Estimate Odds Ratios Research Articles

Adherence to the Mediterranean Diet, Sodium and Potassium Intake in People at a High Risk of Dementia.

Adequate sodium and potassium intake, along with adherence to the Mediterranean diet (MedDiet), are key factors for preventing hypertension and cerebrovascular diseases. However, data on the consumption of these nutrients within the MedDiet are scarce. This cross-sectional study aims to assess the association between MedDiet adherence and sodium/potassium intake in the MIND-Matosinhos randomized controlled trial, targeting Portuguese adults at a high risk of dementia. Good adherence to the MedDiet was defined using the Portuguese Mediterranean Diet Adherence Screener questionnaire (≥10 points), and both sodium/potassium intakes were estimated from 24-hour urine collections. The association between MedDiet adherence and these nutrients' intake (dichotomized by the median) was quantified by calculating odds ratios (OR) and respective 95% confidence intervals (95% CI) using a logistic regression. A total of 169 individuals (60.9% female; median age: 70 years; range: 36-85 years) were included. Good adherence to the MedDiet was observed among 18.3% of the sample. After adjusting for sex, age, education and using antihypertensive drugs, good MedDiet adherence was associated with higher sodium (OR = 3.11; 95% CI: 1.27-7.65) and potassium intake (OR = 9.74; 95% CI: 3.14-30.26). Increased adherence to the MedDiet may contribute to a higher potassium intake but seems to have limited effects on the adequacy of sodium levels.

Identification of bacterial determinants of tuberculosis infection and treatment outcomes: a phenogenomic analysis of clinical strains

Bacterial diversity could contribute to the diversity of tuberculosis infection and treatment outcomes observed clinically, but the biological basis of this association is poorly understood. The aim of this study was to identify associations between phenogenomic variation in Mycobacterium tuberculosis and tuberculosis clinical features. We developed a high-throughput platform to define phenotype-genotype relationships in M tuberculosis clinical isolates, which we tested on a set of 158 drug-sensitive M tuberculosis strains sampled from a large tuberculosis clinical study in Ho Chi Minh City, Viet Nam. We tagged the strains with unique genetic barcodes in multiplicate, allowing us to pool the strains for in-vitro competitive fitness assays across 16 host-relevant antibiotic and metabolic conditions. Relative fitness was quantified by deep sequencing, enumerating output barcode read counts relative to input normalised values. We performed a genome-wide association study to identify phylogenetically linked and monogenic mutations associated with the in-vitro fitness phenotypes. These genetic determinants were further associated with relevant clinical outcomes (cavitary disease and treatment failure) by calculating odds ratios (ORs) with binomial logistic regressions. We also assessed the population-level transmission of strains associated with cavitary disease and treatment failure using terminal branch length analysis of the phylogenetic data. M tuberculosis clinical strains had diverse growth characteristics in host-like metabolic and drug conditions. These fitness phenotypes were highly heritable, and we identified monogenic and phylogenetically linked variants associated with the fitness phenotypes. These data enabled us to define two genetic features that were associated with clinical outcomes. First, mutations in Rv1339, a phosphodiesterase, which were associated with slow growth in glycerol, were further associated with treatment failure (OR 5·34, 95% CI 1·21-23·58, p=0·027). Second, we identified a phenotypically distinct slow-growing subclade of lineage 1 strains (L1.1.1.1) that was associated with cavitary disease (OR 2·49, 1·11-5·59, p=0·027) and treatment failure (OR 4·76, 1·53-14·78, p=0·0069), and which had shorter terminal branch lengths on the phylogenetic tree, suggesting increased transmission. Slow growth under various antibiotic and metabolic conditions served as in-vitro intermediate phenotypes underlying the association between M tuberculosis monogenic and phylogenetically linked mutations and outcomes such as cavitary disease, treatment failure, and transmission potential. These data suggest that Mtuberculosis growth regulation is an adaptive advantage for bacterial success in human populations, at least in some circumstances. These data further suggest markers for the underlying bacterial processes that contribute to these clinical outcomes. National Health and Medical Research Council/A∗STAR, National Institutes of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, and the Wellcome Trust Fellowship in Public Health and Tropical Medicine.

