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.

NCCN Guidelines® Insights: Breast Cancer Screening and Diagnosis, Version 1.2023.

The NCCN Guidelines for Breast Cancer Screening and Diagnosis provide health care providers with a practical, consistent framework for screening and evaluating a spectrum of clinical presentations and breast lesions. The NCCN Breast Cancer Screening and Diagnosis Panel is composed of a multidisciplinary team of experts in the field, including representation from medical oncology, gynecologic oncology, surgical oncology, internal medicine, family practice, preventive medicine, pathology, diagnostic and interventional radiology, as well as patient advocacy. The NCCN Breast Cancer Screening and Diagnosis Panel meets at least annually to review emerging data and comments from reviewers within their institutions to guide updates to existing recommendations. These NCCN Guidelines Insights summarize the panel's decision-making and discussion surrounding the most recent updates to the guideline's screening recommendations.

Expectations of Surveillance for Non-BRCA Gene Mutation Carriers at Increased Risk for Breast Cancer.

BACKGROUND: The University of Alabama at Birmingham Preventative Care Program for Women's Cancer provides genetic testing, risk evaluation, and screening for breast cancer. Women diagnosed with high-risk mutations may opt to undergo active surveillance or prophylactic surgery. This decision requires understanding of the surveillance process and its potential outcomes. In this study, we report specifically on women with non-BRCA1 or BRCA2 mutations. METHODS: A retrospective, cross-sectional study was conducted of women enrolled in our program identified as high risk because of non-BRCA mutations. Events regarding genetic mutations, method of detection of suspicious lesions, number of biopsies, results of those biopsies, prophylactic surgery, and cancer diagnosis were collected. RESULTS: We identified 78 patients with asymptomatic non-BRCA deleterious mutations. Sixteen mutations were identified, with the most common being ATM, CHEK2, and PALB2. In total, 11.5% underwent prophylactic surgery and 88.5% underwent active surveillance. In the surveillance group, 63.8% had no examination or imaging to warrant biopsy, 24.6% had biopsy with benign result, and 11.6% had biopsy with malignant result. For the nine women who developed breast cancer during surveillance, six were diagnosed with ductal carcinoma in situ, two with stage I, and one with stage IIA cancer. CONCLUSIONS: Women with non-BRCA mutations enroll in prevention clinics with hopes of early detection of breast cancer. Because of increased screening, this population undergoes biopsy more frequently; however, during surveillance most do not require a biopsy. For those that do, the result is typically benign. This information can further allow women to make informed decisions about surveillance and establish realistic expectations regarding the likelihood of tissue sampling.

The Impact of Breast Lumpectomy Tray Utilization on Cost Savings.

BACKGROUND: Right-sizing instrument trays reduce processing and replacement costs, physical strain, and turnover times. Historically, a 98-instrument head and neck tray has been used for breast lumpectomy cases at our institution. Observations revealed that many instruments on the tray were not used during the breast cases. With the significant number of surgical breast lumpectomies performed annually, tray downsizing could significantly reduce costs and physical strain. METHODS: Surgical technicians identified instruments needed for a standard breast lumpectomy. Breast surgeons reviewed the list and made final recommendations. Three of 13 existing head and neck trays were converted to breast lumpectomy trays. The number of breast lumpectomies in 2017 was pulled from the institution's health information system. Instrument quantities were verified using instrument management software. Weights were taken on a digital scale, and processing cost was estimated by a consultant. RESULTS: The new breast trays included 51 instruments rather than the standard 98-instrument trays. Reprocessing cost decreased from $49.98 to $26.01. With 449 breast lumpectomies performed at the institution in 2017, the annual reprocessing savings totaled $10,763. The tray weight was reduced from 27 to 16 pounds. Setup time decreased from 7 to 4 min per use (22.5 h saved annually). CONCLUSIONS: Downsizing from a head and neck tray to a specific breast lumpectomy tray demonstrated a reduction in reprocessing cost, tray weight, and setup time. Lighter trays allow for safer handling and transport by surgical personnel. In the current health-care environment, it is important to maximize operating room efficiency and minimize cost.

