Nationwide Analysis of Locoregional Management for Ductal Carcinoma In Situ in Males: An NCDB Analysis of the Surgical Approach to DCIS in Males.

BACKGROUND: Limited data exist regarding the optimal locoregional approach for males with ductal carcinoma in situ (DCIS). This study examined trends in management and survival for males with DCIS. METHODS: The National Cancer Database (NCDB) was queried for males with a diagnosis of DCIS from 2006 to 2017. Patients were categorized by locoregional management. Continuous variables were evaluated by Kruskal-Wallis and categorical variables by chi-square or Fisher's exact test. Univariable and multivariable logistic regressions were performed to evaluate for predictors of patients receiving partial mastectomy (PM) with radiation. Survival was analyzed by Kaplan-Meier. RESULTS: Between 2006 and 2017, 711 males with DCIS were identified. Most received mastectomy alone (57.1%). No change was observed in management approach from 2006 to 2017. Patients who underwent mastectomy alone were mostly hormone-positive (95.9% were estrogen-positive, 90.9% were progesterone-positive), although this cohort was least likely to receive hormone therapy (17.2%). Among those who underwent PM with radiation, only 61% of those who were hormone-positive received hormone therapy. Univariable analysis demonstrated that those of black race had lower odds of receiving PM with radiation (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.36-0.84), which persisted in the multivariable analysis with control for age and tumor size (OR, 0.32; 95% CI, 0.15-0.67). Overall survival did not differ significantly between the four treatment methods (p = 0.08). CONCLUSIONS: The management approach to male DCIS did not change from 2006 to 2017. Survival did not differ between treatment methods. Demographic and clinicopathologic features, including race, may influence locoregional treatments received, and further studies are needed to further understand this.

Internal Mammary Lymphadenopathy Does Not Impact Oncologic Outcomes in Patients Treated with Neoadjuvant Chemotherapy: Results from the I-SPY2 Clinical Trial.

BACKGROUND: Internal mammary lymphadenopathy (IML) plays a role in breast cancer stage and prognosis. We aimed to evaluate method of IML detection, how IML impacts response to neoadjuvant chemotherapy (NAC), and oncologic outcomes. METHODS: We evaluated patients enrolled in the I-SPY-2 clinical trial from 2010 to 2022. We captured the radiographic method of IML detection (magnetic resonance imaging [MRI], positron emission tomography/computed tomography [PET/CT], or both) and compared patients with IML with those without. Rates of locoregional recurrence (LRR), distant recurrence (DR) and event-free survival (EFS) were compared by bivariate analysis. RESULTS: Of 2095 patients, 198 (9.5%) had IML reported on pretreatment imaging. The method of IML detection was 154 (77.8%) MRI only, 11 (5.6%) PET/CT only, and 33 (16.7%) both. Factors associated with IML were younger age (p = 0.001), larger tumors (p < 0.001), and higher tumor grade (p = 0.027). Pathologic complete response (pCR) was slightly higher in the IML group (41.4% vs. 34.0%; p = 0.03). There was no difference in breast or axillary surgery (p = 0.41 and p = 0.16), however IML patients were more likely to undergo radiation (68.2% vs. 54.1%; p < 0.001). With a median follow up of 3.72 years (range 0.4-10.2), there was no difference between IM+ versus IM- in LRR (5.6% vs. 3.8%; p = 0.25), DR (9.1% vs. 7.9%; p = 0.58), or EFS (61.6% vs. 57.2%; p = 0.48). This was true for patients with and without pCR. CONCLUSIONS: In this large cohort of patients treated with NAC, outcomes were not negatively impacted by IML. We demonstrated that IML influences treatment selection but is not a poor prognostic indicator when treated with modern NAC and multidisciplinary disease management.

Society of Surgical Oncology Breast Disease Site Working Group Statement on Contralateral Mastectomy: Indications, Outcomes, and Risks.

