Introduction
Methods
Study population
Methodology and decision-making (pre- and post-CEM) categories
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Group (1): CEM provided no additional information for surgical management as compared to routine imaging studies (Fig. 1).
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Group (2): CEM provided additional clinical information but did not alter the surgical plan (e.g., newly detected suspicious lesions/malignancies in a diseased breast undergoing mastectomy) (Fig. 2).
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Group (3): CEM provided additional clinical information which is clinically significant and altered the surgical plan (e.g., newly detected suspicious lesions in a diseased breast undergoing conservation, newly detected suspicious lesions in the contralateral breast or significant change in tumor size (> 2 cm) or extent-to-breast volume ratio from a clinician-perceived perspective) (Fig. 3).
CEM image acquisition protocol and image analysis
Statistical analysis
Results
Patient characteristics
Parameter | Value (percentage) |
---|---|
Participant characteristics | |
Age, years | |
Mean ± SD | 53.4 ± 10.2 |
Range | 29–81 |
Breast density (based on FFDM and ACR-BI-RADS lexicon) | |
A (entirely fatty) | 1/200 (0.5%) |
B (scattered fibroglandular) | 8/200 (4.0%) |
C (heterogeneously dense) | 160/200 (80.0%) |
D (extremely dense) | 31/200 (15.5%) |
Patient’s history of breast cancer | |
Family history | 33/200 (16.5%) |
Personal history | 10/200 (5.0%) |
Tumor distribution | |
No. of patients with unifocal cancer | 172/200 (86.0%) |
No. of patients with 2 tumors | 24/200 (12.0%) |
No. of patients with ≥ 3 tumors# | 4/200 (2.0%) |
Total no. of tumors identified in 200 subjects | 232## |
Histology* | |
IDC (Invasive ductal carcinoma) | 108/200 (54.0%) |
Grade 1 | 22/108 (20.4%) |
Grade 2 | 54/108 (50.0%) |
Grade 3 | 32/108 (29.6%) |
DCIS (ductal carcinoma in situ) | 60/200 (30.0%) |
Low grade | 10/60 (16.7%) |
Intermediate grade | 25/60 (41.7%) |
High grade | 25/60 (41.7%) |
ILC (invasive lobular carcinoma) | 24/200 (12.0%) |
Others (i.e., mucinous cancer, papillary cancer, tubular carcinoma, etc.) or mixed cancers (e.g., mixed IDC with ILC) | 8/200 (4.0%) |
Tumor markers for invasive tumors | |
Luminal A | 92/140 (65.7%) |
Luminal B | 21/140 (15.0%) |
Triple negative | 11/140 (7.9%) |
Her2 enriched | 16/140 (11.4%) |
Surgical management change
Parameter | Value |
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Benign (n = 15 from 13 patients) | |
Histology | |
Fibrocystic change, sclerosing adenosis, stromal fibrosis | 8/15 (53.3%) |
Fibroadenoma | 5/15 (33.3%) |
Papilloma | 1/15 (6.7%) |
Radial scar | 1/15 (6.7%) |
Biopsy modality for benign lesions | |
Ultrasound guided | 11/15 (73.3%) |
MRI guided | 4/15 (26.7%) |
Malignant (n = 18 for 12 patients) | |
Histology | |
Invasive ductal carcinoma | 11/18 (61.1%) |
Invasive lobular carcinoma | 6/18 (33.3%) |
Ductal carcinoma in situ | 1/18 (5.6%) |
Biopsy modality for malignant lesions | |
Ultrasound guided | 17/18 (94.4%) |
MRI guided | 1/18 (5.6%) |
Treatment change | No. (percentage) |
