Abstract

IntroductionMitotic Activity Index (MAI) is an important independent prognostic factor and an integral part of the breast cancer grading system. Thus, correct estimation of this prognostically relevant feature is essential for guiding treatment decision and assessing patient prognosis.The aim of this study was to validate the use of high resolution Whole Slide Images (WSI) in estimating MAI in breast cancer specimens.MethodsMAI was evaluated in 100 consecutive breast cancer specimens by three observers on two occasions, microscopically and on WSI with a wash out period of 4 months. MAI was also translated to mitotic scores as in grading. Inter- and intra-observer agreement between microscopic and digital MAI counts and scores was measured.ResultsAlmost perfect inter-observer agreements were obtained from counting MAI using a conventional microscope (intra-class correlation coefficient (ICCC) 0.879) as well as on WSI (ICCC 0.924). K coefficients reflected good inter-observer agreements among observers' microscopic mitotic scores (average kappa 0.642). Comparable results were also observed among digital mitotic scores (average kappa 0.635). There was strong to perfect intra-observer agreements between MAI counts and mitotic scores for the two diagnostic modalities (ICCC 0.716–0.863, kappa 0.506–0.617). There were no significant differences in mitotic scores using both diagnostic modalities.ConclusionScoring mitoses using WSI in breast cancer seems to be just as reliable and reproducible as when using a microscope. Further development of software and image quality will definitely encourage the use of WSI in routine pathology practice.

Highlights

  • Mitotic Activity Index (MAI) is an important independent prognostic factor and an integral part of the breast cancer grading system

  • More than a decade ago, the practice of pathology began changing, with the introduction of slide scanners which enable the acquisition of pathology information from glass slides and translate it into a digital form commonly known as digital slides or Whole Slide Images (WSI)

  • Despite the fact that several validation studies have shown that the diagnostic performance using WSI is comparable to that of a conventional microscope [5,6,7,8,9,10,11,12], implementing WSI in primary diagnostics is still in its infancy

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Summary

Introduction

Mitotic Activity Index (MAI) is an important independent prognostic factor and an integral part of the breast cancer grading system. WSI boast many advantages over glass slides and a conventional microscope; including easy image accessibility, sharing, annotating and amenability to automated image analysis which is believed to improve the objectivity and productivity within pathology practice. These features facilitated WSI integration in different pathology applications, mainly used for education, consultation, frozen section diagnosis, quality assurance, clinico-pathological conferences and research [1,2,3,4]. One of the possible factors hindering WSI integration in routine pathology practice is that they have yet to be approved for primary diagnostics by the Food and Drug Administration (FDA) [15]. The FDA has classified whole slide scanners as Class III medical devices (Slide scanner classification) necessitating extensive systematic validation studies and premarket approval before WSI can become a platform for primary diagnostics [16]

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