Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening
Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography. To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DB...
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Veröffentlicht in: | JAMA : the journal of the American Medical Association 2020-02, Vol.323 (8), p.746 |
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creator | Comstock, Christopher E Gatsonis, Constantine Newstead, Gillian M Snyder, Bradley S Gareen, Ilana F Bergin, Jennifer T Rahbar, Habib Sung, Janice S Jacobs, Christina Harvey, Jennifer A Nicholson, Mary H Ward, Robert C Holt, Jacqueline Prather, Andrew Miller, Kathy D Schnall, Mitchell D Kuhl, Christiane K |
description | Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P |
doi_str_mv | 10.1001/jama.2020.0572 |
format | Article |
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To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
ClinicalTrials.gov Identifier: NCT02933489.</description><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2020.0572</identifier><identifier>PMID: 32207768</identifier><language>eng</language><publisher>United States</publisher><subject>Adult ; Aged ; Biopsy ; Breast - diagnostic imaging ; Breast - pathology ; Breast Density ; Breast Neoplasms - diagnostic imaging ; Breast Neoplasms - pathology ; Carcinoma, Intraductal, Noninfiltrating - diagnostic imaging ; Carcinoma, Intraductal, Noninfiltrating - pathology ; Cross-Sectional Studies ; Early Detection of Cancer ; Female ; Follow-Up Studies ; Humans ; Magnetic Resonance Imaging - adverse effects ; Magnetic Resonance Imaging - methods ; Mammography - adverse effects ; Mammography - methods ; Middle Aged ; Neoplasm Invasiveness ; Predictive Value of Tests ; Reference Standards ; Sensitivity and Specificity</subject><ispartof>JAMA : the journal of the American Medical Association, 2020-02, Vol.323 (8), p.746</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27907,27908</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32207768$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Comstock, Christopher E</creatorcontrib><creatorcontrib>Gatsonis, Constantine</creatorcontrib><creatorcontrib>Newstead, Gillian M</creatorcontrib><creatorcontrib>Snyder, Bradley S</creatorcontrib><creatorcontrib>Gareen, Ilana F</creatorcontrib><creatorcontrib>Bergin, Jennifer T</creatorcontrib><creatorcontrib>Rahbar, Habib</creatorcontrib><creatorcontrib>Sung, Janice S</creatorcontrib><creatorcontrib>Jacobs, Christina</creatorcontrib><creatorcontrib>Harvey, Jennifer A</creatorcontrib><creatorcontrib>Nicholson, Mary H</creatorcontrib><creatorcontrib>Ward, Robert C</creatorcontrib><creatorcontrib>Holt, Jacqueline</creatorcontrib><creatorcontrib>Prather, Andrew</creatorcontrib><creatorcontrib>Miller, Kathy D</creatorcontrib><creatorcontrib>Schnall, Mitchell D</creatorcontrib><creatorcontrib>Kuhl, Christiane K</creatorcontrib><title>Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
ClinicalTrials.gov Identifier: NCT02933489.</description><subject>Adult</subject><subject>Aged</subject><subject>Biopsy</subject><subject>Breast - diagnostic imaging</subject><subject>Breast - pathology</subject><subject>Breast Density</subject><subject>Breast Neoplasms - diagnostic imaging</subject><subject>Breast Neoplasms - pathology</subject><subject>Carcinoma, Intraductal, Noninfiltrating - diagnostic imaging</subject><subject>Carcinoma, Intraductal, Noninfiltrating - pathology</subject><subject>Cross-Sectional Studies</subject><subject>Early Detection of Cancer</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Magnetic Resonance Imaging - adverse effects</subject><subject>Magnetic Resonance Imaging - methods</subject><subject>Mammography - adverse effects</subject><subject>Mammography - methods</subject><subject>Middle Aged</subject><subject>Neoplasm Invasiveness</subject><subject>Predictive Value of Tests</subject><subject>Reference Standards</subject><subject>Sensitivity and Specificity</subject><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFjz1PwzAQhi0kREthZUT3Bxr8oZAwlhRUBhZa1LFykkvqqrYjn6nU_8EPxkMz8y53uufRSS9jD4JngnPxdNBWZ5JLnvG8kFdsKnJVzlX-Uk7YLdGBpwhV3LCJkpIXxXM5Zb-Vt4MOhrwD38GirgOejI7YwmtATRE-vz7gRLA0vYn6OF433no6u7hHMgSdDyOotGswwBIjNtGkrwvrXQ9bb9HB1sR9Qo7wohN8uxZD701y1k1AdGm7Y9edPhLeX-aMPb6_barVfPipLba7IRirw3k31lD_Cn8ew1oM</recordid><startdate>20200225</startdate><enddate>20200225</enddate><creator>Comstock, Christopher E</creator><creator>Gatsonis, Constantine</creator><creator>Newstead, Gillian