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Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial

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Cancer Biology & Medicine 2021年第3期18卷 816-824页

作者： Tianqing Chu Jun Lu Minghong Bi Helong Zhang Wu Zhuang Yan Yu Jianhua Shi Zhendong Chen Xiaochun Zhang qisen guo Quan Liu Huijuan Wu Jian Fang Yi Hu Xiuwen Wang Cuicui Han Kai Li Baohui Han Department of Pulmonary Medicine Shanghai Chest HospitalShanghai Jiao Tong UniversitySha nghai 200030China Department of Oncology The First Affiliated Hospital of Bengbu Medical CollegeBengbu 233004China Department of Oncology Tangdu HospitalAir Force Medical University of PLAXi'an 710038China Department of Medical Thoracic Oncology Fujian Cancer HospitalFujian Medical University Cancer HospitalFuzhou 350014China Department of Oncology Harbin Medical University Cancer HospitalHarbin 150081China Department of Oncology Linyi Cancer HospitalLinyi 276000China Department of Oncology The Second Hospital of Anhui Medical UniversityHefei 230601China Department of Oncology The Affiliated Hospital of Qingdao UniversityQingdao 266071China Department of Internal Medicine Shandong Cancer Hospital Affiliated to Shandong UniversityJinan 250117China Department of Oncology Affiliated Hospital of Jiang Nan UniversityWuxi 214122China Department of Internal Medicine Henan Province Tumor HospitalZhengzhou UniversityZhengzhou 450008China Department of Thoracic OncologyⅡ Peking University Cancer Hospital and InstituteBeijing 100142China Department of Oncology Chinese PLA General HospitalBeijing 100039China Department of Oncology Qilu Hospital of Shandong UniversityJinan 250012China Department of Clinical Research Centre Qilu Pharmaceutical Co.LtdJinan 250101China Department of Thoracic Oncology Tianjin Medical University Cancer Institute and HospitalNational Clinical Research Center for CancerKey Laboratory of Cancer Prevention and TherapyTianjinTianjin’s Clinical Research Center for CancerTianjin 300060China

Objective:This phase 3 study aimed to test equivalence in efficacy and safety for QL1101,a bevacizumab analogue in Chinese patients with untreated locally advanced non-squamous non-small cell lung cancer(NSCLC).Methods:Eligible patients were randomly assigned 1:1 to receive carboplatin and paclitaxel in combination with either QL1101 or bevacizumab,15 mg/kg every 3-week for 6 cycles.This was followed by maintenance treatment with single agent QL1101 every 3-week.The primary end-point was objective response rate(ORR),with secondary end-points being progression-free survival(PFS),overall survival(OS),disease control rate(DCR),and adverse events(AEs).Results:Of 675 patients,535 eligible patients were randomized to the QL1101 group(n=269)and bevacizumab group(n=266).ORRs were 52.8%and 56.8%,respectively,for the QL1101 and bevacizumab groups,with an ORR hazard ratio 0.93(95%confidence interval:0.8-0131.1).The PFS,OS,DCR,and AEs were comparable between the 2 groups,which remained the same after stratification according to epidermal growth factor receptor mutation or smoking history.Conclusions:QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients with untreated locally advanced non-squamous NSCLC.

关键词： Biosimilar bevacizumab equivalence non-squamous NSCLC clinical efficacy

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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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Cancer Communications 2022年第1期42卷 3-16页

