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Study protocol of the Asian XELIRI ProjecT(AXEPT):a multinational,randomized,non-inferiority,phase Ⅲ trial of second-line chemotherapy for metastatic colorectal cancer, comparing the eicacy and safety of XELIRI with or without bevacizumab versus FOLFIRI w

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Chinese Journal of Cancer 2016年第12期35卷 735-742页

作者： Masahito Kotaka Ruihua Xu Kei Muro Young Suk Park Satoshi Morita Satoru Iwasa Hiroyuki Uetake Tomohiro Nishina Hiroaki Nozawa Hiroshi Matsumoto Kentaro Yamazaki Sae-Won Han Wei Wang Joong Bae Ahn Yanhong Deng Sang-Hee Cho Yi Ba Keun-Wook Lee Tao Zhang Taroh Satoh Marc E.Buyse Baek-Yeol Ryoo Lin Shen Junichi Sakamoto Tae Won Kim Gastrointestinal Cancer Center Sano HospitalHyogo 655-0031Japan. State Key Laboratory of Oncology in South China Department of Medical OncologyCollaborative Innovation Center for Cancer MedicineSun Yat-sen Univer-sity Cancer CenterGuangzhouGuangdong 510060P.R.China. Depart-ment of Clinical Oncology Aichi Cancer Center HospitalNagoya 464-8681Japan. Department of Medicine Samsung Medical CenterSungkyunkwan University School of MedicineSeoul 135-710South Korea. Department of Biomedical Statistics and Bioinformatics Graduate School of MedicineKyoto UniversityKyoto 606-8501Japan. Gastrointestinal Medical Oncology Division National Cancer Center HospitalTokyo 104-0045Japan. Depart-ment of Surgical Specialties Graduate SchoolTokyo Medical and Dental UniversityTokyo 113-8519Japan. Department of Gastrointestinal Medical Oncology National Hospital Organization Shikoku Cancer CenterMatsuy-ama 791-0280Japan. Department of Surgical Oncology The University of TokyoTokyo 113-0033Japan. Department of Surgery Tokyo Metropoli-tan Komagome HospitalTokyo 113-8677Japan. Division of Gastrointestinal Oncology Shizuoka Cancer CenterShizuoka 411-8777Japan. Department of Internal Medicine Seoul National University HospitalSeoul 110-744South Korea. Department of Gastrointestinal Oncology The First People's Hospital of FoshanFoshanGuangdong 528000P.R.China. Department of Inter-nal Medicine Yonsei University College of MedicineSeoul 120-752South Korea. Department of Medical Oncology The Sixth Ailiated HospitalSun Yat-sen UniversityGuangzhouGuangdong 510655P.R.China. Depart-ment of Hematology-Oncology Chonnam National University Medical SchoolGwangju 519-809South Korea. Department of Digestive Oncology Tianjin Medical University Cancer Institute and HospitalTianjin 300060P.R.China. Department of Internal Medicine Seoul National University Bundang Hos-pitalSeoul National University College of MedicineSeongnam 463-707South Korea. Department of Medical Oncology Union Hospital of Tongji Medical College

Background: Capecitabine and irinotecan combination therapy(XELIRI) has been examined at various dose levels to treat metastatic colorectal cancer(m CRC). Recently, in the Association of Medical Oncology of the German Cancer Society(AIO) 0604 trial, tri?weekly XELIRI plus bevacizumab, with reduced doses of irinotecan(200 mg/m^2 on day 1) and capecitabine(1600 mg/m^2 on days 1–14), repeated every 3 weeks, has shown favorable tolerability and eicacy which were comparable to those of capecitabine and oxaliplatin(XELOX) plus bevacizumab. The doses of capecit?abine and irinotecan in the AIO trial are considered optimal. In a phase I/II study, XELIRI plus bevacizumab(BIX) as second?line chemotherapy was well tolerated and had promising eicacy in Japanese ***: The Asian XELIRI Projec T(AXEPT) is an East Asian collaborative, open?labelled, randomized, phase Ⅲ clinical trial which was designed to demonstrate the non?inferiority of XELIRI with or without bevacizumab versus standard FOLFIRI(5?fluorouracil, leucovorin, and irinotecan combination) with or without bevacizumab as second?line chemo?therapy for patients with m CRC. Patients with 20 years of age or older, histologically conirmed m CRC, Eastern Coop?erative Oncology Group performance status 0–2, adequate organ function, and disease progression or intolerance of the irst?line regimen will be eligible. Patients will be randomized(1:1) to receive standard FOLFIRI with or with?out bevacizumab(5 mg/kg on day 1), repeated every 2 weeks(FOLIRI arm) or XELIRI with or without bevacizumab(7.5 mg/kg on day 1), repeated every 3 weeks(XELIRI arm). A total of 464 events were estimated as necessary to show non?inferiority with a power of 80% at a one?sided α of 0.025, requiring a target sample size of 600 patients. The 95% conidence interval(CI) upper limit of the hazard ratio was pre?speciied as less than ***: The Asian XELIRI Projec T is a multinational phase III trial being conducted to provide evidence fo

