Predicting delayed diagnosis rate of intraoperative rapid frozen section pathological examination for early-stage breast cancer: a real-world retrospective study

Jialei XUE; Jianwei LI; Yue GONG; Guangyu LIU; Zhebin LIU

doi:10.19401/j.cnki.1007-3639.2025.04.008

您当前的位置：

首页 >

文章列表页 >

Predicting delayed diagnosis rate of intraoperative rapid frozen section pathological examination for early-stage breast cancer: a real-world retrospective study

Article | 更新时间：2025-12-31

- Predicting delayed diagnosis rate of intraoperative rapid frozen section pathological examination for early-stage breast cancer: a real-world retrospective study
- China Oncology Vol. 35, Issue 4, Pages: 404-411(2025)
- 作者机构：
  
  1. 复旦大学附属肿瘤医院乳腺外科，复旦大学上海医学院肿瘤学系，上海 200032
  2. 常熟市中医院甲乳外科，南京中医药大学附属常熟医院，江苏常熟 215500
- 作者简介：
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2025.04.008
  CLC：
- Received：15 November 2024，
  
  Revised：2025-03-24，
  
  Published：30 April 2025
- 稿件说明：
移动端阅览
Jialei XUE, Jianwei LI, Yue GONG, et al. Predicting delayed diagnosis rate of intraoperative rapid frozen section pathological examination for early-stage breast cancer: a real-world retrospective study[J]. China Oncology, 2025, 35(4): 404-411.
DOI：

Jialei XUE, Jianwei LI, Yue GONG, et al. Predicting delayed diagnosis rate of intraoperative rapid frozen section pathological examination for early-stage breast cancer: a real-world retrospective study[J]. China Oncology, 2025, 35(4): 404-411. DOI： 10.19401/j.cnki.1007-3639.2025.04.008.

摘要

背景与目的：

对于少数空芯针穿刺未能明确诊断的早期乳腺癌，冰冻切片病理学检查的延迟诊断率尚不清楚。本回顾性队列研究旨在探讨术中快速冰冻切片病理学检查在这种情况下的临床应用价值。

方法：

回顾性分析2006年5月1日—2019年12月31日在复旦大学附属肿瘤医院就诊的乳腺癌患者的临床资料。收集患者的临床特征、影像资料和病理学资料。采用logistic回归分析方法探索患者的临床特征与术中快速冰冻切片病理学检查延迟诊断的相关性，并构建预测延迟诊断率的诺模图。本研究获得复旦大学附属肿瘤医院伦理委员会批准（伦理批号：050432-4-2108*）。

结果：

共876例患者符合入组标准而纳入本研究。对空芯针穿刺未能明确诊断的乳腺癌的术中快速冰冻切片病理学检查诊断率为67.7%，延迟诊断率为32.3%。多因素分析中，空芯针标本伴有非典型增生的乳头状病变[比值比（odds ratio，OR）=4.251，95% CI: 2.804~6.492，

0.001

]

和硬化性腺病（OR=3.727，95% CI: 1.897~7.376，

0.001）是导致冰冻切片延迟诊断的正相关因素，乳房X线摄影见簇状微钙化（OR=0.345，95% CI: 0.216~0.543，

0.001）和超声诊断结果依据乳腺影像报告和数据系统（Breast Imaging Reporting and Data System，BI-RADS）分类为4C~5类（OR=0.250，95% CI: 0.081~0.777，

=0.016）是术中诊断率高的正相关因素。通过这些因素构建的诺模图能较好地预测术中快速冰冻切片病理学检查的延迟诊断率，从而更好地筛选出适合术中快速冰冻切片病理学检查的病例。

结论：

术中快速冰冻切片病理学检查对空芯针穿刺未能明确诊断的乳腺癌有一定的延迟诊断率，通过模型预测的方法可有效地筛除延迟诊断的病例，避免一些不必要的术中快速冰冻切片病理学检查。

Abstract

Background and purpose:

For few of early-stage breast cancers who are undiagnosed by core needle biopsy

the delayed diagnosis rate of intraoperative rapid frozen section pathological examination is unclear. The purpose of this retrospective cohort study was to investigate the clinical application value of frozen sections in this situation.