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 Department of Medical Oncology Shanghai Pulmonary Hospital&Thoracic Cancer InstituteTongji University School of MedicineShanghai 200433P.R.China Department of Chemotherapy Anhui Provincial HospitalHefeiAnhui 230001P.R.China Department of Oncology Fuzhou Pulmonary Hospital of FujianFuzhouFujian 350008P.R.China Department of Respiratory Medicine the First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenan 450052P.R.China Department of Respiration Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030P.R.China Cancer Center Union Hospital of Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430022P.R.China Department of Medical Oncology the First Affiliated Hospital of Anhui Medical UniversityHefeiAnhui 230032P.R.China Department of Respiration Henan Cancer HospitalZhengzhouHenan 450008P.R.China Department of Medical Oncology the Affiliated Hospital of Qingdao UniversityQingdaoShandong 266000P.R.China Department of Medical Oncology Hunan Cancer HospitalChangshaHunan 410013P.R.China Department of Pulmonary and Critical Care Medicine the First Affiliated Hospital of Wenzhou Medical CollegeShangcai villageWenzhouZhejiang 325000P.R.China Department of Medical Oncology the First Affiliated Hospital of Nanchang UniversityNanchangJiangxi 330006P.R.China Department of Medical Oncology Xiang Yang Central HospitalXiangyangHubei 441021P.R.China Department of Medical Oncology Renmin Hospital of Wuhan UniversityWuhanHubei 430060P.R.China Department of Respiration General Hospital of Eastern Theater Command of Chinese People’s Liberation ArmyNanjingJiangsu 210002P.R.China Department of Medical Oncology Zhejiang Cancer HospitalHangzhouZhejiang 310022P.R.China Cancer Center the First Bethune Hospital of Jilin UniversityChangchunJilin 130021P.R.China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbinHeilongjiang 150081P.R.China Department of Respiratory Medicine Weifang People’s HospitalWeifangShandong

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 study.Here,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 LSCC.Methods: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 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.Results: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)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.

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

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Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer:an open-label,randomized controlled phase 3 trial(ORIENT-3)

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Cancer Communications 2022年第12期42卷 1314-1330页

作者： Yuankai Shi Lin Wu Xinmin Yu Puyuan Xing Yan Wang Jianying Zhou Airong Wang Jianhua Shi Yi Hu Ziping Wang Guangyu An Yong Fang Sanyuan Sun Caicun Zhou Changli Wang Feng Ye Xingya Li Junye Wang Mengzhao Wang Yunpeng Liu Yanqiu Zhao Ying Yuan Jifeng Feng Zhendong Chen Jindong Shi Tao Sun Gang Wu Yongqian Shu qisen guo Yi Zhang Yong Song Shucai Zhang Yuan Chen Wei Li Hongrui Niu Wenwei Hu Lijun Wang Jianan Huang Yang Zhang Ying Cheng Zhengdong Wu Bo Peng Jiya Sun Christoph Mancao Yanqi Wang Luyao Sun Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijingP.R.China Department II of Thoracic Medicine Hunan Cancer HospitalChangshaHunanP.R.China Department of Medical Oncology Zhejiang Cancer HospitalHangzhouZhejiangP.R.China Department of Respiratory Diseases The First Affiliated HospitalCollege of MedicineZhejiang UniversityHangzhouZhejiangP.R.China The Third Department of Chemotherapy Weihai Municipal HospitalWeihaiShandongP.R.China Department of Medical Oncology Linyi Cancer HospitalLinyiShandongP.R.China Oncology Department General Hospital of Chinese People’s Liberation ArmyBeijingP.R.China Department of Chest Medicine Beijing Cancer HospitalBeijingP.R.China Department of Oncology Beijing Chao-Yang HospitalCapital Medical UniversityBeijingP.R.China Department of Medical Oncology Sir Run Run Shaw HospitalZhejiang UniversityHangzhouZhejiangP.R.China Department of Medical Oncology Xuzhou Central HospitalXuzhou Medical UniversityXuzhouJiangsuP.R.China Department of Medical Oncology Shanghai Pulmonary HospitalTongji UniversityShanghaiP.R.China Department of Lung Cancer Tianjin Medical University Cancer Institute and HospitalTianjinP.R.China Department of Medical Oncology Cancer HospitalThe First Affiliated Hospital of Xiamen UniversitySchool of MedicineXiamen UniversityThe Third Clinical Medical CollegeFujian Medical UniversityXiamenFujianP.R.China Department of Medical Oncology The First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China Department of Oncology Affiliated Hospital of Jining Medical UniversityJiningShandongP.R.China Department of Respiratory and Critical Care Medicine Peking Union Medical College HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijingP.R.China Department of Medical Oncology Key L