Rates of contralateral mastectomy (CM) among patients with unilateral breast cancer have been increasing in the United States. In this Society of Surgical Oncology position statement, we review the literature addressing the indications, risks, and benefits of CM since the society's 2017 statement. We held a virtual meeting to outline key topics and then conducted a literature search using PubMed to identify relevant articles. We reviewed the articles and made recommendations based on group consensus. Patients consider CM for many reasons, including concerns regarding the risk of contralateral breast cancer (CBC), desire for improved cosmesis and symmetry, and preferences to avoid ongoing screening, whereas surgeons primarily consider CBC risk when making a recommendation for CM. For patients with a high risk of CBC, CM reduces the risk of new breast cancer, however it is not known to convey an overall survival benefit. Studies evaluating patient satisfaction with CM and reconstruction have yielded mixed results. Imaging with mammography within 12 months before CM is recommended, but routine preoperative breast magnetic resonance imaging is not; there is also no evidence to support routine postmastectomy imaging surveillance. Because the likelihood of identifying an occult malignancy during CM is low, routine sentinel lymph node surgery is not recommended. Data on the rates of postoperative complications are conflicting, and such complications may not be directly related to CM. Adjuvant therapy delays due to complications have not been reported. Surgeons can reduce CM rates by encouraging shared decision making and informed discussions incorporating patient preferences.

Clipping the Positive Lymph Node in Patients with Clinically Node Positive Breast Cancer Treated with Neoadjuvant Chemotherapy: Impact on Axillary Surgery in the ISPY-2 Clinical Trial.

BACKGROUND: For patients with clinically node-positive (cN+) breast cancer undergoing neoadjuvant chemotherapy (NAC), retrieving previously clipped, biopsy-proven positive lymph nodes during sentinel lymph node biopsy [i.e., targeted axillary dissection (TAD)] may reduce false negative rates. However, the overall utilization and impact of clipping positive nodes remains uncertain. PATIENTS AND METHODS: We retrospectively analyzed cN+ ISPY-2 patients (2011-2022) undergoing axillary surgery after NAC. We evaluated trends in node clipping and associations with type of axillary surgery [sentinel lymph node (SLN) only, SLN and axillary lymph node dissection (ALND), or ALND only] and event-free survival (EFS) in patients that were cN+ on a NAC trial. RESULTS: Among 801 cN+ patients, 161 (20.1%) had pre-NAC clip placement in the positive node. The proportion of patients that were cN+ undergoing clip placement increased from 2.4 to 36.2% between 2011 and 2021. Multivariable logistic regression showed nodal clipping was independently associated with higher odds of SLN-only surgery [odds ratio (OR) 4.3, 95% confidence interval (CI) 2.8-6.8, p < 0.001]. This was also true among patients with residual pathologically node-positive (pN+) disease. Completion ALND rate did not differ based on clip retrieval success. No significant differences in EFS were observed in those with or without clip placement, both with or without successful clip retrieval [hazard ratio (HR) 0.85, 95% CI 0.4-1.7, p = 0.7; HR 1.8, 95% CI 0.5-6.0, p = 0.3, respectively]. CONCLUSION: Clip placement in the positive lymph node before NAC is increasingly common. The significant association between clip placement and omission of axillary dissection, even among patients with pN+ disease, suggests a paradigm shift toward TAD as a definitive surgical management strategy in patients with pN+ disease after NAC.

Using a Business Model (the 4 Disciplines of Execution) to Improve Consistency, Efficiency, and Length of Stay in Microvascular Autologous Breast Reconstruction.

BACKGROUND: Autologous free tissue transfer is a common method of breast reconstruction in the United States, but it involves many care teams and can incur a large cost on an institution. The consistency and efficiency of performing these procedures can be improved with a method called the 4 disciplines of execution (4DX). METHODS: Patients that underwent autologous breast reconstruction between 2015 and 2020 were included. Midway through the collection period, several preoperative and intraoperative interventions were implemented using the 4DX. Then, 2 cohorts of patients were analyzed for differences in operative times, length of stay (LOS), and major complications. RESULTS: Thirty-two total patients were included. The median operative time before interventions were implemented was 828 minutes, and the median operative time after interventions was 619 minutes (P < 0.05). The median LOS in days before interventions was 5 days, and the median LOS after interventions was 3 days (P < 0.05). There were no statistically significant differences in complications before or after the interventions. CONCLUSIONS: The 4DX successfully improved consistency and efficiency in the process of performing autologous breast reconstruction at our institution, as evidenced by a faster median operative time and shorter patient LOS in the hospital.