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Wider excision (2 cm larger than initial plan) | 5/31 (16.1%) |
Wide excision to mastectomy | 23/31 (74.2%) |
Contralateral surgery | 3/31 (9.7%) |
Predictors for benefit from CEM
Unadjusted analysis | Adjusted analysis | |||||
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Parameter | No change in surgical management | Change in surgical management | Odds ratio (95% CI) | p value | Odds ratio (95% CI) | p value |
Age (± SD) | 53.3 ± 10.1 | 53.6 ± 10.9 | 1.00 (0.97–1.04) | 0.878 | 1.03 (0.98–1.08) | 0.240 |
Mammogram density | ||||||
Fatty + scattered fibroglandular tissue | 8 (88.9%) | 1 (11.1%) | 1.0 | – | 1.0 | – |
Heterogeneously dense + extremely dense | 156 (81.7%) | 35 (18.3%) | 1.8 (0.2–14.8) | 0.587 | 2.4 (0.2–24.4) | 0.459 |
Mammogram abnormality | ||||||
Mass/asymmetry | 83 (84.7%) | 15 (15.3%) | 0.90 (0.39–2.11) | 0.815 | 1.9 (0.4–9.4) | 0.413 |
Microcalcifications | 55 (83.3%) | 11 (16.7%) | 1.0 | – | 1.0 | – |
Architectural distortion | 17 (65.4%) | 9 (34.6%) | 2.6 (0.9–7.5) | 0.065 | 7.6 (1.3–42.9) | 0.022* |
Occult | 9 (90%) | 1 (10%) | 0.56 (0.06–4.84) | 0.595 | NA | NA |
No. of mammogram-detected lesions | ||||||
0 or 1 (i.e., unifocal) | 141 (81.5%) | 32 (18.5%) | 1.0 | – | 1.0 | – |
> 1 (multifocal/multicentric) | 23 (85.2%) | 4 (14.8%) | 0.77 (0.25–2.37) | 0.644 | 1.7 (0.4–7.7) | 0.504 |
Size of dominant abnormality on FFDM | ||||||
≥ 1.5 cm | 97 (80.2%) | 24 (19.8%) | 1.4 (0.6–3.0) | 0.404 | 4.6 (1.3–15.7) | 0.015* |
< 1.5 cm | 67 (84.8%) | 12 (15.2%) | 1.0 | – | 1.0 | – |
Histology | ||||||
Invasive lobular carcinoma (ILC) | 19 (79.2%) | 5 (20.8%) | 1.17 (0.36–3.82) | 0.79 | 0.60 (0.36–9.94) | 0.722 |
Other solid tumors (i.e., IDC, etc.) | 96 (82.8%) | 20 (17.2%) | 0.93 (0.41–2.09) | 0.86 | 0.73 (0.58–9.36) | 0.812 |
Non-solid tumors (i.e., DCIS) | 49 (81.7%) | 11 (18.3%) | 1.0 | – | 1.0 | – |
Hormone profile of detected cancers | ||||||
Luminal A | 74 (78.7%) | 20 (21.3%) | 2.6 (0.6–12.0) | 0.230 | 2.7 (0.5–13.5) | 0.240 |
Luminal B | 19 (90.5%) | 2 (9.5%) | 1.0 | – | 1.0 | – |
Triple negative | 10 (90.9%) | 1 (9.1%) | 0.95 (0.08–11.8) | 0.968 | 1.1 (0.1–21.1) | 0.931 |
Her2 enriched | 14 (87.5%) | 2 (12.5%) | 1.4 (0.2–10.8) | 0.773 | 2.0 (0.2–19.4) | 0.540 |
Pre-CEM decision | ||||||
Breast conservation (wide local excision with/without flap reconstruction) | 91 (75.8%) | 29 (24.2%) | 3.3 (1.4–8.0) | 0.008** | 7.7 (1.9–32.1) | 0.005** |
Others (e.g., neoadjuvant chemotherapy (NACT) + total mastectomy (TM) or bilateral surgery) | 73 (91.3%) | 7 (8.8%) | 1.0 | – | 1.0 | – |
Comparison of CEM vs MRI
Discussion
Conclusion
Acknowledgements
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Dr. Jennie Wong from the Division of Medical & Scientific Communication, NUHS Research Support Unit, Singapore, for proofreading and editing the manuscript
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Ms Yap Qai Wen from the National University of Singapore (NUS) Medicine Biostatistics Unit for assistance in biostatistics
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Ms. Pei-Ying Lin from Kaohsiung Veterans General Hospital for preparing manuscript