Background:Treatment options for Chinese patients with locally advanced or metastatic squamous-cell non-small-cell lung cancer(sqNSCLC)after failure of first-line chemotherapy are limited.This study(ORIENT-3)aimed to evaluate the efficacy and safety of sintilimab versus docetaxel as second-line treatment in patients with locally advanced or metastatic sqNSCLC.Methods:ORIENT-3 was an open-label,multicenter,randomized controlled phase 3 trial that recruited patients with stage IIIB/IIIC/IV sqNSCLC after failure with first-line platinum-based chemotherapy.Patients were randomized in a 1:1 ratio to receive either 200 mg of sintilimab or 75 mg/m^(2) of docetaxel intravenously every 3 weeks,stratified by the Eastern Cooperative Oncology Group performance status.The primary endpoint was overall survival(OS)in the full analysis set(FAS).Secondary endpoints included progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),duration of response(DoR)and safety.Results:Between August 25,2017,and November 7,2018,290 patients were randomized.For FAS,10 patients fromthe docetaxel armwere excluded.Themedian OS was 11.79(n=145;95%confidence interval[CI],10.28-15.57)months with sintilimab versus 8.25(n=135;95%CI,6.47-9.82)months with docetaxel(hazard ratio[HR]:0.74;95%CI,0.56-0.96;P=0.025).Sintilimab treatment significantly prolonged PFS(median 4.30 vs.2.79 months;HR:0.52;95%CI,0.39-0.68;P<0.001)and showed higher ORR(25.50%vs.2.20%,P<0.001)and DCR(65.50%vs.37.80%,P<0.001)than the docetaxel arm.The median DoRwas 12.45(95%CI,4.86-25.33)months in the sintilimab arm and 4.14(95%CI,1.41-7.23)months in the docetaxel arm(P=0.045).Treatment-related adverse events of grade≥3were reported in 26(18.1%)patients in the sintilimab arm and 47(36.2%)patients in the docetaxel arm.Exploratory biomarker analysis showed potential predictive values of expression levels of two transcription factors,including OVOL2(HR:0.35;P<0.001)and CTCF(HR:3.50;P<0.001),for sintilimab treatment.Conclusions:Compared with docetaxel,sintilima

关键词： Non-small cell lung cancer Carcinoma squamous cell Sintilimab Immunotherapy Survival Randomized controlled trial

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晚期NSCLC EGFR-TKIs治疗失败应用PD-1/PD-L1抑制剂进展

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中华肿瘤防治杂志 2023年第7期30卷 430-435页

作者：王晨尹俊程郭其森山东省肿瘤防治研究院(山东省肿瘤医院)肿瘤内科山东第一医科大学(山东省医学科学院) 山东济南250117

目的探讨程序性死亡受体-1/程序性死亡受体配体-1(PD-1/PD-L1)抑制剂在表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)治疗失败的非小细胞肺癌(NSCLC)患者中的最佳治疗方案,为临床治疗提供参考。方法使用PubMed及中国知网数据库检索系统... 详细信息

目的探讨程序性死亡受体-1/程序性死亡受体配体-1(PD-1/PD-L1)抑制剂在表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)治疗失败的非小细胞肺癌(NSCLC)患者中的最佳治疗方案,为临床治疗提供参考。方法使用PubMed及中国知网数据库检索系统,以“非小细胞肺癌、EGFR-TKIs耐药、PD-1/PD-L1抑制剂”为中文关键词,“non-small cell lung cancer、EGFR-TKIs resistance、PD-1/PD-L1 inhibitors”为英文关键词,检索2009-09-03-2022-06-02相关文献。纳入标准:PD-1/PD-L1抑制剂用于EGFR-TKIs治疗失败的晚期NSCLC患者的相关研究。排除标准:数据陈旧的相关研究。共纳入文献56篇。结果PD-1/PD-L1抑制剂单药效果有限,联合EGFR-TKIs由于毒副作用大多停止用药,联合TGF-β及CTLA-4抑制剂或抗血管生成药物研究样本量有限,联合化疗或联合化疗及抗血管生成初见疗效,但联合方案的最优选择仍然存在争议。结论PD-1/PD-L1抑制剂在EGFR-TKIs治疗失败的晚期NSCLC患者的治疗中取得了一定的疗效,但如何根据不同的患者选择最优联合方案仍需要进一步探讨。

关键词：非小细胞肺癌 EGFR-TKIs耐药 PD-1/PD-L1抑制剂综述文献

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Bevacizumab biosimilar LY01008 compared with bevacizumab(Avastin)as first-line treatment for Chinese patients with unresectable,metastatic,or recurrent non-squamous non-small-cell lung cancer:A multicenter,randomized,double-blinded,phase Ⅲ trial

