Bhavika K Patel, Molly B Carnahan, Donald Northfelt, Karen Anderson, Gina L Mazza, Victor J Pizzitola, Marina E Giurescu, Roxanne Lorans, William G Eversman, Richard E Sharpe, Laura K Harper, Heidi Apsey, Patricia Cronin, Juliana Kling, Brenda Ernst, Jennifer Palmieri, Jessica Fraker, Lida Mina, Felipe Batalini, Barbara Pockaj
{"title":"对乳腺癌风险较高的妇女进行对比增强乳腺 X 射线摄影补充筛查的前瞻性研究:患病率调查的结果。","authors":"Bhavika K Patel, Molly B Carnahan, Donald Northfelt, Karen Anderson, Gina L Mazza, Victor J Pizzitola, Marina E Giurescu, Roxanne Lorans, William G Eversman, Richard E Sharpe, Laura K Harper, Heidi Apsey, Patricia Cronin, Juliana Kling, Brenda Ernst, Jennifer Palmieri, Jessica Fraker, Lida Mina, Felipe Batalini, Barbara Pockaj","doi":"10.1200/JCO.22.02819","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Contrast-enhanced mammography (CEM) and magnetic resonance imaging (MRI) have shown similar diagnostic performance in detection of breast cancer. Limited CEM data are available for high-risk breast cancer screening. The purpose of the study was to prospectively investigate the efficacy of supplemental screening CEM in elevated risk patients.</p><p><strong>Materials and methods: </strong>A prospective, single-institution, institutional review board-approved observational study was conducted in asymptomatic elevated risk women age 35 years or older who had a negative conventional two-dimensional digital breast tomosynthesis screening mammography (MG) and no additional supplemental screening within the prior 12 months.</p><p><strong>Results: </strong>Four hundred sixty women were enrolled from February 2019 to April 2021. The median age was 56.8 (range, 35.0-79.2) years; 408 of 460 (88.7%) were mammographically dense. Biopsy revealed benign changes in 22 women (22/37, 59%), high-risk lesions in four women (4/37, 11%), and breast cancer in 11 women (11/37, 30%). Fourteen cancers (10 invasive, tumor size range 4-15 mm, median 9 mm) were diagnosed in 11 women. The overall supplemental cancer detection rate was 23.9 per 1,000 patients, 95% CI (12.0 to 42.4). All cancers were grade 1 or 2, ER+ ERBB2-, and node negative. CEM imaging screening offered high specificity (0.875 [95% CI, 0.844 to 0.906]), high NPV (0.998 [95% CI, 0.993 to 1.000), moderate PPV1 (0.164 [95% CI, 0.076 to 0.253), moderate PPV3 (0.275 [95% CI, 0.137 to 0.413]), and high sensitivity (0.917 [95% CI, 0.760 to 1.000]). At least 1 year of imaging follow-up was available on all patients, and one interval cancer was detected on breast MRI 4 months after negative screening CEM.</p><p><strong>Conclusion: </strong>A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1,000 in women at an elevated risk for breast cancer. Larger, multi-institutional, multiyear CEM trials in patients at elevated risk are needed for validation.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3826-3836"},"PeriodicalIF":42.1000,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Prospective Study of Supplemental Screening With Contrast-Enhanced Mammography in Women With Elevated Risk of Breast Cancer: Results of the Prevalence Round.\",\"authors\":\"Bhavika K Patel, Molly B Carnahan, Donald Northfelt, Karen Anderson, Gina L Mazza, Victor J Pizzitola, Marina E Giurescu, Roxanne Lorans, William G Eversman, Richard E Sharpe, Laura K Harper, Heidi Apsey, Patricia Cronin, Juliana Kling, Brenda Ernst, Jennifer Palmieri, Jessica Fraker, Lida Mina, Felipe Batalini, Barbara Pockaj\",\"doi\":\"10.1200/JCO.22.02819\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Contrast-enhanced mammography (CEM) and magnetic resonance imaging (MRI) have shown similar diagnostic performance in detection of breast cancer. Limited CEM data are available for high-risk breast cancer screening. The purpose of the study was to prospectively investigate the efficacy of supplemental screening CEM in elevated risk patients.</p><p><strong>Materials and methods: </strong>A prospective, single-institution, institutional review board-approved observational study was conducted in asymptomatic elevated risk women age 35 years or older who had a negative conventional two-dimensional digital breast tomosynthesis screening mammography (MG) and no additional supplemental screening within the prior 12 months.