Evidence map›Paper›PMID 39183273›Full record

ArticleBMC biology2024

Flow cytometric analysis for Ki67 assessment in formalin-fixed paraffin-embedded breast cancer tissue.

Natsuki Sato, Masahiko Tsujimoto, Masatoshi Nakatsuji, Hiromi Tsuji, Yuji Sugama, Kenzo Shimazu, Masafumi Shimoda, Hideki Ishihara

Abstract read
In one paragraph

Article in BMC biology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Patient outcomes and clinician perspectives following one year ofTranslational breast cancer research : a journal focusing on translational research in breast cancer · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Natsuki SatoNitto Boseki Co., Ltd, 2-4-1, Kojimachi, Chiyoda-ku, Tokyo, 102-8489, Japan.
Masahiko TsujimotoDepartment of Diagnostic Pathology, Daini Osaka Police Hospital, 2-6-40 Karasugatsuji, Tennoji-Ku, Osaka, 543-8922, Japan.
Masatoshi NakatsujiNitto Boseki Co., Ltd, 2-4-1, Kojimachi, Chiyoda-ku, Tokyo, 102-8489, Japan.
Hiromi TsujiDepartment of Diagnostic Pathology, Osaka Police Hospital, 10-31 Kitayamacho, Tennoji-Ku, Osaka, Japan.
Yuji SugamaNitto Boseki Co., Ltd, 2-4-1, Kojimachi, Chiyoda-ku, Tokyo, 102-8489, Japan.
Kenzo ShimazuDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Masafumi Shimoda *Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. mshimoda@onsurg.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0002-0832-9877
Hideki Ishihara *Nitto Boseki Co., Ltd, 2-4-1, Kojimachi, Chiyoda-ku, Tokyo, 102-8489, Japan. fuyubellsyunjack1@gmail.com.ORCID http://orcid.org/0000-0001-7124-2144

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPathologists commonly employ the Ki67 immunohistochemistry labelling index (LI) when deciding appropriate therapeutic strategies for patients with breast cancer. However, despite several attempts at standardizing the Ki67 LI, inter-observer and inter-laboratory bias remain problematic. We developed a flow cytometric assay that employed tissue dissociation, enzymatic treatment and a gating process to analyse Ki67 in formalin-fixed paraffin-embedded (FFPE) breast cancer tissue.

resultsWe demonstrated that mechanical homogenizations combined with thrombin treatment can be used to recover efficiently intact single-cell nuclei from FFPE breast cancer tissue. Ki67 in the recovered cell nuclei retained reactivity against the MIB-1 antibody, which has been widely used in clinical settings. Additionally, since the method did not alter the nucleoskeletal structure of tissues, the nuclei of cancer cells can be enriched in data analysis based on differences in size and complexity of nuclei of lymphocytes and normal mammary cells. In a clinical study using the developed protocol, Ki67 positivity was correlated with the Ki67 LI obtained by hot spot analysis by a pathologist in Japan (rho = 0.756, P < 0.0001). The number of cancer cell nuclei subjected to the analysis in our assay was more than twice the number routinely checked by pathologists in clinical settings.

conclusionsThe findings of this study showed the application of this new flow cytometry method could potentially be used to standardize Ki67 assessments in breast cancer.

Indexed as

Breast NeoplasmsFlow CytometryKi-67 AntigenParaffin EmbeddingFemaleFormaldehydeHumansTissue FixationFormaldehydeKi-67 AntigenBreast cancerFlow cytometryFormalin-fixed paraffin-embedded tissueImmunohistochemistryKi67 labelling index

Identifiers

PMID39183273
PMCPMC11346000

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.