Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study

Kristina Åhsberg, Anna Gardfjell, Emma Nimeus, Rogvi Rasmussen, Catharina Behmer, Sophia Zackrisson, Lisa Ryden, Kristina Åhsberg, Anna Gardfjell, Emma Nimeus, Rogvi Rasmussen, Catharina Behmer, Sophia Zackrisson, Lisa Ryden

Abstract

Objectives: The aim of this feasibility study was to evaluate the added value of contrast-enhanced mammography (CEM) in preoperative staging of malignant breast lesions, beyond standard assessment with digital mammography and ultrasound, as a base for a future prospective randomized trial.

Materials and methods: Forty-seven patients, with confirmed or strongly suspected malignant breast lesions after standard assessment (digital mammography (DM) and ultrasound (US)), scheduled for primary surgery, were invited to undergo CEM as an additional preoperative procedure. The primary endpoint was change in treatment due to CEM findings, defined as mastectomy instead of partial mastectomy or contrariwise, bilateral surgery instead of unilateral or neoadjuvant treatment instead of primary surgery. Accuracy in tumour extent estimation compared to histopathology was evaluated by Bland-Altman statistics. Number of extra biopsies and adverse events were recorded.

Results: In 10/47 patients (21%), findings from CEM affected the primary treatment. Agreement with histopathology regarding extent estimation was better for CEM (mean difference - 1.36, SD ± 18.45) in comparison with DM (- 4.18, SD ± 26.20) and US (- 8.36, SD ± 24.30). Additional biopsies were taken from 19 lesions in 13 patients. Nine biopsies showed malignant outcome. No major adverse events occurred.

Conclusion: The feasibility of preoperative additional CEM was found to be satisfactory without any serious negative effects. Results imply an added value of CEM in preoperative staging of breast cancer. Further evaluation in larger prospective randomized trials is needed.

Trial registration: ClinicalTrials.gov, NCT03402529. Registered 18 January 2018-retrospectively registered.

Keywords: Breast cancer; CEM; CESM; Contrast-enhanced mammography; Contrast-enhanced spectral mammography; Preoperative staging.

Conflict of interest statement

SZ has received speaker’s fees and travel support from Siemens Healthcare AG and consultancy fees from Collective Minds Radiology AB. All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of how the treatment plan was affected by CEM-related findings and biopsies. *Two patients had biopsies towards both ipsilateral and contralateral breast after CEM. CEM, contrast-enhanced mammography; MDT, multidisciplinary team conference
Fig. 2
Fig. 2
Bland-Altman plots: estimated extent by mammography, ultrasound and CEM compared to histopathology (PAD). Mammography, US and CEM images were compared to histopathological extent (used as the reference value. Mean difference for mammography measurements, − 4.18 mm (95% LOA − 55.534 to 47.179 mm); US, − 8.14 mm (95% LOA − 55.977 to 39.266 mm); and CEM, − 1.36 mm (95% LOA − 37.52 to; 34.812 mm). CEM, contrast-enhanced mammography; LOA, limits of agreement; PAD, pathological anatomical diagnosis

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