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Cited by 12Breast Lesions and CarcinomasAI in cancer detectionGlobal Cancer Incidence and Screening

Estimate of False-Positive Breast Cancer Diagnoses from Accuracy Studies: A Systematic Review

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Segnan, Nereo, Minozzi, Silvia, Ponti, Antonio, Bellisario, Cristina, Balduzzi, Sara, González-Lorenzo, Marien, Gianola, Silvia, Armaroli, Paola·2017·Journal of Clinical Pathology
DOI 10.1136/jclinpath-2016-204184
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Abstract

Background: False-positive histological diagnoses have the same consequences of overdiagnosis in terms of unnecessary treatment. The aim of this systematic review is to assess their frequency at needle core biopsy (CB) and/or surgical excision of the breast. Methods: PubMed, Embase, Cochrane Library were systematically searched up to 30 October 2015. Eligibility criteria: cross-sectional studies assessing diagnostic accuracy of CB compared with surgical excision; studies assessing reproducibility of pathologists reading the same slides. Outcomes: false-positive rates; Misclassification of Benign as Malignant (MBM) histological diagnosis; K statistic. Independent reviewers extracted data and assessed quality using an adapted QUADAS-2 tool. Results: Sixteen studies assessed CB false-positive rates. In 10 studies (41 989 screen-detected lesions), the range of false-positive rates was 0%–7.1%. Twenty-seven studies assessed pathologists' reproducibility. Studies with consecutive, random or stratified samples of all the specimens: at CB the MBM range was 0.25%–2.4% (K values 0.83–0.98); at surgical excision, it was 0.67%–1.2% (K values 0.86–0.94). Studies with enriched samples: the MBM range was 1.4%–6.2% (K values 0.57–0.86). Studies of cases selected for second opinion: the MBM range was 0.29%–12.2% (K values 0.48 and 0.50). Conclusions: High heterogeneity of the included studies precluded formal pooling estimates. When considering studies of higher sample size or methodological quality, false-positive rates and MBM are around 1%. The impact of false-positive histological diagnoses of breast cancer on unnecessary treatment, as well as that of overdiagnosis, is not negligible and is of importance in clinical practice.

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  • False positives in breast cancer diagnoses often arise from misclassifying benign lesions like atypical ductal hyperplasia as invasive cancer, leading to unnecessary and costly treatments such as surgery, radiation, or chemotherapy.

    “For example, false positives in breast cancer diagnoses often arise from misclassifying benign lesions like atypical ductal hyperplasia as invasive cancer, leading to unnecessary and costly treatments such as surgery, radiation, or chemotherapy [195].”

    From Toward Safer Diagnoses: A SEIPS-Based Narrative Review of Diagnostic Errors (2026) · cites this paper as [195]

    The Conclusions (p. 11) report misclassification of benign breast lesions as malignant, and the Discussion (p. 11) says false-positive diagnoses may lead to unnecessary, costly surgery, radiation or, for false-positive invasive cancers, chemotherapy. The paper discusses difficulty distinguishing atypia from DCIS, but does not establish that atypical ductal hyperplasia is often misclassified specifically as invasive cancer. Its estimate for benign-to-malignant misclassification in higher-quality or larger studies is around 1%. (LLM, conf=0.86)

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Cited by

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Authors
Segnan, N., Minozzi, S., Ponti, A., Bellisario, C., Balduzzi, S., González-Lorenzo, M., Gianola, S., & Armaroli, P.
Affiliations
  • Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
  • IRCCS Ospedale Galeazzi - Sant'Ambrogio (IT)
Corresponding author
Armaroli, Paola
ORCID
Venue
Journal of Clinical Pathology
Publisher
BMJ
Published
2017-01-10
Volume
70
Issue
4
Pages
282-294
ISSN
  • 0021-9746 (ISSN-L)
  • 1472-4146
DOI
10.1136/jclinpath-2016-204184
OpenAlex
W2568195983
Cited by
12
References
2
Citations by year
2026: 2 · 2025: 1 · 2023: 3 · 2022: 3 · 2021: 1 · 2020: 1 · 2017: 1
FWCI
0.09
Type
journal article
Language
en
Open access
Licence
other-oa
Locations
  • Journal of Clinical Pathology (publishedVersion)
  • PubMed (publishedVersion)
  • BOA (University of Milano-Bicocca) (submittedVersion, other-oa)
  • HighWire Press Open Archive (submittedVersion)
Topics
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Breast Lesions and Carcinomas
  • Physical Sciences › Computer Science › Artificial Intelligence › AI in cancer detection
  • Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
Keywords
core needle biopsy, breast-conserving surgery, overdiagnosis, interobserver reproducibility, diagnostic accuracy, unnecessary treatment, breast cancer screening
MeSH terms
Breast Neoplasms, False Positive Reactions, Female, Humans

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