialized liposomal formulation of paclitaxel and has demonstrated promising efficacy against locally advanced lung squamous cell carcinoma (LSCC) in a small-scale study. Here, we conducted a multicenter, randomized, phase 3 study to compare the efficacy and safety of cisplatin plus Lipusu (LP) versus cisplatin plus gemcitabine (GP) as first-line treatment in locally advanced or metastatic LSCC.Patients enrolled were aged between 18 to 75 years, had locally advanced (clinical stage IIIB, ineligible for concurrent chemoradiation or surgery) or metastatic (Stage IV) LSCC, had no previous systemic chemotherapy and at least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors (version 1.1) before administration of the trial drug. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety profiles. To explore the possible predictive value of plasma cytokines for LP treatment, plasma samples were collected from the LP group at baseline and first efficacy evaluation time and were then subjected to analysis by 45-Plex ProcartaPlex Panel 1 to detect the presence of 45 cytokines using the Luminex xMAP technology. The correlation between treatment outcomes and dynamic changes in the levels of cytokines were evaluated in preliminary analyses.The median duration of follow-up was 15.4 months. 237 patients in the LP group and 253 patients in the GP group were included in the per protocol set (PPS). In the PPS, the median PFS was 5.2 months versus 5.5 months in the LP and GP group (hazard ratio [HR]: 1.03, P = 0.742) respectively. The median OS was 14.6 months versus 12.5 months in the LP and GP group (HR: 0.83, P = 0.215). The ORR (41.8% versus 45.9%, P = 0.412) and DCR (90.3% versus 88.1%, P = 0.443) were also similar between the LP and GP group. A significantly lower proportion of patients in the LP group experienced adverse events (AEs) leading to treatment interruptions (10.9% versus 26.4%, P < 0.001) or treatment termination (14.3% versus 23.1%, P = 0.011). The analysis of cytokine levels in the LP group showed that low baseline levels of 27 cytokines were associated with an increased ORR, and 15 cytokines were associated with improved PFS, with 14 cytokines, including TNF-α, IFN-γ, IL-6, and IL-8, demonstrating an overlapping trend.The LP regimen demonstrated similar PFS, OS, ORR and DCR as the GP regimen for patients with locally advanced or metastatic LSCC but had more favorable toxicity profiles. The study also identified a spectrum of different cytokines that could be potentially associated with the clinical benefit in patients who received the LP regimen.© 2021 The Authors. Cancer Communications published by John Wiley & Sons Australia, Ltd. on behalf of Sun Yat-sen University Cancer Center.

基金：
Nanjing Luye Pharmaceutical Co. Ltd, Nanjing, China, Grant/Award Number: 2017ZZ02012
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
JCR分区：
出版当年[2022]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Shanghai Pulmonary Hospital & Thoracic Cancer InstituteTongji University School of Medicine, Shanghai 200433,P. R. China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Medical Oncology, Shanghai Pulmonary Hospital & Thoracic Cancer InstituteTongji University School of Medicine, Shanghai 200433,P. R. China [*1]Department of Medical Oncology, Shanghai Pulmonary Hospital & Thoracic Cancer Institute, Tongji University School of Medicine, No. 507, Zheng Min Road, Shanghai 200433, P.R. China
推荐引用方式(GB/T 7714)：
Jie Zhang,Yueyin Pan,Qin Shi,et al.Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study.[J].CANCER COMMUNICATIONS.2022,42(1):3-16.doi:10.1002/cac2.12225.
APA：
Jie Zhang,Yueyin Pan,Qin Shi,Guojun Zhang,Liyan Jiang...&Caicun Zhou.(2022).Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study..CANCER COMMUNICATIONS,42,(1)
MLA：
Jie Zhang,et al."Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study.".CANCER COMMUNICATIONS 42..1(2022):3-16

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