What is a clear margin in breast conserving cancer surgery?

OPINION STATEMENT: Team work is the key to successful breast conservation therapy. Patient education and the informed consent process should include a discussion about the importance of margin status. Specimen management is critically important to obtain the highest quality information about margins. Operating technique should avoid trauma to or disruption of the specimen surface. The specimen should be oriented for the pathologist using standard techniques including sutures, clips, or colored inks. Specimen radiography is mandatory to confirm complete resection of the target tissues and can be used to direct additional margin resections during the initial procedure. With a well-designed and oriented specimen, the pathologist can give an accurate description of the margin distance for both the invasive and in situ components of the cancer. In most cases, decision-making about margins will be straightforward. Positive margins should be re-excised or the treatment is converted to mastectomy. Clear margins (>5 mm) require no further surgical therapy. "Close" margins (1-4 mm) will remain a point of controversy because of conflicting reports from clinical series. At UAB, decision for re-excision is made on a case-by-case basis. Routinely 2 mm is considered adequate, however, volume of disease and intraductal component are important considerations when making recommendations.

Resident perspectives on the role of gender in operative experience during general surgery residency training: A mixed-methods study.

BACKGROUND: It remains unclear why female general surgery residents perform fewer cases than male peers. This exploratory study investigated possible contributors to gender-based disparities and solutions for improving equity in operative experience. METHODS: Surveys, including Likert scale and free-text questions, were distributed to 21 accredited general surgery residency programs. RESULTS: There were 96 respondents, of whom 69% were female. 22% of females personally experienced barriers to operative experience versus 13% of males (p â€‹= â€‹0.41), while 52% of female residents believed operative training was affected by gender (p â€‹= â€‹0.004). Inductive analysis revealed the most common barrier to operating room participation was floor work/clinical tasks. The most common barrier for female residents was perceived sexism/gender bias, with subthemes of "misidentification," "feeling unwelcome," and "poor trust/autonomy." To improve parity, residents proposed structured program-level review, feedback, and transparent expectations about case assignments. CONCLUSION: Female general surgery residents believe gender bias impacts training. Further mixed-methods research is crucial to determine the cause of gender-based disparities in operative experience.

When I Don't see me, Am I seen? Race and student perception of the surgery clerkship.

INTRODUCTION: Increasing interest in general surgery from students who are Under-Represented in Medicine (URiM) is imperative to advancing diversity, equity, and inclusion efforts. We examined medical student third year surgery clerkship evaluations quantitatively and qualitatively to understand the experiences of URiM and non-URiM learners at our institution. METHODS: Evaluations from 235 graduated medical students between the years of 2019 and 2021 were analyzed. T-tests were used to compare numerical data. Free-text comments were qualitatively analyzed using inductive thematic analysis by two independent reviewers with conflicts resolved by a third. RESULTS: Evaluations were completed by 214 non-URiM students (91.1 â€‹%) and 21 (8.9 â€‹%) URiM students. There were no significant differences between URiM and non-URiM students in ratings of faculty and resident teaching. When asked whether residents were positive role models for patient care, non-URiM students were more likely than URiM students to agree (3.284 vs. 2.864, p â€‹= â€‹0.040). When asked whether they considered faculty to be positive role models, non- URM students were also more likely to answer affirmatively than URiM students (3.394 vs. 2.909 p â€‹= â€‹0.013). Qualitative comments were similar between the two groups. When asked what the strengths of the clerkship were, the most commonly evoked theme was "interactions with team" with subthemes of "team integration" "feeling valued" and positive "faculty" or "resident" interactions. "Operative experience" was the second most commonly evoked strength of the clerkship. The most common criticisms of the clerkship involved "negative interactions with team" with subthemes of "not prioritized above other learners" and "ignored." Negative "academic experience" was the next most commonly evoked weakness, with an affiliated theme of "lack of teaching." CONCLUSIONS: URiM students are less likely than non-URiM students to see surgical residents and faculty as positive role models. Integrating medical students into the team, taking time to teach, and allowing students to feel valued in their roles improves the clerkship experience for trainees and can contribute to recruitment efforts.

