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

作     者：Jie Zhang Yueyin Pan Qin Shi Guojun Zhang Liyan Jiang Xiaorong Dong Kangsheng Gu Huijuan Wang Xiaochun Zhang Nong Yang Yuping Li Jianping Xiong Tienan Yi Min Peng Yong Song Yun Fan Jiuwei Cui Gongyan Chen Wei Tan Aimin Zang Qisen Guo Guangqiang Zhao Ziping Wang Jianxing He Wenxiu Yao Xiaohong Wu Kai Chen Xiaohua Hu Chunhong Hu Lu Yue Da Jiang Guangfa Wang Junfeng Liu Guohua Yu Junling Li Jianling Bai Wenmin Xie Weihong Zhao Lihong Wu Caicun Zhou 

作者机构：Department of Medical OncologyShanghai Pulmonary Hospital&Thoracic Cancer InstituteTongji University School of MedicineShanghai 200433P.R.China Department of ChemotherapyAnhui Provincial HospitalHefeiAnhui 230001P.R.China Department of OncologyFuzhou Pulmonary Hospital of FujianFuzhouFujian 350008P.R.China Department of Respiratory Medicinethe First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenan 450052P.R.China Department of RespirationShanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030P.R.China Cancer CenterUnion Hospital of Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430022P.R.China Department of Medical Oncologythe First Affiliated Hospital of Anhui Medical UniversityHefeiAnhui 230032P.R.China Department of RespirationHenan Cancer HospitalZhengzhouHenan 450008P.R.China Department of Medical Oncologythe Affiliated Hospital of Qingdao UniversityQingdaoShandong 266000P.R.China Department of Medical OncologyHunan Cancer HospitalChangshaHunan 410013P.R.China Department of Pulmonary and Critical Care Medicinethe First Affiliated Hospital of Wenzhou Medical CollegeShangcai villageWenzhouZhejiang 325000P.R.China Department of Medical Oncologythe First Affiliated Hospital of Nanchang UniversityNanchangJiangxi 330006P.R.China Department of Medical OncologyXiang Yang Central HospitalXiangyangHubei 441021P.R.China Department of Medical OncologyRenmin Hospital of Wuhan UniversityWuhanHubei 430060P.R.China Department of RespirationGeneral Hospital of Eastern Theater Command of Chinese People’s Liberation ArmyNanjingJiangsu 210002P.R.China Department of Medical OncologyZhejiang Cancer HospitalHangzhouZhejiang 310022P.R.China Cancer Centerthe First Bethune Hospital of Jilin UniversityChangchunJilin 130021P.R.China Department of Medical OncologyHarbin Medical University Cancer HospitalHarbinHeilongjiang 150081P.R.China Department of Respiratory MedicineWeifang People’s HospitalWeifangShandong 261000P.R.China Department of Medical OncologyAffiliated Hospital of Hebei UniversityBaodingHebei 071030P.R.China Department of Internal MedicineShandong Cancer Hospital&InstituteJinanShandong 250117P.R.China Department of Thoracic Surgerythe Third Affiliated Hospital of Kunming Medical UniversityKunmingYunnan 650118P.R.China Department of Medical OncologyBeijing Cancer HospitalBeijing 100142P.R.China Departmentof Thoracic Surgery and Oncologythe First Affiliated Hospital of Guangzhou Medical UniversityGuangzhouGuangdong 510120P.R.China Department of ChemotherapySichuan Cancer Hospital&InstituteChengduSichuan 610041P.R.China Department of Medical Oncologythe Fourth People’s Hospital of WuxiWuxiJiangsu 214062P.R.China Department of Medical Oncologythe First Affiliated Hospital of Soochow UniversitySuzhouJiangsu 215006P.R.China Department of Medical Oncologythe First Affiliated Hospital of Guangxi Medical UniversityNanningGuangxi 530021P.R.China Department of Medical Oncologythe Second Xiangya Hospital of Central South UniversityChangshaHunan 410011P.R.China Department of Medical OncologyQingdao Municipal HospitalQingdaoShandong 266071P.R.China Department of Medical Oncologythe 4th Hospital of Hebei Medical UniversityShijiazhuangHebei 050010P.R.China Department of Respiratory MedicinePeking University First HospitalBeijing 100034P.R.China Department of Thoracic Surgerythe 4th Hospital of Hebei Medical UniversityShijiazhuangHebei 050010P.R.China Department of Medical OncologyWeifang People’s HospitalWeifangShandong 261000P.R.China Cancer Hospital Chinese Academy of Medical SciencesBeijing 100021P.R.China Department of BiostatisticsSchool of Public HealthNanjing Medical UniversityNanjingJiangsu 211166P.R.China Nanjing Luye Pharmaceutical Co.LtdNanjingJiangsu 210061P.R.China Genecast Biotechnology Co.LtdWuxiJiangsu 214104P.R.China 

出 版 物：《Cancer Communications》 (癌症通讯（英文）)

年 卷 期：2022年第42卷第1期

页      面：3-16页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：Nanjing Luye Pharmaceutical Co.Ltd,Nanjing,China,Grant/Award Number:2017ZZ02012 sponsored by Nanjing Luye Pharmaceu-tical Co.Ltd,Nanjing,China,and supported in part by grants from Shanghai Key disciplines of Respiratory(No.2017ZZ02012) and Shanghai Major Diseases Multidisci-plinary Cooperation Diagnosis and Treatment Construc-tion Project 

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

摘      要：Background:Lipusu is the first commercialized liposomal formulation of pacli-taxel and has demonstrated promising efficacy against locally advanced lung squamous cell carcinoma(LSCC)in a small-scale ***,we conducted a multicenter,randomized,phase 3 study to compare the efficacy and safety of cis-platin plus Lipusu(LP)versus cisplatin plus gemcitabine(GP)as first-line treat-ment in locally advanced or metastatic ***: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 chemother-apy and at least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors(version 1.1)before administration of the trial *** primary endpoint was progression-free survival(PFS).The secondary endpoints included objective response rate(ORR),disease control rate(DCR),overall survival(OS),and safety *** 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 *** correlation between treatment outcomes and dynamic changes in the levels of cytokines were evaluated in preliminary ***: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 rtio[HR]:1.03,P=0.742)*** 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)le