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.

Survival outcomes seen with neoadjuvant chemotherapy in the management of locally advanced inflammatory breast cancer (IBC) versus matched controls.

Inflammatory breast cancer (IBC) poses an ongoing challenge as rates of disease recurrence and mortality remain high compared to stage-matched controls. However, frontline therapy has evolved through the years, including the widespread use of neoadjuvant chemotherapy (NAC) given the prognostic importance of pathologic complete response (pCR). Due to these sweeping changes, we need new data to assess current recurrence and survival outcomes for locally advanced IBC in the context of matched non-inflammatory controls. We conducted a retrospective analysis of institutional IBC data from 2010 to 2016 with the primary objective of comparing overall survival (OS), relapse-free survival (RFS), and distant relapse-free survival (DRFS). We matched IBC patients to non-inflammatory controls based on age, receptor status, tumor grade, clinical stage, and receipt of prior NAC. Secondary objectives included assessing pCR rates and identifying prognostic factors. Among NAC recipients, we observed similar pCR rates (47.6 % vs. 49.4 %, p = 0.88) between IBC (n = 84) and matched non-IBC (n = 81) cohorts. However, we noted a significant worsening of OS (p = 0.0001), RFS (p = 0.0001), and DRFS (p = 0.001) in the IBC group. Specifically, 5-year OS in the IBC cohort was 58.9 % vs. 86.7 % for matched controls (p = 0.0003). Older age was a weak negative predictor for OS (HR 1.03, p = 0.001) and RFS (HR 1.02, p = 0.01). For DRFS, older age was also a weak negative predictor (HR 1.02, p = 0.02), whereas the use of NAC was a positive predictor (HR 0.47, p = 0.02). Despite no clear difference in pCR, survival outcomes remain poor for IBC compared to matched non-inflammatory controls.

Robot-assisted Nipple Sparing Mastectomy: Recent Advancements and Ongoing Controversies.

Purpose of review: The purpose of this review is to summarize the recent technical advancements in RNSM, describe the ongoing teaching programs, and discuss the ongoing controversies. Recent findings: Robot-assisted nipple sparing mastectomy (RNSM) is the newest addition to the armamentarium of surgical techniques for patients who require a mastectomy. The potential benefits of using the da Vinci® Robotic Surgical System (Intuitive Surgical, Sunnyvale, CA) are the small 3D camera and lighting offering superior visualization, the Endowrist robotic instruments offering greater range of motion, and surgeon being at a seated position at the console rendering a more ergonomic operating position. Summary: RNSM can potentially help overcome the technical difficulties of performing a conventional NSM. Further studies are needed to elucidate the oncologic safety and cost-effectiveness of RNSM.

Implementation of a Breast Intraoperative Oncoplastic Form to Aid Management of Oncoplastic Surgery.

INTRODUCTION: Oncoplastic breast conservation surgery (BCS) uses concurrent reduction and/or mastopexy with lumpectomy to improve aesthetic outcomes. However, tissue rearrangement can shift the original tumor location site in relation to external breast landmarks, resulting in difficulties during re-excision for a positive margin and accurate radiation targeting. We developed the Breast Intraoperative Oncoplastic (BIO) form to help depict the location of the tumor and breast reduction specimen. This study seeks to assess physician perspectives of the implementation outcomes. METHODS: From February 2021 to April 2021, the BIO form was used in 11 oncoplastic BCS cases at a single institution. With institutional review board approval, surgical oncologists (SOs), plastic surgeons (PSs), and radiation oncologists (ROs) were administered a 12-question validated survey on Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM), using a 5-point Likert scale during initial implementation and at 6-month reassessment. RESULTS: Twelve physicians completed the survey initially (4 SOs, 4 PSs, and 4 ROs). The mean scores for Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure were high (4.44, 4.56, and 4.56, respectively). Twelve completed the second survey (5 SOs, 3 PSs, and 4 ROs). The mean scores were marginally lower (4.06, 4.21, and 4.25). There were no significant differences when stratified by number of years in practice or specialty. Free text comments showed that 75% of physicians found the form helpful in oncoplastic BCS. CONCLUSIONS: The data indicate high feasibility, acceptability, and appropriateness of the BIO form. Results of this study suggest multidisciplinary benefits of implementing the BIO form in oncoplastic BCS.

Utilization of cancer survivorship services during the COVID-19 pandemic in a tertiary referral center.

