Novel Biomarkers in the Continuum of Breast Cancer by Vered Stearns

Novel Biomarkers in the Continuum of Breast Cancer by Vered Stearns

Author:Vered Stearns
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham


On-treatment Ki-67 and PEPI Score are promising approaches to differentiate endocrine sensitive versus resistant ER-positive breast cancer in the early stage setting. However, at present it remains an investigational approach pending results from the ALTERANTE trial. The significant variations in the current analytical practice of Ki-67 IHC could also limit its eventual clinical application. Comprehensive recommendations on pre-analytical and analytical assessment, and interpretation and scoring of Ki-67 have been put forward by the International Ki-67 in Breast Cancer Working Group [54]. Standard operating procedures that incorporate pathologist-guided digital imaging analysis and manual point-counting of selected cases has been developed that allows efficient and consistent scoring of Ki-67 needed in clinical trials , and demonstrated validity in predicting long term outcomes [55, 56]. This standard operating procedure is currently applied for the central Ki-67 analysis in the ALTERNATE trial and several other neoadjuvant endocrine therapy studies. The result of the ALTERNATE trial is however needed to provide the clinical validity for on-treatment Ki-67 based biomarker approach including PEPI 0 score as a prognostic indicator of long term outcomes.



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