Evidence map›Paper›PMID 35819123›Full record

ArticleJournal of clinical laboratory analysis2022

Validation of absolutely quantitated Ki67 and cyclinD1 protein levels for prognosis of Luminal-like breast cancer patients.

Guohua Yu, Jiahong Lyu, Yalun Li, Yunyun Zhang, Yan Lyu, Wengfeng Zhang, Jianbo Zhang, Bocheng Cai, Jiandi Zhang, Fangrong Tang

Abstract read
In one paragraph

Article in Journal of clinical laboratory analysis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

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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

10 authors.

Guohua YuLaboratory of Molecular Pathology, Department of Pathology, Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.
Jiahong LyuYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.
Yalun LiDepartment of Breast Surgical Oncology, Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.
Yunyun ZhangYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.
Yan LyuYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.
Wengfeng ZhangYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.
Jianbo ZhangYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.
Bocheng CaiYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.
Jiandi ZhangYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.ORCID https://orcid.org/0000-0002-9282-9443
Fangrong TangYantai Quanticision Diagnostics, Inc., A Division of Quanticision Diagnostics, Inc of US, Yantai, China.

Funding

Quanticision Diagnostics, Inc.
6 · The paper itself

Abstract

aimsTo translate a clinical research finding into daily clinical practice requires well-controlled clinical trials. We have demonstrated the usage of absolute quantitation of Ki67 and cyclinD1 protein levels to improve prognosis of Luminal-like patients based on overall survival (OS) analysis of a cohort of 155 breast cancer specimens (cohort 1). However, this finding is considered the D level of evidence (LOE) to require subsequent validation before it may be used in daily clinical practice. To set the stage for future clinical trials, our findings were validated through OS analysis of an independent cohort (cohort 2) of 173 Luminal-like patients.

methodsBoth Ki67 and cyclinD1 levels were measured absolutely and quantitatively using the Quantitative Dot Blot (QDB) method in cohort 2. The proposed cutoffs for both biomarkers from cohort 1 were re-evaluated in cohort 2 and in the merged cohort of 1 and 2, respectively, through univariate, multivariate and Kaplan-Meier survival analysis.

resultsThe proposed cutoffs of 2.31 nmol/g for Ki67 and 0.44 μmol/g for cyclinD1 were validated as effective cutoffs in cohort 2 and the merged cohort through OS analysis. The combined use of both biomarkers allowed us to identify patients with both biomarker levels below the cutoffs (59.3%) with10-year survival probability (SP) of 89%, in comparison to those above the cutoffs (8.3%) with 8 year SP of 28% through OS analysis in the merged cohort.

conclusionsThis study validated our findings that absolute quantitation of Ki67 and cyclinD1 allows effective subtyping of luminal-like patients. It sets the stage for prospective or prospective-retrospective clinical studies.

Indexed as

Breast NeoplasmsBiomarkers, TumorCyclin D1FemaleHumansKi-67 AntigenPrognosisProspective StudiesRetrospective StudiesBiomarkers, TumorCCND1 protein, humanCyclin D1Ki-67 AntigenMKI67 protein, humanabsolute quantitationbreast cancercyclinD1FFPEKi67prognosisQDB

Identifiers

PMID35819123
PMCPMC9396173

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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.