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Cancer Communications 2021年第9期41卷 889-903页

作者： Yuankai Shi Kaijian Lei Yuming Jia Bingqiang Ni Zhiyong He Minghong Bi Xicheng Wang Jianhua Shi Ming Zhou Qian Sun guolei Wang Dongji Chen Yongqian Shu Lianke Liu Zhongliang guo Yong Liu Junquan Yang Ke Wang Ke Xiao LinWu Tienan Yi Debin Sun Mafei Kang Tianjiang Ma Yimin Mao Jinsheng Shi Tiegang Tang Yan Wang Puyuan Xing Dongqing Lv Wangjun Liao Zhiguo Luo Bin Wang Xiaohong Wu Xiaoli Zhu Shuhua Han qisen guo Rongyu Liu Zhiwei Lu Jianyong Zhang Jian Fang Changlu Hu Yinghua Ji guolong Liu Hong Lu Dedong Wu Junhong Zhang Shuyang Zhu Zheng Liu Wensheng Qiu Feng Ye Yan Yu Yanqiu Zhao Qinhong Zheng Jun Chen Zhanyu Pan Yiping Zhang Wenjuan Lian Bo Jiang Bo Qiu guojun Zhang Hua Zhang Yanju Chen Yuan Chen Hongbing Duan Manxiang Li Shengming Liu Lijun Ma Hongming Pan Xia Yuan Xueli Yuan Yulong Zheng Emei Gao Li Zhao Shumin Wang Can Wu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021P.R.China Department of Oncology Yibin Second People’s HospitalYibinSichuan 644000P.R.China Department of Oncology Liuzhou People’s HospitalLiuzhouGuangxi 545006P.R.China Department of Thoracic Oncology Fujian Provincial Cancer HospitalFuzhouFujian 350014P.R.China Oncology Department the First Affiliated Hospital of Bengbu Medical CollegeBengbuAnhui 233030P.R.China Department of Oncology the First Affiliated Hospital of Guangdong Pharmaceutical UniversityGuangzhouGuangdong 510030P.R.China Department of Internal medicine Linyi Cancer HospitalLinyiShandong 276002P.R.China Department of Thoracic Surgery the Affiliated Cancer Hospital of Guangzhou Medical UniversityGuangzhouGuangdong 510095P.R.China Department of Internal Medicine-Oncology/Department of thoracic oncology Henan Chest HospitalZhengzhouHenan 450003P.R.China The Second Department of Radiotherapy Wuwei Cancer Hospital of Gansu ProvinceWuweiGansu 730000P.R.China Department of Oncology the People’s Hospital of Jiangsu ProvinceNanjingJiangsu 210000P.R.China Respiratory Medicine Department Shanghai East HospitalShanghai 200120P.R.China The Second Department of Internal Medicine-Oncology Xuzhou Central HospitalXuzhouJiangsu 221009P.R.China Oncology Department Tangshan People’s HospitalTangshanHebei 063001P.R.China Respiratory Medicine Department West China Hospital of Sichuan UniversityChengduSichuan 610041P.R.China Thoracic Surgery the Second Affiliated Hospital of Shantou University Medical CollegeShantouGuangdong 515051P.R.China Internal Medicine-Oncology Hunan Cancer HospitalChangshaHunan 410013P.R.China Department of Oncology Xiangyang Central HospitalXiangyangHubei 441021P.R.China Respiratory Department Lishui Central HospitalLishuiZ

