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.

Vaccination May Be Economically and Epidemiologically Advantageous Over Frequent Screening for Gonorrhea Prevention.

BACKGROUND: Gonorrhea's rapid development of antimicrobial resistance underscores the importance of new prevention modalities. Recent evidence suggests that a serogroup B meningococcal vaccine may be partially effective against gonococcal infection. However, the viability of vaccination and the role it should play in gonorrhea prevention are an open question. METHODS: We modeled the transmission of gonorrhea over a 10-year period in a heterosexual population to find optimal patterns of year-over-year investment of a fixed budget in vaccination and screening programs. Each year, resources could be allocated to vaccinating people or enrolling them in a quarterly screening program. Stratifying by mode (vaccination vs. screening), sex (male vs. female), and enrollment venue (background screening vs. symptomatic visit), we consider 8 different ways of controlling gonorrhea. We then found the year-over-year pattern of investment among those 8 controls that most reduced the incidence of gonorrhea under different assumptions. A compartmental transmission model was parameterized from existing literature in the US context. RESULTS: Vaccinating men with recent symptomatic infection, which selected for higher sexual activity, was optimal for population-level gonorrhea control. Given a prevention budget of $3 per capita, 9.5% of infections could be averted ($299 per infection averted), decreasing gonorrhea sequelae and associated antimicrobial use by similar percentages. These results were consistent across sensitivity analyses that increased the budget, prioritized incidence or prevalence reductions in women, or lowered screening costs. Under a scenario where only screening was implemented, just 5.5% of infections were averted. CONCLUSIONS: A currently available vaccine, although only modestly effective, may be superior to frequent testing for population-level gonorrhea control.

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.

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.

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.

Behavior Change Among HIV-Negative Men Who Have Sex with Men Not Using PrEP in the United States.

This study measures changes in condomless anal sex (CAS) among HIV-negative men who have sex with men (MSM) who are not taking pre-exposure prophylaxis (PrEP). It considers the 2014-2019 cycles of the American Men's Internet Survey, a serial, cross-sectional web-based survey of US cisgender MSM aged ≥ 15 years, in which ~ 10% of each year's sample is drawn from the previous year. Among those surveyed for 2 years who remained HIV-negative and off PrEP, reports of having any CAS and of CAS partner number were compared across years. We disaggregated by partner HIV status, and considered demographic predictors. The overall population saw a significant 2.2 percentage-point (pp) increase in reports of any CAS year-over-year. Sub-populations with the largest year-on-year increases were 15-24-year-olds (5.0-pp) and Hispanic respondents (5.1-pp), with interaction (young Hispanic respondents = 12.8-pp). On the relative scale, these numbers correspond to 3.2%, 7.2%, 7.3% and 18.7%, respectively. Absolute increases were concentrated among partners reported as HIV-negative. Multivariable analyses for CAS initiation found effects concentrated among Hispanic and White youth and residents of fringe counties of large metropolitan areas. CAS partner number increases were similarly predicted by Hispanic identity and young age. Although condom use remains more common than PrEP use, increasing CAS among MSM not on PrEP suggests potential new HIV transmission pathways. Concentration of increases among 18-24-year-old MSM portends future increases in the proportion of newly diagnosed HIV that occur among youth. Concentration among young Hispanic MSM will likely expand existing disparities. Although reducing barriers to PrEP remains vital, condom promotion for MSM remains a key public health practice and appears to be missing key audiences. LGBTQ+-inclusive sex education is one avenue for enhancing these efforts.

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.

An Interactive Modeling Tool for Projecting the Health and Direct Medical Cost Impact of Changes in the Sexually Transmitted Diseases Prevention Program Budgets.

CONTEXT: Estimating the return on investment for public health services, tailored to the state level, is critical for demonstrating their value and making resource allocation decisions. However, many health departments have limited staff capacity and expertise to conduct economic analyses in-house. PROGRAM: We developed a user-friendly, interactive Excel-based spreadsheet model that health departments can use to estimate the impact of increases or decreases in sexually transmitted infection (STI) prevention funding on the incidence and direct medical costs of chlamydia, gonorrhea, syphilis, and STI-attributable HIV infections. Users tailor results to their jurisdictions by entering the size of their population served; the number of annual STI diagnoses; their prior annual funding amount; and their anticipated new funding amount. The interface was developed using human-centered design principles, including focus groups with 15 model users to collect feedback on an earlier model version and a usability study on the prototype with 6 model users to finalize the interface. IMPLEMENTATION: The STI Prevention Allocation Consequences Estimator ("SPACE Monkey 2.0") model will be publicly available as a free downloadable tool. EVALUATION: In the usability testing of the prototype, participants provided overall positive feedback. They appreciated the clear interpretations, outcomes expressed as direct medical costs, functionalities to interact with the output and copy charts into external applications, visualization designs, and accessible information about the model's assumptions and limitations. Participants provided positive responses to a 10-item usability evaluation survey regarding their experiences with the prototype. DISCUSSION: Modeling tools that synthesize literature-based estimates and are developed with human-centered design principles have the potential to make evidence-based estimates of budget changes widely accessible to health departments.

Social Vulnerability and Rurality Associated With Higher Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection-Induced Seroprevalence: A Nationwide Blood Donor Study-United States, July 2020-June 2021.

