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How and on which specimens will you perform Ki-67 testing in newly diagnosed breast cancer?

Should this be sent on initial biopsy or on surgical pathology? What if an initially high risk patient has good risk findings post-operatively? What has been your experience accessing the companion diagnostic (Dako Omnis)? Can results from other testing, including local pathology, be used in determining eligibility for adjuvant abemaciclib per MonarchE?
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How are you performing Ki-67 testing in newly diagnosed breast cancer?

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4 Answers
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Medical Oncology · The Royal Marsden NHS Foundation Trust & The Institute of Cancer Research
Answered on

In the trial, Ki67 testing was performed on the baseline tumour sample which would be a core biopsy of patients who are undergoing neo-adjuvant chemotherapy, which occurred in 37% of patients in the trial, or the surgical excision sample if they went straight to surgery. It is important that it is d...

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Medical Oncology · University of Pittsburgh School of Medicine
Answered on

Likely, this will depend on the institutional standard. Our group at Magee Women's Hospital has extensive experience with Ki67 on core biopsy and it is part of our standard biomarker workup. Other institutions may perform this differently. We may start performing Ki67 on the resected tumor if the in...

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Medical Oncology · Mary Lanning Healthcare Morrison Cancer Center/University of Nebraska Medical Center Adjunct Faculty
Answered on

Many studies confirm that Ki67 is prognostic in early-stage breast cancer. However, these studies display substantial variability in both analytical validity and choice of cutoffs, and most have been studies of convenience in which selection of patients, the intrinsic subtypes of the cancers, and ap...

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Medical Oncology · Duke University
Answered on

The requirement for the Ki-67 testing is problematic. In the trial, the benefit for abemaciclib was greater if Ki-67 was high, but still existed if Ki-67 was not high. In talking to our pathologists and lab, we learned that Ki-67 is a very difficult test to run and results can be very variable. So, ...

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