Incidence of Pathologic Nodal Disease in Clinically Node-Negative, Microinvasive or T1a Breast Cancers.

BACKGROUND: Axillary staging in early-stage breast cancer can impact adjuvant treatment options but also has associated morbidity. The incidence of pathologic nodal positivity (pN+) in patients with microinvasive or T1a disease is poorly characterized and the value of sentinel node biopsy remains controversial. METHODS: Women with cN0 and pathologic microinvasive or T1a cancer who underwent upfront surgery were identified from the National Cancer Database. Pathologic nodal stage at the time of surgery was the primary outcome. Multivariable logistic modeling was used to assess predictors of pN+. RESULTS: Overall, 141,840 women were included; 139,206 had pathologic node-negative (pN0) disease and 2634 had pN+ disease. Rates of pN+ disease differed by receptor status, with the highest rates in hormone receptor-negative/human epidermal growth factor receptor 2-positive (HR-/HER2+) disease compared with triple-negative breast cancer (TNBC), HR-positive/HER2-negative (HR+/HER2-), and triple positive breast cancer. Rates of pN+ were also higher with lobular histology compared with ductal histology. Multivariable analysis demonstrated that compared with White women, Black women had higher odds of pN+ disease, and compared with women <50 years of age, women >70 years of age had higher odds of pN+ disease. Compared with women with HR+/HER2- disease, women with TNBC, triple-positive breast cancer, and HR-/HER2+ all had lower odds, and women with invasive lobular disease had higher odds compared with women with invasive ductal disease. Women with significant comorbidities also had higher odds of node positivity. CONCLUSION: Over 90% of patients with clinically node-negative, microinvasive and T1a breast cancer remain pathologically node-negative following axillary staging. However, higher rates of nodal disease were found among Black patients, older patients, and patients with lobular cancer and significant comorbidities.

National Patterns of Hospital Admission Versus Home Recovery Following Mastectomy for Breast Cancer.

BACKGROUND: We examined national patterns of care and perioperative outcomes for women after mastectomy, comparing home recovery (HR) with hospital admission. PATIENTS AND METHODS: Using Martketscan data (2017-2019), women ≥ 18 years old who underwent mastectomy ± reconstruction were identified and classified as either home recovery (same calendar day discharge) or hospital admission (stays > 1 calendar day). Comorbidities and receipt of chemo/immunotherapy 6 months prior to surgery and post-surgical 30-day complications were measured. Logistic regression calculated the odds of any complication by encounter type, adjusting for age, accompanying lymph node (LN) procedure, reconstruction, neoadjuvant chemo- and/or immunotherapy, and select comorbidities. RESULTS: Of 11,789 mastectomy encounters (N = 11,659 women), 4751 (40%) cases utilized HR while 7038 (60%) had hospital admission. HR patients were older (53.6 years old vs. 51.8 years old) with lower rates of reconstruction (60.2 vs. 74.5%, p < 0.001). Rates of neoadjuvant chemotherapy (19.6 vs. 20.9%, p = 0.099) and immunotherapy (3.6 vs. 3.9%, p = 0.445) were similar between groups. Complication rates were lower among HR patients with fewer postoperative hematomas (0.6 vs. 1.3%, p < 0.001) and decreased wound complications (8.5 vs. 9.8%, p = 0.019). In a multivariable analysis, the odds of any complication were approximately 20% lower for HR patients compared with admission patients (aOR 0.81, 95% CI 0.72-0.91, p < 0.001). Unplanned emergency room visits were similar between groups (6.7 vs. 7.2%, p = 0.374); yet fewer hospital re-admissions (2.5 vs. 3.5%, p = 0.003) occurred in women recovering at home. CONCLUSION: HR is a safe option compared with in-hospital admission for clinically appropriate women after mastectomy as they are less likely to experience postoperative complications, emergency department (ED) visits, or hospitalization.

Evaluating Axillary Lymph Node Yield After Neoadjuvant Chemotherapy.

