Comparing the Sensitivity of HER2 Epitope Detection of HercepTest mAb pharmDx (Dako Omnis, GE001) and Ventana PATHWAY Anti-HER-2/neu (4B5) Using IHC Calibrators DOI Creative Commons

Frederik H. Aidt,

María Sierra,

Karin Salomon

et al.

Applied immunohistochemistry & molecular morphology, Journal Year: 2024, Volume and Issue: 32(10), P. 469 - 475

Published: Oct. 24, 2024

Accurate assessment of HER2 expression levels is paramount for determining eligibility targeted therapies. immunohistochemistry provides a semiquantitative measurement protein overexpression. Historically, little focus has been on the lower end range. The advent novel therapeutic molecules that require fewer membrane epitopes to be effective prompted reevaluation current testing protocols, with special emphasis detection limit. Here, we have used Boston Cell Standards technology determine sensitivity 2 commercially available assays, including limit detection.

Language: Английский

Clinicopathologic Characterization of Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Null, Ultralow, and Low Breast Carcinoma in the Metastatic Setting DOI Creative Commons
Raza S. Hoda, Patrick J. McIntire

Human Pathology, Journal Year: 2025, Volume and Issue: 155, P. 105735 - 105735

Published: Jan. 1, 2025

Language: Английский

Citations

1
HER2-low across solid tumours: different incidences and definitions DOI
Ximena Baez‐Navarro, Floris H. Groenendijk, Lindsey Oudijk

et al.

Pathology, Journal Year: 2025, Volume and Issue: unknown

Published: March 1, 2025

Language: Английский

Citations

0
HER2-Low Breast Cancer—Current Knowledge and Future Directions DOI Creative Commons
Abeer M. Shaaban,

Tanvier Kaur,

Elena Provenzano

et al.

Medicina, Journal Year: 2025, Volume and Issue: 61(4), P. 644 - 644

Published: April 1, 2025

The concept of binary classification HER2 status has recently been challenged following the DESTINY-Breast trial data showing a clinically meaningful response to antibody–drug conjugates (ADCs) in invasive breast cancer expressing low levels HER2. HER2-low is defined as an immunohistochemistry (IHC) score 1+ and 2+ without gene amplification. While does not represent biological entity, it encompasses both hormone receptor-positive triple-negative cancer. Differences exist between this group HER2-null In review, we provide update on HER2-ultralow cancer, including background data, evolution expression, current clinical guidelines, quality issues, future directions.

Language: Английский

Citations

0
Reevaluating HER2-null breast cancer using an enhanced HER2 immunohistochemistry protocol DOI
Takeshi Ushigusa, Nami Yamamoto, Naoki Kanomata

et al.

Breast Cancer, Journal Year: 2025, Volume and Issue: unknown

Published: May 13, 2025

Language: Английский

Citations

0
Reevaluating HER2-null breast cancer using an enhanced HER2 immunohistochemistry protocol DOI Creative Commons
Takeshi Ushigusa,

Nami Hirakawa,

Naoki Kanomata

et al.

Research Square (Research Square), Journal Year: 2025, Volume and Issue: unknown

Published: March 25, 2025

Abstract Background: Human epidermal growth factor receptor 2 (HER2) status is crucial for the classification of breast cancer and selection its treatment. Although HER2-low a recognized therapeutic subgroup, HER2 immunohistochemistry (IHC) 0 remains unclear. Methods: We reassessed 58 HER2-null cases using an enhanced IHC protocol VENTANA OptiView detection system. expression was evaluated based on membrane positivity rate (%) staining intensity. Microscopic assessment performed to determine percentage HER2-positive tumor cells. Digital image analysis used quantify Results: Membrane detected varying degrees in all cases. This indicated that tumors previously classified as exhibited when analyzed with Conclusion: These findings suggest protocols can improve sensitivity. Further research needed clinical significance protocols.

Language: Английский

Citations

0
The “lows”: update on ER-low and HER2-low breast cancer DOI Open Access
Nicola Fusco,

G. Viale

The Breast, Journal Year: 2024, Volume and Issue: 78, P. 103831 - 103831

Published: Oct. 30, 2024

ER-low and HER2-low breast cancers have emerged as clinically significant subtypes that challenge traditional diagnostic categories treatment paradigms. These subtypes, representing a spectrum of disease, exhibit distinct biological behaviors, therapeutic responses, prognostic outcomes. cancer, defined by low HER2 protein expression (IHC score 1+ or 2+ without gene amplification), has achieved clinical significance, particularly following the DESTINY-Breast trials, which demonstrated efficacy trastuzumab deruxtecan (T-DXd) in population patients with advanced disease. Similarly, characterized estrogen receptor (in 1%-10 % invasive tumor cells), poses unique challenges due to its intermediate behavior uncertain response endocrine therapies. The identification these is further complicated inconsistencies testing methodologies, can lead misclassification impact decisions. As our understanding improves, need for standardized approaches individualized decisions becomes increasingly urgent. Ongoing research collaboration between pathologists oncologists are essential refining criteria improving outcomes theragnostic biomarkers. This review aims consolidate current knowledge on cancers, focusing associated their identification, implications treatment, future directions management. By examining recent studies interlaboratory assessments, this emphasizes critical accurate reproducible reporting, development tailored strategies "low" cancers.

Language: Английский

Citations

2
Comparing the Sensitivity of HER2 Epitope Detection of HercepTest mAb pharmDx (Dako Omnis, GE001) and Ventana PATHWAY Anti-HER-2/neu (4B5) Using IHC Calibrators DOI Creative Commons

Frederik H. Aidt,

María Sierra,

Karin Salomon

et al.

Applied immunohistochemistry & molecular morphology, Journal Year: 2024, Volume and Issue: 32(10), P. 469 - 475

Published: Oct. 24, 2024

Accurate assessment of HER2 expression levels is paramount for determining eligibility targeted therapies. immunohistochemistry provides a semiquantitative measurement protein overexpression. Historically, little focus has been on the lower end range. The advent novel therapeutic molecules that require fewer membrane epitopes to be effective prompted reevaluation current testing protocols, with special emphasis detection limit. Here, we have used Boston Cell Standards technology determine sensitivity 2 commercially available assays, including limit detection.

Language: Английский

Citations

0