机构：[1]Department of Medical Oncology and Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.[2]Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.[3]Department of Medical Oncology, Fudan University Cancer Hospital, Shanghai, China.[4]Department of Medical Oncology, The First Hospital of Jilin University, Changchun, China.[5]Department of Medical Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.[6]Department of Medical Oncology, Cancer Hospital of China Medical University/Liaoning Cancer Hospital, Shenyang, China.[7]Department of Medical Oncology, The First Affiliated Hospital of China Medical University, Shenyang, China.[8]Department of Breast Oncology, Hubei Cancer Hospital, Wuhan, China.[9]Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.[10]Department of Head and Neck Cancer, West China Hospital, Sichuan University, Chengdu, China.四川大学华西医院[11]Department of Breast Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.华中科技大学同济医学院附属协和医院[12]Department of Medical Oncology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.中山大学附属第二医院[13]Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, China.[14]Department of Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences/Zhejiang Cancer Hospital, Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Hangzhou, China.浙江省肿瘤医院[15]Department of Oncology, Jiangsu Province Hospital, Nanjing, China.江苏省人民医院[16]Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.[17]Department of Medical Oncology/Chemotherapy, Anhui Provincial Hospital, Hefei, China.[18]Breast Cancer Center, Shandong Cancer Hospital, Jinan, China.[19]Department of Breast, Bone & Soft Tissue Oncology, Guangxi Medical University Cancer Hospital, Nanning, China.[20]Department of Breast Disease, Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.河南省肿瘤医院[21]Breast Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.河北医科大学第四医院[22]Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Blockade of the cyclin-dependent kinase 4 and 6 pathway has been shown to be effective in the treatment of hormone receptor-positive advanced breast cancer (ABC). We report the interim results of DAWNA-1 (NCT03927456), a double-blind, randomized, phase 3 trial of dalpiciclib (a new cyclin-dependent kinase 4 and 6 inhibitor) plus fulvestrant in hormone receptor-positive, HER2-negative ABC with disease progression after endocrine therapy. A total of 361 patients were randomized 2:1 to receive dalpiciclib plus fulvestrant or placebo plus fulvestrant. The study met the primary end point, showing significantly prolonged investigator-assessed progression-free survival with dalpiciclib plus fulvestrant versus placebo plus fulvestrant (median = 15.7, 95% confidence interval (CI) = 11.1-not reached versus 7.2, 95% CI = 5.6-9.2 months; hazard ratio = 0.42, 95% CI = 0.31-0.58; one-sided P < 0.0001 (boundary was P <= 0.008)). The most common grade 3 or 4 adverse events with dalpiciclib plus fulvestrant were neutropenia (84.2%) and leukopenia (62.1%). The incidence of serious adverse events was 5.8% with dalpiciclib plus fulvestrant versus 6.7% with placebo plus fulvestrant. Our findings support dalpiciclib plus fulvestrant as a new treatment option for pretreated hormone receptor-positive, HER2-negative ABC.
基金：
This study was funded by Jiangsu Hengrui Pharmaceuticals (formerly Jiangsu Hengrui
Medicine).
语种：
外文
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PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
最新[2023]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
JCR分区：
出版当年[2021]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构：[1]Department of Medical Oncology and Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
共同第一作者：
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推荐引用方式(GB/T 7714)：
Binghe Xu,Qingyuan Zhang,Pin Zhang,et al.Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial[J].NATURE MEDICINE.2021,27(11):1904-+.doi:10.1038/s41591-021-01562-9.
APA：
Binghe Xu,Qingyuan Zhang,Pin Zhang,Xichun Hu,Wei Li...&DAWNA-1 Study Consortium.(2021).Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial.NATURE MEDICINE,27,(11)
MLA：
Binghe Xu,et al."Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial".NATURE MEDICINE 27..11(2021):1904-+
医学