INTRODUCTION: The benefits that neoadjuvant chemotherapy (NAC) provides in treating patients with breast cancer are well known. However, its effects on axillary lymph nodes and lymph node yield (LNY) following axillary lymph node dissection (ALND) remain unclear. Given the importance of LNY for accurate axillary staging in patients with breast cancer, we retrospectively reviewed a large national cancer database to determine if NAC has an effect on LNY following axillary surgery. METHODS: A retrospective review of the National Cancer Database was performed. Patients diagnosed from 2010 to 2015 with T0-T4, clinical N0-3, and M0 breast cancer who underwent ALND were included. Patients were categorized by NAC and primary surgery (PS). A descriptive analysis of patient and tumor characteristics, as well as extrinsic factors, was performed. A univariate analysis using Student's t-test was performed to evaluate LNY between the two groups. RESULTS: A total of 118,108 patients were included in our study. We found that 29,066 (24.6%) patients underwent NAC, and 89,042 (75.4%) had surgery as initial treatment (PS group). The median LNY by ALND in the NAC group was 11 (Q1, Q3: 6, 16). The median LNY in the PS group was 11 (Q1, Q3: 6, 17), p < 0.001. CONCLUSION: Despite differences in patient characteristics and external factors, we found no difference in LNY following ALND between patients who underwent NAC and those who had initial surgery. Efforts should be made to achieve equivalent LNY whether or not patients receive NAC.

Evaluation of online Spanish and English health materials for preventive mastectomy. are we providing adequate information?

PURPOSE: Breast cancer remains the leading cause of cancer-related death in US Hispanic women. When present, lower health literacy levels potentially within this patient population require tailored materials to address health disparities. We aim to evaluate and compare Spanish and English online health care informative resources on preventive mastectomy. METHODS: A Google web search using "preventive mastectomy" and "mastectomía preventiva" was conducted. The first ten institutional/organizational websites in each language were selected. Assessment of mean reading grade level, cultural sensitivity, understandability, and actionability was carried out utilizing validated tools. RESULTS: The mean reading grade level for English materials was 14.69 compared with 11.3 for Spanish, both exceeding the recommended grade level established by the AMA and NIH. The mean cultural sensitivity score for English information was 2.20 compared with 1.88 for Spanish information, both below the acceptability benchmark of 2.5. English webpages scored 65% and 35% for understandability and actionability, respectively, while Spanish webpages scored 47% and 18%. CONCLUSIONS: Online English and Spanish preventive mastectomy materials were written at an elevated reading level and lacked cultural sensitivity. Spanish language information demonstrated inferior understandability, actionability, and cultural sensitivity. Addressing these issues provides an opportunity to help resolve health literature disparities regarding preventive mastectomy for US Hispanic women.

The Role of Oncotype DX® Recurrence Score in Predicting Axillary Response After Neoadjuvant Chemotherapy in Breast Cancer.

INTRODUCTION: Oncotype DX® recurrence score (RS) is well-recognized for guiding decision making in adjuvant chemotherapy; however, the predictive capability of this genomic assay in determining axillary response to neoadjuvant chemotherapy (NCT) has not been established. METHODS: Using the National Cancer Data Base (NCDB), we identified patients diagnosed with T1-T2, clinically N1/N2, estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER +/HER2 -) invasive ductal carcinoma of the breast between 2010 and 2015. Patients with an Oncotype DX® RS who received NCT were included. RS was defined as low (< 18), intermediate (18-30), or high (> 30). Unadjusted and adjusted analyses were performed to determine the association between axillary pathologic complete response (pCR) and RS. RESULTS: This study included a total of 158 women. RS was low in 56 (35.4%) patients, intermediate in 62 (39.2%) patients, and high in 40 (25.3%) patients. The majority of patients presented with clinical N1 disease (89.2%). Axillary pCR was achieved in 23 (14.6%) patients. When stratifying patients with axillary pCR by RS, 11 (47.8%) patients had a high RS, 6 (26.1%) patients had an intermediate RS, and 6 (26.1%) patients had a low RS. Comparing cohorts by RS, 27.5% of patients with high RS tumors had an axillary pCR, compared with only 9.7% in the intermediate RS group, and 10.7% in the low RS group (p = 0.0268). CONCLUSION: Our findings demonstrate that Oncotype DX® RS is an independent predictor of axillary pCR in patients with ER +/HER2 - breast cancers receiving NCT. A greater proportion of patients with a high RS achieved axillary pCR. These results support Oncotype DX® as a tool to improve clinical decision making in axillary management.

