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Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study

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收录情况： ◇ SCIE

作者：
Xu Binghe[1] ; Sun Tao[2] ; Shi Yanxia[3] ; Cui Jiuwei[4] ; Yin Yongmei[5] ; Ouyang Quchang[6] ; Liu Qiang[7] ; Zhang Qingyuan[8] ; Chen Yiding[9] ; Wang Shouman[10] ; Wang Xiaojia[11] ; Tong Zhongsheng[12] ; Zhong Yahua[13] ; Wang Jiayu[1] ; Yan Min[14] ; Yan Xi[15] ; Wang Chuan[16] ; Feng Jifeng[17] ; Wang Xiuli[18] ; Hu Gang[19] ; Cheng Ying[20] ; Ge Ruimin[21] ; Zhu Zhaoyin[22] ; Zhang Wa[21] ; Shao Zhimin[23] ;
机构： [1]National Cancer Center, Cancer Hospital, Chinese Academyof Medical Sciences and Peking Union Medical College,Beijing, China [2]Department of Breast Medicine, Cancer Hospital of ChinaMedical University, Cancer Hospital of Dalian Universityof Technology, Liaoning Cancer Hospital and Institute,Shenyang, China [3]Department of Medical Oncology, Sun Yat‑Sen UniversityCancer Center, The State Key Laboratory of Oncologyin South China, Collaborative Innovation Center for CancerMedicine, Guangzhou, China [4]Cancer Center, The First Hospital of Jilin University,Changchun, China [5]Department of Oncology, Jiangsu Province Hospital,Nanjing, China [6]Department of Breast Medicine, Hunan Cancer Hospital,Changsha, China [7]Breast Tumor Center, Sun Yat‑Sen Memorial Hospital, SunYat-Sen University, Guangzhou, China [8]Department of Medical Oncology, Harbin MedicalUniversity Cancer Hospital, Harbin, China [9]Department of Surgical Oncology, The Second AffiliatedHospital, Zhejiang University School of Medicine,Hangzhou, China [10]Department of Breast Surgery, Xiangya Hospital, CentralSouth University, Changsha, China [11]Department of Medical Oncology, Zhejiang Cancer Hospital,Hangzhou, China [12]Department of Breast Oncology, Tianjin Medical UniversityCancer Institute and Hospital, Tianjin, China [13]Zhongnan Hospital of Wuhan University, Wuhan, China [14]Department of Breast Disease, Henan Breast Cancer Center,The Affiliated Cancer Hospital of Zhengzhou Universityand Henan Cancer Hospital, Zhengzhou, China [15]West China Hospital of Sichuan University, Chengdu, China [16]Department of Breast Surgery, Fujian Medical UniversityUnion Hospital, Fuzhou, China [17]Department of Medical Oncology, Jiangsu Cancer Hospital,Nanjing, Jiangsu, China [18]The Second Hospital of Jilin University, Jilin, China [19]Department of Breast Surgery, Sichuan Provincial People’sHospital, University of Electronic Science and Technologyof China, Chengdu, Sichuan, China [20]Department of Medical Thoracic Oncology, Jilin ProvincialCancer Hospital, Changchun, China [21]Clinical Development, BeiGene Ltd, Beijing, China [22]BeiGene USA Inc, Ridgefield Park, NJ, USA [23]Department of Breast Surgery, Fudan University ShanghaiCancer Center, Shanghai, China
出处：
DOI： 10.1007/s10549-022-06785-z
ISSN：

摘要：
To evaluate the efficacy and safety of pamiparib in patients with locally advanced or metastatic human epidermal growth factor receptor 2-negative (HER2-) breast cancer, with deleterious or suspected deleterious germline BRCA1/2 mutations (gBRCA1/2 m).In this open-label, phase II, multicenter study in China (NCT03575065), patients with triple-negative breast cancer (TNBC cohort) or hormone receptor-positive (HR+)/HER2- breast cancer (HR+/HER2- cohort) and ≤ 2 prior lines of chemotherapy received pamiparib 60 mg orally twice daily in 28-day, continuous cycles. The primary endpoint was objective response rate (ORR; RECIST v1.1) by independent review committee.In total, 88 patients were enrolled (TNBC cohort: 62; HR+/HER2- cohort: 26). Median age was 45.5 (range: 27-67) years, and 60 patients (68.2%) had received 1 or 2 prior lines of chemotherapy; 42 patients (47.7%) had previously received platinum chemotherapy. In the TNBC cohort, ORR was 38.2% (95% confidence interval [CI] 25.4-52.3) and median duration of response (DoR) was 7.0 months (95% CI 3.9-not estimable). In the HR+/HER2- cohort, ORR was 61.9% (95% CI 38.4-81.9) and median DoR was 7.5 months (95% CI 5.6-14.8). The most common treatment-emergent adverse events (TEAEs), treatment-related TEAEs, and ≥ Grade 3 TEAEs were hematologic (including anemia, decreased neutrophil count, and decreased white blood cell count). Overall, 64.8% of patients had TEAEs leading to dose reduction and 2.3% had TEAEs leading to treatment discontinuation.Pamiparib showed encouraging efficacy and an acceptable safety profile in patients with locally advanced and metastatic HER2- breast cancer with gBRCA1/2 m.ClinicalTrials.gov, NCT03575065; July 2, 2018.© 2022. The Author(s).

基金：
This study was sponsored by BeiGene, Ltd.
语种：
外文
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中科院(CAS)分区：
出版当年[2022]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学
最新[2023]版：
大类 | 3 区 医学
小类 | 3 区 肿瘤学
JCR分区：
出版当年[2022]版：
Q2 ONCOLOGY
最新[2023]版：
Q2 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]National Cancer Center, Cancer Hospital, Chinese Academyof Medical Sciences and Peking Union Medical College,Beijing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Xu Binghe,Sun Tao,Shi Yanxia,et al.Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study[J].BREAST CANCER RESEARCH AND TREATMENT.2022,doi:10.1007/s10549-022-06785-z.
APA：
Xu Binghe,Sun Tao,Shi Yanxia,Cui Jiuwei,Yin Yongmei...&Shao Zhimin.(2022).Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study.BREAST CANCER RESEARCH AND TREATMENT,,
MLA：
Xu Binghe,et al."Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study".BREAST CANCER RESEARCH AND TREATMENT .(2022)

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