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An open-label, multi-center, single-arm, phase 2 study of fluzoparib in patients with germline BRCA1/2 mutation and platinum-sensitive recurrent ovarian cancer.

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收录情况： ◇ SCIE

作者：
Ning Li[1] ; Hualei Bu[2] ; Jihong Liu[3] ; Jianqing Zhu[4] ; Qi Zhou[5] ; Li Wang[6] ; Rutie Yin[7] ; Xiaohua Wu[8] ; Shuzhong Yao[9] ; Kangsheng Gu[10] ; Hui Zhang[11] ; Guiling Li[12] ; Hongming Pan[13] ; Qiang Wu[14] ; Ruifang An[15] ; Xinfeng Yang[16] ; Yaping Zhu[17] ; Xiaoping[][1] ; Wan[18] ; Wei Duan[19] ; Jianping Xiong[20] ; Hongyan Guo[21] ; Ge Lou[22] ; Jing Wang[23] ; Wenjing Hu[24] ; Xin Zhang[25] ; Yuanguang Meng[26] ; Ben Zhang[27] ; Yuting Wang[27] ; Quanren Wang[27] ; Lingying Wu[1,*1] ;
机构： [1]Department of Gynecologic Oncology, National Cancer Center/National ClinicalResearch Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciencesand Peking Union Medical College, Beijing, China [2]Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University,Jinan, China [3]Department of Gynecology, Sun Yat-sen University Cancer Center, Guangzhou,China [4]Gynecologic Surgical Department, Zhejiang Cancer Hospital, Hangzhou, China [5]Gynecological Oncology, Chongqing University Cancer Hospital, Chongqing CancerInstitute and Chongqing Cancer Hospital, Chongqing, China [6]Gynecology, Cancer Hospital of Zhengzhou University (Henan Cancer Hospital),Zhengzhou, China [7]Department of Gynecologic Oncology, West China Second University Hospital,Chengdu, China [8]Gynecological Oncology, Fudan University Shanghai Cancer Center, Shanghai,China [9]Gynecology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou,China [10]Department of Medical Oncology, The First Affiliated Hospital of Anhui MedicalUniversity, Hefei, China [11]Gynecology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China [12]Department of Gynecological Oncology, Union Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan, China [13]Internal Medical Oncology Department, Zhejiang University School of Medicine SirRun Run Shaw Hospital, Hangzhou, China [14]Gynecological Oncology, Jiangsu Cancer Hospital, Nanjing, China [15]Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an JiaotongUniversity, Xi'an, China [16]Department of Female Tumor, Jiangxi Cancer Hospital, Nanchang, China [17]Gynaecology, Shanghai General Hospital, Shanghai, China [18]Gynaecology, Shanghai First Maternity and Infant Hospital, Shanghai, China [19]Department of Gynecologic Oncology, Beijing Obstetrics and Gynecology Hospital,Capital Medical University, Beijing, China [20]Oncology Department, Nanchang University First Affiliated Hospital, Nanchang,China [21]Department of Gynecology and Obstetrics, Peking University Third Hospital,Beijing, China [22]Department of Gynaecology,Harbin Medical University Cancer Hospital, Harbin,China [23]Gynecologic Oncology, Hunan Cancer Hospital, Changsha, China [24]Comprehensive Cancer Centre, Nanjing Drum Tower Hospital/The AffiliatedHospital of Nanjing University Medical School, Nanjing, China [25]Department of Gynecologic Oncology, Cancer Hospital of China Medical University,Liaoning Cancer Hospital and Institute, Shenyang, China [26]Department of Gynecology and Obstetrics, Chinese PLA General Hospital, Beijing,China [27]Clinical Research and Development, Jiangsu Hengrui Medicine Co., Ltd, Shanghai,China
出处：
DOI： 10.1158/1078-0432.CCR-20-3546
ISSN：

