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Ki67 In Breast Cancer Assay: An Ad Hoc Testing Recommendation From The Canadian Association Of Pathologists Task Force
The first session of the CAP-ACP Virtual Education Series 2023 is open to all! Don't forget to register for full series on CAP-ACP website.

Early in 2020year, Health canada approved Abemaciclib which is a CDK4/6 inhibitor in the adjuvant setting in HR+, HER2 negative, node-positive breast cancer patients at high risk of early recurrence.
The approval was based on the results from monarchE, a phase 3 clinical trial in early-stage chemotherapy-naïve, HR+, HER2 negative, node-positive breast cancer patients at high risk of early recurrence. The study has shown significant improvement in invasive disease-free survival (IDFS) with CDK4/6 inhibitor (Abemaciclib) when combined with adjuvant endocrine therapy at two years with a larger absolute benefit in Ki67 high tumors. Although the monarchE data showed that Ki67 is prognostic and has a limited role as a predictive mark

At the end of the session, participants will be able to:
* Identify the limitations associated with Ki67 testing
* Assess when to test and which tissue type to test
* Identify issues related to analytical validation and which antibody clone to use
* Describe how to read it, what constitutes a positive nucleus, how many cells should be counted
* Identify how to report Ki67

Target audience: Pathologists, Residents, Medical Students

CanMEDS Roles: Medical Expert (the integrating role), Communicator, Collaborator, Leader, Health Advocate, Scholar

Speakers: Dr. Hala Faragalla & Dr. Sharon Nofech Mozes
Declaration of Conflict of Interest: Dr. Faragalla has a relationship with PRECISION RX - DX by answering questions related to Ki67 assay and reporting.

This event is an Accredited Group Learning Activity (Section 1) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada and approved by the Canadian Association of Pathologists. You may claim a maximum of 1.5 hour (credits are automatically calculated).


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Dr. Hala Faragalla
Dr. Faragalla is a pathologist at St Michael's Hospital and an assistant Professor at University Of Toronto. She obtained her Royal collage certification in 2012; she did her pathology training at University Of Toronto after which she did a year as a breast fellow at University Health Network. In addition to her clinical work, she is involved in translational research related to biomarkers in breast cancer as Ki67 and other proliferation markers and resident teaching.
Dr. Sharon Nofech-Mozes
Dr. Sharon Nofech-Mozes obtained her medical degree and completed a residency in Anatomic Pathology in Israel. After imigrating to Canada, she completed fellowships in breast and gynecologic pathology at the University of Toronto. Dr. Nofech-Mozes is a Professor in the Department of Laboratory Medicine and Pathobiology at the University of Toronto and has been a staff pathologist at Sunnybrook Health Sciences Centre since 2007. Her academic interest is in prognostic and predictive biomarkers in breast, endometrial and ovarian cancers. Dr. Nofech-Mozes is a member of the International ki67 Working Group and the CAP/ACP Task Force for ki67 testing in breast carcinoma.