BACKGROUND: All Commission on Cancer-accredited comprehensive cancer centers offer survivorship programs (SPs) to women upon completion of treatment. These SPs can include clinical and non-clinical programming such as physical rehabilitation, emotional and psychosocial support, nutrition, and exercise programming. Concern about the availability and access to these programs during the COVID-19 pandemic has been described in recent literature. We sought to identify the impact of the COVID-19 pandemic on participation in these supportive services for breast cancer patients within a single institution. METHODS: The Ohio State University tertiary care center offers clinical and non-clinical breast cancer support services. Descriptive statistics were utilized to summarize referral and patient participation data from January 2019 through July 2021. Data from calendar year 2019 was used as a normative comparison for pre-COVID-19. In-person and telehealth use was tracked longitudinally. RESULTS: During the lockdown due to the COVID-19 pandemic (March through May 2020), provider referrals to SPs declined by 10%, while the overall total for the calendar year modestly increased from 1195 in 2019 to 1210 in 2020, representing a 1.3% increase. Psycho-oncology referrals increased from 280 to 318 (13.5%). The most significant change of participation rates in non-clinical SPs during the pandemic was utilization of exercise content, which increased by 220% from 2019 to 2020. The total proportion of breast cancer participants choosing an exercise program increased from 16.8% in 2019 to 42.2% in 2021, making it the most selected program area overall. Previously, nutrition was the most selected program area as it comprised 42.5% of overall utilization in 2019. CONCLUSION: The pandemic's potential to place barriers to participation in SPs is a legitimate concern. We found a modest decline in provider referrals to clinical services during the lockdown period, while patient-directed participation increased with more survivors engaging in exercise-based programs. Transitioning to virtual platforms served to maintain access for patients. IMPLICATIONS FOR CANCER SURVIVORS: As we grapple with the COVID-19 pandemic, patients with cancer deserve increased attention due to the expected stressors associated with the diagnosis. Those in the survivorship stage utilize services for psychosocial support, and the observed increase in utilization of SPs suggests an elevated need for connectivity. To meet this need, telehealth platforms have been expanded to allow for continued participation. It remains to be seen whether this will be sustained post-COVID-19 or whether reduced human contact will create new needs for programming.

National Cancer Database trends in surgical resection of the breast primary for stage IV breast cancer.

BACKGROUND: Survival benefit after resection of the breast primary for women with metastatic breast cancer reported in retrospective studies has not been uniformly confirmed by randomized controlled trials. To assess the need for dissemination of trial results by the ACS Cancer Research Program Dissemination and Implementation (ACS CRP D&I) committee, we analyzed trends and predictors of surgery and other therapies for stage IV breast cancer. METHODS: The National Cancer Database (NCDB) was queried to identify women diagnosed with clinical stage IV breast cancer of ductal, lobular, or metaplastic histology between 2004 and 2017. Trends in utilization of breast surgery and other treatments and possible predictors of breast surgery were examined in univariable and multivariable analyses. RESULTS: We identified 87,331 cases meeting inclusion criteria. Rates of surgical resection rose until 2009, peaking at 37%, then declined to a rate of 18% in 2017. The largest decline was seen in the hormone receptor positive (HR+), HER2 negative (HER2-) subgroup with up to 70% of patients undergoing surgery in 2007, down to 15% in 2017. In 2004, the rate of systemic therapy alone was slightly more common than locoregional therapy (surgery and/or radiation) with or without systemic therapy (48% vs 37%). However, by 2017, systemic therapy alone was by far more common (69% vs 20%). CONCLUSION: Rates of surgical resection of the breast primary for stage IV breast cancer have been on the decline in recent years, suggesting that providers at Commission on Cancer accredited hospitals are becoming more selective about who will be offered surgical resection.

Practical Guide to Implementation Science for Surgical Oncologists: Case Study of Breast Cancer Short Stay Program.

BACKGROUND: Long lags exist in adoption and uptake of evidence-based interventions into real-world clinical practice based on oncology clinical trial results. Implementation science (IS) is a distinct field of health services research that aims to understand the barriers related to adoption of evidence-based guidelines and research in clinical practice. METHODS: Use of IS study design, methods, and outcomes can be elusive to surgical oncologists despite the tremendous need for the application of IS to bridge the evidence-to-practice gap. This report describes key components of high-quality IS. RESULTS: Herein, we illustrate how IS can be used in surgical oncology practice. Examples from implementation of the breast cancer Short Stay Program (SSP) in Netherlands is used to illustrate IS methods. Specific funding and training opportunities in implementation science are described in detail. CONCLUSION: Use of IS in surgical oncology can help improve the uptake of evidence based medicine.

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM).