National trends for axillary lymph node dissection and survival outcomes for clinical T3/T4 node-negative breast cancer patients undergoing mastectomy with positive lymph nodes.

PURPOSE: Previous studies have suggested axillary lymph node dissection (ALND) can be omitted in early breast cancer patients undergoing mastectomy with positive lymph nodes (LNs). We assessed the national utilization of ALND and overall survival (OS) for larger, locally advanced tumors in patients undergoing mastectomy with positive LNs. METHODS: The National Cancer Database from 2006 to 2016 was queried for mastectomy patients with clinical T3/T4, N0 tumors, and 1-2 positive LNs. Trends and outcomes for ALND were compared to sentinel lymph node biopsy (SLNB) alone. RESULTS: Thousand nine hundred and seventeen women were included. The proportion of ALND decreased from 70% pre-Z0011 to 52% post-Z0011. On Kaplan-Meier analysis, ALND had better OS compared to SLNB alone (p < 0.01). On multivariate analysis, age (p < 0.01), chemotherapy (p < 0.01), and hormonal therapy (p < 0.01) were associated with better OS. In patients who received adjuvant radiation therapy (ART) ALND improved OS on multivariate analysis (p < 0.01). CONCLUSION: This is the first large database study to demonstrate a national trend to forego ALND in mastectomy patients with large or locally advanced tumors (T3/T4abc) and 1-2 positive lymph nodes. This study suggests a survival benefit for ALND, particularly in patients receiving ART. Careful consideration and further investigations should be performed prior to omitting ALND this patient population.

Trends and Outcomes Associated With Axillary Management of Males With Clinical N0 Breast Cancer-An NCDB Analysis.

BACKGROUND: Sentinel Lymph Node Biopsy (SLNB) is standard of care for women with clinically N0 breast cancer. However, there are no randomized controlled studies in men determining optimal surgical axillary management. METHODS: Using the National Cancer Database, males diagnosed from 2006-2016 with clinical T1-4 N0 tumors treated with primary surgery were identified and categorized by axillary management. Clinicopathologic variables were compared between two timeframes, 2006-2011 and 2012-2016. Survival analysis was performed. RESULTS: We identified 2,646 males meeting criteria. Use of SLNB increased (65.9%-72.8%, P < 0.01). For those who underwent ALND, administration of radiation (31.1% versus 48.8%, P < 0.01) and endocrine therapy (70.2% versus 80.7%, P < 0.01) increased. There was no difference in survival between timeframes (P = 0.42). For those who underwent SLNB, tumor grade (P = 0.02) and pathologic T stage (P < 0.01) were higher and more patients underwent mastectomy (74.9% versus 79.4%, P = 0.02). Administration of chemotherapy decreased (35.1% versus 27.2%, P < 0.01) and endocrine therapy increased (72.1% versus 81.3%, P < 0.01). Survival of those who underwent sentinel lymph node biopsy (SLNB) diagnosed 2012-2016 was worse than those diagnosed 2006-2011 (P = 0.01). CONCLUSIONS: Use of SLNB alone has increased while ALND has declined in males with clinically N0 breast cancer. However, patients who underwent SLNB alone in the later time period had worse clinical characteristics and experienced differences in adjuvant therapy. This suggests increased acceptance of the use of SLNB for axillary management. Further analysis is warranted to evaluate methods of axillary staging and the impact on outcomes in males with breast cancer.

National Trend of Axillary Management in Clinical T3/T4 N0 Patients Having Breast Conserving Therapy.

