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Pertuzumab and trastuzumab as adjuvant treatment for HER2-positive early breast cancer: outcomes in Chinese patients in the APHINITY study.

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机构: [1]Fudan University, Shanghai Cancer Center, Shanghai, China. [2]Taipei-Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan. [3]National Taiwan University Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. [4]Harbin Medical University Cancer Hospital, Harbin, China. [5]Taichung Veterans General Hospital, Taichung, Taiwan and College of Medicine, China Medical University, Taichung, Taiwan. [6]The First Hospital of Jilin University, Changchun, China. [7]Guangdong General Hospital, Guangzhou, China. [8]Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [9]Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China. [10]Sun Yatsen University Cancer Hospital, Guangzhou, China. [11]The University of Hong Kong, Hong Kong. [12]Roche (China) Holding Ltd, Shanghai, China, [13]Klinikum Frankfurt Höchst, Frankfurt, Germany, [14]Ottawa Hospital Cancer Centre, Ottawa, ON, Canada, [15]Breast International Group, Brussels, Belgium, [16]Frontier- Science Scotland Ltd, Kincraig, Scotland, [17]Institut Jules Bordet, Brussels, Belgium, [18]German Breast Group, Neu-Isenburg, Germany, [19]Chinese PLA General Hospital, 5th Medical Center, Beijing, China
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关键词: pertuzumab breast cancer adjuvant HER2 Chinese

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The addition of pertuzumab to trastuzumab plus standard chemotherapy as adjuvant therapy following surgery significantly improved invasive disease-free survival (IDFS) in patients with HER2-positive early breast cancer in the multinational randomized APHINITY trial (NCT01358877, BIG 4-11/BO25126/TOC4939G). We analyzed clinical outcomes in the subgroup of patients recruited at Chinese sites. Patients were randomized to standard adjuvant chemotherapy plus 1 year of trastuzumab with pertuzumab or placebo. Patients recruited in mainland China, Hong Kong and Taiwan are included in this descriptive analysis. Chinese patients had similar demographic characteristics to the global population, but a higher proportion had nodal involvement. Although this subgroup analysis was not powered to detect statistical significance, a numerical improvement in IDFS was observed with the addition of pertuzumab to trastuzumab in Chinese patients (hazard ratio, 0.69; 95% confidence interval: 0.39-1.19; 3-year IDFS event-free estimates 92.5% [pertuzumab] and 91.7% [placebo]), which was consistent with the primary analysis of the global population. Further subgroup analyses showed numerical improvements in the Chinese node-positive, hormone receptor-negative and -positive subgroups, although confidence intervals were wide due to the low number of events. The incidence of diarrhea was higher in the pertuzumab arm, and no primary cardiac events occurred in Chinese patients in either arm. Pertuzumab, used in combination with trastuzumab and chemotherapy in APHINITY, is effective as an adjuvant treatment regimen for Chinese patients with HER2-positive early breast cancer in a setting with curative intent. The safety profile in Chinese patients was consistent with that of the global population. © The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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出版当年[2021]版:
大类 | 4 区 医学
小类 | 4 区 肿瘤学
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大类 | 4 区 医学
小类 | 4 区 肿瘤学
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Q3 ONCOLOGY
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Q3 ONCOLOGY

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第一作者机构: [1]Fudan University, Shanghai Cancer Center, Shanghai, China.
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通讯机构: [18]German Breast Group, Neu-Isenburg, Germany, [19]Chinese PLA General Hospital, 5th Medical Center, Beijing, China [*1]German Breast Group, GBG Forschungs GmbH,Martin-Behaim-Str. 12, 63263 Neu-Isenburg, Germany. [*2]Chinese PLA General Hospital 5th Medical Center, Dongda Street No. 8, Fengtai District, Beijing100071, China.
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