Media Tip Sheet Contact: Jeanne-Marie Phillips HealthFlash Marketing 203-977-3333 jphillips@healthflashmarketing.com Additional Notable Research and Presented at the 15th Annual Meeting of the American Society of Breast Surgeons The following newsworthy abstracts presented at the 15th Annual Meeting of the American Society of Breast Surgeons (ASBrS) may be of particular interest to press, in addition to presentations during the Media Press Briefing. Researchers are available for telephone interviews. Onsite media is invited to attend all scientific sessions. Abstracts Contralateral Prophylactic Mastectomy Provides No Survival Benefit In Young Women With Estrogen Receptor Negative Breast Cancer Lead Author: Dr. Catherine Pesce NorthShore University HealthSystem Evanston, IL Total Skin-Sparing Mastectomy and Immediate Breast Reconstruction: An Evolution of Technique over 986 Cases. Lead Author: Dr. Frederick Wang University of California, San Francisco San Francisco, CA Reasons for Re-excision After Lumpectomy for Breast Cancer can be Identified in the American Society of Breast Surgeons (ASBrS) MasterySM Program Lead Author: Jeffrey Landercasper Gundersen Health System La Crosse, WI Page 1 of 8 Breast Imaging Second Opinions at a Tertiary Care Center: Impact on Clinical and Surgical Management Lead Author: Kjirsten Carlson Rush University Medical Center Chicago, IL Prospective Randomized Trial of Drain Antisepsis to Reduce Bacterial Colonization of Surgical Drains After Mastectomy with Immediate Expander/Implant Reconstruction Lead Author: Amy Degnim Mayo Clinic Rochester, MN ATTRIBUTION TO THE 15th ANNUAL MEETING OF THE AMERICAN SOCIETY OF BREAST SURGEONS IS REQUESTED IN ALL COVERAGE. Page 2 of 8 Presenter: Catherine Pesce Institution: NorthShore University HealthSystem, Evanston, IL Title: Contralateral Prophylactic Mastectomy Provides No Survival Benefit In Young Women With Estrogen Receptor Negative Breast Cancer Objective: Several studies have shown that contralateral prophylactic mastectomy (CPM) provides a disease free and overall survival benefit in young women with unilateral breast cancer that is estrogen receptor (ER) negative. We utilized the National Cancer Data Base to evaluate CPM’s survival benefit for young women with early stage breast cancer in the years that ER status was available. Method: We selected women <45 years old with AJCC Stage I-II breast cancer who underwent unilateral mastectomy or CPM from 2004-2006. Five-year overall survival (OS) was compared between those who had unilateral mastectomy and CPM using the Kaplan-Meier method and Cox regression analysis. Median follow up was 5.9 years. Results: A total of a 393,582 women fulfilled eligibility criteria. 84.3% of women underwent unilateral mastectomy and 15.7% of women underwent CPM. 58.2% of women had Stage 1 disease vs 41.8% with Stage 2 disease. 79.7% were ER positive and 20.3% ER negative. Of all women <45 years old who underwent CPM, there was no improvement in OS compared with women who underwent unilateral mastectomy (HR=1.183, 95% CI 0.985-1.422) after adjusting for patient age, race, insurance status, year of diagnosis, ER status, tumor size, nodal status, grade, histology, facility type, facility location, co-morbidities, use of adjuvant radiation and chemohormonal therapy. When women <45 years old with T1N0 tumors were examined, there was also no improvement in OS compared with women who underwent unilateral mastectomy (HR=1.317, p=0.2071) after adjusting for the aforementioned factors. Among women <45 years old with ER negative tumors who underwent CPM, there was no improvement in OS compared with women who underwent unilateral mastectomy (HR=0.947, p=0.6922) adjusting for the same aforementioned factors for both Stage I and II disease. Conclusion: CPM provides no survival benefit to young patients with early stage breast cancer and no benefit to ER negative patients. Future studies with longer follow up are required to determine if CPM will provide a survival benefit in this cohort of patients. Page 3 of 8 Presenter: Frederick Wang Institution: University of California, San Francisco, San Francisco, CA Title: Total Skin-Sparing Mastectomy and Immediate Breast Reconstruction: An Evolution of Technique over 986 Cases. Objective: Total skin-sparing mastectomy (TSSM) with complete preservation of the breast and nipple-areolar complex (NAC) skin