Methods:

This study reviewed data of 876 breast cancer patients that were undiagnosed by core needle biopsy in Fudan University Shanghai Cancer Center from May 1

2006 to December 31

2019. Clinical characteristics and image data and pathological data of patients were collected. The correlation between clinical features and delayed diagnosis rate (DDR) of frozen section was explored using logistic regression analysi

then a nomogram was constructed to predict the probability of delayed diagnosis. This study was approved by Ethics Committee of Fudan University Shanghai Cancer Center (No.: 050432-4-2108*).

Results:

A total of 876 patients met the inclusion standards. The intraoperative diagnosis rate of frozen section for breast cancers that were undiagnosed by core needle biopsy was 67.7%

and the DDR was 32.3%. In multivariate analysis

papillary lesion [odds ratio (OR)=4.251

95% CI: 2.804-6.492;

0.001) and sclerosing adenosis (OR=3.727; 95% CI: 1.897-7.376;

0.001) accompanied by atypical epithelial hyperplasia on core needle biopsy (CNB) were positive correlation factors of delayed diagnosis

while clustered microcalcifications on mammography (OR=0.345; 95% CI: 0.216-0.543;

0.001) and ultrasonic category 4C-5 according to Breast Imaging Reporting and Data System (BI-RADS) (OR=0.250; 95% CI: 0.081-0.777;

=0.016) were positive correlation factors of intraoperative diagnosis. The nomogram constructed by these factors could better predict the delayed diagnosis rate of frozen section and screen out low delayed diagnosis population.

Conclusion:

Frozen section has a certain delayed diagnosis rate for breast cancer that is not clearly diagnosed by core needle biopsy. The method of model prediction can effectively eliminate the delayed diagnosis cases and avoid some unnecessary frozen sections.

关键词

Keywords

references

MA J F , CHEN L Y , WU S L , et al . Clinical practice guidelines for ultrasound-guided breast lesions and lymph nodes biopsy: Chinese Society of Breast Surgery (CSBrS) practice guidelines 2021 [J ] . Chin Med J (Engl) , 2021 , 134 ( 12 ): 1393 - 1395 .

HAO S , LIU Z B , LING H , et al . Changing attitudes toward needle biopsies of breast cancer in Shanghai: experience and current status over the past 8 years [J ] . Onco Targets Ther , 2015 , 8 : 2865 - 2871 .

SCHIAFFINO S , CALABRESE M , MELANI E F , et al . Upgrade rate of percutaneously diagnosed pure atypical ductal hyperplasia: systematic review and meta-analysis of 6 458 lesions [J ] . Radiology , 2020 , 294 ( 1 ): 76 - 86 .

PAWLOSKI K R , CHRISTIAN N , KNEZEVIC A , et al . Atypical ductal hyperplasia bordering on DCIS on core biopsy is associated with higher risk of upgrade than conventional atypical ductal hyperplasia [J ] . Breast Cancer Res Treat , 2020 , 184 ( 3 ): 873 - 880 .

NIU Y , FU X L , YU Y , et al . Intra-operative frozen section diagnosis of breast lesions: a retrospective analysis of 13 243 Chinese patients [J ] . Chin Med J (Engl) , 2007 , 120 ( 8 ): 630 - 635 .

王泽英 . 乳腺肿瘤冰冻切片病理诊断分析 [J ] . 实验与检验医学 , 2023 , 41 ( 5 ): 669 - 672 .

WANG Z Y . Pathological diagnosis of frozen section of breast tumor [J ] . Exp Lab Med , 2023 , 41 ( 5 ): 669 - 672 .

STOLNICU S , RĂDULESCU D , PLEŞEA I E , et al . The value of intraoperative diagnosis in breast lesions [J ] . Rom J Morphol Embryol , 2006 , 47 ( 2 ): 119 - 123 .

王悦 , 李晓洁 , 杨璐 . 探讨影响乳腺癌患者术中冰冻切片病理诊断结果准确性的临床因素 [J ] . 中国处方药 , 2023 , 21 ( 10 ): 175 - 178 .

WANG Y , LI X J , YANG L . To explore the clinical factors affecting the accuracy of pathological diagnosis results of intraoperative frozen section in breast cancer patients [J ] . J Chin Prescr Drug , 2023 , 21 ( 10 ): 175 - 178 .

CSERNI G . Pitfalls in frozen section interpretation: a retrospective study of palpable breast tumors [J ] . Tumori , 1999 , 85 ( 1 ): 15 - 18 .

FECHNER R E . Frozen section examination of breast biopsies. Practice parameter [J ] . Am J Clin Pathol , 1995 , 103 ( 1 ): 6 - 7 .