Background:Previous studies have demonstrated the preclinical pharmacological and toxicological consistency,and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab(Avastin).This randomized controlled trial aimed to compare the efficacy and safety of LY01008 with Avastin in first-line treatment of Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer(NSCLC).Methods:StageⅢB-ⅣNSCLC patients with evaluable lesions,good physical status,and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in combination with paclitaxel/carboplatin(combined treatment)for 4-6 cycles,followed by maintenance monotherapy with LY01008 until disease progression,intolerable toxicity,or death.The primary endpoint was objective response rate(ORR)in accordance with Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 confirmed by independent radiological review committees(IRRC).Secondary endpoints included disease control rate(DCR),duration of response(DoR),progression-free survival(PFS),overall survival(OS),and safety.This study was registered in Clinical Trials.gov(NCT03533127).Results:Between December 15^(th),2017,and May 15^(th),2019,a total of 649 patients were randomized to the LY01008(n=324)or Avastin(n=325)group.As of September 25th,2019 for primary endpoint analysis,589 patients received ORR evaluation,with a median number of combined treatment cycles of 5(range 1-6)andmedian duration of treatment of 3.0(range 0.0-5.1)months.ORRof responseevaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%,respectively.The stratified ORR ratio was 0.91(90%CI 0.80-1.04,within the prespecified equivalence margin of 0.75-1.33).Up to May 15^(th),2020,with a median follow-up of 13.6(range 0.8-28.4)months,no notable differences in DCR,median DoR,median PFS,median OS,and 1-year OS rate were observed between the LY01008 and Avastin groups.There were no clinically m

关键词： anti-angiogenesis anti-VEGF monoclonal antibody avastin bevacizumab biosimilar nonsmall cell lung cancer LY01008 vascular endothelial growth factor

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治疗效果显著的1例AFP增高的原发性肺鳞癌病例报道

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中国肺癌杂志 2022年第1期25卷 66-70页

作者：陈青王衍博张文杰王晨尹俊程郭其森山东第一医科大学附属山东省肿瘤医院肿瘤内科山东第一医科大学济南250117 淄博市齐都医院淄博255400 潍坊医学院潍坊261000

背景与目的产生甲胎蛋白(alpha-fetoprotein,AFP)的原发性肺鳞癌很少见,迄今为止只有4例相关报道。AFP增高的具体原因和治疗产生AFP原发性肺鳞癌的有效方案目前还不清楚。现报告1例产生AFP的肺鳞癌诊断和治疗经过,为后续临床工作提供参... 详细信息

背景与目的产生甲胎蛋白(alpha-fetoprotein,AFP)的原发性肺鳞癌很少见,迄今为止只有4例相关报道。AFP增高的具体原因和治疗产生AFP原发性肺鳞癌的有效方案目前还不清楚。现报告1例产生AFP的肺鳞癌诊断和治疗经过,为后续临床工作提供参考价值。方法回顾性分析山东省肿瘤医院2020年10月23日收治的1例AFP增高的原发性肺鳞癌患者的诊断、治疗过程并进行文献复习。结果患者男性,52岁,初始诊断:右肺上叶鳞癌T4N3M0、Ⅲc期纵隔淋巴结转移肺内多发转移。肿瘤标记物以血清异常增高的AFP为主。两线化疗快速进展后,三线予以安罗替尼+卡瑞丽珠单抗方案治疗,2个周期和4个周期后疗效评估分别为部分反应(partial response,PR)和病情稳定(stable disease,SD)。第5个周期治疗后因消化道出血更换为白蛋白紫杉醇+卡瑞丽珠单抗方案治疗,病情得到持续控制。结论案例报道中产生AFP的原发性肺鳞癌患者对安罗替尼联合免疫治疗反应良好,可为今后临床工作和研究AFP增高的原发性肺鳞癌带来指导意义。

关键词：甲胎蛋白原发性肺鳞癌安罗替尼免疫治疗疗效评价

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EGFR-TKIs治疗失败非小细胞肺癌患者采用免疫联合化疗及贝伐珠单抗治疗的疗效及影响因素

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中华医学杂志 2023年第16期103卷 1210-1216页

作者：王晨李艳管燕杨圣杰尹俊程张初峰郭其森史文娜山东省医学科学院山东第一医科大学附属肿瘤医院肿瘤内科济南250117 首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室北京100038 山东省医学科学院山东第一医科大学附属肿瘤医院药学部济南250117

目的探讨表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)治疗失败非小细胞肺癌(NSCLC)患者采用免疫联合化疗及贝伐珠单抗治疗的疗效及其影响因素。方法回顾性分析山东第一医科大学附属肿瘤医院2019年1月至2022年3月收治的60例免疫联合化... 详细信息