关键词： Metastatic colorectal cancer Randomized phase Ⅲ clinical trial XELIRI Bevacizumab Second-line therapy

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Immunogenicity and Safety of Homologous Booster Doses of CoronaVac COVID-19 Vaccine in Elderly Individuals Aged 60 Years and Older:A Dosing Interval Study—Yunnan Province,China,2021–2022

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China CDC weekly 2023年第6期5卷 125-130,I0008-I0012页

作者： Haitao Yang Xing Meng Tingyu Zhuang Cangning Wang Zhongliang Yang Taotao Zhu Mei Li Yan Zheng Qianhui Wu Yaling Hu Hongjie Yu Xiaoqiang Liu Gang Zeng Yunnan Provincial Center for Disease Control and Prevention Kunming CityYunnan ProvinceChina Sinovac Biotech Co. Ltd.Beijing MunicipalityChina School of Public Health Fudan UniversityKey Laboratory of Public Health SafetyMinistry of EducationShanghai MunicipalityChina Yongde County Center for Disease Control and Prevention Lincang CityYunnan ProvinceChina Sinovac Life Sciences Beijing MunicipalityChina

Summary What is already known about this topic?Neutralization levels induced by inactivated vaccines rapidly wane after primary immunization,and a homologous booster can recall specific immune memory,resulting in a re... 详细信息

关键词： concentration. doses remarkable

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Erlotinib versus gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non-small-cell lung cancer:final overall survival analysis of the EMERGING-CTONG 1103 randomised phase II trial

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Signal Transduction and Targeted Therapy 2023年第3期8卷 1310-1317页

作者： Wen-Zhao Zhong Hong-Hong Yan Ke-Neng Chen Chun Chen Chun-Dong Gu Jun Wang Xue-Ning Yang Wei-Min Mao Qun Wang Gui-Bin Qiao Ying Cheng Lin Xu Chang-Li Wang Ming-Wei Chen Xiao-Zheng Kang Wan-Pu Yan Ri-Qiang Liao Jin-Ji Yang Xu-Chao Zhang Si-Yang Liu Qing Zhou Yi-Long Wu Guangdong Provincial People’s Hospital Guangdong Academy of Medical Sciences510080 GuangzhouChina Peking University Cancer Hospital and Institute 100142 BeijingChina Fujian Medical University Union Hospital 350001 FuzhouChina First Affiliated Hospital of Dalian Medical University 116011 DalianChina Peking University People’s Hospital 100044 BeijingChina Zhejiang Cancer Hospital 310022 HangzhouChina Zhongshan Hospital 200032 ShanghaiChina Guangzhou Liuhuaqiao Hospital 510000 GuangzhouChina Jilin Provincial Tumor Hospital 130012 ChangchunChina Jiangsu Cancer Institute and Hospital 210009 NanjingChina Tianjin Medical University Cancer Institute and Hospital 300060 TianjinChina First Affiliated Hospital of Xi’an Jiaotong University 710061 Xi’anChina

EMERGING-CTONG 1103 showed improved progression-free survival(PFS)with neoadjuvant erlotinib *** for patients harbouring EGFR sensibility mutations and R0 resected stage IIIA-N2 non-small cell lung cancer(NSCLC)(NCT01407822).Herein,we report the final *** patients were randomly allocated 1:1 to the erlotinib group(150 mg/day orally;neoadjuvant phase for 42 days and adjuvant phase to 12 months)or to the GC group(gemcitabine 1250 mg/m2 plus cisplatin 75 mg/m2 intravenously;2 cycles in neoadjuvant phase and 2 cycles in adjuvant phase).Objective response rate(ORR),complete pathologic response(pCR),PFS,and overall survival(OS)were assessed along with *** hoc analysis was performed for subsequent treatments after disease *** investigated 72 patients(erlotinib,n=37;GC,n=35),the median follow-up was 62.5 *** median OS was 42.2 months(erlotinib)and 36.9 months(GC)(hazard ratio[HR],0.83;95%confidence interval[CI],0.47-1.47;p=0.513).The 3-and_(5-y)ear OS rates were 58.6%and 40.8%with erlotinib and 55.9%and 27.6%with GC(p_(3-y)=0.819,p_(5-y)=0.252).Subsequent treatment was administered in 71.9%and 81.8%of patients receiving erlotinib and GC,respectively;targeted therapy contributed mostly to OS(HR,0.35;95%CI,0.18-0.70).After disease progression,the ORR was 53.3%,and the median PFS was 10.9 months during the EGFR-TKI *** postoperative therapy,grade 3 or 4 adverse events(AEs)were 13.5%in the erlotinib group and 29.4%in the GC *** serious adverse events were *** exhibited clinical feasibility for resectable IIIA-N2 NSCLC over chemotherapy in the neoadjuvant setting.

关键词： neoadjuvant cisplatin chemotherapy

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