施昀 , 马世荣 , 杨巧 , 等 . 手术中快速冷冻切片3 303例病理诊断分析 [J ] . 临床与实验病理学杂志 , 2012 , 28 ( 11 ): 1270 - 1272 .

SHI Y , MA S R , YANG Q , et al . Pathological diagnosis of 3 303 cases of quick frozen section during operation [J ] . Chin J Clin Exp Pathol , 2012 , 28 ( 11 ): 1270 - 1272 .

刘彤华 . 不易鉴别良恶性的乳腺病变 [J ] . 中华病理学杂志 , 1997 , 26 ( 6 ): 379 - 380 .

LIU T H . It is difficult to distinguish benign from malignant breast lesions [J ] . Chin J Pathol , 1997 , 26 ( 6 ): 379 - 380 .

COUTANT C , OLIVIER C , LAMBAUDIE E , et al . Comparison of models to predict nonsentinel lymph node status in breast cancer patients with metastatic sentinel lymph nodes: a prospective multicenter study [J ] . J Clin Oncol , 2009 , 27 ( 17 ): 2800 - 2808 . DOI: 10.1200/JCO.2008.19.7418 http://doi.org/10.1200/JCO.2008.19.7418

HARRELL F E Jr , LEE K L , MARK D B . Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors [J ] . Stat Med , 1996 , 15 ( 4 ): 361 - 387 . DOI: 10.1002/(SICI)1097-0258(19960229)15:4<361::AID-SIM168>3.0.CO;2-4 http://doi.org/10.1002/(SICI)1097-0258(19960229)15:4<361::AID-SIM168>3.0.CO;2-4

STEYERBERG E W , HARRELL F E , BORSBOOM G J J M , et al . Internal validation of predictive models efficiency of some procedures for logistic regression analysis [J ] . J Clin Epidemiol , 2001 , 54 ( 8 ): 774 - 781 .

TINNEMANS J G , WOBBES T , HOLLAND R , et al . Mammographic and histopathologic correlation of nonpalpable lesions of the breast and the reliability of frozen section diagnosis [J ] . Surg Gynecol Obstet , 1987 , 165 ( 6 ): 523 - 529 .

MOGAL H , BROWN D R , ISOM S , et al . Intracystic papillary carcinoma of the breast: a SEER database analysis of implications for therapy [J ] . Breast , 2016 , 27 : 87 - 92 . DOI: 10.1016/j.breast.2016.01.003 http://doi.org/10.1016/j.breast.2016.01.003

丁雨飞 , 陈建华 . 乳腺实性乳头状癌临床病理研究及治疗 [J ] . 中华乳腺病杂志(电子版) , 2014 , 8 ( 4 ): 280 - 282 .

DING Y F , CHEN J H . Solid papillary carcinoma of the breast [J ] . Chin J Breast Dis (Electro Ed) , 2014 , 8 ( 4 ): 280 - 282 .

曾祥菲 , 魏兵 . 乳腺包裹型乳头状癌的病理诊断 [J ] . 临床与实验病理学杂志 , 2024 , 40 ( 9 ): 901 - 906 .

ZENG X F , WEI B . Pathological diagnosis of encapsulated papillary carcinoma of breast [J ] . Chin J Clin Exp Pathol , 2024 , 40 ( 9 ): 901 - 906 .

郑小草 , 葛荣 , 蒙伶俐 , 等 . 乳腺实性乳头状癌的临床病理研究 [J ] . 中国癌症杂志 , 2014 , 24 ( 3 ): 208 - 211 . DOI: 10.3969/j.issn.1007-3969.2014.03.009 http://doi.org/10.3969/j.issn.1007-3969.2014.03.009

ZHENG X C , GE R , MENG L L , et al . Clinicopathologic study of solid papillary carcinoma of the breast [J ] . Chin Oncol , 2014 , 24 ( 3 ): 208 - 211 .

TAN P H , SCHNITT S J , VAN DE VIJVER M J , et al . Papillary and neuroendocrine breast lesions: the WHO stance [J ] . Histopathology , 2015 , 66 ( 6 ): 761 - 770 . DOI: 10.1111/his.12463 http://doi.org/10.1111/his.12463

WANG H , TSANG P , D’CRUZ C , et al . Follow-up of breast papillary lesion on core needle biopsy: experience in African-American population [J ] . Diagn Pathol , 2014 , 9 : 86 . DOI: 10.1186/1746-1596-9-86 http://doi.org/10.1186/1746-1596-9-86

YU B H , TANG S X , XU X L , et al . Breast carcinoma in sclerosing adenosis: a clinicopathological and immunophenotypical analysis on 206 lesions [J ] . J Clin Pathol , 2018 , 71 ( 6 ): 546 - 553 .

