4.1 Article

Two Instrument Comparison of Reagents From a US FDA-Approved Assay for the Assessment of Ki-67 in High-Risk Early Breast Cancer

Related references

Note: Only part of the references are listed.
Article Anatomy & Morphology

A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone

Monika D. Polewski et al.

Summary: The objective of this study was to develop a standardized Ki-67 immunohistochemistry method for precise assessment of patients with early breast cancer and to evaluate the prognostic value of Ki-67 expression in these patients. The results showed that patients with high Ki-67 expression had a higher risk of developing invasive disease within 2 years compared to those with low Ki-67 expression.

APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY (2022)

Article Oncology

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

Melanie Royce et al.

Summary: Abemaciclib in combination with endocrine therapy has been approved for high-risk early breast cancer patients, showing a statistically significant improvement in invasive disease-free survival (IDFS) without detriment to overall survival.

JOURNAL OF CLINICAL ONCOLOGY (2022)

Article Oncology

Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study

N. Harbeck et al.

Summary: Adjuvant abemaciclib combined with endocrine therapy significantly improved invasive disease-free survival in patients with early breast cancer, with an acceptable safety profile. Ki-67 index was prognostic but did not affect the benefits of abemaciclib. The robust treatment benefit of abemaciclib extended beyond the planned 2-year treatment period.

ANNALS OF ONCOLOGY (2021)

Article Oncology

Assessment of Ki67 in Breast Cancer: Updated Recommendations From the International Ki67 in Breast Cancer Working Group

Torsten O. Nielsen et al.

Summary: Ki67 immunohistochemistry (IHC) is commonly used in breast cancer as a proliferation marker, but its analytical validity has been questioned. The International Ki67 in Breast Cancer Working Group (IKWG) recommends careful preanalytical handling, adoption of a standardized visual scoring method, and participation in quality assurance and quality control programs. Clinical utility of Ki67 IHC in breast cancer care is currently limited to prognosis assessment in stage I or II breast cancer.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2021)

Article Anatomy & Morphology

UK NEQAS ICC & ISH Ki-67 Data Reveal Differences in Performance of Primary Antibody Clones

Suzanne Parry et al.

Summary: The study highlights the importance of not only choosing the right primary antibody, but also matching it with other methodological factors for optimal staining results.

APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY (2021)

Article Medicine, General & Internal

20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years

Hongchao Pan et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

Article Anatomy & Morphology

Development of a Companion Diagnostic PD-L1 Immunohistochemistry Assay for Pembrolizumab Therapy in Non-Small-cell Lung Cancer

Charlotte Roach et al.

APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY (2016)

Article Anatomy & Morphology

Development of an Automated PD-L1 Immunohistochemistry (IHC) Assay for Non-Small Cell Lung Cancer

Therese Phillips et al.

APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY (2015)

Article Medical Laboratory Technology

Principles of Analytic Validation of Immunohistochemical Assays Guideline From the College of American Pathologists Pathology and Laboratory Quality Center

Patrick L. Fitzgibbons et al.

ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE (2014)

Article Oncology

US Incidence of Breast Cancer Subtypes Defined by Joint Hormone Receptor and HER2 Status

Nadia Howlader et al.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2014)

Editorial Material Oncology

Assessment of Ki67 in Breast Cancer: Recommendations from the International Ki67 in Breast Cancer Working Group

Mitch Dowsett et al.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2011)

Article Medicine, General & Internal

A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer

S Paik et al.

NEW ENGLAND JOURNAL OF MEDICINE (2004)