Comparison of Resource Utilization and Clinical Outcomes Following Screening with Digital Breast Tomosynthesis Versus Digital Mammography: Findings From a Learning Health System

doi:10.1016/j.acra.2018.05.026

Academic Radiology

Volume 26, Issue 5, May 2019, Pages 597-605

https://doi.org/10.1016/j.acra.2018.05.026 Get rights and content

Rationale and Objectives

To compare outcomes associated with breast cancer screening with digital mammography (DM) alone versus in combination with digital breast tomosynthesis (DBT) in a large representative cohort.

Materials and Methods

A total of 325,729 screening mammograms from 247,431 women were analyzed, across two healthcare systems, from June 2015 to September 2017. Patient level demographic, calculated risk levels, and clinical outcomes were extracted from radiology information system and electronic medical records. Multivariable regression modeling adjusting for institution, age, breast density, and first exam was conducted to compare patient characteristics, recall rates, time to biopsy and final diagnosis, clinical outcomes, and diagnostic performance. Participating institutions and the Coordinating Center received Institutional Review Board approval for a waiver of consent to collect and link data and perform analysis.

Results

A total of 194,437 (59.7%) screens were DBT versus 131,292 (40.3%) with DM. Women with dense breasts and higher calculated risk were more likely to be screened with DBT. Recall rates were lower for DBT overall (8.83% DBT vs 10.98% DM, adjusted odds ratio, 95% confidence interval = 0.85, 0.83–0.87) and across all age groups, races, and breast densities, and at facilities that used predominantly DBT (8.05%) versus predominantly DM (11.22%), or a combination (10.73%). The most common diagnostic pathway after recall was mammography and ultrasound. Women recalled from DBT were more likely to proceed directly to ultrasound. The median time to biopsy (18 vs 22 days) and final diagnosis (10 vs 13 days) was shorter for DBT. The adjusted cancer rate, cancer detection rate, and specificity were higher for DBT.

Conclusion

DBT demonstrated a more efficient screening pathway and improved quality measures with lower recall rates in all patient types, reduced diagnostic mammography and shorter time to biopsy and final diagnosis.

Section snippets

INTRODUCTION

Breast cancer is the most frequently diagnosed cancer among women in the United States (1, 2). Breast cancer mortality rates have declined significantly secondary to early mammographic screen detection and improved treatment (3, 4).

Digital breast tomosynthesis (DBT) is rapidly becoming the standard of care secondary to improved sensitivity and specificity (5, 6, 7). The quasi-3D data acquired with DBT improves lesion conspicuity allowing both better characterization and localization of lesions.

MATERIALS AND METHODS

Participating institutions and the Coordinating Center received Institutional Review Board approval for a waiver of consent to collect and link data and perform analysis. All study procedures were Health Insurance Portability and Accountability Act compliant.

RESULTS

Overall, 194,437 or 59.6% of screening examinations were with DBT and 131,292 or 40.3% were with DM. Caucasian women, women identified at elevated risk for breast cancer based on the Gail Model or the Tyrer-Cuzick score, women with dense breasts, and those with subsequent (not baseline) screening exams were more likely to receive DBT (Table 1). These differences were significant after adjustment for institution to account for population differences at each institution.

Overall, recall rates were

DISCUSSION

This study utilized a learning health system to examine clinical outcomes and downstream imaging after screening with DBT or DM in two large, geographically and clinically diverse U.S. health care networks. The results of this study confirm previous reports of recall rate reduction achieved with DBT with the clinical benefits of improved PPV-1, specificity, and cancer detection rate (7, 9). Recall rate reduction was most significant in the 40–44 year old age group, while increased cancer

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Citation Excerpt :
In clinical practice, this change is already achieved. In a recent multicenter, retrospective study of 194,437 DBT screenings compared with 131,292 DM screening, women screened with DBT were more likely to proceed directly to ultrasound without additional mammography views compared with women screened with DM [47]. However, the body of evidence on DBT by comparison to additional mammography views is limited [48].
Digital breast tomosynthesis (DBT) is a new imaging technology that addresses the limitation caused by overlapping structures in conventional two-dimensional digital mammography owing to the acquisition of a series of low-dose projection images. This unique technique provides a dual benefit to patients screened for breast cancer. First, DBT increases the cancer detection rate mostly by highlighting architectural distortions and allowing better assessment of masses shape and margins. Second, DBT helps reduce recall rate by discarding asymmetries related to overlapping tissue. However, DBT is not included in the majority of cancer screening programs worldwide. Several issues still need to be addressed such as over-diagnosis and over-treatment, lack of reduction of interval breast cancer, quality control and storage, and radiation dose. In the diagnostic setting, DBT increases the diagnostic accuracy and reduces the number of indeterminate lesions in symptomatic women. Its aforementioned performances regarding asymmetries, masses and architectural distortions allow reducing the number of additional views while working-up a screening-detected lesion. Tumor size is also better assessed at DBT as well as multicentricity, two significant benefits in the staging of breast cancer. Finally, DBT allows a better analysis of scars and helps reduce the rate of indeterminate findings after surgery. Although somewhat limited by high breast density, DBT globally outperforms digital mammography in both screening and diagnostic breast imaging. Additional research is however needed, particularly on relevant screening outcomes. This review describes the main performances of breast DBT in breast cancer screening and diagnosis and the resulting consequences in both settings.
Mammographic Screening in Routine Practice: Multisite Study of Digital Breast Tomosynthesis and Digital Mammography Screenings
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^☆: Acknowledgments: This study was supported by Hologic Inc., Marlborough, Massachusetts

^✰✰: Declaration of Interest: Nila H. Alsheik MD—employee of Advocate Health and is also on Hologic's scientific advisory panel; Firas Dabbous PhD—employee of Advocate Health; Scott K. Pohlman—employee of Hologic Inc.; Kathleen M. Troeger—employee of Hologic Inc.; Richard E. Gliklich MD—employee of OM1 Inc.; Gregory M. Donadio—employee of OM1 Inc.; Zhaohui Su PhD—employee of OM1 Inc.; Vandana Menon MD PhD—employee of OM1 Inc.; Emily F. Conant MD—has grant from Hologic and is also on their scientific advisory panel.

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Original InvestigationComparison of Resource Utilization and Clinical Outcomes Following Screening with Digital Breast Tomosynthesis Versus Digital Mammography: Findings From a Learning Health System☆,✰✰

Rationale and Objectives

Materials and Methods

Results

Conclusion

Section snippets

INTRODUCTION

MATERIALS AND METHODS

RESULTS

DISCUSSION

Lancet Oncol

Value Analysis of digital breast tomosynthesis for breast cancer screening in a US medicaid population

J Am Coll Radiol

The benefits and harms of breast cancer screening: an independent review: a report jointly commissioned by Cancer Research UK and the Department of Health (England) October 2012

Br J Cancer.

Pan-Canadian study of mammography screening and mortality from breast cancer

JNCI

Breast cancer screening using tomosynthesis in combination with digital mammography compared to digital mammography alone: a cohort study within the PROSPR consortium

Breast Cancer Res Treat

Original Investigation
Comparison of Resource Utilization and Clinical Outcomes Following Screening with Digital Breast Tomosynthesis Versus Digital Mammography: Findings From a Learning Health System☆,✰✰