Ki-67 Proliferation Index Assessment in Gastroenteropancreatic Neuroendocrine Tumors by Digital Image Analysis With Stringent Case and Hotspot Level Concordance Requirements

Sarag A Boukhar; Matthew D Gosse; Andrew M Bellizzi; Anand Rajan K D

doi:10.1093/ajcp/aqaa275

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Ki-67 Proliferation Index Assessment in Gastroenteropancreatic Neuroendocrine Tumors by Digital Image Analysis With Stringent Case and Hotspot Level Concordance Requirements

Journal article

Peer reviewed

Ki-67 Proliferation Index Assessment in Gastroenteropancreatic Neuroendocrine Tumors by Digital Image Analysis With Stringent Case and Hotspot Level Concordance Requirements

Sarag A Boukhar, Matthew D Gosse, Andrew M Bellizzi and Anand Rajan K D

American journal of clinical pathology, Vol.156(4), pp.607-619

04/13/2021

DOI: 10.1093/ajcp/aqaa275

PMID: 33847759

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https://www.ncbi.nlm.nih.gov/pmc/articles/8427716View

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Abstract

Abstract Objectives The Ki-67 proliferation index is integral to gastroenteropancreatic neuroendocrine tumor (GEP-NET) assessment. Automated Ki-67 measurement would aid clinical workflows, but adoption has lagged owing to concerns of nonequivalency. We sought to address this concern by comparing 2 digital image analysis (DIA) platforms to manual counting with same-case/different-hotspot and same-hotspot/different-methodology concordance assessment. Methods We assembled a cohort of GEP-NETs (n = 20) from 16 patients. Two sets of Ki-67 hotspots were manually counted by three observers and by two DIA platforms, QuantCenter and HALO. Concordance between methods and observers was assessed using intraclass correlation coefficient (ICC) measures. For each comparison pair, the number of cases within ±0.2xKi-67 of its comparator was assessed. Results DIA Ki-67 showed excellent correlation with manual counting, and ICC was excellent in both within-hotspot and case-level assessments. In expert-vs-DIA, DIA-vs-DIA, or expert-vs-expert comparisons, the best-performing was DIA Ki-67 by QuantCenter, which showed 65% cases within ±0.2xKi-67 of manual counting. Conclusions Ki-67 measurement by DIA is highly correlated with expert-assessed values. However, close concordance by strict criteria (>80% within ±0.2xKi-67) is not seen with DIA-vs-expert or expert-vs-expert comparisons. The results show analytic noninferiority and support widespread adoption of carefully optimized and validated DIA Ki-67.

Ki-67

Validation immunohistochemistry

Neuroendocrine

Digital image analysis

Concordance

Grading

Whole-slide imaging

Details

Title: Subtitle: Ki-67 Proliferation Index Assessment in Gastroenteropancreatic Neuroendocrine Tumors by Digital Image Analysis With Stringent Case and Hotspot Level Concordance Requirements
Creators: Sarag A Boukhar - University of Iowa Hospitals and Clinics
Matthew D Gosse - University of Iowa Hospitals and Clinics
Andrew M Bellizzi - University of Iowa Hospitals and Clinics
Anand Rajan K D - University of Iowa Hospitals and Clinics
Resource Type: Journal article
Publication Details: American journal of clinical pathology, Vol.156(4), pp.607-619
DOI: 10.1093/ajcp/aqaa275
PMID: 33847759
NLM abbreviation: Am J Clin Pathol
ISSN: 0002-9173
eISSN: 1943-7722
Publisher: Oxford University Press
Grant note: DOI: 10.13039/100000002, name: National Institutes of Health, award: P50 CA174521-01A1
Language: English
Date published: 04/13/2021
Academic Unit: Pathology
Record Identifier: 9984183995502771

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