BACKGROUND: The ACOSOG Z0011 trial has essentially eliminated axillary lymph node dissection (ALND) in breast conserving therapy (BCT) patients with clinical T1/T2 and 1-2 positive sentinel lymph nodes (SLNs). Currently, ALND is recommended for positive SLNs unless ACOSOG Z0011 criteria are applicable. We aimed to assess the national trends and axillary management before and after the publication of ACOSOG Z0011 for larger tumors. METHODS: An IRB-approved study evaluated the National Cancer Database from 2006 to 2016. Women with clinical T3/T4, N0 who otherwise fit ACOSOG Z0011 criteria were included. Neoadjuvant systemic therapy or known nodal disease was excluded. Clinicopathologic data were compared between two timeframes based on ACOSOZ Z0011 publication and by axillary management. Patients were categorized into SLNB alone (1-5 lymph nodes examined) and ALND (≥10 lymph nodes examined) groups. RESULTS: A total of 230 women fit inclusion criteria, of whom 36% underwent ALND. ALND use decreased from 54% in 2006 to 14% in 2016 (P < 0.01). Comparing ALND to SLNB alone within the pre-Z0011 era, comprehensive community cancer programs had higher proportions of ALND, whereas academic centers had higher rates of SLND alone (P = 0.03). Comparing similar axillary management between eras, SLNB-alone patients in the post-Z0011 era had higher pT and pN stages, were less likely to be Her2 positive, and were more likely to receive systemic treatment. CONCLUSIONS: There is a national trend to forgo ALND in women who have tumors larger than those included in the Z0011 criteria without any clear clinicopathologic indications.

Screening of populations at high risk for breast cancer.

The approach to screening patients at high risk for breast cancer has thus far been challenging to standardize, given limited high-level evidence in this population. The approach has evolved given the development of more effective screening modalities, including digital breast mammography, magnetic resonance imaging, and other emerging technologies. This review will discuss identification of high-risk patients, approaches to genetic counseling and testing, and evidence behind screening modalities and algorithms in this special population.

Outcomes of Sentinel Lymph Node-Positive Breast Cancer Patients Treated with Mastectomy Without Axillary Therapy.

PURPOSE: Early-stage breast cancer patients with minimal axillary disease identified by sentinel lymph node dissection (SLND) have low regional recurrence rates when treated with breast-conserving surgery and radiation therapy (XRT) and many avoid a completion axillary lymph node dissection (CLND). As the incidence of total mastectomy (TM) has increased, it has become important to characterize which TM patients with a positive SLN may not benefit from further axillary treatment. METHODS: An institutional database was utilized to identify patients treated with a TM for invasive breast cancer and who had a positive SLN from 1994 to 2010. Clinicopathologic factors were analyzed. Regional recurrence rate, recurrence-free survival (RFS), and overall survival (OS) were determined. RESULTS: A total of 525 patients with invasive breast cancer and a positive SLN were treated with TM, including 58 patients who did not have CLND or XRT and 12 patients who did not have CLND but did receive XRT. Median follow-up was 66 months. The incidence of regional recurrence was not significantly different for patients who received no further axillary treatment compared to those who underwent CLND without XRT or those treated with XRT without CLND (10 years rate: 3.8 vs. 1.6 and 0 % respectively). RFS and OS were not significantly different among patients who received no further axillary treatment compared to those who underwent CLND, XRT, or both. CONCLUSIONS: In select patients with early-stage breast cancer treated with mastectomy with a positive SLN, CLND may be avoided without adversely affecting recurrence or survival.

Impact of axillary ultrasound (AUS) on axillary dissection in breast conserving surgery (BCS).

BACKGROUND AND OBJECTIVES: Preoperative axillary ultrasound (AUS) in clinically node-negative patients may increase axillary lymph node dissection (ALND) in ACoSOG Z0011-eligible patients. We hypothesize that AUS identifies operative axillary disease (>3 positive nodes) in women undergoing breast conserving surgery (BCS). METHODS: After IRB approval, a retrospective review of female breast cancer patients was performed; patients with clinical T1/T2 tumors undergoing BCS were included. Clinical, radiologic, and pathologic data were collected. RESULTS: Of 139 eligible subjects, 119/139 (86%) had nonpalpable axillary nodes. 47/119 patients (40%) had abnormal AUS and 15/47 (32%) had a positive FNA. Fourteen had ALND ;10/14 (71%) had >3 positive nodes. 6/32 (18%) with abnormal AUS but FNA negative were sentinel lymph node (SLN) positive. Of 72 normal AUS, 15 (22%) were SLN positive; 9/15 (60%) had ALND; 1 (11%) had >3 positive nodes. When evaluating for >3 positive nodes, AUS plus FNA had a sensitivity of 91%, specificity of 95%, NPV of 99%, and PPV of 71%. CONCLUSIONS: AUS/FNA has a high NPV for axillary metastasis and remarkable sensitivity for three or more positive axillary nodes, therefore AUS-identified metastasis should be treated as clinically node-positive disease, and is appropriate even in patients planning breast conserving surgery.