From the Reading Room to Operating Room: Retrospective Data and Pictorial Review After 806 SCOUT Placements.

OBJECTIVE: Non-wire localization techniques are becoming more common. SCOUT surgical guidance system has been shown to increase flexibility in scheduling patients for surgery. The objective of this article is to provide institutional experiences with pictorial review after placement of 806 SCOUT devices. MATERIALS AND METHODS: Radiology procedure reports of SCOUT device placements from January 11, 2018 to May 19, 2020 were reviewed to assess demographics of patient population, imaging method of placement, size of reflector delivery system used, placement approach, and time spent in the radiology suite or Turn Around Time (TAT). TAT was compared to that of wire placement using a Two-tailed Mann-Whitney U Test. Reports were assessed for those with absent signal at time of placement. In cases where signal was absent, migration was found, or complications noted, further case review was performed using the Electronic Medical Record to assess whether the devices were successfully retrieved. RESULTS: There were 806 total SCOUT placements identified from radiology procedure reports in patients aged 12-92 with 64.3% (518/806) placed using ultrasound-guidance and 35.7% (288/806) by mammographic-guidance. The most common delivery device was a 7.5 cm needle. Only 0.9% (7/806) of SCOUT reflectors were >1cm from target, all of which were successfully excised. After radiology placement, signal was not heard in 1.4% (9/806) of cases and individual case review revealed that all were successfully excised. In 2019, TATs of SCOUT procedures were significantly lower than TATs from wire localizations (P = 0.00024). CONCLUSIONS: SCOUT localization for breast surgery can provide solutions to problems encountered by patients and providers. A year after implementation, SCOUT use was found to result in shorter TATs in radiology. In addition, 100% of devices that were either migrated or inaudible at the time of radiology placement were successfully excised.

Feasibility and Short-Term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-Stage Breast Cancer Patients Receiving Partial Breast Irradiation.

Background: For appropriately selected patients with early-stage breast cancer (ESBC), accelerated partial breast irradiation (APBI) yields equivalent rates of ipsilateral breast tumor recurrence with mixed results in patient-rated cosmesis compared with whole-breast radiotherapy depending on the technique utilized. When utilizing external beam radiotherapy for APBI, techniques to reduce target margins and overall treatment volume are potentially important to decrease rates of long-term adverse cosmesis. Stereotactic body radiotherapy (SBRT) is a promising technique to deliver APBI because of its increased accuracy and sparing of uninvolved breast tissue. We report the initial results of a prospective clinical trial investigating feasibility, safety, and cosmetic outcomes of a daily five-fraction SBRT regimen for APBI. Methods: Twenty-three patients with ESBC after lumpectomy who met APBI suitability were enrolled. During lumpectomy, a bioabsorbable three-dimensional fixed array tissue marker (BioZorb™, Hologic, Marlborough, MA) was placed for enhanced visualization of the cavity boundaries. Clinical target volume (CTV) was defined as the delineable cavity plus a 1-cm isotropic expansion followed by a 3-mm isotropic planning target volume (PTV) expansion. Patients received 30 Gy delivered in five planned consecutive daily fractions in either prone or supine positioning depending on individual anatomy. Two patients completed the five-fraction treatments in 9-day interval and 11-day interval due to external circumstances. A maximum PTV of 124cc was allowed to minimize incidence of fat necrosis. Plans utilized 10-MV flattening filter-free beams delivered on a Varian Edge linear accelerator. Local control, toxicity, and nurse/patient-scored cosmesis at pre-treatment baseline, 1 month post-treatment, and at subsequent 6-month intervals were recorded. Results: Twenty-three patients were accrued at the time of submission with median follow-up of 6 months. No patients experienced grade ≥3 acute toxicity. Of the 10 events reported probably related to SBRT, nine were grade 1 (n = 9/10, 90%). There was no evidence of difference, deterioration, or change in patient or nurse-scored cosmesis from baseline to 1 and 6 months post-treatment. One patient developed nodal failure shortly after APBI. Conclusions: Although longer follow-up is needed to assess long-term toxicity and local control, this study demonstrated a five-fraction SBRT regimen delivered over consecutive days is a safe, efficient, well-tolerated, and cosmetically favorable means of delivering APBI in suitable women. Clinical Trial Registration: https://www.clinicaltrials.gov/ct2/show/NCT03643861, NCT03643861.