关键词： PARP inhibitor fluzoparib BRCA1/2 ovarian cancer

摘要：
Fluzoparib (PARP inhibitor) showed promising anti-tumor activity for advanced ovarian cancer in a phase 1 study. This study aimed to assess the efficacy and safety of fluzoparib in patients with germline BRCA1/2-mutated recurrent ovarian cancer. This open-label, multi-center, single-arm, phase 2 study enrolled patients with platinum-sensitive recurrent ovarian cancer and germline BRCA1/2 mutation who had previously received 2-4 lines of platinum-based chemotherapy. Fluzoparib 150 mg was administered orally twice daily. The primary endpoint was independent review committee (IRC)-assessed objective response rate per RECIST v1.1. 113 patients were enrolled and received at least one dose of fluzoparib. As of data cutoff on March 21, 2020, the median follow-up period was 15.9 months (IQR 13.5-18.5). The IRC- and investigator-assessed objective response rates were 69.9% (95% CI 60.6-78.2) and 70.8% (95% CI 61.5-79.0), respectively. The objective response rates were similar across all pre-specified subgroups. The median IRC- and investigator-assessed progression-free survival was 12.0 months (95% CI 9.3-13.9) and 10.3 months (95% CI 9.2-12.0), respectively. The 12-month survival rate was 93.7% (95% CI 87.2-96.9). Grade {greater than or equal to}3 adverse events occurred in 63.7% (72/113) of the patients, with the most common one being anaemia/decreased haemoglobin. Adverse events that led to treatment interruption, dose reduction, and discontinuation occurred in 39.8%, 34.5%, and 0.9% of patients, respectively. One treatment-related death occurred. Fluzoparib demonstrated promising anti-tumor activity and acceptable safety profile in germline BRCA1/2-mutated, platinum-sensitive relapsed ovarian cancer. Thus, fluzoparib might be a novel treatment option for this population. Clinical Trial number: NCT03509636. Copyright ©2021, American Association for Cancer Research.

基金：
Jiangsu Hengrui Medicine Co., Ltd
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
JCR分区：
出版当年[2021]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[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]Department of Gynecologic Oncology, National Cancer Center/National ClinicalResearch Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciencesand Peking Union Medical College, Beijing, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Gynecologic Oncology, National Cancer Center/National ClinicalResearch Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciencesand Peking Union Medical College, Beijing, China [*1]Department of Gynecologic Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing 100021, China
推荐引用方式(GB/T 7714)：
Ning Li,Hualei Bu,Jihong Liu,et al.An open-label, multi-center, single-arm, phase 2 study of fluzoparib in patients with germline BRCA1/2 mutation and platinum-sensitive recurrent ovarian cancer.[J].CLINICAL CANCER RESEARCH.2021,27(9):2452-2458.doi:10.1158/1078-0432.CCR-20-3546.
APA：
Ning Li,Hualei Bu,Jihong Liu,Jianqing Zhu,Qi Zhou...&Lingying Wu.(2021).An open-label, multi-center, single-arm, phase 2 study of fluzoparib in patients with germline BRCA1/2 mutation and platinum-sensitive recurrent ovarian cancer..CLINICAL CANCER RESEARCH,27,(9)
MLA：
Ning Li,et al."An open-label, multi-center, single-arm, phase 2 study of fluzoparib in patients with germline BRCA1/2 mutation and platinum-sensitive recurrent ovarian cancer.".CLINICAL CANCER RESEARCH 27..9(2021):2452-2458

相关文献

[1]Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial [2]Pamiparib Monotherapy for Patients With Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated With at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study. [3]A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis [4]Pamiparib Monotherapy for Patients With Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated With at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study. [5]Olaparib and niraparib as maintenance therapy in patients with newly diagnosed and platinum-sensitive recurrent ovarian cancer: A single-center study in China [6]BRCA、HRD与PARP抑制剂:卵巢癌临床研究中的相问题与思考 [7]Targeting Krebs-cycle-deficient renal cell carcinoma with Poly ADP-ribose polymerase inhibitors and low-dose alkylating chemotherapy [8]Systems biology approaches based discovery of a small molecule inhibitor targeting both c-Met/PARP-1 and inducing cell death in breast cancer [9]Prevalence and clinical significance of pathogenic germline BRCA1/2 mutations in Chinese non-small cell lung cancer patients [10]Erratum to Prevalence and clinical significance of pathogenic germline BRCA1/2 mutations in Chinese non-small cell lung cancer patients.

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