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Lancet Reg Health Eur
Lancet Reg Health Eur
The Lancet Regional Health - Europe
2666-7762
Elsevier

S2666-7762(24)00238-2
10.1016/j.lanepe.2024.101071
101071
Correspondence
Refining the role of Contrast-enhanced Mammography in breast cancer screening: insights from the RACER trial– author's reply
Lobbes Marc B.I. m.lobbes@zuyderland.nl
a∗
Neeter Lidewij M.F.H. bc
Smidt Marjolein L. cd
Wildberger Joachim E. bc
a Zuyderland Medical Center, Department of Medical Imaging, Sittard-Geleen, the Netherlands
b Maastricht University Medical Center, Department of Radiology and Nuclear Medicine, Maastricht, the Netherlands
c GROW School for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands
d Maastricht University Medical Center, Department of Surgery, Maastricht, the Netherlands
∗ Corresponding author. Zuyderland Medical Center, Department of Medical Imaging, H. van der Hoffplein 1, 6162BG, Geleen, the Netherlands. m.lobbes@zuyderland.nl
06 9 2024
10 2024
06 9 2024
45 10107129 8 2024
30 8 2024
© 2024 The Author(s)
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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pmcWe thank our colleagues Pesapane and Cassano1 for their valuable comments on the publication of our RACER trial results.2 The implementation of all new and advanced diagnostic tests needs to be critically evaluated. According to the Fryback and Thornbury methodology, several steps must be taken before the full potential of (in this case) CEM can finally be judged.3 In our opinion, CEM is now being tested for its ‘diagnostic impact’ according to this methodology, since the RACER trial focused on patients recalled from breast cancer screening. We wish to emphasize that we prospectively included women recalled after undergoing primary mammography screening.

Selection bias can be adjusted equally in study arms by robust randomization processes like the ones we applied in our study group allocation. Biases like length-time and lead time bias are without doubt important to consider when interpreting breast cancer screening outcomes, which are expected to be published in the near future, because there is an increasing interest in moving CEM toward the breast cancer screening setting.

Awareness is growing that CEM-based screening benefits outweigh its disadvantages, such as its increased radiation dose and the necessity to administer contrast agents intravenously. The diagnostic accuracy of (screening) mammography is decreased with increasing breast density, and it is becoming more evident that perfusion-based imaging methods are required to cope with this limitation in women with dense breasts, as was shown for example by the DENSE trial results.4 Several CEM-based screening studies are ongoing or being prepared, such as ‘Contrast-enhanced Mammography Imaging Screening Trial’ (CMIST), the ‘Breast screening Risk Adapted Imaging for Density’ (BRAID) trial, and the ‘Contrast-enhanced Mammography, Early detection biomarkers, Risk assessment, Imaging Technologies’ (C-MERIT) trial. In the Netherlands, we aim to study CEM or abbreviated MRI as supplemental screening in women with dense breasts and negative screening mammography (working title: ‘DENSE-2’). In these studies, the aforementioned biases should definitely be addressed.

We would like to thank our colleagues for their thoughts on length-time, lead and selection biases, which are often discussed in the context of breast cancer screening, and which would move CEM to the next level of the Thornbury methodology (‘therapeutic efficacy’). A combination with cost-effectiveness analyses will help to provide the full picture of CEM in the diagnostic work-up of patients recalled from breast cancer screening.

Contributors

M. Lobbes: writing the original draft, review and editing; L. Neeter: review and editing; M. Smidt: review and editing; J. Wildberger: review and editing.

Declaration of interests

M.L received research funding from GE Healthcare, Hologic Inc., and Sirius Medical B.V. M.L. received honorary fees for presentation and participation of medical advisory boards from GE Healthcare, Hologic Inc., Sirius Medical B.V., Bayer, Guerbet, and Tromp Medical B.V. J.W. received institutional grants from Adora/Oldelft, Anaconda, Bard, Bayer, Bentley, Boston, Brainlab, GE Healthcare, Inari Medical, Johnson & Johnson, Merit Medical, Nico-Lab, Philips, Sectra, Siemens, and Stryker. J.W. received speaker's fees from Bayer and Siemens. L.N. and M.S. had no conflicts of interest to report.
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References

1 Pesapane F. Cassano E. Refining the role of contrast-enhanced mammography in breast cancer screening: insights from the RACER trial Lancet Reg Health Eur 2024 10.1016/j.lanepe.2024.101068
2 Neeter L. Nelemans P.J. Raat H.P.J. Contrast-enhanced mammography versus conventional imaging in women recalled from breast cancer screening (RACER trial): a multicentre, open-label, randomised controlled clinical trial Lancet Reg Health Eur 44 2024 100987
3 Fryback D.G. Thornbury J.R. The efficacy of diagnostic imaging Med Decis Making 11 1991 88 94 1907710
4 Bakker M.F. De Lange S.V. Pijnappel R.M. Supplemental MRI screening for women with extremely dense breast tissue N Engl J Med 381 2019 2091 2102 31774954