and excision of nipple tissue was developed to improve aesthetic outcomes for treatment of early stage breast cancer or for prophylactic indications. Over the past 12 years, TSSM has been offered for a wider range of indications as NAC preservation rates improved and as locoregional recurrence rates were shown to be similar to other mastectomy techniques. We aim to demonstrate that the technique of TSSM has developed into a feasible standard for mastectomy. Methods: We reviewed our experience of TSSM and immediate breast reconstruction from October 2001 to December 2012. Cases were divided into several learning cohorts defined by intentional changes in technique and management, which led to serial improvements in outcomes. The initial cohort focused on defining the appropriate placement of incisions for TSSM to maximize NAC survival. Subsequent improvements included increasing the minimum time from completion of radiation therapy to expander-implant exchange from 3 months to 6 months, switching from cephalosporins to trimethoprim-sulfamethoxazole for standard postoperative antibiotic prophylaxis unless contraindicated, and examining the utility of acellular dermal matrix in tissue expander/implant reconstruction. Postoperative complications and outcomes were obtained via retrospective chart review from 2001-2005 and gathered prospectively from 2005-2012. Results: A total of 640 patients underwent 986 cases of TSSM with mean follow-up time of 25±20 months. The mean age at mastectomy was 47±10 years. 32.5% of patients underwent neoadjuvant chemotherapy and 16.4% underwent adjuvant chemotherapy for breast cancer treatment. Comorbidities among patients included diabetes (1.6%), current or prior smoking (16.6%), and prior radiation history (7.7%). Of all TSSM cases, 35.0% were performed for prophylactic indications while therapeutic cases included stage 0 (35.9%), stage 1 (28.9%), stage 2 (23.4%), stage 3 (10.9%), and stage 4 (0.9%) disease. Post-mastectomy radiation therapy was performed in 18.9% of the therapeutic cases. Immediate breast reconstruction was performed in all cases with either tissue expander placement (85.1%), pedicle TRAM (6.3%), free TRAM (4.8%), permanent implant (3.0%), or latissimus flap (0.4%). Postoperative complications included the development of serious infection requiring IV antibiotics or operative intervention (9.8%), partial nipple necrosis (0.6%), complete nipple necrosis (1.0%), skin flap necrosis (8.4%), and expander/implant loss (8.4%). Radiation therapy was shown to increase the risk for developing serious infections (RR 2.7, p<0.05), major skin flap necrosis (RR 2.1, p<0.05), and expander/implant loss (RR 3.6, p<0.05) but had no significant effect on partial or complete NAC necrosis. Smoking history was shown to increase the risk of serious infection (RR 1.9, p<0.05), skin necrosis (RR 1.6, p<0.05), and expander/implant loss (RR 1.8, p<0.05). The 5-year cumulative incidence of locoregional recurrence was 3.0%, and the 5-year diseasefree survival was 92.2%. Conclusion: Our technique of TSSM and immediate breast reconstruction has undergone substantial development since 2001. We have improved outcomes and decreased postoperative complications through a systematic series of learning cohorts. Serial improvements in technique and emerging data on longer-term oncologic safety make this surgical approach feasible as a standard for mastectomy. Page 4 of 8 Presenter: Jeffrey Landercasper Institution: Gundersen Health System, La Crosse, WI Title: Reasons for re-excision after lumpectomy for breast cancer can be identified in the American Society of Breast Surgeons (ASBrS) MasterySM Program Objective: There is strong evidence of marked variability of re-excision rates after initial lumpectomy for breast cancer. Reasons for re-excision have not been well documented. Recent research suggests some re-excisions are performed unnecessarily due to differences in surgeon opinion regarding adequacy of margin width. We hypothesized the ASBrS MasterySM Program can identify variation in re-excision rates and reasons for re-excision to aid the development of performance improvement strategies to reduce secondary breast operations. Methods: In the ASBrS MasterySM Program, surgeons can enter information on patient demographics, surgical procedures and quality measures with immediate peer performance comparison as a method