Adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts: Interim report of a prospective comparative trial

Alberto S. Tagliafico, Massimo Calabrese, Giovanna Mariscotti, Manuela Durando, Simona Tosto, Francesco Monetti, Sonia Airaldi, Bianca Bignotti, Jacopo Nori, Antonella Bagni, Alessio Signori, Maria Pia Sormani, Nehmat Houssami

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Abstract

Purpose Debate on adjunct screening in women with dense breasts has followed legislation requiring that women be informed about their mammographic density and related adjunct imaging. Ultrasound or tomosynthesis can detect breast cancer (BC) in mammography-negative dense breasts, but these modalities have not been directly compared in prospective trials. We conducted a trial of adjunct screening to compare, within the same participants, incremental BC detection by tomosynthesis and ultrasound in mammography-negative dense breasts. Patients and Methods Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts is a prospective multicenter study recruiting asymptomatic women with mammography-negative screens and dense breasts. Eligible women had tomosynthesis and physician-performed ultrasound with independent interpretation of adjunct imaging. Outcome measures included cancer detection rate (CDR), number of false-positive (FP) recalls, and incremental CDR for each modality; these were compared using McNemar's test for paired binary data in a preplanned interim analysis. Results Among 3,231 mammography-negative screening participants (median age, 51 years; interquartile range, 44 to 78 years) with dense breasts, 24 additional BCs were detected (23 invasive): 13 tomosynthesis-detected BCs (incremental CDR, 4.0 per 1,000 screens; 95% CI, 1.8 to 6.2) versus 23 ultrasound-detected BCs (incremental CDR, 7.1 per 1,000 screens; 95% CI, 4.2 to 10.0), P = .006. Incremental FP recall occurred in 107 participants (3.33%; 95% CI, 2.72% to 3.96%). FP recall (any testing) did not differ between tomosynthesis (FP = 53) and ultrasound (FP = 65), P = .26; FP recall (biopsy) also did not differ between tomosynthesis (FP = 22) and ultrasound (FP = 24), P = .86. Conclusion The Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts' interim analysis shows that ultrasound has better incremental BC detection than tomosynthesis in mammography-negative dense breasts at a similar FP-recall rate. However, future application of adjunct screening should consider that tomosynthesis detected more than 50% of the additional BCs in these women and could potentially be the primary screening modality.

Original languageEnglish
Pages (from-to)1882-1888
Number of pages7
JournalJournal of Clinical Oncology
Volume34
Issue number16
DOIs
Publication statusPublished - Jun 1 2016

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Mammography
Breast
Breast Neoplasms
Neoplasms
Mammary Ultrasonography
Legislation
Multicenter Studies
Outcome Assessment (Health Care)
Prospective Studies
Physicians
Biopsy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts : Interim report of a prospective comparative trial. / Tagliafico, Alberto S.; Calabrese, Massimo; Mariscotti, Giovanna; Durando, Manuela; Tosto, Simona; Monetti, Francesco; Airaldi, Sonia; Bignotti, Bianca; Nori, Jacopo; Bagni, Antonella; Signori, Alessio; Sormani, Maria Pia; Houssami, Nehmat.

In: Journal of Clinical Oncology, Vol. 34, No. 16, 01.06.2016, p. 1882-1888.

Research output: Contribution to journalArticle

Tagliafico, AS, Calabrese, M, Mariscotti, G, Durando, M, Tosto, S, Monetti, F, Airaldi, S, Bignotti, B, Nori, J, Bagni, A, Signori, A, Sormani, MP & Houssami, N 2016, 'Adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts: Interim report of a prospective comparative trial', Journal of Clinical Oncology, vol. 34, no. 16, pp. 1882-1888. https://doi.org/10.1200/JCO.2015.63.4147
Tagliafico, Alberto S. ; Calabrese, Massimo ; Mariscotti, Giovanna ; Durando, Manuela ; Tosto, Simona ; Monetti, Francesco ; Airaldi, Sonia ; Bignotti, Bianca ; Nori, Jacopo ; Bagni, Antonella ; Signori, Alessio ; Sormani, Maria Pia ; Houssami, Nehmat. / Adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts : Interim report of a prospective comparative trial. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 16. pp. 1882-1888.
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abstract = "Purpose Debate on adjunct screening in women with dense breasts has followed legislation requiring that women be informed about their mammographic density and related adjunct imaging. Ultrasound or tomosynthesis can detect breast cancer (BC) in mammography-negative dense breasts, but these modalities have not been directly compared in prospective trials. We conducted a trial of adjunct screening to compare, within the same participants, incremental BC detection by tomosynthesis and ultrasound in mammography-negative dense breasts. Patients and Methods Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts is a prospective multicenter study recruiting asymptomatic women with mammography-negative screens and dense breasts. Eligible women had tomosynthesis and physician-performed ultrasound with independent interpretation of adjunct imaging. Outcome measures included cancer detection rate (CDR), number of false-positive (FP) recalls, and incremental CDR for each modality; these were compared using McNemar's test for paired binary data in a preplanned interim analysis. Results Among 3,231 mammography-negative screening participants (median age, 51 years; interquartile range, 44 to 78 years) with dense breasts, 24 additional BCs were detected (23 invasive): 13 tomosynthesis-detected BCs (incremental CDR, 4.0 per 1,000 screens; 95{\%} CI, 1.8 to 6.2) versus 23 ultrasound-detected BCs (incremental CDR, 7.1 per 1,000 screens; 95{\%} CI, 4.2 to 10.0), P = .006. Incremental FP recall occurred in 107 participants (3.33{\%}; 95{\%} CI, 2.72{\%} to 3.96{\%}). FP recall (any testing) did not differ between tomosynthesis (FP = 53) and ultrasound (FP = 65), P = .26; FP recall (biopsy) also did not differ between tomosynthesis (FP = 22) and ultrasound (FP = 24), P = .86. Conclusion The Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts' interim analysis shows that ultrasound has better incremental BC detection than tomosynthesis in mammography-negative dense breasts at a similar FP-recall rate. However, future application of adjunct screening should consider that tomosynthesis detected more than 50{\%} of the additional BCs in these women and could potentially be the primary screening modality.",
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T1 - Adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts

T2 - Interim report of a prospective comparative trial

AU - Tagliafico, Alberto S.

AU - Calabrese, Massimo

AU - Mariscotti, Giovanna

AU - Durando, Manuela

AU - Tosto, Simona

AU - Monetti, Francesco

AU - Airaldi, Sonia

AU - Bignotti, Bianca

AU - Nori, Jacopo

AU - Bagni, Antonella

AU - Signori, Alessio

AU - Sormani, Maria Pia

AU - Houssami, Nehmat

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N2 - Purpose Debate on adjunct screening in women with dense breasts has followed legislation requiring that women be informed about their mammographic density and related adjunct imaging. Ultrasound or tomosynthesis can detect breast cancer (BC) in mammography-negative dense breasts, but these modalities have not been directly compared in prospective trials. We conducted a trial of adjunct screening to compare, within the same participants, incremental BC detection by tomosynthesis and ultrasound in mammography-negative dense breasts. Patients and Methods Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts is a prospective multicenter study recruiting asymptomatic women with mammography-negative screens and dense breasts. Eligible women had tomosynthesis and physician-performed ultrasound with independent interpretation of adjunct imaging. Outcome measures included cancer detection rate (CDR), number of false-positive (FP) recalls, and incremental CDR for each modality; these were compared using McNemar's test for paired binary data in a preplanned interim analysis. Results Among 3,231 mammography-negative screening participants (median age, 51 years; interquartile range, 44 to 78 years) with dense breasts, 24 additional BCs were detected (23 invasive): 13 tomosynthesis-detected BCs (incremental CDR, 4.0 per 1,000 screens; 95% CI, 1.8 to 6.2) versus 23 ultrasound-detected BCs (incremental CDR, 7.1 per 1,000 screens; 95% CI, 4.2 to 10.0), P = .006. Incremental FP recall occurred in 107 participants (3.33%; 95% CI, 2.72% to 3.96%). FP recall (any testing) did not differ between tomosynthesis (FP = 53) and ultrasound (FP = 65), P = .26; FP recall (biopsy) also did not differ between tomosynthesis (FP = 22) and ultrasound (FP = 24), P = .86. Conclusion The Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts' interim analysis shows that ultrasound has better incremental BC detection than tomosynthesis in mammography-negative dense breasts at a similar FP-recall rate. However, future application of adjunct screening should consider that tomosynthesis detected more than 50% of the additional BCs in these women and could potentially be the primary screening modality.

AB - Purpose Debate on adjunct screening in women with dense breasts has followed legislation requiring that women be informed about their mammographic density and related adjunct imaging. Ultrasound or tomosynthesis can detect breast cancer (BC) in mammography-negative dense breasts, but these modalities have not been directly compared in prospective trials. We conducted a trial of adjunct screening to compare, within the same participants, incremental BC detection by tomosynthesis and ultrasound in mammography-negative dense breasts. Patients and Methods Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts is a prospective multicenter study recruiting asymptomatic women with mammography-negative screens and dense breasts. Eligible women had tomosynthesis and physician-performed ultrasound with independent interpretation of adjunct imaging. Outcome measures included cancer detection rate (CDR), number of false-positive (FP) recalls, and incremental CDR for each modality; these were compared using McNemar's test for paired binary data in a preplanned interim analysis. Results Among 3,231 mammography-negative screening participants (median age, 51 years; interquartile range, 44 to 78 years) with dense breasts, 24 additional BCs were detected (23 invasive): 13 tomosynthesis-detected BCs (incremental CDR, 4.0 per 1,000 screens; 95% CI, 1.8 to 6.2) versus 23 ultrasound-detected BCs (incremental CDR, 7.1 per 1,000 screens; 95% CI, 4.2 to 10.0), P = .006. Incremental FP recall occurred in 107 participants (3.33%; 95% CI, 2.72% to 3.96%). FP recall (any testing) did not differ between tomosynthesis (FP = 53) and ultrasound (FP = 65), P = .26; FP recall (biopsy) also did not differ between tomosynthesis (FP = 22) and ultrasound (FP = 24), P = .86. Conclusion The Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts' interim analysis shows that ultrasound has better incremental BC detection than tomosynthesis in mammography-negative dense breasts at a similar FP-recall rate. However, future application of adjunct screening should consider that tomosynthesis detected more than 50% of the additional BCs in these women and could potentially be the primary screening modality.

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