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.
| Original language | English (US) |
|---|---|
| Article number | 106 |
| Journal | npj Breast Cancer |
| Volume | 8 |
| Issue number | 1 |
| DOIs | |
| State | Published - Dec 2022 |
ASJC Scopus subject areas
- Oncology
- Radiology Nuclear Medicine and imaging
- Pharmacology (medical)
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Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE. / Loibl, Sibylle; Huang, Chiun Sheng; Mano, Max S. et al.
In: npj Breast Cancer, Vol. 8, No. 1, 106, 12.2022.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE
AU - Loibl, Sibylle
AU - Huang, Chiun Sheng
AU - Mano, Max S.
AU - Mamounas, Eleftherios P.
AU - Geyer, Charles E.
AU - Untch, Michael
AU - Thery, Jean Christophe
AU - Schwaner, Ingo
AU - Limentani, Steven
AU - Loman, Niklas
AU - Lübbe, Kristina
AU - Chang, Jenny C.
AU - Hatschek, Thomas
AU - Tesarowski, David
AU - Song, Chunyan
AU - Lysbet de Haas, Sanne
AU - Boulet, Thomas
AU - Lambertini, Chiara
AU - Wolmark, Norman
N1 - Funding Information: Si.L. declares no competing non-financial Interests but the following competing financial Interests. Si.L. received research funding and/or honoraria for advisory boards and speaker roles paid to her institution from Abbvie, Amgen, AstraZeneca, Bristol-Myers-Squibb, Celgene, Daiichi Sankyo, EirGenix, Eli Lilly, F. Hoffmann-La Roche, GSK, Gilead, Medscape, Merck kG, Myriad Pharmaceuticals, Novartis, PEER, Pfizer, Pierre Fabre, Puma Biotechnology, Sanofi, and SeaGen. She holds several patents: EP14153692.0; EP21152186.9; EP15702464.7; EP19808852.8. GBG Forschungs GmbH receives royalties from VMscope. Si.L. is the CEO of the GBG Forschungs GmbH (GBG). C.-S.H. declares no competing non-financial Interests but the following competing financial Interests. He reports receiving research funding to his institution from AstraZeneca, Daiichi Sankyo, EirGenix, Eli Lilly, MSD, Novartis, OBI Pharma, Pfizer, and Roche; travel expenses from AstraZeneca, Pfizer, and Roche; and honoraria for advisory boards and speaker roles from Amgen, AstraZeneca, Eli Lilly, Novartis, Pfizer, and Roche. M.S.M. declares no competing non-financial Interests but the following competing financial Interests. He has owned stock in Biotoscana, Fleury, and Hypera. He reported receiving honoraria from Dasa, Lilly, Novartis, Oncologia Brasil, Pfizer, and Roche; and travel expenses from Roche. He has served as an advisor to AstraZeneca, Lilly, Novartis, Pfizer, and Roche. He has been a principal subinvestigator for clinical trials from Lilly, Novartis, Pfizer, and Roche. E.P.M. declares no competing non-financial Interests but the following competing financial Interests. He reports receiving honoraria from Biotheranostics, Daiichi Sankyo, Genentech/Roche, Genomic Health, and Merck; and research funding from the NSABP Foundation. C.E.G. declares no competing non-financial Interests but the following competing financial Interests. C.E.G. reports receiving consulting fees from Athenex, Celgene, Exact Science, Myriad Genetics, and Heron; uncompensated consulting for Daiichi Sankyo, Genentech, Roche, and Seattle Genetics; travel expenses from AstraZeneca, Daiichi Sankyo, Genentech, and Roche; and medical writing support from Abbvie and Roche. M.U. reported receiving honoraria from Odonate and PUMA Biotechnology, and non-financial support from Odonate. His institution has received fees and non-financial support from Abbvie, Amgen GmbH, AstraZeneca, Celgene GmbH, Clovis Oncology, Daiichi Sankyo, Eisai GmbH, Lilly Int., MSD Merck, Mundipharma, Myriad Genetics, Novartis, Pfizer GmbH, Roche Pharma AG, Sanofi Aventis Deutschland GmbH, and Teva Pharmaceuticals Ind Ltd. His institution has received fees from BMS, Pierre Fabre, and Lilly Deutschland. J.-C.T. declares no competing non-financial Interests but the following competing financial Interests. He reports receiving travel expenses from AstraZeneca, Esai, GSK, Mundi Pharma, Novartis, Pfizer, Pharmamar, and Roche; and research funding to his institution from Mundi Pharma. He serves as an advisor to Astra Zeneca and Pfizer. I.S. declares no competing non-financial Interests but the following competing financial Interests. He reports receiving travel expenses from Celgene, Janssen, Novartis, and Roche; and honoraria from Servier. He serves as an advisor to Abbvie, Amgen, Celgene, Hexal, Janssen, Novartis, Roche, and Servier. N.L. declares no competing non-financial Interests but the following competing financial Interests. He reports receiving honoraria from Astra Zeneca, MSD, Pierre Fabre, and Roche. K.L. declares no competing non-financial Interests but the following competing financial Interests. She reports receiving honoraria from Exact Science, Lilly, MSD, Novartis, Pfizer, and Roche for serving as an advisor. J.C.C. declares no competing non-financial Interests but the following competing financial Interests. She has served as an advisor to Celgene, Genentech, and Lilly. T.H. declares no competing non-financial Interests but the following competing financial Interests. He reports receiving travel expenses from Roche. He has served as an advisor to Pierre Fabre, Pfizer, and Roche. His institution has received research funding from Pfizer and Roche. D.T., C.S., and S.L.deH. declare no competing non-financial Interests but the following competing financial Interests. They own stock in and are employees of Roche. C.L. declares no competing non-financial Interests but the following competing financial Interests. She is an employee of Roche. T.B. declares no competing non-financial Interests but the following competing financial Interests. He is an employee of Parexel International GmbH contracted by Roche for statistical services in the conduct of the study. St. L. and N.W. declared no competing interests. Funding Information: The authors thank the patients, their families, and all KATHERINE investigators and study sites. The authors thank Malgorzata Nowicka, PhD of F. Hoffmann-La Roche, Ltd. for compiling the gene expression data. This work was supported by F. Hoffmann-La Roche, Ltd. Medical writing assistance for this manuscript was provided by Tracy McNally, PhD, and Holly Strausbaugh, PhD, of Twist Medical, and was funded by F. Hoffmann-La Roche, Ltd. All authors received support for third-party writing assistance for this manuscript, provided by F. Hoffmann–La Roche Ltd. These data were presented, in part, at the European Society of Medical Oncology Breast Cancer Congress 2020. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85138309735&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85138309735&partnerID=8YFLogxK
U2 - 10.1038/s41523-022-00477-z
DO - 10.1038/s41523-022-00477-z
M3 - Article
AN - SCOPUS:85138309735
VL - 8
JO - npj Breast Cancer
JF - npj Breast Cancer
SN - 2374-4677
IS - 1
M1 - 106
ER -