INTRODUCTION: Nipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM (RNSM) has the potential to improve the ergonomic challenges of open NSM. Recent studies in RNSM demonstrate the feasibility and safety of the procedure, but this technique is still novel in the USA. METHODS AND ANALYSIS: This is a single-arm prospective pilot study to determine the safety, efficacy and potential risks of RNSM. Up to 12 RNSM will be performed to assess the safety and feasibility of the procedure. Routine follow-up visits and study assessments will occur at 14 days, 30 days, 6 weeks, 6 months and 12 months. The primary outcome is to assess the feasibility of removing the breast gland en bloc using the RNSM technique. To assess safety, postoperative complication information will be collected. Secondary outcomes include defining benefits and challenges of RNSM for both surgeons and patients using surveys, as well as defining the breast and nipple-areolar complex sensation recovery following RNSM. Mainly, descriptive analysis will be used to report the findings. ETHICS AND DISSEMINATION: The RNSM protocol was reviewed and approved by the US Food and Drug Administration using the Investigational Device Exemption mechanism (reference number G200096). In addition, the protocol was registered with ClinicalTrials.gov (NCT04537312) and approved by The Ohio State University Institutional Review Board, reference number 2020C0094 (18 August 2020). The results of this study will be distributed through peer-reviewed journals and presented at surgical conferences. TRIAL REGISTRATION NUMBER: NCT04537312.

Full Abstract to Published Manuscript: Evaluation of the Scientific Impact of the American Society of Breast Surgeons Conference.

BACKGROUND: The scientific rigor of the abstracts presented at the American Society of Breast Surgeons (ASBrS) annual meeting has not been recently evaluated. In this study, we sought to determine the rate at which abstracts presented at the 2017 and 2018 ASBrS meetings were published in peer-reviewed journals, and compared the rates with breast abstracts presented at the 2018 Society of Surgical Oncology (SSO) meeting. METHODS: Abstracts from the 2017 and 2018 ASBrS and 2018 SSO conferences were searched in PubMed for published manuscripts using the abstract title and/or first or last author. RESULTS: In 2017, 21.6% of the 268 abstracts presented at the ASBrS conference resulted in full publication, compared with 36.6% of the 273 abstracts presented at the 2018 ASBrS conference, resulting in a significant difference in the publication rate (p < 0.001). Of the 158 abstracts published from the 2017 and 2018 meetings, 75 (47.8%) were published in Annals of Surgical Oncology (ASO). There was no correlation between impact factor and time to publication. Oral presentations and quick shots were more likely to be published than poster presentations, and oral presentations were more likely to be published in higher-impact journals. The 2018 SSO meetings resulted in 54 of 111 (48.6%) breast abstracts leading to full publication. CONCLUSION: Approximately 29.2% of the abstracts presented at the ASBrS 2017 and 2018 conferences resulted in a published manuscript. A higher publication rate in higher impact journals for oral presentations indicates that the abstract review process properly stratifies the research.

The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials.

PURPOSE OF REVIEW: The COVID-19 pandemic has had a devastating impact on virtually all aspects of the healthcare system, including oncology clinical trials. The purpose of this review is to describe the impact of the pandemic on national breast cancer clinical trials. RECENT FINDINGS: Of the 61 breast cancer-specific cooperative group breast cancer clinical trials open to accrual during the pandemic, 32% of them received supplementary tailored guidance regarding current and foreseeable challenges for clinical sites and investigators due to COVID-19. Many clinical trial sites reported decreases in enrollment and accrual, drastic disruptions to protocol, and challenges related to research infrastructure, staff burden, and assuring social distancing. SUMMARY: The challenges early in pandemic led to many operational changes in clinical trials, including use of electronic consent for enrollment, telemedicine visits, and mail order pharmacy. The pandemic highlighted aspects of breast cancer clinical trial that could be modernized while maintaining research integrity.

De-escalation of radiation therapy in patients with stage I, node-negative, HER2-positive breast cancer.

In the modern era, highly effective anti-HER2 therapy is associated with low local-regional recurrence (LRR) rates for early-stage HER2+ breast cancer raising the question of whether local therapy de-escalation by radiation omission is possible in patients with small-node negative tumors treated with lumpectomy. To evaluate existing data on radiation omission, we used the National Cancer Database (NCDB) to test the hypothesis that RT omission results in equivalent overall survival (OS) in stage 1 (T1N0) HER2+ breast cancer. We excluded patients that received neoadjuvant systemic therapy. We stratified the cohort by receipt of adjuvant radiation. We identified 6897 patients (6388 RT; 509 no RT). Patients that did not receive radiation tended to be ≥70 years-old (odds ratio [OR] = 3.69, 95% CI: 3.02-4.51, p < 0.0001), to have ≥1 comorbidity (OR = 1.33, 95% CI: 1.06-1.68, p = 0.0154), to be Hispanic (OR = 1.49, 95% CI: 1.00-2.22, p = 0.049), and to live in lower income areas (OR = 1.32, 95% CI: 1.07-1.64, p = 0.0266). Radiation omission was associated with a 3.67-fold (95% CI: 2.23-6.02, p < 0.0001) increased risk of death. While other selection biases that influence radiation omission likely persist, these data should give caution to radiation omission in T1N0 HER2+ breast cancer.