of performance assessment and improvement. Data from January 1 – November 5, 2013 were evaluated to determine re- excision lumpectomy rate (RELR). On June 1, 2013, a dropdown menu was added to the MasterySM data collection tool to track reasons for re-excision. RELR was defined as the number of patients undergoing re-excision after lumpectomy divided by the number of patients having initial lumpectomy for cancer. Variation in re-excision rates by surgeon and patient characteristics was performed by chi square for univariate analysis. Results: Three hundred twenty six surgeons reported on 6523 unique patients who had undergone initial lumpectomy for cancer, with 1458 (22.4%) undergoing one or more reexcisions. Two hundred thirteen surgeons reported at least 10 lumpectomies (range 10-163) during the queried period. For patients having re-excision by these surgeons, the number of reexcisions ranged from 1- 4 (mean 1.1). Re-excision rates were higher in non-Caucasian (p=0.006) and Hispanic (p=0.008) patients, were lower in surgeons who had been in practice longer (p< 0.001), and were no different according to primary insurance type (p=0.15). Reasons for re-excision were documented in 1575 re-excision procedures and are detailed in the table below. The most common reasons were an ink positive margin (49.7%) or a margin < 1 mm (34.3%). Conclusion: The ASBrS MasterySM Program provides a rapid, contemporary, and valuable source of data on specific reasons for re-excision lumpectomy. Variability of re-excision by surgeon and patient characteristics was identified. Most re-excisions are performed for margins that are positive or < 1 mm. This information corroborates surgeon survey data regarding reasons for re-excision and provides proof of concept the MasterySM Program can measure reexcisions in real time, providing a method for monitoring during future performance initiatives. Reasons for Re-excision Lumpectomy Procedures Reason N Percent Ink positive margin Margin < 1 mm Margin 1-2 mm Post lumpectomy imaging demonstrated evidence of residual disease Prior surgery elsewhere, margin status uncertain Margin >2 mm but desire wider margins 783 540 114 38 49.7% 34.3% 7.2% 2.4% 25 16 1.6% 1.0% Page 5 of 8 Tumor board recommended wider margins Fragmented specimen, margin status uncertain Radiation oncologist recommended wider margins Other Total procedures Page 6 of 8 6 3 2 48 1575 0.4% 0.2% 0.1% 3.1% 100% Presenter: Kjirsten Carlson Institution: Rush University Medical Center, Chicago, IL Title: Breast Imaging Second Opinions at a Tertiary Care Center: Impact on Clinical and Surgical Management Objective: Breast surgeons often see women for second opinions for abnormalities found on breast imaging. For second opinions, these images are submitted for review and interpretation by dedicated breast imagers. This study aims to evaluate the conformity of results among interpretation of imaging submitted from outside hospitals both from tertiary care centers as well as community programs, in an attempt to evaluate the utility of this practice for the sake of clinical management and resource utilization. Methods: A retrospective chart review was conducted on all breast patients that submitted outside imaging films for the years 2011 to 2013 at our University Medical Center (UMC). The radiologic diagnosis and each patient’s proposed management plan was collected and evaluated for concordance between the outside institutions and UMC. Results: A total of 380 patients who presented for second opinions with an interpretation of outside exams were evaluated. In 47.4% (95% confidence interval [CI] 42.4 – 52.4%) of cases there was distinct variance in radiologic impression. For 53.5% (95% CI 48.4 – 58.5%) of patients there was a change in recommended management plan which included recommendations for either additional imaging or need for additional biopsy. In total, this changed the overall surgical management in 27.1% (95% CI 22.8 – 31.9%) of cases. In five patients the re-interpretation of outside imaging detected new malignancies not previously identified. Overall, 83.7% (95% CI 79.7 – 87.1%) of patients who submitted imaging from outside institutions chose to complete the remainder of their treatment at UMC. Conclusion: The practice of submission of outside imaging to a dedicated breast imager is a common practice and the impact was evaluated in terms of