Survey results of COVID-19 pandemic on female surgical trainees: New normal work environment.

BACKGROUND: The COVID-19 pandemic has had a profound impact on surgical training globally. We aimed to explore and identify the specific challenges faced by women surgeons during the pandemic and provide recommendations for improvement. METHODS: A survey was conducted among trainee members of the Association of Women Surgeons, assessing various aspects of clinical training, mental well-being, and personal and professional life. RESULTS: The respondents were distributed across the United States, with the majority (28%) from the Midwest and Northeast. Training settings were predominantly academic university hospital programs (85%). The majority (92%) were resident trainees and 32% were in research. General surgery, constituting 86% of the respondents, was the most common specialty. There was a decline in surgical cases, research, mental health, and quality of didactics. Limited learning opportunities and challenges in job search were reported. Although virtual conferences were deemed affordable, the lack of networking was noted to be significant. CONCLUSION: The study highlights the need for ongoing support and adaptation in surgical training programs. These programs include the optimization of virtual platforms, prioritizing mental well-being, and ensuring equal opportunities. Strategies to mitigate the impact of future disruptions and promote gender equality are essential. Further research and workflow changes are warranted for effective capacity building.

Implementation of a novel peer review academy by Surgery and the Association of Women Surgeons.

BACKGROUND: A novel Peer Review Academy was developed as a collaborative effort between the Association of Women Surgeons and the journal Surgery to provide formal training in peer review. We aimed to describe the outcomes of this initiative using a mixed methods approach. METHODS: We developed a year-long curriculum with monthly online didactic sessions. Women surgical trainee mentees were paired 1:1 with rotating women surgical faculty mentors for 3 formal peer review opportunities. We analyzed pre-course and post-course surveys to evaluate mentee perceptions of the academy and assessed changes in mentee review quality over time with blinded scoring of unedited reviews. Semi-structured interviews were conducted upon course completion. RESULTS: Ten women surgical faculty mentors and 10 women surgical trainees from across the United States and Canada successfully completed the Peer Review Academy. There were improvements in the mentees' confidence for all domains of peer review evaluated, including overall confidence in peer review, study novelty, study design, analytic approach, and review formatting (all, P ≤ .02). The mean score of peer review quality increased over time (59.2 ± 10.8 vs 76.5 ± 9.4; P = .02). In semi-structured interviews, important elements were emphasized across the Innovation, Implementation Process, and Individuals Domains, including the values of (1) a comprehensive approach to formal peer review education; (2) mentoring relationships between women faculty and resident surgeons; and (3) increasing diversity in the scientific peer review process. CONCLUSION: Our novel Peer Review Academy was feasible on a national scale, resulting in significant qualitative and quantitative improvements in women surgical trainee skillsets, and has the potential to grow and diversify the existing peer review pool.

Lessons from other fields of medicine, Part 1: Breast cancer.

Through the understanding of multiple etiologies, pathologies, and disease progression trajectories, breast cancer shifted historically from a singular malignancy of the breast to a complex of molecular/biological entities, translating into individualized disease-modifying treatments. As a result, this led to various de-escalations of treatment compared with the gold standard in the era preceding systems biology: radical mastectomy. Targeted therapies have minimized morbidity from the treatments and mortality from the disease. Biomarkers further individualized tumor genetics and molecular biology to optimize treatments targeting specific cancer cells. Landmark discoveries in breast cancer management have evolved through histology, hormone receptors, human epidermal growth factor, single-gene prognostic markers, and multigene prognostic markers. Relevant to the reliance on histopathology in neurodegenerative disorders, histopathology evaluation in breast cancer can serve as a marker of overall prognosis rather than predict response to therapies. This chapter reviews the successes and failures of breast cancer research through history, with focus on the transition from a universal approach for all patients to divergent biomarker development and individualized targeted therapies, discussing future areas of growth in the field that may apply to neurodegenerative disorders.

