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Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial

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作者：
Jiong Wu[1] * ; Zefei Jiang[2] * ; Zhenzhen Liu[3] * ; Benlong Yang[1] * ; Hongjian Yang[4] ; Jinhai Tang[5] ; Kun Wang[6] ; Yunjiang Liu[7] ; Haibo Wang[8] ; Peifen Fu[9] ; Shuqun Zhang[10] ; Qiang Liu[11] ; Shusen Wang[12] ; Jian Huang[13] ; Chuan Wang[14] ; Shu Wang[15] ; Yongsheng Wang[16] ; Linlin Zhen[17] ; Xiaoyu Zhu[18] ; Fei Wu[18] ; Xiang Lin[18] ; Jianjun Zou[18] ;
机构： [1]Department of Breast Surgery, Fudan University Shanghai Cancer Center,No.270, Dong’an Road, Xuhui District, Shanghai 200032, China [2]Departmentof Medical Oncology, The Fifth Medical Center of Chinese PLA GeneralHospital, Beijing, China [3]Department of Breast Disease, Henan Breast CancerCenter, The Affiliated Cancer Hospital of Zhengzhou University & HenanCancer Hospital, Zhengzhou, China [4]Breast Surgery, Zhejiang Cancer Hospital,Hangzhou, China [5]Breast Surgery, Jiangsu Province Hospital, Nanjing, China [6]Department of Breast Cancer, Cancer Center, Guangdong Provincial People’sHospital, Guangdong Academy of Medical Sciences, Guangzhou, China [7]Breast Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang,China [8]Breast Disease Center, The Affiliated Hospital of Qingdao University,Qingdao, China [9]Breast Surgery, The First Affiliated Hospital ZhejiangUniversity, Hangzhou, China [10]Oncology Department, The Second AffiliatedHospital of Xi’an Jiaotong University, Xi’an, China [11]Department of BreastSurgery, Sun Yat‑Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou,China [12]Internal Medicine, Sun Yat-Sen University Cancer Center, Guangzhou,China [13]Breast Surgery, The Second Affiliated Hospital, Zhejiang University,Hangzhou, China [14]Department of Breast Surgery, Fujian Medical UniversityUnion Hospital, Fuzhou, China [15]Department of Breast Surgery, PekingUniversity People’s Hospital, Beijing, China [16]Department of Breast, ShandongCancer Hospital, Jinan, China [17]Department of Thyroid and Breast Surgery, TheAffiliated Huai’an No.1 People’s Hospital of Nanjing Medical University, Huai’an,China [18]Clinical Research & Development, Jiangsu Hengrui PharmaceuticalsCo., Ltd, Shanghai, China
出处：
DOI： 10.1186/s12916-022-02708-3
ISSN：

关键词： Breast cancer HER2 Pyrotinib Neoadjuvant treatment Phase 3

摘要：
Pyrotinib (an irreversible pan-ErbB inhibitor) plus capecitabine has survival benefits and acceptable tolerability in patients with HER2-positive metastatic breast cancer. We further assessed addition of pyrotinib to trastuzumab and docetaxel in the neoadjuvant setting.In this multicenter, double-blind, phase 3 study (PHEDRA), treatment-naive women with HER2-positive early or locally advanced breast cancer were randomly assigned (1:1) to receive four neoadjuvant cycles of oral pyrotinib or placebo (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) and docetaxel (100 mg/m2) every 3 weeks. The primary endpoint was the total pathological complete response (tpCR; ypT0/is and ypN0) rate per independent central review.Between Jul 23, 2018, and Jan 8, 2021, 355 patients were randomly assigned, 178 to the pyrotinib group and 177 to the placebo group. The majority of patients completed four cycles of neoadjuvant treatment as planned (92.7% and 97.7% in the pyrotinib and placebo groups, respectively). The tpCR rate was 41.0% (95% CI 34.0 to 48.4) in the pyrotinib group compared with 22.0% (95% CI 16.6 to 28.7) in the placebo group (difference, 19.0% [95% CI 9.5 to 28.4]; one-sided P < 0.0001). The objective response rate per investigator was 91.6% (95% CI 86.6 to 94.8) in the pyrotinib group and 81.9% (95% CI 75.6 to 86.9) in the placebo group after the neoadjuvant treatment, resulting in an increase of 9.7% (95% CI 2.7 to 16.6). The most common grade 3 or worse adverse events were diarrhea (79 [44.4%] in the pyrotinib group and nine [5.1%] in the placebo group), neutropenia (33 [18.5%] and 36 [20.3%]), and decreased white blood cell count (29 [16.3%] and 24 [13.6%]). No deaths were reported during neoadjuvant treatment.The primary endpoint of the study was met. Neoadjuvant pyrotinib, trastuzumab, and docetaxel significantly improved the tpCR rate compared with placebo, trastuzumab, and docetaxel, with manageable toxicity, providing a new option for HER2-positive early or locally advanced breast cancer.ClinicalTrials.gov, NCT03588091.© 2022. The Author(s).

基金：
This study was funded by Jiangsu Hengrui Pharmaceuticals Co, Ltd.
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外文
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出版当年[2022]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2022]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[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]Department of Breast Surgery, Fudan University Shanghai Cancer Center,No.270, Dong’an Road, Xuhui District, Shanghai 200032, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Breast Surgery, Fudan University Shanghai Cancer Center,No.270, Dong’an Road, Xuhui District, Shanghai 200032, China
推荐引用方式(GB/T 7714)：
Jiong Wu,Zefei Jiang,Zhenzhen Liu,et al.Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial[J].BMC MEDICINE.2022,20(1):doi:10.1186/s12916-022-02708-3.
APA：
Jiong Wu,Zefei Jiang,Zhenzhen Liu,Benlong Yang,Hongjian Yang...&Jianjun Zou.(2022).Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial.BMC MEDICINE,20,(1)
MLA：
Jiong Wu,et al."Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial".BMC MEDICINE 20..1(2022)

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