Malpractice Cases in Breast Surgery: An Assessment of Litigation Involving Surgeons.

INTRODUCTION: Improving patient safety and quality are priorities in health care. The study of malpractice cases provides an opportunity to identify areas for quality improvement. While the issues surrounding malpractice cases in breast cancer are often multifactorial, there are few studies providing insight into malpractice cases specifically related to common breast cancer surgical procedures. We sought to characterize the factors in liability cases involving breast cancer surgery. METHODS: Closed cases from 2008 to 2019 involving a breast cancer diagnosis, a primary responsible service of general surgery, surgical oncology, or plastic surgery, and a breast cancer procedure were reviewed using data from the Controlled Risk Insurance Company (CRICO) Strategies Comparative Benchmarking System database, a national repository of professional liability data. RESULTS: A total of 174 malpractice cases were reviewed, of which 41 cases were closed with payment. Plastic surgeons were most commonly named (64%, 111/174), followed by general surgeons (30%, 53/174), and surgical oncologists (6%, 10/174). The most common allegation was error in surgical treatment (87%, 152/174), and infection, cosmetic injury, emotional trauma, foreign body, and nosocomial infections represented the top five injury descriptions. On average, indemnity payments were larger for high clinical severity cases. Technical skills, followed by clinical judgment, were the most commonly named contributing factors. The average payment per case was $130,422. CONCLUSION: Malpractice cases predominantly involve technical complications related to plastic surgery procedures. Better understanding of the malpractice environment involving surgical procedures performed for breast cancer may provide practical insight to guide initiatives aimed at improving patient outcomes.

The Tyrer-Cuzick Model Inaccurately Predicts Invasive Breast Cancer Risk in Women With LCIS.

BACKGROUND: The Tyrer-Cuzick model has been shown to overestimate risk in women with atypical hyperplasia, although its accuracy among women with lobular carcinoma in situ (LCIS) is unknown. We evaluated the accuracy of the Tyrer-Cuzick model for predicting invasive breast cancer (IBC) development among women with LCIS. METHODS: Women with LCIS participating in surveillance from 1987 to 2017 were identified from a prospectively maintained database. Tyrer-Cuzick score (version 7) was calculated near the time of LCIS diagnosis. Patients with prior or concurrent breast cancer, a BRCA mutation, receiving chemoprevention, or with pleomorphic LCIS were excluded. Invasive cancer-free probability was estimated using the Kaplan-Meier method. RESULTS: A total of 1192 women with a median follow-up of 6 years (interquartile range [IQR] 2.5-9.9) were included. Median age at LCIS diagnosis was 49 years (IQR 45-55), 88% were white; 37% were postmenopausal, 28% had ≥ 1 first-degree family member with breast cancer, and 13% had ≥ 2 second-degree family members with breast cancer. In total, 128 patients developed an IBC; median age at diagnosis was 54 years (IQR 49-61). Five- and 10-year cumulative incidences of invasive cancer were 8% (95% confidence interval [CI] 6-9%) and 14% (95% CI 12-17%), respectively. The median Tyrer-Cuzick 10-year risk score was 20.1 (IQR 17.4-24.3). Discrimination measured by the C-index was 0.493, confirming that the Tyrer-Cuzick model is not well calibrated in this patient population. CONCLUSIONS: The Tyrer-Cuzick model is not accurate and may overpredict IBC risk for women with LCIS, and therefore should not be used for breast cancer risk assessment in this high-risk population.