Transcatheter Aortic Valve Replacement in Low Surgical Risk Patients: An Updated Metanalysis of Extended Follow-Up Randomized Controlled Trials

The long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low surgical risk has not been evaluated in a pooled analysis. An electronic database search was conducted for randomized controlled trials with a maximal 5 years clinical and echocardiographic follow-up including low surgical risk patients who underwent TAVR or SAVR. We calculated odds ratio (OR) and 95% confidence intervals (CIs) using a random-effects model. Subgroups analysis was performed for permanent pacemaker implantation and paravalvular leaks. Three randomized controlled trials were included with a total of 2,611 low surgical risk patients (Society of Thoracic Surgeons score <4%). Compared with SAVR, the TAVR group had similar rates of all-cause mortality (OR 0.94,95% CI 0.65 to 1.37, p = 0.75) and disabling stroke (OR 0.84, 95% CI 0.52 to 1.36, p = 0.48). No significant differences were registered in the TAVR group in terms of major cardiovascular events (OR 0.96, 95% CI 0.67 to 1.38, p = 0.83), myocardial infarction (OR 0.69, 95% CI 0.34 to 1.40, p = 0.31), valve thrombosis (OR 3.11, 95% CI 0.29 to 33.47, p = 0.35), endocarditis (OR 0.71,95% CI 0.35 to 1.48, p = 0.36), aortic valve reintervention (OR 0.93, 95% CI 0.52 to 1.66, p = 0.80), and rehospitalization (OR 0.80, 95% CI 0.52 to 1.02, p = 0.07) compared with SAVR. However, TAVR patients had a higher risk of paravalvular leaks (OR 8.21, 95% CI 4.18 to 16.14, p <0.00001), but lower rates of new-onset atrial fibrillation (OR 0.27,95% CI 0.17 to 0.30, p <0.0001). The rates of permanent pacemaker implantation were comparable from 1 year up to a maximum of 5 years (OR 1.32, 95% CI 0.88 to 1.97, p = 0.18). Lastly, TAVR had a greater effective orifice area (0.10 cm2/m2, 95% CI 0.05 to 0.15, p = 0.0001), but similar transvalvular mean gradients (0.60, 95% CI 3.94 to 2.73, p = 0.72). In conclusion, TAVR patients had similar long-term outcomes compared with SAVR, except for an elevated risk of paravalvular leaks in the TAVR group and increased rates of atrial fibrillation in the SAVR cohort.

Association of circulating long-chain free fatty acids and incident diabetes risk among normoglycemic Chinese adults: a prospective nested case–control study

BackgroundLong-chain free fatty acids (FFAs) are associated with risk of incident diabetes. However, a comprehensive assessment of the associations in normoglycemic populations is lacking. ObjectivesOur study aimed to comprehensively investigate the prospective associations and patterns of FFA profiles with diabetes risk among normoglycemic Chinese adults. MethodsThis is a prospective nested case–control study from the China Cardiometabolic Disease and Cancer Cohort (4C) study. We quantitatively measured 53 serum FFAs using a targeted metabolomics approach in 1707 incident diabetes subjects and 1707 propensity score–matched normoglycemic controls. Conditional logistic regression models were employed to estimate odds ratios (ORs) for associations. Least Absolute Shrinkage and Selection Operator (LASSO) penalty regression and quantile g-computation (qg-comp) analyses were implemented to estimate the association between multi-FFA exposures and incident diabetes. ResultsThe majority of odd-chain FFAs exhibited an inverse association with incident diabetes, wherein the ORs per SD increment of all 7 saturated fatty acids (SFAs), monounsaturated fatty acid (MUFA) 15:1, and polyunsaturated fatty acid (PUFA) 25:2 were ranging from 0.79 to 0.88 (95% CIs ranging between 0.71 and 0.97). Even-chain FFAs comprised 99.3% of total FFAs and displayed heterogeneity with incident diabetes. SFAs with 18–26 carbon atoms are inversely linked to incident diabetes, with ORs ranging from 0.81 to 0.86 (95% CIs ranging between 0.73 and 0.94). MUFAs 26:1 (OR: 0.85; 95% CI: 0.76, 0.94), PUFAs 20:4 (OR: 0.84; 95% CI: 0.75, 0.94), and 24:2 (OR: 0.87; 95% CI: 0.78, 0.97) demonstrated significant associations. In multi-FFA exposure model, 24 FFAs were significantly associated with incident diabetes, most of which were consistent with univariate results. The mixture OR was 0.78 (95% CI: 0.61, 0.99; P = 0.04159). Differential correlation network analysis revealed pre-existing perturbations in intraclass and interclass FFA coregulation before diabetes onset. ConclusionsThese findings underscore the variations in diabetes risk associated with FFAs across chain length and unsaturation degree, highlighting the importance of recognizing FFA subtypes in the pathogenesis of diabetes.

Preexisting Diabetes and Breast Cancer Treatment Among Low-Income Women

Diabetes is associated with poorer prognosis of patients with breast cancer. The association between diabetes and adjuvant therapies for breast cancer remains uncertain. To comprehensively examine the associations of preexisting diabetes with radiotherapy, chemotherapy, and endocrine therapy in low-income women with breast cancer. This population-based cohort study included women younger than 65 years diagnosed with nonmetastatic breast cancer from 2007 through 2015, followed up through 2016, continuously enrolled in Medicaid, and identified from the linked Missouri Cancer Registry and Medicaid claims data set. Data were analyzed from January 2022 to October 2023. Preexisting diabetes. Logistic regression was used to estimate odds ratios (ORs) of utilization (yes/no), timely initiation (≤90 days postsurgery), and completion of radiotherapy and chemotherapy, as well as adherence (medication possession ratio ≥80%) and persistence (<90-consecutive day gap) of endocrine therapy in the first year of treatment for women with diabetes compared with women without diabetes. Analyses were adjusted for sociodemographic and tumor factors. Among 3704 women undergoing definitive surgery, the mean (SD) age was 51.4 (8.6) years, 1038 (28.1%) were non-Hispanic Black, 2598 (70.1%) were non-Hispanic White, 765 (20.7%) had a diabetes history, 2369 (64.0%) received radiotherapy, 2237 (60.4%) had chemotherapy, and 2505 (67.6%) took endocrine therapy. Compared with women without diabetes, women with diabetes were less likely to utilize radiotherapy (OR, 0.67; 95% CI, 0.53-0.86), receive chemotherapy (OR, 0.67; 95% CI, 0.48-0.93), complete chemotherapy (OR, 0.71; 95% CI, 0.50-0.99), and be adherent to endocrine therapy (OR, 0.71; 95% CI, 0.56-0.91). There were no significant associations of diabetes with utilization (OR, 0.95; 95% CI, 0.71-1.28) and persistence (OR, 1.09; 95% CI, 0.88-1.36) of endocrine therapy, timely initiation of radiotherapy (OR, 1.09; 95% CI, 0.86-1.38) and chemotherapy (OR, 1.09; 95% CI, 0.77-1.55), or completion of radiotherapy (OR, 1.25; 95% CI, 0.91-1.71). In this cohort study, preexisting diabetes was associated with subpar adjuvant therapies for breast cancer among low-income women. Improving diabetes management during cancer treatment is particularly important for low-income women with breast cancer who may have been disproportionately affected by diabetes and are likely to experience disparities in cancer treatment and outcomes.

Dual-energy CT in acute cholecystitis- features predicting culture-positive bile and outcome

PurposeLow mono-energetic CT has been shown to improve visualization of acute abdominal inflammatory processes. We aimed to determine its utility in patients with acute cholecystitis and potential added value in clinical decision making. MethodsSixty-seven consecutive patients with radiological signs of cholecystitis on contrast-enhanced dual-layer CT imaging were retrospectively identified over a four-year period (2/17–8/21). A ranked Likert scale was created for imaging findings present in acute cholecystitis, including gallbladder mucosal integrity and enhancement and pericholecystic liver parenchymal enhancement. These rankings were correlated with laboratory data, followed by sensitivity, specificity, and odds-ratios calculations. ResultsMucosal integrity and pericholecystic liver enhancement were better seen on low-energetic images by unanimous consensus. Presence of pericholecystic liver enhancement and poorer mucosal wall integrity correlated with positive bile cultures (sensitivity: 93.8 % and 96.9 %, specificity: 37.5 and 50.0 %; odds-ratio: 9.0[1.1–68.1 95 %CI] and 31.0 [2.7–350.7 95 %CI], p = 0.017 and p ≤ 0.001) in patients undergoing cholecystostomy (n = 40/67). Moreover, binary regression modeling showed that the strongest predictor variable for bile culture positivity was the score for pericholecystic liver enhancement (Exp(B) = 0.6, P = 0.022). By contrast, other laboratory markers and other imaging findings (such as GB wall thickness) showed lower sensitivities (76–82 %), specificities (16–21 %) and odds ratios (0.2–4.4) for the prediction of infected bile. ConclusionsPericholecystic liver enhancement and gallbladder wall integrity are better visualized on low-DECT images. These findings also potentially predict bile culture positivity in patients with cholecystitis, which may influence clinical management including the need for intervention.

Persistent Inequities in Intravenous Thrombolysis for Acute Ischemic Stroke in the United States: Results From the Nationwide Inpatient Sample.

