Abstract

Aims. To compare the results of estrogen and progesterone receptors (ER, PR), and human epidermal growth factor receptor-2 (HER2) expression status on biopsy and excision specimens and to evaluate the effect of cold ischemia time and/or formalin fixation on these biomarkers. Methods. Breast carcinomas that were diagnosed between 2007 and 2009 by core needle biopsy, and subsequently excised in our institution, were included in the study. Data regarding the tumor morphology, grade, and ER, PR, and HER2 status were retrospectively collected from the pathology reports. Results. Five out of 149 (3.4%) cases with ER-positive receptor status in the biopsy specimen became ER-negative in the subsequent excision specimen. Nine out of 126 (7.1%) cases with PR-positive receptor status in the biopsy specimen became PR-negative in the excision specimen. Receptor status change was predominantly seen in tumors with low ER and PR receptor expression. HER2 results were consistent between biopsy and excision specimens in all cases tested. Conclusions. Cold ischemia time and/or formalin fixation affect mainly ER and PR testing with low Allred scores and support the implementation of the ASCO/CAP guidelines. HER2 results, however, were not affected in our limited number of patients.

Highlights

  • Breast cancer is one of the best examples where antibodydefined tumor markers are used as both prognostic and predictive factors

  • Prognostic factors are independently associated with the clinical outcome, whereas predictive factors are independently associated with response or lack of response to a particular treatment

  • All steps of specimen handling, including cold ischemia time, duration of fixation, and type of fixative, have an impact on the result, and optimization of tissue handling is essential for clinical utility of these tests

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Summary

Introduction

Breast cancer is one of the best examples where antibodydefined tumor markers are used as both prognostic and predictive factors. Progesterone receptor (PR) expression is correlated with better prognosis and higher response to hormone-based treatments and increases the predictive power of ER [3,4,5]. Another important marker in the evaluation of breast cancer is the human epidermal growth factor receptor-2 (HER2; c-erbB-2), which is a member of the epidermal growth factor receptor family. HER2 status is predictive for sensitivity to anthracyclinebased chemotherapies and relative resistance to cytoxanbased and tamoxifen-based adjuvant therapies [8] It is essential for the therapeutic decisions regarding the use of agents targeting the HER2 gene product such as the humanized, monoclonal antibody, trastuzumab [9]

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