National survey results on effect of COVID-19 pandemic on female surgeons: A new normal work environment.

BACKGROUND: The impact of COVID-19 reaches the overall well-being of women surgeons. We aimed to describe the impact of transitioning to a new challenging environment. METHODS: A survey of 60 quantitative questions using a Likert-like scale was distributed electronically via email across 1200 members of the Association of Women Surgeons in 2021. Family lifestyle factors including care for children, elderly family members, extent of household chores, and impact of COVID-19 pandemic were queried. RESULTS: A total of 139 members responded. Fifty one percent of these respondents had children at home and 31.2% indicated they needed additional help at home during that time. Eighteen percent of those in practice cared for their elderly family members. Of the survey participants, 71.2% felt the COVID pandemic resulted in a worsened clinical practice, with 30.9% noting a decrease in income. CONCLUSIONS: Women surgeons faced crucial challenges during and post pandemic. An awareness of the changing needs of women surgeons is essential.

Outcomes of a pilot virtual mentorship program for medical students interested in surgery.

BACKGROUND: Lack of mentorship may deter medical students who identify as underrepresented minorities (URM) from entering academic surgery. METHODS: 30 mentor-medical student pairs from the AWS 2020 virtual mentorship pilot-program were surveyed pre-and post-program to explore 1) feasibility of meetings, and, 2) program's perceived efficacy in fostering professional development skills. Participants responded using a 5-point Likert scale (1 = not at all; 5 = completely). Proportions of participants in each category were compared. RESULTS: Proportion of participants perceiving monthly meetings to be completely feasible did not differ from pre-to post-program surveys for mentees (75%(21/28) vs. 71%(12/17); p = 0.743) or mentors (71%(17/24) vs 71%(13/18); p = 1.00). Compared to pre-program responses, mentees endorsed "completely" (Likert scale 5) improving with regard to their elevator speech (p = 0.001), developing their curriculum vitae (p = 0.003), ability to network (p = 0.021), and acquiring skills for career advancement (p = 0.003). CONCLUSION: Virtual mentorship may be a feasible and effective means of increasing access to mentors for URM medical students.

Exploiting the advantages of a wireless seed localization system that differentiates between the seeds: Breast cancer resection following neoadjuvant chemotherapy.

BACKGROUND: Most wireless localization methods utilize only one means of detection for the surgeon, sufficient to localize a single small breast lesion for excision. Complex cases requiring bracketing of a larger lesion or localization of two or more close lesions can superimpose the signal from separate "seeds" with such methods. The lack of discernment between the localization "seeds" can disorient the surgeon, risking a missed lesion on excision and longer operative times. with the use of neoadjuvant chemotherapy prior to breast surgery, the necessity of localizing both a breast lesion and an axillary lymph node previously biopsied is becoming frequent. CASE: A 44 year-old woman underwent neoadjuvant chmotherapy for a breast cancer the did not express estrogen receptor, progesterone receptor, or HER2 receptor. In establishing the extent of disease, a suspicious ipsilateral lymph node was biopsied and found to contain metastatic disease. She had an excellent response to the chemotherapy, with decreased size of the primary tumor and the previously biopsied lymph node. The patient desired breast conservation. The primary tumor and associated calcifications were bracketed using two different Smartclips™, with a third localizing the lymph node biopsied. CONCLUSION: This report illustrates how the use of three SmartClips™, within the EnVisioTM system, allowed for separate tracking of each "seed" throughout a complex surgery in a patient following neoadjuvant chemotherapy. This resulted in successful resection of both the tumor and the tagged lymph node.

Association of Women Surgeons' Comprehensive Initiative for Healthy Surgical Families During Residency and Fellowship Training.

Importance: The lack of family-friendly policies continues to contribute to the underrepresentation and attrition of surgical trainees. Women in surgery face unique challenges in balancing surgical education with personal and family needs. Observations: The Association of Women Surgeons is committed to supporting surgical families and developing equitable family-friendly guidelines. Herein we detail recommendations for adequate paid parental leave, access to childcare, breastfeeding support, and insurance coverage of fertility preservation and assisted reproductive technology. Conclusions and Relevance: The specific recommendations outlined in this document form the basis of a comprehensive initiative for supporting surgical families.