RICHARDS D , AYALA A A , WU Y , et al . Carcinoma in situ involving sclerosing adenosis on core biopsy: diagnostic pearls to aid the practicing clinician and avoid overtreatment [J ] . Oncol Ther , 2020 , 8 ( 1 ): 81 - 89 .

卢佳 , 胡兵 . 误诊乳腺广泛导管内乳头状瘤合并硬化性腺病为乳腺癌1例 [J ] . 中国介入影像与治疗学 , 2022 , 19 ( 9 ): 607 .

LU J , HU B . Extensive intraductal papilloma of breast with sclerosing adenosis as breast cancer: case report [J ] . Chin J Interv Imag Ther , 2022 , 19 ( 9 ): 607 .

EUSEBI V , COLLINA G , BUSSOLATI G . Carcinoma in situ in sclerosing adenosis of the breast: an immunocytochemical study [J ] . Semin Diagn Pathol , 1989 , 6 ( 2 ): 146 - 152 .

付丽梅 , 孙向洁 , 吕泓 , 等 . 乳腺硬化性腺病基础上的低级别腺鳞癌1例 [J ] . 中华病理学杂志 , 2019 , 48 ( 5 ): 415 - 417 .

FU L M , SUN X J , LYU H , et al . Low grade adenosquamous carcinoma arising from sclerosing adenosis of the breast: report of a case [J ] . Chin J Pathol , 2019 , 48 ( 5 ): 415 - 417 .

张久存 , 马爱玲 . 13例乳腺硬化性腺病临床病理分析 [J ] . 宁夏医科大学学报 , 2010 , 32 ( 1 ): 134 - 135 .

ZHANG J C , MA A L . Clinicopathological analysis of 13 cases of breast sclerosing gonadism [J ] . J Ningxia Med Univ , 2010 , 32 ( 1 ): 134 - 135 .

皋岚湘 , 丁华野 , 杨光之 , 等 . 乳腺粗针穿刺活检219例病理诊断分析、问题及对策 [J ] . 诊断病理学杂志 , 2009 , 16 ( 3 ): 166 - 170 .

GAO L X , DING H Y , YANG G Z , et al . Problems and strategy in pathologic diagnosis of mammary needle core biopsies: an analysis of 219 cases [J ] . Chin J Diagn Pathol , 2009 , 16 ( 3 ): 166 - 170 .

CUI X Y , WEI S . Carcinoma in situ involving sclerosing adenosis: seeking the salient histological characteristics to prevent overdiagnosis [J ] . Ann Clin Lab Sci , 2017 , 47 ( 5 ): 529 - 534 .

LI S J , HAO X P , HUA B , et al . Clinical practice guidelines for ultrasound-guided vacuum-assisted breast biopsy: Chinese Society of Breast Surgery (CSBrS) practice guidelines 2021 [J ] . Chin Med J (Engl) , 2021 , 134 ( 12 ): 1390 - 1392 .

Views

772

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Construction of the prediction model of breast cancer bone metastasis based on machine learning

Guidelines for breast cancer diagnosis and treatment by China Anti-Cancer Association (2026 edition)

Progress and prospects of CENPA-driven chromosomal instability in breast cancer: mechanisms, prognostic implications, and therapeutic perspectives

A study of 30-year trends in incidence and mortality risks of breast cancer among young women in China

Impact of miR-193a-3p on migration and invasion of breast cancer stem cells through targeting TRIM14

Related Author

Fei OUYANG

Yang WANG

Yu CHEN

Guoqing PEI

Ling WANG

Yang ZHANG

Lei SHI

The Society of Breast Cancer China Anti-Cancer Association

Related Institution

Department of Orthopaedics, The First Affiliated Hospital of Air Force Medical University, Xi 'an

Department of Neurology, The First Affiliated Hospital of Air Force Medical University

Department of Health Statistics, Department of Military Preventive Medicine, Air Force Military Medical University

Department of Breast Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Department of Breast Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital& Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

AI问答

⁰