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.

Repurposing a Small Community Hospital Surgical Residency Program in an Epicenter of the COVID-19 Pandemic.

BACKGROUND: COVID-19 put a stop to the operative experience of surgical residents, leaving reassignment of the team, to the frontlines. Each program has adapted uniquely; we discuss how our surgical education changed in our hospital. STUDY DESIGN: A retrospective review of changes in general surgery cases, bedside procedures, and utilization of residents before and during the pandemic. Procedures were retrieved from electronic medical records. Operating room (OR) cases 1 month before and 5 weeks after the executive order were collected. Triple lumen catheter (TLC), temporary hemodialysis catheter (HDC), and pneumothorax catheter (PC) insertions by surgical residents were recorded for 5 weeks. RESULTS: Before the pandemic, an average of 27.9 cases were done in the OR, with an average of 10.1 general surgery cases. From March 23 to April 30, 2020, the average number of cases decreased to 5.1, and general surgery cases decreased to 2.2. Elective, urgent, and emergent cases represented 83%, 14.6%, and 2.4% prior to the order and 66.7%, 15.1%, and 18.2%, respectively, after the order. Bedside procedures over 5 weeks totaled to 153, 93 TLCs, 39 HDCs, and 21 PCs. CONCLUSION: Repurposing the surgical department for the concerns of the pandemic has involved all surgical staff. We worked with other departments to allocate our team to areas of need and re-evaluated daily. The strengths of our team to deliver care and perform many bedside procedures allowed us to meet the demands posed by this disease while remaining as a cohesive unit.

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.

Role of Sentinel Lymph Node Biopsy in Microinvasive Breast Cancer.

BACKGROUND: Microinvasive ductal carcinoma (DCISM), defined as DCIS with a focus of invasive carcinoma ≤ 1 mm, can be managed similarly to pure DCIS; however, management of the axilla in DCISM has been a subject of debate. Reports in the literature differ on the utility and necessity of sentinel lymph node biopsy (SLNB) for DCISM. The aim of the present study was to identify risk factors for nodal disease in patients with DCISM, which can help develop a selective approach to SLNB in this patient population. METHODS: The National Cancer Database was used to select patients with DCISM (pT1mi), diagnosed from 2012 to 2015, who underwent SLNB. Multivariable regression analysis was performed to determine associations between sentinel lymph node metastasis and relevant clinical variables. RESULTS: Our cohort comprised of 2609 patients with pT1mi who underwent SLNB. Of these, 76 (2.9%) were found to have sentinel lymph node metastases on final pathology. Low/intermediate grade tumors were associated with decreased SLN metastasis (OR 0.50, CI 0.28-0.92). Age and receptor status of the tumor did not have a clear association in predicting SLN metastases. CONCLUSIONS: The rate of sentinel node metastases in DCISM is low at only 2.9% in this national study. Tumor grade was identified as influencing the risk of SLN metastases. This information can factor into shared decision-making for SLNB in patients with DCISM.

Evaluating the role of sentinel lymph node biopsy in patients with DCIS treated with breast conserving surgery.

INTRODUCTION: The role of sentinel lymph node biopsy (SLNB) for patients with ductal carcinoma in-situ (DCIS) is limited given the rarity of nodal metastasis in non-invasive disease. Although SLNB is typically a safe procedure, there are potential complications and associated costs. The purpose of this study is to assess national surgical practice patterns and clinical outcomes with respect to the use of SLNB for DCIS in patients undergoing breast conserving surgery (BCS). METHODS: Case-level data from the National Cancer Data Base (NCDB) was assessed to identify adult patients ≥ 18 with DCIS, who underwent BCS and SLNB. Patient demographics and hospital characteristics were grouped for analytic purposes. A multivariate analysis was performed for patient and hospital characteristics. RESULTS: We identified 15,422 patients with DCIS undergoing BCS in 2015, of which 2,698 (18%) underwent SLNB. A multivariate analysis demonstrated a significant association between greater frequency of SLNB in patients age range of 60-69, receipt of care at a community facility, and higher nuclear grade DCIS. Positive sentinel nodes metastasis was identified in 0.9% patients undergoing BCS and SLNB for DCIS. CONCLUSION: The role of SLNB in patients with DCIS undergoing BCS is limited and does not routinely provide meaningful information or benefit to clinical management. Despite this, nearly one in five patients undergoing BCS for DCIS had lymph node sampling performed. Given the potential increased morbidity and financial implications, this finding represents an opportunity for further education and improvement in patient selection for SLNB.

Analysis of active surveillance as a treatment modality in ductal carcinoma in situ.

