TY - JOUR
T1 - Selecting patients with HER2-low Breast Cancer: getting out of the tangle
AU - Baez-Navarro, Ximena
AU - Salgado, Roberto
AU - Denkert, Carsten
AU - K. Lennerz, Jochen
AU - Penault-Llorca, Frédérique
AU - Viale, Giuseppe
AU - Bartlett, John
AU - H.M. van Deurzen, Carolien
N1 - Funding Information:
CvD received funding from AstraZeneca. The funder had no role in the design or writing of this manuscript.JB reports consultancies from Insight Genetics, Inc. BioNTech AG Biotheranostics, Inc. Pfizer, Rna Diagnostics Inc., oncoXchange/MedcomXchange Communications Inc. Herbert Smith French Solicitors and OncoCyte Corporation. He is involved in a scientific advisory board of MedcomXchange Communications Inc. He received honoraria from NanoString Technologies, Inc. Oncology Education, Biotheranostics, Inc, MedcomXchange Communications Inc. and research funding from Thermo Fisher Scientific Genoptix, Agendia, NanoString Technologies, Inc. Stratifyer GmbH Biotheranostics, Inc. Travel, accommodation expenses were received from Biotheranostics, Inc., NanoString Technologies, Inc, and the Breast Cancer Society of Canada. He reports the following patents: 1) CIN4 predicts benefit from anthracycline, National Phase Application, (Canada, Jan. 11, 2017), 2) Systems, Devices and Methods for Constructing and Using a Biomarker, National Phase Application, 15/328,108 (United States, Jan. 23, 2017); 15824751.0 (Europe, Jan. 12, 2017); (Canada, Jan. 12, 2017), 3) Targeting the Histone Pathway to Detect and Overcome Anthracycline Resistance (IP Title), National Phase Application, PCT/CA2016/000247, Patent Application #: 3000858 (Country of filing: Canada – Patent Application Date: Apr. 4, 2018) and 4) Immune Gene Signature Predicts Anthracycline Benefit, PCT (international application), PCT/CA2016/000305, Filing date: Dec. 7, 2016.FPL reports personal fees from Astrazeneca, BMS, Daiichy-Sankyo, MSD, Roche, Seagen, Diaceutics, Veracyte, research support from Astrazeneca, Daiichy Sankyo, Roche, MSD and BMS.GV reports personal fees from AstraZeneca, BMS, Daiichy-Sankyo, MSD, Roche, Seagen, Pfizer, and research support from AstraZeneca and Roche.RS is supported by the Breast Cancer Research Foundation (BCRF, grant nr. 17-194).
Funding Information:
RS is supported by the Breast Cancer Research Foundation (BCRF, grant nr. 17-194 ).
Funding Information:
CvD received funding from AstraZeneca . The funder had no role in the design or writing of this manuscript.
Funding Information:
JB reports consultancies from Insight Genetics, Inc. BioNTech AG Biotheranostics, Inc. Pfizer, Rna Diagnostics Inc., oncoXchange/MedcomXchange Communications Inc. Herbert Smith French Solicitors and OncoCyte Corporation. He is involved in a scientific advisory board of MedcomXchange Communications Inc. He received honoraria from NanoString Technologies, Inc. Oncology Education, Biotheranostics, Inc, MedcomXchange Communications Inc. and research funding from Thermo Fisher Scientific Genoptix , Agendia, NanoString Technologies, Inc. Stratifyer GmbH Biotheranostics, Inc. Travel, accommodation expenses were received from Biotheranostics, Inc., NanoString Technologies, Inc, and the Breast Cancer Society of Canada. He reports the following patents: 1) CIN4 predicts benefit from anthracycline, National Phase Application, (Canada, Jan. 11, 2017), 2) Systems, Devices and Methods for Constructing and Using a Biomarker, National Phase Application, 15/328,108 (United States, Jan. 23, 2017); 15824751.0 (Europe, Jan. 12, 2017); (Canada, Jan. 12, 2017), 3) Targeting the Histone Pathway to Detect and Overcome Anthracycline Resistance (IP Title), National Phase Application, PCT/CA2016/000247, Patent Application #: 3000858 (Country of filing: Canada – Patent Application Date: Apr. 4, 2018) and 4) Immune Gene Signature Predicts Anthracycline Benefit, PCT (international application), PCT/CA2016/000305, Filing date: Dec. 7, 2016.
Funding Information:
FPL reports personal fees from Astrazeneca , BMS , Daiichy-Sankyo , MSD , Roche , Seagen , Diaceutics , Veracyte , research support from Astrazeneca, Daiichy Sankyo, Roche, MSD and BMS.
Funding Information:
RS reports non-financial support from Merck and Bristol Myers Squibb (BMS), research support from Merck, Puma Biotechnology and Roche, and personal fees from Roche, BMS and Exact Sciences for advisory boards.
Funding Information:
GV reports personal fees from AstraZeneca, BMS, Daiichy-Sankyo, MSD, Roche, Seagen, Pfizer , and research support from AstraZeneca and Roche.
Publisher Copyright:
© 2022 The Author(s)
PY - 2022/9/19
Y1 - 2022/9/19
N2 - The promising effect of antibody–drug conjugates on breast cancer with low expression of HER2 (HER2-low) raises many questions regarding the optimal selection of patients for this treatment. A key question is whether HER2 immunohistochemistry, an assay optimised to detect HER2 amplification, is reliable enough to assess HER2 protein levels to select patients with HER2-low breast cancer in daily pathology practices worldwide. Moreover, whether this assessment can be performed with sufficient reproducibility between pathologists in daily practices is debatable. Herein, we address the historical track record of the CAP-ASCO HER2 Guidelines, the reported limited reproducibility by pathologists of HER2 immunohistochemistry in the non-amplified cases, and the performance variation of different antibodies. Based on this summary, we propose solutions to improve the robustness to enable reliable identification of patients with HER2-low breast cancer.
AB - The promising effect of antibody–drug conjugates on breast cancer with low expression of HER2 (HER2-low) raises many questions regarding the optimal selection of patients for this treatment. A key question is whether HER2 immunohistochemistry, an assay optimised to detect HER2 amplification, is reliable enough to assess HER2 protein levels to select patients with HER2-low breast cancer in daily pathology practices worldwide. Moreover, whether this assessment can be performed with sufficient reproducibility between pathologists in daily practices is debatable. Herein, we address the historical track record of the CAP-ASCO HER2 Guidelines, the reported limited reproducibility by pathologists of HER2 immunohistochemistry in the non-amplified cases, and the performance variation of different antibodies. Based on this summary, we propose solutions to improve the robustness to enable reliable identification of patients with HER2-low breast cancer.
U2 - 10.1016/j.ejca.2022.08.022
DO - 10.1016/j.ejca.2022.08.022
M3 - Article
SN - 0959-8049
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -