Screening for Breast Cancer with Contrast-enhanced Mammography as an Alternative to MRI: SCEMAM Trial Results
Menée auprès de 601 femmes (âge moyen : 56 ans), cette étude évalue, par rapport à une IRM et du point de vue de la détection des cancers du sein à un stade précoce, l'intérêt d'une mammographie avec rehaussement de contraste après une tomosynthèse numérique mammaire
Background : Many state laws require insurance coverage for supplemental screening MRI in women at elevated risk for breast cancer, but MRI capacity is limited.
Purpose : To evaluate the impact of contrast-enhanced mammography (CEM) on incremental cancer detection rate (ICDR), false-positive rate (FPR) due to recall, and positive predictive value of biopsies performed (PPV3) when added to digital breast tomosynthesis (DBT) in women eligible for screening MRI.
Materials and Methods : From March 2021 to December 2022, 615 eligible women were prospectively recruited and consented to a single screening CEM examination with clinical DBT. Two radiologists interpreted each imaging study: Reader 1 recorded DBT findings first, and reader 2 recorded CEM findings first. Incremental cancer detection rate, cancer type and/or nodal status, FPR, PPV3, interval cancer rate, and areas under receiver operating characteristic curve (AUCs) based on forced Breast Imaging Reporting and Data System assessments were evaluated.
Results : Six hundred one women (mean age, 56 years [range: 30–75 years]) completed CEM. Twelve of the 601 women (2.0%) were diagnosed with 16 malignant lesions; cancers in five of the 12 women (42%) were detected by reader 1 at DBT, and one was detected at DBT by reader 2 (also seen on CEM by both observers). Cancers in the other six women were identified only with CEM (ICDR, six per 601 or 10.0 per 1000 women [95% CI: 3.3, 18.3]): five had invasive disease, all node negative, with a median lesion size of 0.7 cm (range: 0.4–1.1 cm); three were lobular. The FPR of combined DBT plus CEM was 127 of 589 (21.6%) for reader 1, which was an increase of 13.4% (95% CI: 10.8, 16.4) over DBT alone at 48 of 589 (8.1%). Despite increased FPR, the addition of CEM improved the overall AUC for reader 1 to 0.92 versus 0.73 for DBT alone (P = .016). Among the 601 women, 50 (8.3%) were recommended for biopsy according to CEM by reader 1, and six of the 50 (12%) were diagnosed with cancer. At the lesion level, the PPV3 was seven of 62 (11%) for biopsies prompted only with CEM by reader 1. There were no interval cancers at 1 year.
Conclusion : A significant increase in the detection of early-stage breast cancer was achieved using CEM after DBT. Despite substantially increasing the FPR, adding CEM to DBT improved the overall AUC by 0.19.
ClinicalTrials.gov registration no.: NCT04764292
Radiology , article en libre accès, 2025