Breast cancer detection using single-reading of breast tomosynthesis (3D-mammography) compared to double-reading of 2D-mammography: Evidence from a population-based trial.

BACKGROUND Most population breast cancer (BC) screening programs use double-reading of 2D-mammography. We recently reported the screening with tomosynthesis or standard mammography-2 (STORM-2) trial, showing that double-read tomosynthesis (pseudo-3D-mammography) detected more BC than double-read 2D-mammography. In this study, we compare screen-detection measures for single-reading of 3D-mammography with those for double-reading of 2D-mammography, to inform screening practice. METHODS This is a secondary analysis based on STORM-2 which prospectively compared 3D-mammography and 2D-mammography in sequential screen-readings. Asymptomatic women ≥49 years who attended population-based screening (Trento, 2013-2015) were recruited. Participants recalled at any screen-read from parallel double-reading arms underwent further testing and/or biopsy. Single-reading of 3D-mammography, integrated with acquired or synthetized 2D-mammograms, was compared to double-reading of 2D-mammograhy alone for screen-detection measures: number of detected BCs, cancer detection rate (CDR), number and percentage of false-positive recall (FPR). Paired binary data were compared using McNemar's test. RESULTS Screening detected 90, including 74 invasive, BCs in 85 of 9672 participants. CDRs for single-reading using integrated 2D/3D-mammography (8.2 per 1000 screens; 95% CI 6.5-10.2) or 2D synthetic/3D-mammography (8.4 per 1000 screens; 95% CI: 6.7-10.4) were significantly higher than CDR for double-reading of 2D-mammography (6.3 per 1000 screens; 95% CI: 4.8-8.1), P<0.001 both comparisons. FPR% for single-read 2D/3D-mammography (2.60%; 95% CI: 2.29-2.94), or single-read 2D synthetic/3D-mammography (2.76%; 95% CI: 2.45-3.11), were significantly lower than FPR% for double-read 2D-mammography (3.42%; 95% CI: 3.07-3.80), P<0.001 and P=0.002 respectively. CONCLUSIONS Single-reading of 3D-mammography (integrated 2D/3D or 2Dsynthetic/3D) detected more BC, and had lower FPR, compared to current practice of double-reading 2D-mammography alone - these findings have implications for population BC screening programs.

[1]  R. Warren,et al.  Mammography screening: an incremental cost effectiveness analysis of double versus single reading of mammograms , 1996, BMJ.

[2]  Madhavi Raghu,et al.  Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. , 2013, Radiology.

[3]  B. Muir,et al.  The efficacy of double reading mammograms in breast screening. , 1994, Clinical radiology.

[4]  Timothy J Wilt,et al.  Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. , 2009, Annals of internal medicine.

[5]  Emily F Conant,et al.  Breast cancer screening using tomosynthesis in combination with digital mammography. , 2014, JAMA.

[6]  Diana L Miglioretti,et al.  Digital Breast Tomosynthesis: A Brave New World of Mammography Screening. , 2016, JAMA oncology.

[7]  K. Straif,et al.  Breast-cancer screening--viewpoint of the IARC Working Group. , 2015, The New England journal of medicine.

[8]  T. Wilt,et al.  Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement , 2011 .

[9]  Daniel F Heitjan,et al.  Screening outcomes following implementation of digital breast tomosynthesis in a general-population screening program. , 2014, Journal of the National Cancer Institute.

[10]  Petra Macaskill,et al.  Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based prospective study. , 2016, The Lancet. Oncology.

[11]  Madhavi Raghu,et al.  Early clinical experience with digital breast tomosynthesis for screening mammography. , 2015, Radiology.

[12]  A. Holland,et al.  Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. , 2014, AJR. American journal of roentgenology.

[13]  Paul Taylor,et al.  Computer aids and human second reading as interventions in screening mammography: two systematic reviews to compare effects on cancer detection and recall rate. , 2008, European journal of cancer.

[14]  A. Barratt.  Overdiagnosis in mammography screening: a 45 year journey from shadowy idea to acknowledged reality , 2015, BMJ : British Medical Journal.

[15]  Andriy I. Bandos,et al.  Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration , 2013, European Radiology.

[16]  Anne Marie McCarthy,et al.  Breast cancer screening using tomosynthesis in combination with digital mammography compared to digital mammography alone: a cohort study within the PROSPR consortium , 2016, Breast Cancer Research and Treatment.

[17]  Lorraine Tucker,et al.  Digital breast tomosynthesis (DBT): a review of the evidence for use as a screening tool. , 2016, Clinical radiology.

[18]  Anders Tingberg,et al.  Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmö Breast Tomosynthesis Screening Trial, a population-based study , 2015, European Radiology.

[19]  S Ciatto,et al.  Independent Double Reading of Screening Mammograms , 1995, Journal of medical screening.

[20]  N. Houssami.  Digital breast tomosynthesis (3D-mammography) screening: data and implications for population screening , 2015, Expert review of medical devices.

[21]  E. Thurfjell,et al.  Benefit of independent double reading in a population-based mammography screening program. , 1994, Radiology.

[22]  S. Ciatto,et al.  Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. , 2013, The Lancet. Oncology.

[23]  P. Skaane,et al.  Digital breast tomosynthesis (3D-mammography) screening: A pictorial review of screen-detected cancers and false recalls attributed to tomosynthesis in prospective screening trials. , 2016, Breast.