机构:[1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China.[2]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.[3]Department of Hematology, West China Hospital, Sichuan University, Chengdu, China.四川大学华西医院[4]Department of Medical Oncology, Sun Yat-sen University Cancer Centre, Guangzhou, China.[5]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.[6]Lymphatic Comprehensive Internal Medicine Ward, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.河南省肿瘤医院[7]Lymphoma Clinic, Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjing, China.[8]Department of Hematology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.浙江大学医学院附属第一医院[9]Department ofHematology, The First AffiliatedHospital of Soochow University, Suzhou, China.[10]Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China.[11]Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.[12]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.华中科技大学同济医学院附属协和医院[13]Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China.[14]Department of Oncology, Cancer Hospital Harbin Medical University, Harbin, China.[15]Department of Oncology, Jiangsu Hengrui Medicine Co. Ltd, Shanghai, China.[16]Department of Clinical Statistics and Programming, Jiangsu Hengrui Medicine Co. Ltd, Shanghai, China.
Purpose: For classical Hodgkin lymphoma (cHL), programmed death-l (PD-1) is a well-recognized attractive target. This multicenter, single-arm, phase II study evaluated the efficacy and safety of camrelizumab, a humanized high-affinity IgG4 mAb against PD-1, in Chinese patients with relapsed or refractory cHL. Patients and Methods: Patients who had failed to achieve a remission or experienced progression after autologous stem cell transplantation or had received at least two lines of systemic chemotherapies were given camrelizumab 200 mg every 2 weeks. The primary endpoint was objective response rate per independent review committee (IRC) assessment. This study is registered with ClinicalTrials.gov (NCT03155425). Results: Between June 9, 2017 and September 18, 2017, 75 patients were enrolled and treated. At a median follow-up of 12.9 months, 57 of 75 (76.0%; 95% CI, 64.7-85.1) patients achieved an IRC-assessed objective response, including 21 (28.0%) and 36 (48.0%) patients who had complete and partial remission, respectively. Median duration of response was not reached (range, 0.0(+) - 12.8(+) months). Treatment-related adverse events (AE) occurred in all patients. The most common ones included cutaneous reactive capillary endothelial proliferation (97.3%, 73/75) and pyrexia (42.7%, 32/75). Grade 3 or 4 treatment-related AEs occurred in 20 patients (26.7%); the most common AE was decreased white blood cell count (4.0%, 3/75). There were no grade 5 treatment-related AEs. Conclusions: Camrelizumab demonstrated a high response rate, durable response and controllable safety in Chinese patients with relapsed or refractory cHL, becoming a new safe and effective treatment option in this setting.
基金:
This study was sponsored by Jiangsu Hengrui Medicine Co., Ltd. The sponsor
funded this study, participated in data analysis, and provided medical writing
support.
第一作者机构:[1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China.
通讯作者:
通讯机构:[1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China.[2]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.[*1]Peking University Cancer Hospital & Institute, No. 52, Fucheng Road, Haidian District, Beijing 100142, China.[*2]Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research &Nanjing Medical University Affiliated Cancer Hospital, No. 42, Baiziting, Nanjing 210029, China.
推荐引用方式(GB/T 7714):
Yuqin Song,Jianqiu Wu,Xinchuan Chen,et al.A Single-Arm, Multicenter, Phase II Study of Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma[J].CLINICAL CANCER RESEARCH.2019,25(24):7363-7369.doi:10.1158/1078-0432.CCR-19-1680.
APA:
Yuqin Song,Jianqiu Wu,Xinchuan Chen,Tongyu Lin,Junning Cao...&Jun Zhu.(2019).A Single-Arm, Multicenter, Phase II Study of Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma.CLINICAL CANCER RESEARCH,25,(24)
MLA:
Yuqin Song,et al."A Single-Arm, Multicenter, Phase II Study of Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma".CLINICAL CANCER RESEARCH 25..24(2019):7363-7369