Impact on the recall rate of digital breast tomosynthesis as an adjunct to digital mammography in the screening setting. A double reading experience and review of the literature

https://doi.org/10.1016/j.ejrad.2016.01.004Get rights and content

Abstract

Objectives

To estimate the impact on recall rate (RR) of digital breast tomosynthesis (DBT) associated with digital mammography (DM + DBT), compared to DM alone, evaluate the impact of double reading (DR) and review the literature.

Methods

Ethics committees approved this multicenter study. Patients gave informed consent. Women recalled from population-based screening reading were included. Reference standard was histology and/or ≥1 year follow up. Negative multiple assessment was considered for patients lost at follow up. Two blinded readers (R1, R2) evaluated first DM and subsequently DM + DBT. RR, sensitivity, specificity, accuracy, positive and negative predictive values (PPV, NPV), were calculated for R1, R2, and DR. Cohen κ and χ2 were used for R1-R2 agreement and RR related to breast density.

Results

We included 280 cases (41 malignancies, 66 benign lesions, and 173 negative examinations). The RR reduction was 43% (R1), 58% (R2), 43% (DR). Sensitivity, specificity, accuracy, PPV and NPV were: 93%, 67%, 71%, 33%, 98% for R1; 88%, 73%, 75%, 36%, 97% for R2; 98%, 55%, 61%, 27%, 99% for DR. The agreement was higher for DM + DBT (κ=0.459 versus κ=0.234). Reduction in RR was independent from breast density (p = 0.992).

Conclusion

DBT was confirmed to reduce RR, as shown by 13 of 15 previous studies (reported reduction 6–82%, median 31%). This reduction is confirmed when using DR. DBT allows an increased inter-reader agreement.

Introduction

Clinical trials have shown that screening mammography is able to reduce mortality from breast cancer [1]. Even though, there is still intense discussion and criticism regarding screening programs [2]. Being a two-dimensional imaging method, digital mammography (DM) has several limitations: small lesions can be hidden by dense breast parenchyma and thus cancers can be missed, especially in women with dense breasts [3]. On the other hand, the superimposition of normal breast glandular tissue can create false images, leading to a high percentage of unnecessary recalls. Furthermore, with the introduction of screening mammography, the diagnosis of lesions with unknown or low clinical significance has increased, raising the issues of overdiagnosis and overtreatment [4].

Recalling patients for further examinations (additional mammographic views, ultrasound, magnetic resonance imaging, or even biopsy) is cause of anxiety for the women and determines significant additional costs for screening programs [5]. According to European and U.S. guidelines, recall rates should be kept beneath 7% and 12%, respectively [6], [7]; these different thresholds are due to the variability in clinical practice, with higher recall rates in the U.S., as compared to European countries [8]. The site where mammography is interpreted has also been found to influence the number of women recalled [9]. These differences are not associated with a comparable variability in detection rate, which does not improve with higher recalls [10].

Digital breast tomosynthesis (DBT), used in association with DM, is able to detect a higher number of cancers, compared to DM alone. In particular, initial result of trials, both in Europe and in the U.S., showed that DBT in the screening setting is able to enhance the number of invasive malignant lesions diagnosed. At the same time, thanks to its capability to obtain various images of the same breast and reduce the effect of tissue superimposition, studies showed that DBT is able to reduce the number of women recalled because of unspecific findings and false positives mammographic images [11].

In this study we aimed at evaluating the effect on recall rate of two-view DBT in association with DM, as compared to DM alone. Furthermore, we assessed inter-reader agreement and whether breast density influenced the effect of DBT on recall rates. Finally, we performed a review of the literature published on this topic.