Ductal carcinoma in situ (DCIS) is a nonobligate precursor of invasive breast cancer. Current clinical trials are exploring active surveillance (AS) of DCIS. The purpose of this study is to characterize current practice trends in the use of AS. The findings may inform clinical trials and provide insight into factors influencing adoption into practice. The National Cancer Database was used to identify women diagnosed with DCIS from 2004 to 2015. Management with AS was defined as any patient not undergoing surgery, chemotherapy, or radiation therapy. Multivariable logistic regression was used to assess patterns of AS. Of 84 281 women with DCIS, 342 (0.4%) underwent AS. Increased age (OR 1.16, CI 1.15-1.17), Hispanic or non-Hispanic black ethnicities (OR 1.91 CI 1.42-2.56; 1.54 CI 1.13-2.10), treatment at an academic facility (OR 1.64 CI 1.31-2.10), and low-volume facilities (OR 1.60 CI 1.06-2.42) were associated with an increased use of AS. Patients with ≥1 comorbidities (OR 0.70 CI 0.49-0.98), high-grade tumors (OR 0.671 CI 0.51-0.89), and private insurance (OR 0.69 CI 0.53-0.89) less frequently underwent AS. Of all patients undergoing AS, 11% received endocrine therapy. Active surveillance is currently an infrequently used treatment modality for patients with DCIS. We observed variations in AS based on age, ethnicity, comorbidities, facility type, facility volume, insurance status, and tumor grade. Most patients managed with AS did not receive hormone therapy. This information may further inform strategies for clinical trials, as well as guide quality of care in the adoption of future management options for DCIS.

Delayed adjuvant hormonal therapy and its impact on mortality in women with breast cancer.

Adjuvant hormonal therapy (HT) is important for the management of hormone-sensitive breast cancer. However, the timeliness for adjuvant HT and the consequences of delayed initiation of treatment have not been analyzed. The purpose of this study was to characterize delays to HT and assess the impact on clinical outcomes. The study cohort consisted of female patients with invasive ductal and/or lobular, hormone receptor-positive breast cancer diagnosed between 2010 and 2015. Initiation of HT >6 months (180 days) after surgery was defined as delayed. Patients receiving chemotherapy were excluded from the study cohort. Multivariable logistic regression modeling was performed to establish associations between delayed HT and demographic, facility, and clinical factors. Survival analysis was performed using the Kaplan-Meier estimation and Cox proportional hazards regression to evaluate overall survival. Of 179 590 women assessed in the National Cancer Database, 3.2% had a delay in the initiation of adjuvant HT. Positive demographic-related risk factors were younger age, ethnic minority groups, and multiple comorbidities. Clinical factors significantly associated with delayed initiation of adjuvant HT were high-grade tumor, larger tumor size, greater lymph node involvement, having an unplanned readmission within 30 days of surgery, and positive final surgical margins. Adjusted survival analysis showed a survival disadvantage of delayed initiation of HT. Risk factors for delayed initiation of HT specific to demographic and clinical characteristics were identified. Delayed initiation of HT was associated with a survival detriment.

Assessing Burnout and Professional Fulfillment in Breast Surgery: Results From a National Survey of the American Society of Breast Surgeons.

BACKGROUND: Physician burnout is a well-recognized problem in health care that has a negative impact on professional well-being and quality of patient care. Rates of burnout in breast surgery are not well-defined. This study sought to understand the degree of burnout among breast surgeons and to identify factors that influence professional fulfillment. METHODS: All U.S. members of the American Society of Breast Surgeons with a valid email address were surveyed in October 2017. The results were anonymous, and the participants were blinded to the study hypothesis. The survey included 30 questions (16-item Professional Fulfillment Index [PFI] and 14-item demographics/practice patterns). Multivariable linear regressions were performed to assess overall burnout and high professional fulfillment. RESULTS: Of the 2568 surveys delivered, 708 surveys were initiated, and 660 were completed. Among breast surgeons, 270 (41.3%) expressed burnout, whereas 281 (42.5%) reported high professional fulfillment. In the multivariable analysis, years in practice was inversely associated with burnout and positively correlated with professional fulfillment. Working more than 60 h per week was positively associated with burnout, and having more than 50% of practice dedicated to breast surgery correlated positively with fulfillment. CONCLUSION: Approximately 4 of 10 breast surgeons have symptoms of burnout, whereas 4 of 10 surgeons report high professional fulfillment. Specific clinical practice conditions largely influence rates of burnout and professional fulfillment. The contributing factors identified in the study analysis may be useful in identifying breast surgeons at higher risk for burnout. The study findings also help to inform the design of interventions focused on the clinical practice environment to promote professional fulfillment and sustainability.

Comparison of breast-conserving therapy vs mastectomy in women under age 40: National trends and potential survival implications.

INTRODUCTION: Despite initial increased rates of breast-conserving therapy compared to mastectomy after 1990, mastectomy rates have increased in women under age 40 since 2000. Our study explores the demographic and survival implications of this trend. METHODS: The National Cancer Database was used to study stage 1 breast cancer diagnosed in women under age 40 between 2004 and 2014. Demographic and clinical data were obtained. Multivariable regression and survival analyses were performed. RESULTS: Of 11 859 patients under age 40, 57.2% underwent mastectomy (39.0% unilateral and 61.0% bilateral) rather than breast-conserving therapy (42.8%). The rate of mastectomy was significantly higher in 2014 compared to 2004 (43.6% in 2004 vs 62.4% in 2014; P < 0.001). The rate of bilateral mastectomy was significantly higher in 2014 compared to 2004 in contrast to unilateral mastectomy (31.7% in 2004 vs 73.0% in 2014; P < 0.001). Non-Hispanic Caucasian ethnicity and private insurance status were predictors of bilateral mastectomy (OR 2.06 [95% CI: 1.84-2.30], P < 0.001; OR 1.39 [95% CI: 1.21-1.59], P < 0.001). Controlling for demographics, tumor grade, and adjuvant therapies, bilateral mastectomy was associated with significantly increased 10-year survival vs unilateral mastectomy (HR 0.75 [0.59-0.96], P = 0.023). Additionally, breast-conserving therapy was associated with significantly increased 10-year survival vs unilateral (HR 2.36 [95% CI: 1.83-3.05]; P < 0.001) and bilateral mastectomy (HR 2.30 [95% CI: 1.61-3.27]; P < 0.001). CONCLUSIONS: The majority of women under age 40 with stage 1 invasive breast cancer underwent mastectomy instead of breast-conserving therapy. This largely reflects increased rates of contralateral prophylactic mastectomy. Bilateral mastectomy and breast-conserving therapy vs unilateral mastectomy were associated with a small but significant increase in survival. This finding warrants further investigation to determine the clinical implications of decision-making in younger women.

Association between socioeconomic factors and outcomes in breast cancer.

BACKGROUND: Persistent socioeconomic disparities are evident in the delivery of health care. Despite previous research into health disparities, the extent of the effect of economic inequalities in the management of breast cancer is not well understood. The purpose of our study is to perform a national assessment of the impact of economic factors on key aspects of breast cancer management. METHODS: This is a retrospective study using data from the National Cancer Database. The population consisted of female patients with primary breast cancer diagnosed between 2011 and 2015. Patients were categorized based on household income and insurance status. Outcomes investigated were stage at diagnosis, rate of breast conservation therapy, use of immediate reconstruction following mastectomy, and administration of systemic therapy for stage 3 and 4 disease. Multivariable logistic regression analyses were performed to determine significant associations between economic factors and clinical outcomes. Survival analysis was performed to evaluate the influence of income and insurance on survival. RESULTS: In total, 666 487 women were evaluated. Multivariable regression analyses revealed that patients with lower income (OR, 1.23) and no insurance (OR, 1.64) were more often diagnosed with later stage disease. Patients with lower income (OR, 1.08) and no insurance (OR, 1.05) had a higher likelihood of undergoing mastectomy instead of breast conserving therapy. Patients with lower income (OR, 0.51) and no insurance (OR, 0.27) were less likely to receive immediate breast reconstruction. Administration of systemic therapy was less frequent in patients with lower income (OR, 0.90) and no insurance (OR, 0.52). A survival benefit was demonstrated in patients with high income and insurance. CONCLUSION: Our findings demonstrate prevailing disparities in the delivery of care among patients with limited economic resources, which pertains to some of the most important aspects of breast cancer care. The full etiology of the observed disparities is complex and multifactorial, and a better understanding of these issues offers the potential to close the existing gap in quality of care.

Characterizing Response to Neoadjuvant Chemotherapy in Invasive Lobular Breast Carcinoma.

BACKGROUND: Pathological complete response (pCR) after neoadjuvant chemotherapy (NCT) for breast cancer is associated with improved survival and facilitates conservative surgical strategies. Invasive lobular carcinoma (ILC) has been observed to have decreased response to NCT compared with invasive ductal carcinoma (IDC). This study seeks to evaluate national trends in the use of NCT for ILC compared with IDC, and determine if there is a subset of ILC patients who demonstrate favorable response rates. METHODS: This is a study using the National Cancer Database. The cohort consisted of patients with stage 1-3 ILC treated between 2010 and 2014, and a reference cohort of patient with IDC. For patients receiving NCT, pCR was assessed and clinically relevant variables were used in multivariable logistic regression models for each histologic subtype, modeling for pCR achievement. Survival analysis was performed for each histologic group to evaluate potential survival benefits of achieving pCR. RESULTS: Our study cohort consisted of 384,887 women, of which 9.7% had ILC. A significantly lower rate of pCR after NCT was found in the cases of ILC compared with those of IDC (8.7% versus 23.2%). Increased response was seen in ILC patients with HER2-positive and TNBC subtypes. A survival benefit was demonstrated in patients with ILC who achieved pCR. CONCLUSIONS: While response to NCT in patients with ILC is uncommon, our findings demonstrate a selective benefit for patients with HER2-positive tumors and TNBC. In addition, pCR is correlated with a clear survival advantage in ILC.