Neoadjuvant endocrine therapy use in early stage breast cancer during the covid-19 pandemic.

PURPOSE: Physician treatment preferences for early stage, estrogen positive breast cancer (ER + BC) patients were evaluated during the initial surge of the COVID-19 pandemic in the US when neoadjuvant endocrine therapy (NET) was recommended to allow safe deferral of surgery. METHODS: A validated electronic survey was administered May-June, 2020 to US medical oncologists (MO), radiation oncologists (RO), and surgeons (SO) involved in clinical trials organizations. Questions on NET use included practice patterns for locoregional management following NET. RESULTS: 114 Physicians from 29 states completed the survey-42 (37%) MO, 14 (12%) RO, and 58 (51%) SO. Before COVID-19, most used NET 'rarely' (49/107, 46%) or 'sometimes' (36, 33%) for ER + BC. 46% would delay surgery 2 months without NET. The preferred NET regimen was tamoxifen for premenopausal and aromatase inhibitor for postmenopausal women. 53% planned short term NET until surgery could proceed. Most recommended omitting axillary lymph node dissection (ALND) for one micrometastatic node after 1, 2, or 3 months of NET (1 month, N = 56/93, 60%; 2 months, N = 54/92, 59%; 3 months, N = 48/90, 53%). With longer duration of NET, omission of ALND decreased, regardless of years in practice, percent of practice in BC, practice type, participation in multidisciplinary tumor board, or number of regional COVID-19 cases. CONCLUSION: More physicians preferred NET for ER + BC during the pandemic, compared with pre-pandemic times. As the duration of NET extended, more providers favored ALND in low volume metastatic axillary disease. The Covid-19 pandemic affected practice of ER + BC; it remains to be seen how this may impact outcomes.

Comparing Surgeon Approaches to Patient-Centered Cancer Care Using Vignette Methodology.

BACKGROUND: We sought to characterize surgeon perceptions of patient attachment-related behaviors relative to patient-centered approaches during treatment decision-making within the clinical encounter. METHODS: An online survey including clinical vignettes was sent to board-certified surgeons to assess their approach to patient-centered treatment decision-making. Within these vignettes, patient behaviors associated with attachment styles (secure vs 3 insecure subtypes: avoidant, anxious, and fearful) were fixed and patient factors (age, race, occupation, and gender) were randomized. Analysis included repeated measures mixed-effects linear regression. RESULTS: Among the 208 respondents, the majority were male (65.4%) and White/Caucasian (84.5%) with an average age of 51.6 years (SD = 9.9). Most surgeons had been in practice for more than 10 years (66.8%) and treated adult patients (77.4%). Surgical specializations included breast (27.2%), HPB (35.0%), and broad-based/general (21.8%). Patient race, age, and gender did not impact surgeons' patient-centered approach to treatment decision-making (all ps > 0.05). However, when the "patient" had a white collar occupation and were securely attached, surgeons reported a greater likeliness to spend equal time presenting all treatment options (p = 0.02 and p < 0.001, respectively) and believe the patient wanted an active role in decision-making (p = 0.01 and p < 0.001, respectively). Surgeons reported being least likely to agree with a patient's treatment decision (p < 0.001) and an increased likelihood of being directive (p = 0.002) when patients exhibited behaviors associated with avoidant attachment. CONCLUSION: Attachment-related behaviors were associated with differences in surgeon approaches to patient-centered decision-making. Attachment styles may offer a framework for providers to understand patient behaviors and needs, thereby providing insight on how to tailor their approach and provide optimal patient-centered care.

Residual breast tissue after robot-assisted nipple sparing mastectomy.

INTRODUCTION: While the long-term oncologic safety of robot-assisted nipple sparing mastectomy (RNSM) remains to be elucidated, histologically detected residual breast tissue (RBT) can be a surrogate for oncologically sound mastectomy. The objective of this study is to determine the presence of RBT after RNSM. METHODS: Between August 2019-January 2020, we completed 5 cadaveric RNSMs. Full thickness biopsies from the mastectomy skin flap were obtained from predefined locations radially around the mastectomy skin envelop and nipple areolar complex to histologically evaluate for RBT. RESULTS: The first case was not technically feasible due to inability to obtain adequate insufflation. Five mastectomy flaps were analyzable. The average mastectomy flap thickness was 2.3 mm (range 2-3 mm) and the average specimen weight was 382.72 g (range 146.9-558.3 g). Of 70 total biopsies, RBT was detected in 11 (15.7%) biopsies. Most common location for RBT was in the nipple-areolar complex, with no RBT detected from the peripheral skin flaps. CONCLUSIONS: In this cadaveric study, RNSM is feasible leaving minimal RBT on the mastectomy flap. The most common location for RBT is in the periareolar location consistent with previous published findings after open NSM. Clinical studies are underway to evaluate the safety of RNSM.