Evidence map›Paper›PMID 34234148›Full record

ArticleNPJ breast cancer2021

Automated and rapid detection of cancer in suspicious axillary lymph nodes in patients with breast cancer.

Juanjuan Li, Bradley M Downs, Leslie M Cope, Mary Jo Fackler, Xiuyun Zhang, Chuan-Gui Song, Christopher VandenBussche, Kejing Zhang, Yong Han, Yufei Liu and 7 more

Open access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 34% of its field
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

4 citing papers in PubMed, 11 citations in OpenAlex.

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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

17 authors at 6 institutions in 2 countries.

Juanjuan Li *Department of Breast and Thyroid Surgery, Renmin Hospital of Wuhan University, Wuhan, China.ORCID http://orcid.org/0000-0003-3759-1038
Bradley M Downs *Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0001-6156-510X
Leslie M CopeDepartment of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Mary Jo FacklerDepartment of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Xiuyun ZhangDepartment of Pathology, Renmin Hospital of Wuhan University, Wuhan, China.ORCID http://orcid.org/0000-0002-5695-7042
Chuan-Gui SongDepartment of Breast Surgery, Union Hospital Affiliated by Fujian Medical University, Fuzhou, China.ORCID http://orcid.org/0000-0002-3384-0634
Christopher VandenBusscheDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-8822-5655
Kejing ZhangDepartment of Breast Surgery, Xiangya Hospital, Central South University, Changsha, China.ORCID http://orcid.org/0000-0002-8143-012X
Yong HanDepartment of Thyroid and Breast Surgery, Binzhou Medical University Hospital, Binzhou, China.ORCID http://orcid.org/0000-0002-2550-3072
Yufei LiuDepartment of Pathology, Yichang Central People's Hospital, Yichang, China.ORCID http://orcid.org/0000-0002-3619-5941
Suzana TulacOncology R&D, Cepheid, Sunnyvale, CA, USA.
Neesha VenkatesanOncology R&D, Cepheid, Sunnyvale, CA, USA.
Timothy de GuzmanOncology R&D, Cepheid, Sunnyvale, CA, USA.
Chuang ChenDepartment of Breast and Thyroid Surgery, Renmin Hospital of Wuhan University, Wuhan, China.ORCID http://orcid.org/0000-0003-4285-4496
Edwin W LaiOncology R&D, Cepheid, Sunnyvale, CA, USA.
Jingping YuanDepartment of Pathology, Renmin Hospital of Wuhan University, Wuhan, China. 785421101@qq.com.ORCID http://orcid.org/0000-0001-7470-6899
Saraswati SukumarDepartment of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. saras@jhmi.edu.ORCID http://orcid.org/0000-0002-5656-6703
Johns Hopkins University · USWuhan University · CNBinzhou Medical University · CNCentral South University · CNFujian Medical University · CNYichang Central People's Hospital · CN

Funding

United States Department of Defense | United States Army | Army Medical Command | Congressionally Directed Medical Research Programs (CDMRP) W81XWH-18-1-0018United States Department of Defense | United States Army | Army Medical Command | Congressionally Directed Medical Research Programs (CDMRP) W81XWH1810482
6 · The paper itself

Abstract

Preoperative staging of suspicious axillary lymph nodes (ALNs) allows patients to be triaged to ALN dissection or to sentinel lymph node biopsy (SLNB). Ultrasound-guided fine needle aspiration (FNA) and cytology of ALN is moderately sensitive but its clinical utility relies heavily on the cytologist's experience. We proposed that the 5-h automated GeneXpert system-based prototype breast cancer detection assay (BCDA) that quantitatively measures DNA methylation in ten tumor-specific gene markers could provide a facile, accurate test for detecting cancer in FNA of enlarged lymph nodes. We validated the assay in ALN-FNA samples from a prospective study of patients (N = 230) undergoing SLNB. In a blinded analysis of 218 evaluable LN-FNAs from 108 malignant and 110 benign LNs by histology, BCDA displayed a sensitivity of 90.7% and specificity of 99.1%, achieving an area under the ROC curve, AUC of 0.958 (95% CI: 0.928-0.989; P < 0.0001). Next, we conducted a study of archival FNAs of ipsilateral palpable LNs (malignant, N = 72, benign, N = 53 by cytology) collected in the outpatient setting prior to neoadjuvant chemotherapy (NAC). Using the ROC-threshold determined in the prospective study, compared to cytology, BCDA achieved a sensitivity of 94.4% and a specificity of 92.5% with a ROC-AUC = 0.977 (95% CI: 0.953-1.000; P < 0.0001). Our study shows that the automated assay detects cancer in suspicious lymph nodes with a high level of accuracy within 5 h. This cancer detection assay, scalable for analysis to scores of LN FNAs, could assist in determining eligibility of patients to different treatment regimens.

Identifiers

PMID34234148
PMCPMC8263765
OpenAlexW3181672635

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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.