目的探讨表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)治疗失败非小细胞肺癌(NSCLC)患者采用免疫联合化疗及贝伐珠单抗治疗的疗效及其影响因素。方法回顾性分析山东第一医科大学附属肿瘤医院2019年1月至2022年3月收治的60例免疫联合化疗及贝伐珠单抗治疗EGFR-TKIs治疗失败NSCLC患者的临床资料。采用电话或门诊复查的方式对患者进行随访,随访截至2022年10月1日,中位随访8.2(95%CI:7.1~9.3)个月,60例患者均获得随访。应用实体瘤的疗效评价标准进行近期疗效评价,根据不良事件通用术语标准评价患者不良反应。以Kaplan-Meier法绘制生存曲线,采用Cox比例风险回归模型分析无进展生存时间(PFS)的影响因素。结果60例NSCLC患者中,男22例;年龄41~75岁,中位年龄61岁。部分缓解11例,疾病稳定19例,疾病进展30例。中位PFS为8.2(95%CI:7.2~9.2)个月,其中程序性细胞死亡受体配体1(PD-L1)低表达[肿瘤细胞阳性比(TPS)65岁(HR=4.017,95%CI:1.468~10.992,P=0.007)是接受免疫联合化疗及贝伐珠单抗治疗EGFR-TKIs治疗失败NSCLC患者PFS的危险因素,而PD-L1中表达(HR=0.360,95%CI:0.139~0.930,P=0.035)和PD-L1高表达(HR=0.155,95%CI:0.039~0.625,P=0.009)是接受免疫联合化疗及贝伐珠单抗治疗EGFR-TKIs治疗失败NSCLC患者PFS的保护因素。治疗相关不良反应主要为1~2级,包括骨髓抑制(24例)、恶心(25例)、食欲下降(24例)、乏力(22例)、呕吐(18例)、肝功能异常(17例)、血肌酐升高(10例)等,患者可耐受。结论EGFR-TKIs治疗失败的NSCLC患者接受免疫联合化疗及贝伐珠单抗治疗的相关不良反应可耐受,年龄≤65岁以及PD-L1中、高表达者的PFS明显延长。

关键词：癌,非小细胞肺表皮生长因子受体酪氨酸激酶抑制剂程序性细胞死亡受体配体1 预后安全性随访

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阿帕替尼治疗肺原发性滑膜肉瘤术后多发转移1例

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中国肺癌杂志 2018年第11期21卷 880-884页

作者：张娣张初峰郭其森山东大学附属山东省肿瘤医院山东大学济南250100 山东大学附属山东省肿瘤医院山东省医学科学院山东省肿瘤防治研究院济南250117

原发性肺滑膜肉瘤是一种起源于原始间叶细胞的罕见肺部恶性肿瘤,其临床特点包括生存期短、预后差,目前国内外仅有少数相关报道。近年来,靶向治疗的发展为肿瘤患者带来显著的获益。甲磺酸阿帕替尼是我国自主研发的小分子血管内皮生长因... 详细信息

原发性肺滑膜肉瘤是一种起源于原始间叶细胞的罕见肺部恶性肿瘤,其临床特点包括生存期短、预后差,目前国内外仅有少数相关报道。近年来,靶向治疗的发展为肿瘤患者带来显著的获益。甲磺酸阿帕替尼是我国自主研发的小分子血管内皮生长因子受体-2(vascular endothelial growth factor receptor-2, VEGFR-2)抑制剂,可高度选择性地抑制VEGFR-2酪氨酸激酶活性,阻断血管内皮生长因子(vascular endothelial growth factor,VEGF)结合后的信号通路,从而强效抑制肿瘤血管的生成,目前已在多种瘤种中显示出确切的抗肿瘤效果和可接受的毒副反应。本文介绍了阿帕替尼治疗原发性肺滑膜肉瘤术后多发转移1例,以期在临床工作中为医生提供新的治疗思路。

关键词：甲磺酸阿帕替尼肺肿瘤原发性肺滑膜肉瘤

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山东地区非小细胞肺癌分子靶向治疗驱动基因表达情况及临床特征分析