</p><p><strong>Results: </strong>Four hundred sixty women were enrolled from February 2019 to April 2021. The median age was 56.8 (range, 35.0-79.2) years; 408 of 460 (88.7%) were mammographically dense. Biopsy revealed benign changes in 22 women (22/37, 59%), high-risk lesions in four women (4/37, 11%), and breast cancer in 11 women (11/37, 30%). Fourteen cancers (10 invasive, tumor size range 4-15 mm, median 9 mm) were diagnosed in 11 women. The overall supplemental cancer detection rate was 23.9 per 1,000 patients, 95% CI (12.0 to 42.4). All cancers were grade 1 or 2, ER+ ERBB2-, and node negative. CEM imaging screening offered high specificity (0.875 [95% CI, 0.844 to 0.906]), high NPV (0.998 [95% CI, 0.993 to 1.000), moderate PPV1 (0.164 [95% CI, 0.076 to 0.253), moderate PPV3 (0.275 [95% CI, 0.137 to 0.413]), and high sensitivity (0.917 [95% CI, 0.760 to 1.000]). At least 1 year of imaging follow-up was available on all patients, and one interval cancer was detected on breast MRI 4 months after negative screening CEM.</p><p><strong>Conclusion: </strong>A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1,000 in women at an elevated risk for breast cancer. Larger, multi-institutional, multiyear CEM trials in patients at elevated risk are needed for validation.</p>\",\"PeriodicalId\":15384,\"journal\":{\"name\":\"Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"3826-3836\"},\"PeriodicalIF\":42.1000,\"publicationDate\":\"2024-11-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/JCO.22.02819\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/26 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/JCO.22.02819","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/26 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的:对比增强乳腺 X 光造影术(CEM)和磁共振成像(MRI)在检测乳腺癌方面显示出相似的诊断性能。用于高危乳腺癌筛查的 CEM 数据有限。本研究旨在前瞻性地调查高危患者补充筛查 CEM 的疗效:这项前瞻性、单一机构、机构审查委员会批准的观察性研究针对35岁或35岁以上、常规二维数字乳腺断层合成筛查乳腺X线摄影(MG)呈阴性且在之前12个月内未进行额外补充筛查的无症状高危女性:从 2019 年 2 月到 2021 年 4 月,共有 4600 名妇女参加了此次筛查。中位年龄为 56.8 岁(35.0-79.2 岁);460 名女性中有 408 名(88.7%)乳腺组织致密。活检结果显示,22 名女性(22/37,59%)为良性病变,4 名女性(4/37,11%)为高危病变,11 名女性(11/37,30%)为乳腺癌。11 名妇女中确诊了 14 例癌症(10 例为浸润性,肿瘤大小范围为 4-15 毫米,中位数为 9 毫米)。癌症总补充检测率为每千名患者 23.9 例,95% CI (12.0 至 42.4)。所有癌症均为 1 级或 2 级、ER+ ERBB2-、结节阴性。CEM成像筛查具有高特异性(0.875 [95% CI, 0.844 to 0.906])、高NPV(0.998 [95% CI, 0.993 to 1.000])、中度PPV1(0.164 [95% CI, 0.076 to 0.253])、中度PPV3(0.275 [95% CI, 0.137 to 0.413])和高灵敏度(0.917 [95% CI, 0.760 to 1.000])。所有患者都接受了至少一年的影像学随访,其中一名患者在CEM筛查阴性后4个月通过乳腺核磁共振检查发现了间期癌:一项试点试验表明,在乳腺癌风险较高的妇女中,癌症补充检测率为 23.9‰。需要对高危患者进行更大规模、多机构、多年期的 CEM 试验,以进行验证。
Prospective Study of Supplemental Screening With Contrast-Enhanced Mammography in Women With Elevated Risk of Breast Cancer: Results of the Prevalence Round.
Purpose: Contrast-enhanced mammography (CEM) and magnetic resonance imaging (MRI) have shown similar diagnostic performance in detection of breast cancer. Limited CEM data are available for high-risk breast cancer screening. The purpose of the study was to prospectively investigate the efficacy of supplemental screening CEM in elevated risk patients.
Materials and methods: A prospective, single-institution, institutional review board-approved observational study was conducted in asymptomatic elevated risk women age 35 years or older who had a negative conventional two-dimensional digital breast tomosynthesis screening mammography (MG) and no additional supplemental screening within the prior 12 months.
Results: Four hundred sixty women were enrolled from February 2019 to April 2021. The median age was 56.8 (range, 35.0-79.2) years; 408 of 460 (88.7%) were mammographically dense. Biopsy revealed benign changes in 22 women (22/37, 59%), high-risk lesions in four women (4/37, 11%), and breast cancer in 11 women (11/37, 30%). Fourteen cancers (10 invasive, tumor size range 4-15 mm, median 9 mm) were diagnosed in 11 women. The overall supplemental cancer detection rate was 23.9 per 1,000 patients, 95% CI (12.0 to 42.4). All cancers were grade 1 or 2, ER+ ERBB2-, and node negative. CEM imaging screening offered high specificity (0.875 [95% CI, 0.844 to 0.906]), high NPV (0.998 [95% CI, 0.993 to 1.000), moderate PPV1 (0.164 [95% CI, 0.076 to 0.253), moderate PPV3 (0.275 [95% CI, 0.137 to 0.413]), and high sensitivity (0.917 [95% CI, 0.760 to 1.000]). At least 1 year of imaging follow-up was available on all patients, and one interval cancer was detected on breast MRI 4 months after negative screening CEM.
Conclusion: A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1,000 in women at an elevated risk for breast cancer. Larger, multi-institutional, multiyear CEM trials in patients at elevated risk are needed for validation.
期刊介绍:
The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.