A prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2)

Alberto S Tagliafico, Giovanna Mariscotti, Francesca Valdora, Manuela Durando, Jacopo Nori, Daniele La Forgia, Ilan Rosenberg, Francesca Caumo, Nicoletta Gandolfo, Maria Pia Sormani, Alessio Signori, Massimo Calabrese, Nehmat Houssami

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Increased risk of breast cancer (BC) and increased risk of an interval BC at mammography screening are associated with high mammographic density. Adjunct imaging detects additional BCs not detected at mammography screening in women with dense breasts.

AIM: The aim is to estimate the incremental cancer detection rate (CDR) and false-positive recall for each of tomosynthesis and ultrasound, as adjunct screening modalities in women with mammography-negative dense breasts.

METHODS: A multicentre prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2) recruited asymptomatic women attending Italian breast screening services. All participants had independently interpreted tomosynthesis and ultrasound. Outcomes were ascertained from excision histopathology or completed assessment. Paired binary data were compared using McNemar's test.

RESULTS: We recruited 5300 screening participants with median age of 50 (interquartile range 43-79) years who had negative mammography and dense breasts (April 2015-September 2017). Adjunct screening detected 29 additional BCs (27 invasive, 2 in situ): 12 detected on both tomosynthesis and ultrasound, 3 detected only on tomosynthesis, 14 detected only on ultrasound. Incremental CDR for tomosynthesis (+15 cancers) was 2.83/1000 screens (95% confidence interval [CI]: 1.58-4.67) versus ultrasound (+26 cancers) with an incremental CDR of 4.90/1000 screens (95% CI: 3.21-7.19), P = 0.015. Mean size of these cancers was 14.2 mm (standard deviation: 7.8 mm), and six had nodal metastases. Incremental false-positive recall was 1.22% (95% CI: 0.91%-1.49%) and differed significantly between tomosynthesis (0.30%) and ultrasound (1.0%), P < 0.001.

CONCLUSIONS: Ultrasound detected more BCs but caused more false positives than tomosynthesis, underscoring trade-offs in screening outcomes when adjunct imaging is used for screening dense breasts.

Original languageEnglish
Pages (from-to)39-46
Number of pages8
JournalEuropean Journal of Cancer
Volume104
DOIs
Publication statusPublished - Nov 2018

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Mammography
Breast
Neoplasms
Confidence Intervals
Breast Neoplasms
Neoplasm Metastasis

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A prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2). / Tagliafico, Alberto S; Mariscotti, Giovanna; Valdora, Francesca; Durando, Manuela; Nori, Jacopo; La Forgia, Daniele; Rosenberg, Ilan; Caumo, Francesca; Gandolfo, Nicoletta; Sormani, Maria Pia; Signori, Alessio; Calabrese, Massimo; Houssami, Nehmat.

In: European Journal of Cancer, Vol. 104, 11.2018, p. 39-46.

Research output: Contribution to journalArticle

Tagliafico, Alberto S ; Mariscotti, Giovanna ; Valdora, Francesca ; Durando, Manuela ; Nori, Jacopo ; La Forgia, Daniele ; Rosenberg, Ilan ; Caumo, Francesca ; Gandolfo, Nicoletta ; Sormani, Maria Pia ; Signori, Alessio ; Calabrese, Massimo ; Houssami, Nehmat. / A prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2). In: European Journal of Cancer. 2018 ; Vol. 104. pp. 39-46.
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author = "Tagliafico, {Alberto S} and Giovanna Mariscotti and Francesca Valdora and Manuela Durando and Jacopo Nori and {La Forgia}, Daniele and Ilan Rosenberg and Francesca Caumo and Nicoletta Gandolfo and Sormani, {Maria Pia} and Alessio Signori and Massimo Calabrese and Nehmat Houssami",
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year = "2018",
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TY - JOUR

T1 - A prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2)

AU - Tagliafico, Alberto S

AU - Mariscotti, Giovanna

AU - Valdora, Francesca

AU - Durando, Manuela

AU - Nori, Jacopo

AU - La Forgia, Daniele

AU - Rosenberg, Ilan

AU - Caumo, Francesca

AU - Gandolfo, Nicoletta

AU - Sormani, Maria Pia

AU - Signori, Alessio

AU - Calabrese, Massimo

AU - Houssami, Nehmat

N1 - Copyright © 2018 Elsevier Ltd. All rights reserved.

