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Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial

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收录情况： ◇ SCIE

作者：
Ma Fei[1] ; Yan Min[2] ; Li Wei[3] ; Ouyang Quchang[4] ; Tong Zhongsheng[5] ; Teng Yuee[6] ; Wang Yongsheng[7] ; Wang Shusen[8] ; Geng Cuizhi[9] ; Luo Ting[10] ; Zhong Jincai[11] ; Zhang Qingyuan[12] ; Liu Qiang[13] ; Zeng Xiaohua[14] ; Sun Tao[14,15] ; Mo Qinguo[16] ; Liu Hu[17] ; Cheng Ying[18] ; Cheng Jing[19] ; Wang Xiaojia[20] ; Nie Jianyun[21] ; Yang Jin[22] ; Wu Xinhong[23] ; Wang Xinshuai[24] ; Li Huiping[25] ; Ye Changsheng[26] ; Dong Fangli[27] ; Wu Shuchao[27] ; Zhu Xiaoyu[27] ; Xu Binghe[1] ;
机构： [1]Department of Medical Oncology, Cancer Hospital ChineseAcademy of Medical Sciences and Peking Union Medical College,Beijing, China [2]Department of Breast Disease, Henan Breast Cancer Center, TheAffiliated Cancer Hospital of Zhengzhou University & Henan CancerHospital, Zhengzhou, China [3]Department of Oncology, The First Hospital of Jilin University,Changchun, China [4]Breast Internal Medicine Department, Hunan Cancer Hospital, TheAffiliated Cancer Hospital of Xiangya School of Medicine, CentralSouth University, Changsha, China [5]Department of Breast Oncology, Tianjin Medical University CancerInstitute & Hospital, Tianjin, China [6]Department of Breast Internal Medicine, The First Hospital of ChinaMedical University, Shenyang, China [7]Breast Surgery, Shandong Cancer Hospital and Institute, Jinan, China [8]Department of Internal Medicine, Sun Yat-sen University CancerCenter, Guangzhou, China [9]Breast Center, The Fourth Hospital of Hebei Medical University andHebei Tumor Hospital, Shijiazhuang, China [10]Department of Medical Oncology of Cancer Center, West ChinaHospital, Sichuan University, Chengdu, China [11]Medical Oncology, The First Affiliated Hospital of Guangxi MedicalUniversity, Nanning, China [12]Ward One of Mammary Department, Harbin Medical UniversityCancer Hospital, Harbin, China [13]Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-senUniversity, Guangzhou, China [14]Breast Cancer Center, Affiliated Cancer Hospital of ChongqingUniversity, Chongqing, China [15]Breast Internal Medicine Department, Liaoning Cancer Hospital &Institute, Shenyang, China [16]Breast Surgery, Guangxi Medical University Affiliated TumorHospital, Nanning, China [17]Department of Medical Oncology, The First Affiliated Hospital ofUSTC West District, Hefei, China [18]Department of Thoracic Oncology, Jilin Cancer Hospital,Changchun, China [19]Oncology Center Breast Department, Union Hospital, TongjiMedical College, Huazhong University of Science & Technology,Wuhan, China [20]Breast Medicine, Zhejiang Cancer Hospital, Hangzhou, China [21]Breast Surgery, Yunnan Cancer Hospital, Kunming, China [22]Department of Medical Oncology, The First Affiliated Hospital ofXi’an Jiaotong University, Xi’an, China [23]Department of Breast Oncology, Hubei Cancer Hospital, Wuhan,China [24]Department of Medical Oncology, Henan Key Laboratory of CancerEpigenetics, Cancer Hospital, The First Affiliated Hospital, Collegeof Clinical Medicine, Medical College of Henan University of Scienceand Technology, Luoyang, China [25]Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education), Department of Breast Oncology, PekingUniversity Cancer Hospital and Institute, Beijing, China [26]Department of Breast, Southern Medical University NanfangHospital, Guangzhou, China [27]Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China
出处：
DOI： 10.1136/bmj-2023-076065
ISSN：

摘要：
To assess the efficacy and safety of pyrotinib (an irreversible pan-HER (human epidermal growth factor receptor) inhibitor), trastuzumab, and docetaxel compared with placebo, trastuzumab, and docetaxel for untreated HER2 positive metastatic breast cancer.Randomised, double blind, placebo controlled, multicentre, phase 3 trial.40 centres in China between 6 May 2019 and 17 January 2022.590 female patients (median age 52 (interquartile range 46-58) years) with untreated HER2 positive metastatic breast cancer.Eligible patients were randomised 1:1 to receive either oral pyrotinib (400 mg once daily) or placebo, both combined with intravenous trastuzumab (8 mg/kg in cycle 1 and 6 mg/kg in subsequent cycles) and docetaxel (75 mg/m2) on day 1 of each 21 day cycle. Randomisation was stratified by treatment history of trastuzumab in the (neo)adjuvant setting and hormone receptor status. Patients, investigators, and the sponsor's study team were masked to treatment assignment.The primary endpoint was progression-free survival as assessed by the investigator.Of the 590 randomised patients, 297 received pyrotinib, trastuzumab, and docetaxel treatment (pyrotinib group), and 293 received placebo, trastuzumab, and docetaxel treatment (placebo group). At data cut-off on 25 May 2022, the median follow-up was 15.5 months. The median progression-free survival according to the investigator was significantly longer in the pyrotinib group than in the placebo group (24.3 (95% confidence interval 19.1 to 33.0) months versus 10.4 (9.3 to 12.3) months; hazard ratio 0.41 (95% confidence interval 0.32 to 0.53); one sided P<0.001). Treatment related adverse events of grade 3 or higher were reported in 267 (90%) of the 297 patients in the pyrotinib group and 224 (76%) of the 293 patients in the placebo group. No treatment related deaths occurred in the pyrotinib group, and one (<1%; diabetic hyperosmolar coma) treatment related death occurred in the placebo group. Survival and toxicities are still under assessment with longer follow-up.Pyrotinib, trastuzumab, and docetaxel showed superiority by significantly improving progression-free survival compared with placebo, trastuzumab, and docetaxel in patients with untreated HER2 positive metastatic breast cancer. The toxicity was manageable. The findings support this dual anti-HER2 regimen as an alternative first line treatment option in this patient population.ClinicalTrials.gov NCT03863223.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

基金：
This study was funded by Jiangsu Hengrui Pharmaceuticalsand partly supported by the CAMS Innovation Fund for MedicalSciences (CIFMS; 2021-I2M-1-014).
语种：
外文
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中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

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

第一作者：
第一作者机构： [1]Department of Medical Oncology, Cancer Hospital ChineseAcademy of Medical Sciences and Peking Union Medical College,Beijing, China
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推荐引用方式(GB/T 7714)：
Ma Fei,Yan Min,Li Wei,et al.Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial[J].BMJ-BRITISH MEDICAL JOURNAL.2023,383:doi:10.1136/bmj-2023-076065.
APA：
Ma Fei,Yan Min,Li Wei,Ouyang Quchang,Tong Zhongsheng...&Xu Binghe.(2023).Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial.BMJ-BRITISH MEDICAL JOURNAL,383,
MLA：
Ma Fei,et al."Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial".BMJ-BRITISH MEDICAL JOURNAL 383.(2023)

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