BACKGROUND: Most studies on health disparities during the coronavirus disease 2019 (COVID-19) pandemic focused on reported cases and deaths, which are influenced by testing availability and access to care. This study aimed to examine severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody seroprevalence in the United States and its associations with race/ethnicity, rurality, and social vulnerability over time. METHODS: This repeated cross-sectional study used data from blood donations in 50 states and Washington, DC, from July 2020 through June 2021. Donor zip codes were matched to counties and linked with Social Vulnerability Index (SVI) and urban-rural classification. SARS-CoV-2 antibody seroprevalences induced by infection and infection-vaccination combined were estimated. Association of infection-induced seropositivity with demographics, rurality, SVI, and its 4 themes were quantified using multivariate regression models. RESULTS: Weighted seroprevalence differed significantly by race/ethnicity and rurality, and increased with increasing social vulnerability. During the study period, infection-induced seroprevalence increased from 1.6% to 27.2% and 3.7% to 20.0% in rural and urban counties, respectively, while rural counties had lower combined infection- and vaccination-induced seroprevalence (80.0% vs 88.1%) in June 2021. Infection-induced seropositivity was associated with being Hispanic, non-Hispanic Black, and living in rural or more socially vulnerable counties, after adjusting for demographic and geographic covariates. CONCLUSIONS: The findings demonstrated increasing SARS-CoV-2 seroprevalence in the United States across all geographic, demographic, and social sectors. The study illustrated disparities by race-ethnicity, rurality, and social vulnerability. The findings identified areas for targeted vaccination strategies and can inform efforts to reduce inequities and prepare for future outbreaks.

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.

Costs Associated With Incorporation of Network Approaches Into Sexually Transmitted Disease Program Activities.

BACKGROUND: Network approaches can be used to study sociosexual partnerships and identify individuals at high risk of infection. Little is known about the cost structure of these services and their association with STD diagnoses. METHOD: We collected costs associated with using a peer network strategy to recruit men who have sex with men and transwomen of color in 4 counties in North Carolina: Guilford, Forsyth, Durham, and Wake from February through October 2019. We used a comprehensive costing approach to gather detailed retrospective information on the intervention cost, broken down by category and programmatic activity. RESULTS: The sociosexual networks collected consisted of 31 initial seeds (index cases) and 49 peers of those seeds. In peers, 5 cases of human immunodeficiency virus (HIV) and 10 cases of syphilis were identified. The cost per case (HIV or syphilis) identified was $7325. Personnel costs accounted for 80% of total expenditures, followed by laboratory expenses (12%). Personnel cost was distributed between disease intervention specialist patient navigators (51%), nonclinical (37%), and management (12%) staff. General administration was the costliest programmatic activity (37%), followed by case management and field services (37%), and study activities (11%). The estimated average cost per patient tested was $2242. CONCLUSIONS: Finding positive peer cases in nonclinical settings is costly but may be crucial for limiting the spread of sexually transmitted diseases. The cost of staff was the major driver. This study demonstrates that using a network strategy can be a cost-effective way to identify, test, and refer patients at high risk of syphilis and HIV infections to care.

The Cost of Operating Sexual Health Clinics During the Ending the (HIV) Epidemic Initiative in New York City.

BACKGROUND: As part of New York State's Ending the Epidemic (EtE) initiative, sexual health clinics (SHCs) in New York City invested in clinic enhancements and expanded their HIV-related services to increase access to HIV prevention interventions and treatment. The objective of this study was to estimate and describe the change in SHC operating costs related to clinic enhancements and expanded patient services implemented as part of the EtE initiative. METHODS: A comprehensive microcosting approach was used to collect retrospective cost information from SHCs, broken down by category and programmatic activity. Cost information was collected from 8 clinics across New York City during two 6-month time periods before (2015) and during (2018-2019) EtE. RESULTS: Eight SHCs reported comprehensive cost data. Costs increased by $800,000 on average per clinic during the 6-month EtE period. The cost per visit at an SHC increased by $120 on average to $381 (ranging from $302 to $464) during the EtE period. Personnel costs accounted for 69.9% of EtE costs, and HIV-related medications accounted for 8.9% of costs. Employment of social workers and patient navigators increased costs by approximately $150,000 on average per clinic. Postexposure prophylaxis was the costliest medication with average expenditures of $103,800 per clinic. CONCLUSIONS: This study demonstrates the key drivers of cost increases when offering enhanced HIV services in SHCs. Documenting the changes in resources necessary to implement these services and their costs can inform other health departments on the viability of offering enhanced HIV services within their own clinics.

Superhydrophobic and Anti-Icing Coatings Made of Hierarchically Nanofibrillated Polymer Colloids.

The deposition of coatings with hierarchical morphology from hydrophobic and hydrophilic polymers is a common approach for making superhydrophobic and superhydrophilic coatings. The water-repellent, water-wicking, and anti-icing coatings reported here are made from a class of materials called soft dendritic colloids (SDCs). The branched, nanofibrous SDCs are produced in suspension through nonsolvent-induced phase separation in a turbulent medium. The properties of coatings formed by drying ethanol suspensions of SDCs made of polystyrene, polyvinyl alcohol, and polyester are compared. The highly branched SDC morphology creates entangled, porous coating layers with strong physical adhesion to the substrate due to the multitude of nanofiber sub-contacts analogous to the "gecko leg effect". Polystyrene SDC coatings show excellent superhydrophobicity but weaker adhesion due to low surface energy. Alternatively, polyvinyl alcohol SDC coatings show superhydrophilicity and strong adhesion from their high surface energy. Two strategies to improve the adhesivity and cohesivity of the SDCs layers are shown effective - use of intertwined networks and of silicone droplet microbinders. The water repulsion, together with the air trapped in the blended superhydrophobic coatings also makes them effective against ice nucleation and adhesion. Finally, these SDCs make thin, flexible, and durable nonwovens with similar properties.