Association of Residual Ductal Carcinoma In Situ With Breast Cancer Recurrence in the Neoadjuvant I-SPY2 Trial.

Importance: Pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) in breast cancer strongly correlates with overall survival and has become the standard end point in neoadjuvant trials. However, there is controversy regarding whether the definition of pCR should exclude or permit the presence of residual ductal carcinoma in situ (DCIS). Objective: To examine the association of residual DCIS in surgical specimens after neoadjuvant chemotherapy for breast cancer with survival end points to inform standards for the assessment of pathologic complete response. Design, Setting, and Participants: The study team analyzed the association of residual DCIS after NAC with 3-year event-free survival (EFS), distant recurrence-free survival (DRFS), and local-regional recurrence (LRR) in the I-SPY2 trial, an adaptive neoadjuvant platform trial for patients with breast cancer at high risk of recurrence. This is a retrospective analysis of clinical specimens and data from the ongoing I-SPY2 adaptive platform trial of novel therapeutics on a background of standard of care for early breast cancer. I-SPY2 participants are adult women diagnosed with stage II/III breast cancer at high risk of recurrence. Interventions: Participants were randomized to receive taxane and anthracycline-based neoadjuvant therapy with or without 1 of 10 investigational agents, followed by definitive surgery. Main Outcomes and Measures: The presence of DCIS and EFS, DRFS, and LRR. Results: The study team identified 933 I-SPY2 participants (aged 24 to 77 years) with complete pathology and follow-up data. Median follow-up time was 3.9 years; 337 participants (36%) had no residual invasive disease (residual cancer burden 0, or pCR). Of the 337 participants with pCR, 70 (21%) had residual DCIS, which varied significantly by tumor-receptor subtype; residual DCIS was present in 8.5% of triple negative tumors, 15.6% of hormone-receptor positive tumors, and 36.6% of ERBB2-positive tumors. Among those participants with pCR, there was no significant difference in EFS, DRFS, or LRR based on presence or absence of residual DCIS. Conclusions and Relevance: The analysis supports the definition of pCR as the absence of invasive disease after NAC regardless of the presence or absence of DCIS. Trial Registration: ClinicalTrials.gov Identifier NCT01042379.

Erratum: Author Correction: Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint.

[This corrects the article DOI: 10.1038/s41523-018-0074-6.].

Evolution of Operative Technique for Mastectomy.

The radical mastectomy was the mainstay of breast cancer treatment through the majority of the twentieth century. However, as the understanding of breast cancer increased, the indications for more extensive surgical intervention decreased. The mastectomy has evolved so that skin-sparing or nipple-sparing mastectomy can be performed in the majority of women who undergo mastectomy currently. Today, nearly 40% of all women undergo mastectomy for breast cancer. The improved cosmetic appearance associated with skin- or nipple-sparing mastectomies does not compromise oncologic outcomes.

Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint.

Advances in the surgical management of the axilla in patients treated with neoadjuvant chemotherapy, especially those with node positive disease at diagnosis, have led to changes in practice and more judicious use of axillary lymph node dissection that may minimize morbidity from surgery. However, there is still significant confusion about how to optimally manage the axilla, resulting in variation among practices. From the viewpoint of drug development, assessment of response to neoadjuvant chemotherapy remains paramount and appropriate assessment of residual disease-the primary endpoint of many drug therapy trials in the neoadjuvant setting-is critical. Therefore decreasing the variability, especially in a multicenter clinical trial setting, and establishing a minimum standard to ensure consistency in clinical trial data, without mandating axillary lymph node dissection, for all patients is necessary. The key elements which include proper staging and identification of nodal involvement at diagnosis, and appropriately targeted management of the axilla at the time of surgical resection are presented. The following protocols have been adopted as standard procedure by the I-SPY2 trial for management of axilla in patients with node positive disease, and present a framework for prospective clinical trials and practice.