Increase in Utilization of Nipple-Sparing Mastectomy for Breast Cancer: Indications, Complications, and Oncologic Outcomes.

BACKGROUND: Nipple-sparing mastectomy (NSM) is increasingly performed for invasive breast cancer. Growing evidence supporting the oncologic safety of NSM has led to its widespread use and broadened indications. In this study, we examine the indications, complications, and long-term outcomes of therapeutic NSM. METHODS: From 2003 to 2016, women undergoing NSM for invasive cancer or ductal carcinoma in situ (DCIS) were identified from a prospectively maintained database. Patient and disease characteristics were compared by procedure year, while complications were compared by procedure year using generalized mixed-effects models accounting for a random surgeon effect. Overall survival and time to recurrence were examined. RESULTS: Of the 467 therapeutic NSMs, 337 (72%) were invasive cancer, 126 (27%) were DCIS, and 4 (1%) were phyllodes tumors. Median age was 45 years (range 24-75) and median follow-up among survivors was 39.4 months. Three hundred and fifty-seven (76.4%) cases were performed in 2011 or after. When comparing NSMs performed before and after 2011, there was a significant increase in NSMs performed for invasive tumors (58% vs. 77%; p < 0.001). There was no difference in family history, genetic mutations, smoking status, neoadjuvant chemotherapy, prior radiation, nodal involvement, or tumor subtype. Twenty-one (4.5%) nipple excisions were performed, of which 14 were performed for cancer at the nipple margin. Forty-four breasts (9.4%) had complications that required re-operation. Fifteen patients had locoregional recurrence or distant metastasis. CONCLUSIONS: NSM use for invasive carcinoma has doubled at our institution since 2011, while postoperative complications and recurrence rates remain low. Our experience supports the selective use of NSM in the malignant setting with careful patient selection.

Bilateral mastectomy operations and the role for the cosurgeon technique: A Nationwide analysis of surgical practice patterns.

Traditionally, bilateral mastectomy (BM) operations are performed by a single surgeon but a two-attending co-surgeon technique (CST) has been described. A questionnaire was sent to members of the American Society of Breast Surgeons to assess national BM practices and analyze utilization and perceived benefits of the CST. Among surgeons responding, most continue to use the single-surgeon approach for BMs; however, 14.1% utilize the CST and up to 31% are interested in future CST use. Time savings, mentorship, cost savings, and opportunity to learn new techniques were identified as perceived CST advantages.

Impact of geographic distribution of accredited breast centers.

The National Accreditation Program for Breast Centers (NAPBCs) is dedicated to improving the quality of care in patients with breast disease. Geographic distribution of health care resources is an important measure of quality, yet little is known regarding breast center allocation patterns concerning population demand and impact on health outcomes. The purpose of this study was to analyze the distribution of NAPBC programs in the United States (USA) and evaluate the impact on breast cancer survival. Using the Centers for Disease Control and Prevention 2014 data base, we identified the incidence and mortality rates for breast cancer by state. We also determined the concentration of NAPBC programs in each state (ie, the number of centers per 1000 cases of breast cancer). Data were analyzed using Spearman's (nonparametric) rank correlation coefficients. Five hundred and seventy NAPBC programs were identified. Across the United States, there was a mean of 2.8 programs/1000 breast cancer diagnoses. A positive correlation (r = .45) between breast cancer incidence and the number of programs was identified (P = .0009). There was no statistically significant correlation between mortality and NAPBC program concentration (r = -0.20, P = .16). NAPBC-accredited program distribution within the United States correlates with breast cancer incidence per state. However, the number of NAPBC programs per state did not alter overall mortality rates. Added measures beyond survival, as well as further insight into referral patterns to NAPBC programs, may be required to demonstrate the value and impact of NAPBC accreditation.