M</creator><creator>Snyder, Bradley S</creator><creator>Gareen, Ilana F</creator><creator>Bergin, Jennifer T</creator><creator>Rahbar, Habib</creator><creator>Sung, Janice S</creator><creator>Jacobs, Christina</creator><creator>Harvey, Jennifer A</creator><creator>Nicholson, Mary H</creator><creator>Ward, Robert C</creator><creator>Holt, Jacqueline</creator><creator>Prather, Andrew</creator><creator>Miller, Kathy D</creator><creator>Schnall, Mitchell D</creator><creator>Kuhl, Christiane K</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>20200225</creationdate><title>Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening</title><author>Comstock, Christopher E ; Gatsonis, Constantine ; Newstead, Gillian M ; Snyder, Bradley S ; Gareen, Ilana F ; Bergin, Jennifer T ; Rahbar, Habib ; Sung, Janice S ; Jacobs, Christina ; Harvey, Jennifer A ; Nicholson, Mary H ; Ward, Robert C ; Holt, Jacqueline ; Prather, Andrew ; Miller, Kathy D ; Schnall, Mitchell D ; Kuhl, Christiane K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-pubmed_primary_322077683</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biopsy</topic><topic>Breast - diagnostic imaging</topic><topic>Breast - pathology</topic><topic>Breast Density</topic><topic>Breast Neoplasms - diagnostic imaging</topic><topic>Breast Neoplasms - pathology</topic><topic>Carcinoma, Intraductal, Noninfiltrating - diagnostic imaging</topic><topic>Carcinoma, Intraductal, Noninfiltrating - pathology</topic><topic>Cross-Sectional Studies</topic><topic>Early Detection of Cancer</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Magnetic Resonance Imaging - adverse effects</topic><topic>Magnetic Resonance Imaging - methods</topic><topic>Mammography - adverse effects</topic><topic>Mammography - methods</topic><topic>Middle Aged</topic><topic>Neoplasm Invasiveness</topic><topic>Predictive Value of Tests</topic><topic>Reference Standards</topic><topic>Sensitivity and Specificity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Comstock, Christopher E</creatorcontrib><creatorcontrib>Gatsonis, Constantine</creatorcontrib><creatorcontrib>Newstead, Gillian M</creatorcontrib><creatorcontrib>Snyder, Bradley S</creatorcontrib><creatorcontrib>Gareen, Ilana F</creatorcontrib><creatorcontrib>Bergin, Jennifer T</creatorcontrib><creatorcontrib>Rahbar, Habib</creatorcontrib><creatorcontrib>Sung, Janice S</creatorcontrib><creatorcontrib>Jacobs, Christina</creatorcontrib><creatorcontrib>Harvey, Jennifer A</creatorcontrib><creatorcontrib>Nicholson, Mary H</creatorcontrib><creatorcontrib>Ward, Robert C</creatorcontrib><creatorcontrib>Holt, Jacqueline</creatorcontrib><creatorcontrib>Prather, Andrew</creatorcontrib><creatorcontrib>Miller, Kathy D</creatorcontrib><creatorcontrib>Schnall, Mitchell D</creatorcontrib><creatorcontrib>Kuhl, Christiane K</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Comstock, Christopher E</au><au>Gatsonis, Constantine</au><au>Newstead, Gillian M</au><au>Snyder, Bradley S</au><au>Gareen, Ilana F</au><au>Bergin, Jennifer T</au><au>Rahbar, Habib</au><au>Sung, Janice S</au><au>Jacobs, Christina</au><au>Harvey, Jennifer A</au><au>Nicholson, Mary H</au><au>Ward, Robert C</au><au>Holt, Jacqueline</au><au>Prather, Andrew</au><au>Miller, Kathy D</au><au>Schnall, Mitchell D</au><au>Kuhl, Christiane K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2020-02-25</date><risdate>2020</risdate><volume>323</volume><issue>8</issue><spage>746</spage><pages>746-</pages><eissn>1538-3598</eissn><abstract>Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
ClinicalTrials.gov Identifier: NCT02933489.</abstract><cop>United States</cop><pmid>32207768</pmid><doi>10.1001/jama.2020.0572</doi></addata></record> |
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subjects | Adult Aged Biopsy Breast - diagnostic imaging Breast - pathology Breast Density Breast Neoplasms - diagnostic imaging Breast Neoplasms - pathology Carcinoma, Intraductal, Noninfiltrating - diagnostic imaging Carcinoma, Intraductal, Noninfiltrating - pathology Cross-Sectional Studies Early Detection of Cancer Female Follow-Up Studies Humans Magnetic Resonance Imaging - adverse effects Magnetic Resonance Imaging - methods Mammography - adverse effects Mammography - methods Middle Aged Neoplasm Invasiveness Predictive Value of Tests Reference Standards Sensitivity and Specificity |
title | Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening |
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