Palmieri, Jennifer

PURPOSE Contrast-enhanced mammography (CEM) and magnetic resonance imaging (MRI) have shown similar diagnostic performance in detection of breast cancer. Limited CEM data are available for high-risk breast cancer screening. The purpose of the study was to prospectively investigate the efficacy of supplemental screening CEM in elevated risk patients. MATERIALS AND METHODS A prospective, single-institution, institutional review board–approved observational study was conducted in asymptomatic elevated risk women age 35 years or older who had a negative conventional two-dimensional digital breast tomosynthesis screening mammography (MG) and no additional supplemental screening within the prior 12 months. RESULTS Four hundred sixty women were enrolled from February 2019 to April 2021. The median age was 56.8 (range, 35.0-79.2) years; 408 of 460 (88.7%) were mammographically dense. Biopsy revealed benign changes in 22 women (22/37, 59%), high-risk lesions in four women (4/37, 11%), and breast cancer in 11 women (11/37, 30%). Fourteen cancers (10 invasive, tumor size range 4-15 mm, median 9 mm) were diagnosed in 11 women. The overall supplemental cancer detection rate was 23.9 per 1,000 patients, 95% CI (12.0 to 42.4). All cancers were grade 1 or 2, ER+ ERBB2–, and node negative. CEM imaging screening offered high specificity (0.875 [95% CI, 0.844 to 0.906]), high NPV (0.998 [95% CI, 0.993 to 1.000), moderate PPV1 (0.164 [95% CI, 0.076 to 0.253), moderate PPV3 (0.275 [95% CI, 0.137 to 0.413]), and high sensitivity (0.917 [95% CI, 0.760 to 1.000]). At least 1 year of imaging follow-up was available on all patients, and one interval cancer was detected on breast MRI 4 months after negative screening CEM. CONCLUSION A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1,000 in women at an elevated risk for breast cancer. Larger, multi-institutional, multiyear CEM trials in patients at elevated risk are needed for validation.

Abstract Objective and Rationale: To investigate the utility of screening Contrast Enhanced Mammography (CEM) imaging as a supplemental screening tool in women at elevated risk for breast cancer. Materials and Methods: This prospective, single institution, IRB approved observational study was conducted in asymptomatic women 35 years of age or older who were deemed at elevated risk of breast cancer, defined as IBIS v.8.0 lifetime risk of breast cancer score >15% or a prior personal history of breast cancer. Enrollment started in January 2019 and is on-going. An interim data analysis was performed. Women were invited to undergo supplemental CEM screening within 180 days of negative (BI-RADS 1 or 2) conventional 2D/3D screening mammography (MG). Patients with prior screening MBI, ultrasound or MR imaging within 12 months were excluded from study participation. Outcome measures were supplemental cancer detection rates, sensitivity, specificity, positive predictive value, and negative predictive value of CEM, along with their 95% confidence intervals, as well as the biologic profiles of MG-occult, CEM detected cancers. Results: A total of 351 women were enrolled in this prospective study over a 20-month period. To date, we have 1 year follow up on 106 cases with negative follow-up MG. Average age of the participants was 56 years ± 9.44 (standard deviation); 11 patients had screening 2D MG, 333 had combined 3-D and 2-D screening MG; 309 dense and 37 non-dense breasts based on ACR BI-RADS categories. CEM depicted 8 additional breast cancers (table 1), which were otherwise MG occult, for an overall supplemental cancer detection rate of 22.7 per 1000 patients, 95% CI (9.9, 44.3). 1 false negative cancer on CEM imaging which was further detected on MR imaging only. Biopsy revealed 16 benign changes (16/28=57%), 4 high-risk lesions (4/28=14%), and 8 breast cancers (8/28=29%) (table 2). CEM imaging screening offered high specificity (0.942, 95% CI (0.917, 0.967), high NPV 0.997, 95% CI (0.991, 1.000) and moderate PPV (0.286, 95% CI (0.118, 0.453) and sensitivity (0.889, 95% CI (0.684, 1.000)). Size of CEM detected cancers ranged from 7 to 57 mm. Conclusion: This pilot trial demonstrates a supplemental cancer detection rate of 22.7 per 1000 during prevalence round of CEM screening in women at an elevated risk for breast cancer. These initial results are comparable to results reported for high-risk surveillance MR imaging. Larger, multi-institutional high-risk CEM trials are needed for those patients who are not otherwise undergoing regular supplemental surveillance MR imaging. Citation Format: Bhavika K. Patel, Victor Pizzitola, Donald Northfelt, Karen Anderson, Marina Giurescu, Gina Mazza, Roxanne Lorans, William Eversman, Richard Sharpe, Juliana Kling, Denise Millstine, Ernst Brenda, Patricia Cronin, Heidi Apsey, Jennifer Palmieri, Barbara Pockaj, Michele Halyard. Supplemental contrast enhanced mammography screening of women with elevated risk of breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS2-41.

Abstract Objective Breast implant augmentation is the most common cosmetic surgical procedure performed in the United States. The purpose of this study was to determine if patients with breast augmentation surgery are aware of the effect of breast implants on the mammographic detection of cancer. Methods An institutional review board exempt patient awareness survey was distributed at a single breast imaging facility to women undergoing screening mammography. Comparative statistical analyses were performed between patients with and without breast implants. Results The respondents were divided into three groups: no prior breast surgery (74%; 524/711), breast surgery with implants (21%; 152/711), and breast surgery without implants (5%; 35/711). Patients with breast implants were more aware that implants decrease the amount of breast tissue seen on a mammogram (75%; 105/141) and that implants result in the need for more mammogram views (70%; 103/147), as compared with patients with no surgery (46%; 221/484 and 31%; 147/478, respectively) (P < 0.001). More women with breast implants reported learning from breast imaging staff rather than from their surgeon that implants decrease the amount of breast tissue seen on a mammogram (46%; 49/106 vs. 38%; 40/106). Of 137 respondents, 35% (n = 48) reported that the effect of implants on their mammogram was discussed preoperatively. Of those who did not recall a preoperative discussion, 42% (16/38) indicated this knowledge would have factored into their decision to get breast implants. Conclusion This study highlights an opportunity for providers to engage in more education and shared decision-making with patients considering breast augmentation surgery to ensure preoperative counseling includes discussion of the effect of implants on mammography.