Section snippets

Study population and screening reading protocol

This multicenter prospective study obtained the ethics committee approval at all three centers involved, and the patients included signed a written informed consent. Between January 2012 and December 2013 all women recalled from the screening program and afferent to the involved institutions for diagnostic work-up could be enrolled in this study. In two of the three regions involved, screening mammography is offered every second year to women between 50 and 69 years of age. In the third region,

Patients

A total of 280 women were enrolled (mean age, 55 years, range 45–74). Breast density distribution was: class a in 48 cases, class b in 90 cases, class c in 82 cases, and class d in 60 cases. In 107 women (38%) a histopathological verification was obtained. Image-guided needle biopsy or surgical excision resulted in 66 (62%) benign findings and 41 (38%) cancers (Table 1). The remaining 173 cases were found to be negative or benign lesions during diagnostic work-up (multiple assessment). During

Discussion

We obtained a strong reduction in recall rate (about 40%) when DBT was used as an adjunct to DM, as compared to DM alone, in a blinded reading of patients recalled from a population-based screening setting. This reduction was observed for the two different readers and also for double reading, and it was independent of breast density. Furthermore, we noted that the variability between the two readers was higher when reading DM alone i.e., the adjunct of DBT improved the agreement between

Funding sources

This work had no specific funding source.

Conflict of interest

The authors declare that there are no conflict of interest.

References (30)

  • J. Rothschild et al.

    Screening mammography recall rate: does practice site matter?

    Radiology

    (2013)
  • S. Hofvind et al.

    False-positive results in mammographic screening for breast cancer in Europe: a literature review and survey of service screening programmes

    J. Med. Screen.

    (2012)
  • S.P. Poplack et al.

    Digital breast tomosynthesis: initial experience in 98 women with abnormal digital screening mammography

    AJR Am. J. Roentgenol.

    (2007)
  • D. Gur et al.

    Digital breast tomosynthesis: observer performance study

    AJR Am. J. Roentgenol.

    (2009)
  • S.L. Rose et al.

    Implementation of breast tomosynthesis in a routine screening practice: an observational study

    AJR Am. J. Roentgenol.

    (2013)
  • Cited by (25)

    • Breast cancer diagnosis in Inner-City African American and Hispanic women: The importance of early screening

      2022, Clinical Imaging
      Citation Excerpt :

      In fact, the recall rate of screening mammography is higher without prior mammograms, regardless of age.5 Recent studies have found that digital breast tomosynthesis (DBT) has resulted in a significant decrease in recall rates on screening mammography.5–7 In addition, invasive cancers detected by DBT were more likely to be smaller and node negative when compared with cancers detected by two-dimensional (2D) digital mammography, particularly in women ages 40 to 49 years.8

    • Comparison of breast density assessment between human eye and automated software on digital and synthetic mammography: Impact on breast cancer risk

      2020, Diagnostic and Interventional Imaging
      Citation Excerpt :

      Another issue was to assess the use of SM to evaluate breast density and the consequent impact on BC risk evaluation. The sensitivity and specificity of breast tomosynthesis has been shown to be increasingly good for BC detection with lower recall rates reported in several studies and a meta-analysis [43–45]. The main drawback of this technique is the potential extra radiation dose because of its use in addition to conventional DM.

    • Breast cancer screening with digital breast tomosynthesis - 4 year experience and comparison with national data

      2018, Journal of the Chinese Medical Association
      Citation Excerpt :

      Mass or mass-like lesions may have invasive potential compared with microcalcifications alone. From the review of Carbonaroa et al.,26 DBT was confirmed to reduce recall rate by previous studies (reported reduction 6–82%, median 31%). Studies performed in the real screening setting, showed a reduction in RR higher than 15%7,10,27,28 and a 17.8% reduction RR in our result is in keeping with this finding.

    • A randomised trial of screening with digital breast tomosynthesis plus conventional digital 2D mammography versus 2D mammography alone in younger higher risk women

      2017, European Journal of Radiology
      Citation Excerpt :

      In the Oslo study the false positive rate before arbitration was lower for 2D + DBT but the actual number of false positive recalls was higher [13]. Many of the studies that have shown a reduced recall rate with DBT had a higher recall rate with 2D mammography than ours [16,23,24,26–28] and thus had a larger proportion of women who could potentially benefit. There are a number of factors which determine recall rate, including the prevailing culture within the institution and the training, experience and attitude of the individual readers.

    • Breast Tomosynthesis

      2016, Breast Tomosynthesis
    View all citing articles on Scopus
    View full text