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中国肺癌杂志 2017年第1期20卷 14-20页

作者：乔秀丽艾丹梁洪陆穆殿斌郭其森济南大学山东省医学科学院医学与生命科学学院济南250200 山东省肿瘤医院山东省医学科学院济南250117

背景与目的分子生物学靶向治疗已逐渐成为非小细胞肺癌(non-small cell lung cancer,NSCLC)的一个重要治疗手段,本研究通过分析山东地区NSCLC多种驱动基因表达情况及临床病理特征,为筛选分子靶向治疗目标人群提供理论依据。方法采用荧... 详细信息

背景与目的分子生物学靶向治疗已逐渐成为非小细胞肺癌(non-small cell lung cancer,NSCLC)的一个重要治疗手段,本研究通过分析山东地区NSCLC多种驱动基因表达情况及临床病理特征,为筛选分子靶向治疗目标人群提供理论依据。方法采用荧光探针PCR法检测表皮生长因子受体(epidermal growth factor receptor,EGFR)、棘皮动物微管相关蛋白4-间变性淋巴瘤激酶(echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase,EML4-ALK)、肉瘤致癌因子-受体酪氨酸激酶(ROS proto-oncogene 1,receptor tyrosine kinase,ROS1)、鼠类肉瘤病毒癌基因(Kirsten rat sarcoma viral oncgene,KRAS)基因表达情况,回顾性分析阳性病例的临床病理特征。结果 EGFR基因突变阳性率为36.70%,主要为19、21外显子突变,突变人群主要为女性、腺癌、不吸烟患者,组间差异有统计学意义。EML4-ALK融合基因重排阳性率为9.37%。人群特征主要为60岁以下不吸烟人群,组间差异有统计学意义,基因突变与病理类型和性别间无明显差异。ROS1融合基因重排阳性率为3.67%,均为60岁以下患者,组间差异有统计学意义。23份病例标本开展KRAS基因检测,阳性标本数2例,阳性率为8.70%。2份阳性标本均为60岁以上病例,男女各占1例,病理类型均为腺癌,均无吸烟史。此外,未发现有两种基因同时突变的病例。结论 EGFR、EML4-ALK、ROS1、KARS基因在NSCLC患者中存在较高的突变率,且具有不同的人群特征,在选择靶向治疗人群中具有重要意义。

关键词：肺肿瘤分子靶向治疗表皮生长因子受体棘皮动物微管相关蛋白4-间变性淋巴瘤激酶肉瘤致癌因子-受体酪氨酸激酶鼠类肉瘤病毒癌基因

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PD-1/PD-L1免疫检查点抑制剂在肺癌中的研究进展

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中国肺癌杂志 2019年第6期22卷 369-379页

作者：张娣黄架旗张初峰管燕郭其森山东大学附属山东省肿瘤医院山东大学济南250100 山东大学附属山东省肿瘤医院山东省医学科学院山东省肿瘤防治研究院济南250117

近年来,免疫治疗的研究成果突出,多项临床试验捷报频传。目前,肺癌的免疫治疗研究已取得重大突破,特别是程序性死亡受体1(programmed death 1, PD-1)或程序性死亡配体1(programmed death-ligand 1,PD-L1)免疫检查点抑制剂(如Nivolumab、... 详细信息

近年来,免疫治疗的研究成果突出,多项临床试验捷报频传。目前,肺癌的免疫治疗研究已取得重大突破,特别是程序性死亡受体1(programmed death 1, PD-1)或程序性死亡配体1(programmed death-ligand 1,PD-L1)免疫检查点抑制剂(如Nivolumab、Pembrolizumab、Atezolizumab、Durvalumab和Avelumab等)在各项临床试验的成功应用,为包括鳞癌、腺癌和小细胞肺癌在内的多种病理类型肺癌患者均带来了临床获益。本文通过回顾并解读具有代表性的重要临床研究,全面分析PD-1/PD-L1免疫检查点抑制剂在肺癌中的应用价值和地位。基于各项大型临床试验的探索成果,肺癌免疫治疗细节正在不断优化,肺癌免疫治疗适应证也在不断拓宽。然而,免疫治疗仍面临很多挑战,例如免疫联合策略的选择、生物标志物的探索、不良反应的管理、驱动基因突变人群的应用可行性等等。本文就肺癌免疫治疗的最新重要进展作一系统综述,以期为广大临床工作者提供前沿参考。

关键词：程序性死亡受体1 程序性死亡配体1 免疫检查点抑制剂免疫治疗肺肿瘤

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