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KATHERINE研究中,辅助曲妥珠单抗恩美曲妥珠单抗用于HER2阳性乳腺癌且HER2阴性残余浸润性疾病患者

Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE.

作者信息

Loibl Sibylle, Huang Chiun-Sheng, Mano Max S, Mamounas Eleftherios P, Geyer Charles E, Untch Michael, Thery Jean-Christophe, Schwaner Ingo, Limentani Steven, Loman Niklas, Lübbe Kristina, Chang Jenny C, Hatschek Thomas, Tesarowski David, Song Chunyan, Lysbet de Haas Sanne, Boulet Thomas, Lambertini Chiara, Wolmark Norman

机构信息

GBG, Neu-Isenburg, Germany.

Centre for Haematology and Oncology Bethanien, Frankfurt, Germany.

出版信息

NPJ Breast Cancer. 2022 Sep 19;8(1):106. doi: 10.1038/s41523-022-00477-z.

DOI:10.1038/s41523-022-00477-z
PMID:36117201
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9482917/
Abstract

Following chemotherapy and human epidermal growth factor 2 (HER2)-targeted neoadjuvant therapy for HER2-positive early breast cancer, residual invasive breast cancer at surgery may be HER2-negative on retesting in some patients. We evaluated outcomes with T-DM1 and trastuzumab in patients randomized in the phase III KATHERINE trial based on HER2-positive central testing of the pre-treatment core biopsy with HER2-negative central testing on their corresponding surgical specimen after neoadjuvant treatment. In the 70/845 (8.3%) patients with HER2-negative residual disease on retesting at surgery, there were 11 IDFS events in the 42 trastuzumab-treated patients (26.2%) and none in the 28 T-DM1-treated patients, suggesting that T-DM1 should not be withheld in this patient population.

摘要

对于HER2阳性早期乳腺癌患者,在接受化疗和以人表皮生长因子2(HER2)为靶点的新辅助治疗后,部分患者手术时残留的浸润性乳腺癌再次检测时可能为HER2阴性。在III期KATHERINE试验中,我们根据新辅助治疗前核心活检的HER2阳性中心检测结果及相应手术标本新辅助治疗后的HER2阴性中心检测结果,对随机分组的患者使用曲妥珠单抗和ado曲妥珠单抗进行评估。在手术时再次检测为HER2阴性残留疾病的70/845例(8.3%)患者中,42例接受曲妥珠单抗治疗的患者中有11例(26.2%)出现侵袭性无病生存期(IDFS)事件,而28例接受ado曲妥珠单抗治疗的患者中无一例出现此类事件,这表明在该患者群体中不应停用ado曲妥珠单抗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a47f/9482917/55f506e272cd/41523_2022_477_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a47f/9482917/55f506e272cd/41523_2022_477_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a47f/9482917/55f506e272cd/41523_2022_477_Fig1_HTML.jpg

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Breast Care (Basel). 2021 Apr;16(2):135-143. doi: 10.1159/000516114. Epub 2021 Apr 7.
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