PY - 2018/11

Y1 - 2018/11

N2 - BACKGROUND: Increased risk of breast cancer (BC) and increased risk of an interval BC at mammography screening are associated with high mammographic density. Adjunct imaging detects additional BCs not detected at mammography screening in women with dense breasts.AIM: The aim is to estimate the incremental cancer detection rate (CDR) and false-positive recall for each of tomosynthesis and ultrasound, as adjunct screening modalities in women with mammography-negative dense breasts.METHODS: A multicentre prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2) recruited asymptomatic women attending Italian breast screening services. All participants had independently interpreted tomosynthesis and ultrasound. Outcomes were ascertained from excision histopathology or completed assessment. Paired binary data were compared using McNemar's test.RESULTS: We recruited 5300 screening participants with median age of 50 (interquartile range 43-79) years who had negative mammography and dense breasts (April 2015-September 2017). Adjunct screening detected 29 additional BCs (27 invasive, 2 in situ): 12 detected on both tomosynthesis and ultrasound, 3 detected only on tomosynthesis, 14 detected only on ultrasound. Incremental CDR for tomosynthesis (+15 cancers) was 2.83/1000 screens (95% confidence interval [CI]: 1.58-4.67) versus ultrasound (+26 cancers) with an incremental CDR of 4.90/1000 screens (95% CI: 3.21-7.19), P = 0.015. Mean size of these cancers was 14.2 mm (standard deviation: 7.8 mm), and six had nodal metastases. Incremental false-positive recall was 1.22% (95% CI: 0.91%-1.49%) and differed significantly between tomosynthesis (0.30%) and ultrasound (1.0%), P < 0.001.CONCLUSIONS: Ultrasound detected more BCs but caused more false positives than tomosynthesis, underscoring trade-offs in screening outcomes when adjunct imaging is used for screening dense breasts.

AB - BACKGROUND: Increased risk of breast cancer (BC) and increased risk of an interval BC at mammography screening are associated with high mammographic density. Adjunct imaging detects additional BCs not detected at mammography screening in women with dense breasts.AIM: The aim is to estimate the incremental cancer detection rate (CDR) and false-positive recall for each of tomosynthesis and ultrasound, as adjunct screening modalities in women with mammography-negative dense breasts.METHODS: A multicentre prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2) recruited asymptomatic women attending Italian breast screening services. All participants had independently interpreted tomosynthesis and ultrasound. Outcomes were ascertained from excision histopathology or completed assessment. Paired binary data were compared using McNemar's test.RESULTS: We recruited 5300 screening participants with median age of 50 (interquartile range 43-79) years who had negative mammography and dense breasts (April 2015-September 2017). Adjunct screening detected 29 additional BCs (27 invasive, 2 in situ): 12 detected on both tomosynthesis and ultrasound, 3 detected only on tomosynthesis, 14 detected only on ultrasound. Incremental CDR for tomosynthesis (+15 cancers) was 2.83/1000 screens (95% confidence interval [CI]: 1.58-4.67) versus ultrasound (+26 cancers) with an incremental CDR of 4.90/1000 screens (95% CI: 3.21-7.19), P = 0.015. Mean size of these cancers was 14.2 mm (standard deviation: 7.8 mm), and six had nodal metastases. Incremental false-positive recall was 1.22% (95% CI: 0.91%-1.49%) and differed significantly between tomosynthesis (0.30%) and ultrasound (1.0%), P < 0.001.CONCLUSIONS: Ultrasound detected more BCs but caused more false positives than tomosynthesis, underscoring trade-offs in screening outcomes when adjunct imaging is used for screening dense breasts.

U2 - 10.1016/j.ejca.2018.08.029

DO - 10.1016/j.ejca.2018.08.029

M3 - Article

VL - 104

SP - 39

EP - 46

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -