Should patients with hormone receptor-positive, HER2-negative breast cancer and one or two positive sentinel nodes undergo axillary dissection to determine candidacy for adjuvant abemaciclib?

BACKGROUND: The monarchE trial demonstrated improved outcomes with the use of adjuvant abemaciclib in patients with high-risk hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer defined as ≥4 positive lymph nodes (+LNs) or one to three +LNs with one or more additional high-risk features (HRFs). The proportion of patients with one or two positive sentinel lymph nodes (+SLNs) without HRFs who had ≥4 +LNs at the time of completion axillary lymph node dissection (cALND), and who therefore qualified for receipt of abemaciclib, was investigated. METHODS: Females with pathologically node-positive nonmetastatic HR+/HER2- breast cancer stratified by the number of +SLNs and +LNs and the presence of one or more HRFs were identified from the National Cancer Database (2018-2019). The proportion of patients meeting the criteria for abemaciclib both before and after ALND was assessed. RESULTS: Of the 22,048 patients identified, 1578 patients underwent upfront surgery, had one or two +SLNs without HRFs, and went on to cALND. Only 213 (13%) of these patients had ≥4 +LNs; thus, cALND performed solely to determine abemaciclib candidacy would have constituted surgical overtreatment in 1365 patients (87%). When stratified by the number of +SLNs, only 10% of those with one +SLN and 24% of those with two +SLNs had ≥4 +LNs after cALND, which meets the criteria for abemaciclib. CONCLUSIONS: Patients with one +SLN without HRFs are unlikely to have ≥4 +LNs and should not be subjected to the morbidity of ALND in order to inform candidacy for abemaciclib. An individualized multidisciplinary discussion should be undertaken about the risk:benefit ratio of ALND and abemaciclib for those with two +SLNs.

Evolving Economics: The Erosion of Medicare Reimbursement in Breast Surgery (2003-2023).

INTRODUCTION: Medicare significantly influences reimbursement rates, setting a standard that impacts private insurance policies. Despite declining rates in various specialties, the magnitude of these trends has not been examined in breast surgery. This study examines Medicare reimbursement trends for breast surgery operations. METHODS: Data for 10 breast operations from 2003 to 2023 were collected from the Medicare Physician Fee Look-Up Tool and yearly reimbursement was computed using the conversion factor. The year-to-year percentage change in reimbursement was calculated, and the overall median change was compared with the consumer price index (CPI) for inflation evaluation. All data were adjusted to 2023 United States dollars. The compound annual growth rate (CAGR) was calculated using inflation-adjusted data. RESULTS: Over the study period, reimbursement for the 10 breast operations had a mean unadjusted percentage increase of + 25.17%, while the CPI increased by 69.15% (p < 0.001). However, after adjustment, overall reimbursement decreased by - 20.70%. Only two operations (lumpectomy and simple mastectomy) saw increased inflation-adjusted Medicare reimbursement (+ 0.37% and + 3.58%, respectively). The CAGR was - 1.54% overall but remained positive for the same two operations (+ 0.02% and + 0.18%, respectively). Based on these findings, breast surgeons were estimated to be reimbursed $107,605,444 less in 2023 than if rates had kept pace with inflation over the past decade. CONCLUSION: Inflation-adjusted Medicare reimbursement rates for breast surgeries have declined from 2003 to 2023. This downward trend may strain resources, potentially leading to compromises in care quality. Surgeons, administrators, and policymakers must take proactive measures to address these issues and ensure the ongoing accessibility and quality of breast surgery.

Nodal Surgery for Patients ≥ 70 Undergoing Mastectomy for DCIS? Choose Wisely.

BACKGROUND: Routine sentinel lymphadenectomy (SLNB) for early-stage HR+/HER2- breast cancer in women ≥70 is discouraged by Choosing Wisely, but whether SLNB can be routinely omitted in women ≥70 with DCIS undergoing mastectomy is unclear. This study aims to evaluate rates of axillary surgery and nodal positivity (pN+) in this population to determine the impact of axillary surgery on treatment decisions. METHODS: Females ≥70 with DCIS undergoing mastectomy were identified from the National Cancer Database (2012-2020). The rate of upstaging to invasive cancer (≥pT1) or pN+ was assessed. Subset analyses were conducted for ER+ patients. Adjuvant therapies were evaluated among ≥pT1 patients after stratifying by nodal status. RESULTS: Of 9,030 patients, 1,896 (21%) upstaged to ≥pT1. Axillary surgery was performed in 86% of patients, predominantly sentinel lymphadenectomy (SLNB, 65%). Post hoc application of Choosing Wisely criteria demonstrated that 93% of the entire cohort and 97% of ER+ DCIS patients could have avoided axillary surgery. Nodal positivity was 0.3% among those who didn't upstage, and 12% among those upstaging to ≥pT1, with <2% having pN2-3 disease, irrespective of receptor subtype. Node-positive patients had higher adjuvant therapy usage, but there was no recommendation for adjuvant chemotherapy or radiation for 71% and 66% of pN+ patients, respectively. CONCLUSIONS: Axillary surgery can be omitted for most patients ≥70 undergoing mastectomy for ER+ DCIS, aligning with recommendations for invasive cancer, and omission can be considered in those with ER- disease. Future guidelines incorporating preoperative imaging, as in the SOUND trial, may aid in identifying patients benefiting from axillary surgery.

Should Palpable Nodes Be Exclusionary in Patients Who Are Otherwise Candidates for ACOSOG Z0011-Type Trials?

BACKGROUND: Palpable nodes were exclusionary in American College of Surgeons Oncology Group (ACOSOG) Z0011, while SINODAR-ONE excluded those with positive axillary nodes by palpation and ultrasound. To determine whether clinical nodal status should be exclusionary in those fulfilling pathologic criteria for ACOSOG Z0011 and similar trials, this study analyzed the accuracy and implications of clinical nodal positivity. METHODS: Patients ≥ 18 years old with cT1-T2, cN0-cN1, M0 breast cancer were identified in the National Cancer Database between 2004 and 2019. Subset characteristics of cN1 and cN0 were compared with respect to final pathologic nodal status and overall survival (OS). RESULTS: Of 57,823 patients identified, 77.0% were cT1 and 23.0% were cT2. Of the 93.9% of patients who were staged as cN0, 16.7% were pN1; of the remaining 6.1% staged as cN1, 9.6% were found to be pN0. Among cN1/pN0 patients, 14.9% underwent axillary dissection without sentinel node biopsy. There was no difference in adjusted OS for patients staged as cN0 versus cN1 who were found to be pN1 (HR 1.13, 95% CI 0.93-1.37, p = 0.22), a finding that persisted on subset analysis in those with two positive nodes (HR 0.91, 95% CI 0.62-1.33, p = 0.63). CONCLUSIONS: Clinical nodal stage does not affect OS in pN1 patients. Clinical nodal assessment can both overstage patients and result in unnecessary axillary surgery. These data suggest that cN1 patients who are otherwise candidates for a Z0011-like paradigm should still be considered eligible. Their final candidacy should be determined by surgical lymph node pathology and not preoperative clinical status.

A Bilingual Readability Assessment of Online Breast Cancer Screening and Treatment Information.

INTRODUCTION: Presenting health information at a sixth-grade reading level is advised to accommodate the general public's abilities. Breast cancer (BC) is the second-most common malignancy in women, but the readability of online BC information in English and Spanish, the two most commonly spoken languages in the United States, is uncertain. METHODS: Three search engines were queried using: "how to do a breast examination," "when do I need a mammogram," and "what are the treatment options for breast cancer" in English and Spanish. Sixty websites in each language were studied and classified by source type and origin. Three readability frameworks in each language were applied: Flesch Kincaid Reading Ease, Flesch Kincaid Grade Level, and Simple Measure of Gobbledygook (SMOG) for English, and Fernández-Huerta, Spaulding, and Spanish adaptation of SMOG for Spanish. Median readability scores were calculated, and corresponding grade level determined. The percentage of websites requiring reading abilities >sixth grade level was calculated. RESULTS: English-language websites were predominantly hospital-affiliated (43.3%), while Spanish websites predominantly originated from foundation/advocacy sources (43.3%). Reading difficulty varied across languages: English websites ranged from 5th-12th grade (Flesch Kincaid Grade Level/Flesch Kincaid Reading Ease: 78.3%/98.3% above sixth grade), while Spanish websites spanned 4th-10th grade (Spaulding/Fernández-Huerta: 95%/100% above sixth grade). SMOG/Spanish adaptation of SMOG scores showed lower reading difficulty for Spanish, with few websites exceeding sixth grade (1.7% and 0% for English and Spanish, respectively). CONCLUSIONS: Online BC resources have reading difficulty levels that exceed the recommended sixth grade, although these results vary depending on readability framework. Efforts should be made to establish readability standards that can be translated into Spanish to enhance accessibility for this patient population.

What Proportion of BRCA-Associated Breast Cancer Is Human Epidermal Growth Factor 2-Low and Eligible for Additional Targeted Therapy?

INTRODUCTION: DESTINY B04 provided clinical meaning to a new classification of human epidermal growth factor 2 (HER2) expression in breast cancer: HER2-low. Patients with germline breast cancer type 1 gene pathogenic variants (gBRCA1) often develop triple negative breast cancer (TNBC), but the proportion who could be classified as HER2-low and qualify for an additional targeted therapy option is unknown. This study aims to characterize the proportion of gBRCA1 or germline breast cancer type 2 gene pathogenic variants patients for whom these novel targeted therapies may be an option. METHODS: We performed a retrospective chart review of patients with gBRCA1/2 treated at our institution for invasive breast cancer from 2000 to 2021. Synchronous or metachronous contralateral breast cancers were recorded separately. HER2 status was determined by immunohistochemistry and fluorescence in situ hybridization. We excluded patients without complete HER2 data. RESULTS: Among the 95 breast cancers identified in our cohort of 85 gBRCA1/2 patients, 41 (43%) were TNBC, 38 (40%) were hormone receptor positive (HR+)/HER2-negative, and 16 (17%) were HER2-positive based on standard conventions. We found that 82% of the HR+/HER2-cancers and 66% of TNBCs would be reclassified as HER2-low. After stratifying by BRCA gene status, 64% of cancers in patients with gBRCA1 and 58% of cancers in patients with germline breast cancer type 2 gene pathogenic variants were HER2-low. CONCLUSIONS: A significant portion of gBRCA1/2 patients who were previously diagnosed with TNBC or HR+/HER2- breast cancer would now be classified as HER2-low and could be considered for the use of trastuzumab deruxtecan in the metastatic setting. Outcome differences from therapy changes in this cohort should now be assessed.

Lost in Translation: Multilingual Analysis of Online Breast Cancer Information.

INTRODUCTION: Patients use the internet to learn more about health conditions. Non-English-speaking patients may face additional challenges. The quality of online breast cancer information, the most common cancer in women, is uncertain. This study aims to examine the quality of online breast cancer information for English and non-English-speaking patients. METHODS: Three search engines were queried using the terms: "how to do a breast examination," "when do I need a mammogram," and "what are the treatment options for breast cancer" in English, Spanish, and Chinese. For each language, 60 unique websites were included and classified by type and information source. Two language-fluent reviewers evaluated website quality using the Journal of American Medical Association benchmark criteria (0-4) and the DISCERN tool (1-5), with higher scores representing higher quality. Scores were averaged for each language. Health On the Net code presence was noted. Inter-rater reliability between reviewers was assessed. RESULTS: English and Spanish websites most commonly originated from US sources (92% and 80%, respectively) compared to Chinese websites (33%, P < 0.001). The most common website type was hospital-affiliated for English (43%) and foundation/advocacy for Spanish and Chinese (43% and 45%, respectively). English websites had the highest and Chinese websites the lowest mean the Journal of American Medical Association (2.2 ± 1.4 versus 1.0 ± 0.8, P = 0.002) and DISCERN scores (3.5 ± 0.9 versus 2.3 ± 0.6, P < 0.001). Health On the Net code was present on 16 (8.9%) websites. Inter-rater reliability ranged from moderate to substantial agreement. CONCLUSIONS: The quality of online information on breast cancer across all three languages is poor. Information quality was poorest for Chinese websites. Improvements to enhance the reliability of breast cancer information across languages are needed.

Liposomal Bupivacaine Use During Orthognathic Surgery in Cleft Lip and Palate Patients.

INTRODUCTION: Effective pain management is crucial in cleft lip and palate (CLP) patients undergoing orthognathic surgery for earlier recovery and decreased opioid reliance. Liposomal bupivacaine (Exparel) is a local anesthetic that provides extended postoperative analgesia in adult patients; however, research on its use in adolescents is limited. This study explores the efficacy of liposomal bupivacaine for postoperative pain management in adolescent CLP patients undergoing orthognathic surgery. METHODS: The authors performed a retrospective chart review at their institution between July 2020 and December 2022 to identify patients who underwent LeFort I or mandibular osteotomy. Two cohorts were compared: patients who received liposomal bupivacaine and patients who received standard pain medications alone. Outcome measures included intraoperative pain medications, length of stay, breakthrough opioid use, time to first oral intake, volume of oral intake, and opioids prescribed at discharge. RESULTS: This study included 22 patients who underwent orthognathic surgery. The liposomal bupivacaine group (n=10) demonstrated earlier and greater oral intake during hospitalization compared with controls (n=12). The most significant difference was observed in total breakthrough opioid use, with an average of 8.60 morphine milligram equivalents for liposomal bupivacaine patients compared with 35.1 morphine milligram equivalents for controls ( P =0.037). CONCLUSIONS: This study provides the first analysis of liposomal bupivacaine use in adolescent CLP patients undergoing orthognathic surgery, demonstrating a significant reduction in postoperative opioid consumption compared with controls. These results may guide future studies of liposomal bupivacaine within CLP patients, potentially as a component of enhanced recovery after surgery guidelines, as well as in cost-analysis studies.

Racial and socioeconomic disparities in breast cancer diagnosis and mortality in Pennsylvania.

PURPOSE: Many studies have demonstrated disparities in breast cancer (BC) incidence and mortality among Black women. We hypothesized that in Pennsylvania (PA), a large economically diverse state, BC diagnosis and mortality would be similar among races when stratified by a municipality's median income. METHODS: We collected the frequencies of BC diagnosis and mortality for years 2011-2015 from the Pennsylvania Cancer Registry and demographics from the 2010 US Census. We analyzed BC diagnoses and mortalities after stratifying by median income, municipality size, and race with univariable and multivariable logistic regression models. RESULTS: In this cohort, of 5,353,875 women there were 54,038 BC diagnoses (1.01% diagnosis rate) and 9,828 BC mortalities (0.18% mortality rate). Unadjusted diagnosis rate was highest among white women (1.06%) but Black women had a higher age-adjusted diagnosis rate (1.06%) than white women (1.02%). Race, age and income were all significantly associated with BC diagnosis, but there were no differences in BC diagnosis between white and Black women across all levels of income in the multivariable model. BC mortality was highest in Black women, a difference which persisted when adjusted for age. Black women 35 years and older had a higher mortality rate in all income quartiles. CONCLUSION: We found that in PA, age, race and income are all associated with BC diagnosis and mortality with noteworthy disparities for Black women. Continued surveillance of differences in both breast cancer diagnosis and mortality, and targeted interventions related to education, screening and treatment may help to eliminate these socioeconomic and racial disparities.

Use of a supervised machine learning model to predict Oncotype DX risk category in node-positive patients older than 50 years of age.

PURPOSE: The use of the Oncotype DX recurrence score (RS) to predict chemotherapy benefit in patients with hormone receptor-positive/HER2 negative (HR+/HER2-) breast cancer has recently expanded to include postmenopausal patients with N1 disease. RS availability is limited in resource-poor settings, however, prompting the development of statistical models that predict RS using clinicopathologic features. We sought to assess the performance of our supervised machine learning model in a cohort of patients > 50 years of age with N1 disease. METHODS: We identified patients > 50 years of age with pT1-2N1 HR+/HER2- breast cancer and applied the statistical model previously developed in a node-negative cohort, which uses age, pathologic tumor size, histology, progesterone receptor expression, lymphovascular invasion, and tumor grade to predict RS. We measured the model's ability to predict RS risk category (low: RS ≤ 25; high: RS > 25). RESULTS: Our cohort included 401 patients, 60.6% of whom had macrometastases, with a median of 1 positive node. The majority of patients had a low-risk observed RS (85.8%). For predicting RS category, the model had specificity of 97.3%, sensitivity of 31.8%, a negative predictive value of 87.9%, and a positive predictive value of 70.0%. CONCLUSION: Our model, developed in a cohort of node-negative patients, was highly specific for identifying cN1 patients > 50 years of age with a low RS who could safely avoid chemotherapy. The use of this model for identifying patients in whom genomic testing is unnecessary would help decrease the cost burden in resource-poor settings as reliance on RS for adjuvant treatment recommendations increases.

Neoadjuvant Chemotherapy for Breast Cancer In the Elderly: Are We Accomplishing Our Treatment Goals?

INTRODUCTION: Rates of downstaging and tolerability to NAC in women age ≥ 70 years with operable breast cancer have not been well studied. We sought to compare downstaging rates and NAC completion between women age 50-69 years and age ≥ 70 years. METHODS: Consecutively treated women age ≥ 50 years with cT1-3N0-1 breast cancer receiving NAC followed by surgery from November 2013 to April 2020 were studied. Rates of downstaging from breast-conserving surgery (BCS)-ineligible to BCS-eligible and avoidance of axillary dissection (ALND) in cN1 patients were compared between patients age 50-69 and ≥ 70 years. NAC regimens and rates of completion also were assessed. RESULTS: Overall, 651 women, age ≥ 50 years, with 668 cT1-3N0-1 breast cancers that were treated with NAC, were identified; 75 (11.1%) were age ≥ 70 years. Patients age ≥ 70 years were less likely to have lobular cancers (5% vs. 10%, p = 0.03), receive an anthracycline-based regimen (69% vs. 93%, p < 0.001), and complete their entire prescribed regimen (57% vs. 78%, p < 0.001). Of 312 BCS-ineligible patients eligible for downstaging, conversion rates to BCS-eligibility were similar between age groups (72% [≥ 70] vs. 74% [50-69], p > 0.9). Women age ≥ 70 years who converted to BCS-eligible post-NAC were more likely to undergo BCS than younger patients (93% vs. 74%, p = 0.04). Of 390 cN1 patients, 162 (42%) achieved a nodal pCR; ALND avoidance was similar between age groups (43% [≥ 70] vs. 42% [50-69], p > 0.9). CONCLUSIONS: While patients age ≥ 70 years received less anthracycline-based NAC and were less likely to complete their prescribed regimen, they experienced high rates of breast and axillary downstaging, similar to younger patients, suggesting that well-selected elderly patients can safely receive NAC with substantial clinical benefit.

Omission of Intraoperative Frozen Section May Reduce Axillary Overtreatment Among Clinically Node-Negative Patients Having Upfront Mastectomy.

BACKGROUND: The growing use of postmastectomy radiation/regional nodal irradiation (PMRT) has resulted in many women receiving both axillary dissection (ALND) and PMRT, increasing lymphedema rates. After developing standardized PMRT criteria, we adopted a policy of ALND omission among cN0 patients with 1-2 positive sentinel nodes (+SLNs) requiring PMRT. We evaluated how often overtreatment with ALND+PMRT was avoided with this approach. METHODS: A retrospective review of a prospectively maintained database was performed beginning 1 year before policy adoption. Intraoperative SLN evaluation was routine pre- and post-policy. ALND was performed for SLN macrometastasis pre-policy, and selectively performed post-policy for 1-2 +SLNs based on PMRT criteria. ALND+PMRT was required for ≥ 3 +SLNs. RESULTS: From March 1, 2018 to November 30, 2020, a total of 2207 cT1-3N0 patients had mastectomy and 231 had +SLNs; 109 (47%) were treated pre-policy and 122 (53%) post-policy. Most (81%) had 1-2 +SLNs. There was no change in rates of ALND+PMRT (64% pre-policy vs. 58% post-policy, p = 0.09), including in patients with 1-2 +SLNs (61% vs. 51%, p = 0.20). Post-policy, ALND was omitted in 9 (7%) patients recognized intraoperatively as PMRT candidates; avoidable ALND was performed in 40 (33%) patients not identified as PMRT candidates until receipt of final pathology. Overall, had intraoperative SLN evaluation been deferred, only 5.7% of patients would have required completion ALND: 2.2% (n = 49/2207) for ≥ 3 +SLNs and 3.5% (n = 77/2207) for 1-2 +SLNs without PMRT indication. CONCLUSIONS: Most patients could have avoided ALND+PMRT if decision making was deferred until final pathology was available. Selective intraoperative SLN evaluation in cN0 patients having upfront mastectomy may reduce avoidable overtreatment.

Neoadjuvant Endocrine Therapy and Delays in Surgery for Ductal Carcinoma in Situ: Implications for the Coronavirus Pandemic.

BACKGROUND: Surgical delays are associated with invasive cancer for patients with ductal carcinoma in situ (DCIS). During the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic, neoadjuvant endocrine therapy (NET) was used as a bridge until postponed surgeries resumed. This study sought to determine the impact of NET on the rate of invasive cancer for patients with a diagnosis of DCIS who have a surgical delay compared with those not treated with NET. METHODS: Using the National Cancer Database, the study identified women with hormone receptor-positive (HR+) DCIS. The presence of invasion on final pathology was evaluated after stratifying by receipt of NET and by intervals based on time from diagnosis to surgery (≤30, 31-60, 61-90, 91-120, or 121-365 days). RESULTS: Of 109,990 women identified with HR+ DCIS, 276 (0.3%) underwent NET. The mean duration of NET was 74.4 days. The overall unadjusted rate of invasive cancer was similar between those who received NET ((15.6%) and those who did not (12.3%) (p = 0.10). In the multivariable analysis, neither the use nor the duration of NET were independently associated with invasion, but the trend across time-to-surgery categories demonstrated a higher rate of upgrade to invasive cancer in the no-NET group (p < 0.001), but not in the NET group (p = 0.97). CONCLUSIONS: This analysis of a pre-COVID cohort showed evidence for a protective effect of NET in HR+ DCIS against the development of invasive cancer as the preoperative delay increased, although an appropriately powered prospective trial is needed for a definitive answer.

Institutions Treating Breast Cancer Patients of a Low Socioeconomic Status Achieve Multidisciplinary Quality Standards at Lower Rates.

BACKGROUND: The National Accreditation Program of Breast Centers (NAPBC) certifies institutions that provide quality breast care. Whereas low socioeconomic status (SES) has a negative impact on patient outcomes, it is unknown whether an institution's patient SES mix is associated with meeting NAPBC standards. METHODS: All institutions submitting at least 100 breast cancer patients to the National Cancer Database (2006-2017) were ranked based on the patients' insurance status, income, and education. The 10% treating the largest proportion of low-SES patients were termed low-SES institutions (LSES). Patient cohorts were created based on the 2018 NAPBC standards. Uni- and multivariate comparisons of patient, tumor, and treatment factors were made to calculate adjusted odds of meeting each standard between low- and non-low-SES institutions. RESULTS: The analysis included 1319 institutions. Both the LSES and non-LSES reached the benchmark rate of 50% lumpectomies (61.2 vs 62.9%; p < 0.001), but the unadjusted and adjusted rates of lumpectomy were lower in LSES. The rate for sentinel lymphadenectomy was lower for LSES (49.2 vs 53.7%; p < 0.001). Similarly, the unadjusted and adjusted rates of adjuvant chemotherapy and endocrine therapy were lower at LSES. Although the unadjusted rate of adjuvant radiation was higher at LSES, adjusted odds demonstrated that patients treated at LSES were less likely to undergo adjuvant radiation when appropriate. CONCLUSIONS: Small but significant differences in achieving multidisciplinary standards for quality breast cancer care exist between LSES and non-LSES and may exacerbate disparities already faced by patients of low SES.

Effectiveness of a Short Duration of Neoadjuvant Endocrine Therapy in Patients with HR+ Breast Cancer-An NCDB Analysis (2004-2016).

BACKGROUND: National medical/surgical organizations have recommended the use of neoadjuvant endocrine therapy (NET) to bridge surgery delay of weeks to months for patients with hormone receptor positive (HR+) breast cancer during the ongoing coronavirus disease 2019 (COVID-19) pandemic. The effects of NET of varying durations on pathologic response are unclear. Using the National Cancer Database (NCDB), we evaluated objective response to short (< 9 weeks), moderate (9-27 weeks), and long (> 27 weeks) duration of NET. PATIENTS AND METHODS: The study cohort included female patients diagnosed with nonmetastatic invasive HR+ breast cancer, stratifying by those who received NET versus no NET between 2004 and 2016. Pathologic response was grouped into four categories (complete, downstaged, stable, upstaged) by comparing clinical and pathologic staging data. Objective response to NET included complete, downstaged, and stable pathologic response. Clinical characteristics were compared using χ2 and analysis of variance (ANOVA) tests. Multivariable logistic regression was used to determine factors associated with NET use and objective response according to NET duration. RESULTS: A minority (1.2%) received NET in our cohort. Factors associated with NET use included older age, non-Black patients, more advanced clinical stage, higher comorbidity score, government insurance, and lobular histology. Objective response rate (ORR) was 56.7%, 52.1%, and 49.0% after short, moderate, and long NET duration, respectively. CONCLUSION: Short NET duration did not result in an inferior ORR. Future study to evaluate the interaction between surgery delay and NET use on clinical outcome will provide insights into the safety of NET to bridge potential surgery delay in patients with HR+ breast cancer.

COVID-19 Pandemic: Changes in Care for a Community Academic Breast Center and Patient Perception of Those Changes.

BACKGROUND: Philadelphia and its suburbs were an epicenter for the initial COVID-19 outbreak. Accordingly, alterations were made in breast cancer care at a community hospital. METHODS: The authors developed a prospective database of all the patients with invasive or in situ breast cancer between March 1 and June 15 at their breast center. Any change in a breast cancer plan due to the pandemic was documented, and the patients were grouped into two cohorts according to whether a change was made (CTX) or no change was made (NC) in their care. The patients were asked a series of questions about their care, including those in the Generalized Anxiety Disorder two-item questionnaire (GAD-2), via telephone. RESULTS: The study enrolled 73 patients: 41 NC patients (56%) and 32 CTX patients (44%). The two cohorts did not differ in terms of age, race, or stage. Changes included delay in therapy (15.1%) and use of neoadjuvant endocrine therapy (NET, 28.8%). The median time to surgery was 24 days (interequartile range [IQR], 16-45 days) for the NC patients and 82 day s (IQR, 52-98 days) for the CTX patients (p ≤ 0.001). The median duration of NET was 78 days. The GAD-2 showed anxiety positivity to be 29.6% for the CTX patients and 32.4% for the NC patients (p = 1.00). More than half (55.6%) of the CTX patients believed COVID-19 affected their treatment outlook compared with 25.7% of the NC patients (p = 0.021). CONCLUSIONS: A prospective database captured changes in breast cancer care at a community academic breast center during the initial phase of the COVID-19 pandemic. 44% of patients experienced a change in breast cancer care due to COVID-19. The same level of anxiety and depression was seen in both change in therapy (CTX) and no change (NC). 55.6% of CTX cohort believed COVID-19 affected their treatment outlook.

Comparison of open and minimally invasive approaches to colon cancer resection in compliance with 12 regional lymph node harvest quality measure.

BACKGROUND: There has been a growing trend toward minimally invasive surgery (MIS) for colon cancer. Pathological analysis of a minimum of 12 lymph nodes (LNs) is a benchmark for adequate resection. Here, we present a comparison of surgical techniques in achieving a full oncologic resection. METHODS: Patients undergoing surgery for Stage I-III colon cancer (2010-2016) were identified from the National Cancer Database. Cases were stratified by surgical approach. Trends in approach were assessed, including whether the 12-LN benchmark was met. Uni- and multivariate regression was used to assess overall survival (OS). RESULTS: A total of 290,776 colectomies were analyzed. MIS increased from 32.8% to 57.2% from 2010 to 2016 (p < .001). An overall median of 18 LNs were harvested and compliance with the 12-LN benchmark increased (84.6%-91.6%, p < .001); there were no difference between open and MIS. A subset analysis comparing hospital type revealed that regardless of approach, compliance was lower at community hospitals (p < .001). OS was better for patients treated at academic or National Cancer Institute centers, underwent MIS, and in those meeting the 12-LN benchmark (all p ≤ .002). CONCLUSION: As MIS colon resections continue to increase, we demonstrate that there is no difference in the ability to achieve the 12-LN benchmark with open and MIS approaches.

Bedside Tunneled Hemodialysis Catheter Placement in Patients with COVID-19.

BACKGROUND: COVID-19, the syndrome caused by the novel SARS-CoV2, is associated with high rates of acute kidney injury requiring renal replacement therapy (RRT). It is well known that despite the ease of bedside insertion, the use of nontunneled dialysis catheters (NTDCs) is associated with increased complications compared to tunneled dialysis catheters (TDCs). Our objective was to develop a strategy for TDC placement at the bedside to provide effective dialysis access, conserve resources and decrease personnel exposure at our medical center in an epicenter of the COVID-19 pandemic. METHODS: A technique for bedside TDC insertion with ultrasound and plain radiographs in the intensive care unit was developed. Test or clinically COVID-19-positive patients requiring RRT were evaluated for bedside emergent NTDC or nonemergent TDC placement. Patients who underwent NTDC placement were monitored for ongoing RRT needs and were converted to TDC at the bedside after 3-5 days. We prospectively collected patient data focusing on complications and mortality. RESULTS: Of the 36 consultations for dialysis access in COVID-positive patients from March 19 through June 5, 2020, a total of 24 bedside TDCs were placed. Only one patient developed a complication, which was pneumothorax and cardiac tamponade during line placement. In-hospital mortality in the cohort was 63.9%. CONCLUSIONS: Bedside TDC placement has served to conserve resources, prevent complications with transport to and from the operating room, and decrease personnel exposure during the COVID-19 pandemic. This strategy warrants further consideration and could be used in critically ill patients regardless of COVID status.

Utility of Oncotype DX in Male Breast Cancer Patients and Impact on Chemotherapy Administration: A Comparative Study with Female Patients.

BACKGROUND: Use of the Oncotype DX recurrence score (RS) has been widely adopted in women with early-stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER-) breast cancer (BC). Validation studies on the use of RS in male BC (MBC) are lacking. OBJECTIVE: The aim of this study was to identify the utilization of RS and association with chemotherapy recommendations in early-stage MBC compared with female BC (FBC). METHODS: Using the National Cancer Database (NCDB), a retrospective review was performed for patients with T1/T2, node-negative, HR+/HER2- BC between 2010 and 2014. Patients were stratified by demographics, tumor characteristics, RS, and chemotherapy use comparing MBC with FBC over the allotted time period. RESULTS: A total of 358,497 patients-3068 (0.8%) males and 355,429 (99.1%) females-met the inclusion criteria. A smaller proportion of MBC patients received RS testing compared with FBC patients (32% vs. 35%, p < 0.001). Male patients who had RS were younger, had T2 tumors, lymphovascular invasion, and private insurance. The distribution of RS was similar in both groups. Only 4% of MBC patients with low RS received adjuvant chemotherapy, compared with 4.9% of FBC patients. Overall chemotherapy rates were similar in MBC and FBC patients. CONCLUSIONS: Our results showed that RS has not been completely embraced in the management of MBC, although when performed in MBC, chemotherapy recommendations vary based on RS. Whether the use of RS affects the clinical outcomes of MBC is unknown. A prospective registry would help clarify and evaluate the impact of RS on clinical outcomes in MBC.

Changing practice patterns of adjuvant radiation among elderly women with early stage breast cancer in the United States from 2004 to 2014.

Randomized controlled trials (RCTs) have challenged the need for routine radiation therapy (RT) in women ≥ age 70 with favorable early stage breast cancer (BC) due to modest improvement in local control and no survival benefit. We studied practice patterns in RT among elderly women in the United States. We analyzed data from the National Cancer Database (NCDB) of women ≥age 70 diagnosed with T1 or T2 and N0 invasive BC treated with breast conservation surgery (BCS) between 2004 and 2014. Patients were divided into four groups: (1) no RT, (2) partial breast irradiation (PBI); (3) hypofractionation (HF); and (4) conventional whole breast RT (CWBI). Univariable and multivariable analyses (MVA) were performed to compare characteristics among the four RT groups. A subgroup analysis of women with favorable disease (T1N0 ER + HER2-) was also performed with similar statistical comparisons. Of the 66,126 meeting eligibility, 9,570 (14.5%) had PBI, 16,340 (24.7%) had HF, and 40,117 (60.7%) had CWBI. Only 99 patients (0.15%) had RT omitted. Omission of RT increased marginally from 0.04% in 2004 to 0.24% in 2014. MVA identified older age (OR 1.18, CI 1.08-1.28), more comorbidities (Charlson-Deyo Score of 1) (OR 3.36, CI 1.29-8.72), and no hormone therapy (OR 22.07, CI 5.79-84.07) as more likely to have RT omitted. The use of HF increased from 3.9% to 47.0%, P < .001 with a concomitant decrease in CWBI from 88% to 41%, P < .001. MVA identified older age, treatment location, and omission of chemotherapy as associated with HF. No significant differences from the larger cohort were found among the T1N0 subgroup analysis. Despite RCT evidence, omission of RT was rare in the United States, suggesting that more effective outreach methods to disseminate clinical guideline information may be needed.