radiologic concordance among institutions, differences in recommended workup, and how the second opinion ultimately affected definitive management. Review by a dedicated breast imager at our specialized center (UMC) resulted in an increased number of breast abnormalities detected. Second opinion review also resulted in a spectrum of additional workup including further mammographic views, different imaging modalities (ultrasound and/or MRI), and in some cases, additional biopsies. In rare cases the re-interpretation of imaging reported benign findings when additional workup was recommended by the outside institution. Overall definitive management was changed based on the second opinions at our specialty center in more than one in four cases. Most importantly, the review identified five previously unrecognized malignancies. For every 100 images submitted for review 1.3 new malignancies were identified. Given this data, the practice of second opinions and interpretation of outside exams should continue despite the additional resources required. Page 7 of 8 Presenter: Amy Degnim Institution: Mayo Clinic, Rochester, MN Title: Prospective Randomized Trial of Drain Antisepsis to Reduce Bacterial Colonization of Surgical Drains After Mastectomy with Immediate Expander/Implant Reconstruction Objective: Bacterial colonization of surgical drains after breast and axillary surgery may contribute to surgical site infection (SSI). In the setting of implant-based immediate breast reconstruction, SSI can result in reconstruction failure. We designed a randomized trial to investigate the efficacy of antiseptic drain care in reducing bacterial colonization of surgical drains placed at mastectomy with immediate expander/implant reconstruction. Methods: With IRB approval, patients undergoing bilateral mastectomy and immediate tissue expander or implant-based breast reconstruction were randomly assigned to standard drain care (control) for one side, and drain antisepsis (treatment) for the other side. Thus, the design was a paired, within-patient comparison of the treated and control sides. For standard drain care (control), the exit site was cleaned twice daily with alcohol and covered with sterile gauze. Antisepsis drain care (treatment) included: 1) a chlorhexidine disc and occlusive dressing at the drain exit site, and 2) irrigation of the drain bulb twice daily with dilute sodium hypochlorite solution. Drain bulb fluid was collected at one week for bacterial culture (primary endpoint). At drain removal, both subcutaneous drain tubing and drain bulb fluid were also cultured. Primary analysis was modified intent-to-treat. A side was classified as positive for colonization if any of the drains on that side demonstrated positive cultures (1+ or greater growth in drain fluid; >50 CFU for drain tubing). Colonization and SSI outcomes were compared between sides within patients using the exact sign test for paired proportions. Results: Overall, 104 patients across two institutions were included and 101 (97%) had results for the primary endpoint. Cultures of drain bulb fluid at one week were positive in 20.8% (21/101) of control sides compared to 9.9% of treatment sides (10/101), (p=0.03). Among 45 patients whose drains were removed after the 1 week visit, positive cultures of drain bulb fluid at removal were also more frequent among control sides as compared to treatment sides, 47% (21/45) vs 27% (12/45), p=0.02. Drain tubing cultures demonstrated >50 CFU in 5.9% (6/101) of control drains versus 0% of treated drains (p=0.03). SSI was diagnosed within 30 days for 3 sides in 3 patients; these infections all occurred on the control side, for a frequency of 2.9% (3/104) of control sides versus 0% of antisepsis sides (p = 0.25). Including all infections within 1 year, infections occurred in 5/104 (4.8%) of control sides as compared to 3/104 (2.9%) of antisepsis sides (p = 0.69). The sides with colonization of either tubing or bulb fluid at any time point showed a subsequent infection rate of 8.1% as compared to 1.4% infection rate on sides without colonization of bulb fluid or tubing (p = 0.04). Conclusion: Simple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains, and reduced colonization is associated with fewer SSIs. Drain antisepsis techniques warrant further study toward reducing SSI in immediate tissue expander/implant breast reconstruction. Page 8 of 8