Despite its approval for acute ischemic stroke >25 years ago, intravenous thrombolysis (IVT) remains underused, with inequities by age, sex, race, ethnicity, and geography. Little is known about IVT rates by insurance status. We assessed temporal trends from 2002 to 2015 in IVT for acute ischemic stroke in the Nationwide Inpatient Sample using adjusted, survey-weighted logistic regression. We calculated odds ratios for IVT for each category in 2002 to 2008 (period 1) and 2009 to 2015 (period 2). IVT use for acute ischemic stroke increased from 1.0% in 2002 to 6.8% in 2015 (adjusted annual relative ratio, 1.15). Individuals aged ≥85 years had the most pronounced increase during 2002 to 2015 (adjusted annual relative ratio, 1.18) but were less likely to receive IVT compared with 18- to 44-year-olds in period 1 (adjusted odds ratio [aOR], 0.23) and period 2 (aOR, 0.36). Women were less likely than men to receive IVT, but the disparity narrowed over time (period 1: aOR, 0.81; period 2: aOR, 0.94). Inequities in IVT resolved for Hispanic individuals in period 2 (aOR, 0.96) but not for Black individuals (period 2: aOR, 0.81). The disparity in IVT for Medicare patients, compared with privately insured patients, lessened over time (period 1: aOR, 0.59; period 2: aOR, 0.75). Patients treated in rural hospitals remained less likely to receive IVT than in urban hospitals; a more dramatic increase in urbanity widened the inequity (period 2, urban nonteaching versus rural: aOR, 2.58, period 2, urban teaching versus rural: aOR, 3.90). IVT for acute ischemic stroke increased among adults. Despite some encouraging trends, the remaining disparities highlight the need for intensified efforts at addressing inequities.

Association between serum albumin concentration change trajectory and risk of hypertension: a cohort study in China.

We sought to assess the risk of hypertension based on the trajectory of changes in serum albumin concentrations. A total of 11,946 nonhypertension adults aged 30-60 years who underwent at least 3 medical examinations between 2009 and 2016 were included in this study. Group-based trajectory models were obtained for 4 category groups, and logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for each category group of serum albumin concentration and the risk of hypertension. During a mean follow-up period of 4.30 years, 1,537 hypertension events occurred in 11,946 subjects without hypertension. A high stable trajectory of serum albumin concentrations (OR, 0.70, 95% CI, 0.51-0.96) was associated with a significantly lower risk of developing hypertension. The results of the sensitivity analysis of the high stable trajectory (OR, 0.64, 95% CI, 0.43-0.96) remained statistically significant. Subjects with normal weight and those ≥45 years of age had a significantly lower risk of hypertension at moderate increase (P = 0.053 or 0.026) and high stable trajectories (P = 0.011 or 0.016). In males and overweight subjects, the risk of hypertension was significantly lower in the high stable trajectory (P = 0.038 or 0.044). In this study, we found that moderate increase in serum albumin concentrations and a high stable trajectory were significantly associated with a reduced risk of hypertension in subjects aged ≥45 years and those with normal weight and that high stable serum albumin concentrations were significantly associated with a reduced risk of hypertension in males and overweight subjects.

Cross-Sectional Study of Flood Damage Assumptions in Medical Facilities Using Geographic Information Systems.

Introduction Floods not only directly damage medical facilities but also hinder access to medical facilities, potentially disrupting local medical services. The scale of damage that medical facilities suffer from floods in Japan is unknown. In this study, we assessed the potential impact of floods on Japanese healthcare facilities by facility characteristics. Methods We conducted a cross-sectional study involving medical facilities registered in the Japan Medical Association Regional Medical Information System. Geographic data for the inundation area was obtained from open data of the Japanese government. Facilities that overlap with flooded areas were designated as affected facilities. The primary outcomes were the percentage of damaged facilities and beds. We calculated odds ratios (OR) and 95% confidence intervals (95%CI) using the Wald method to assess the impact of disaster base hospital designation on damage extent. Results We included 140,826 general clinics and 8,126 hospitals, which had 137,731 and 1,483,347 beds, respectively. The planned scale of flooding is estimated to affect 8.0% of general clinics and 10.8% of their beds. For hospitals, these figures were 8.8% and 7.8%, respectively. The maximum potential scale of flooding is estimated to affect 23.6% of general clinics and 23.9% of their beds. For hospitals, these figures were 22.5% and 20.6%, respectively. At the planned scale of flooding, there was no difference found in therate of damaged facilities between disaster base hospitals and non-disaster base hospitals, and the rate of damaged beds was lower at non-disaster base hospitals (OR = 0.92, 95%CI = 0.71-1.18 for damaged facilities and OR = 0.79, 95%CI = 0.78-0.80 for damaged beds). At the maximum potential scale of flooding, there was no difference found in the expected damage between disaster base hospitals and non-disaster base hospitals (OR = 1.14, 95%CI = 0.95-1.38 for damaged facilities and OR = 0.99, 95%CI = 0.98-1.00 for damaged beds). Conclusion In Japan, floods can hinder nationwide medical functions, particularly in certain regions. Healthcare professionals should assess potential flood damage in advance and ensure that their workplace's business continuity plan includes appropriate countermeasures.

Psoriasis and mental health in adolescents: A cross-sectional study within the Danish National Birth Cohort

BackgroundPsoriasis is a chronic skin disease associated with lower quality of life and higher risk of anxiety and depression in adults. We investigate whether adolescents with psoriasis also experience poorer mental health than their peers. MethodsIn this cross-sectional study, we included questionnaire data on psoriasis and mental health from the 18-year follow-up of the Danish National Birth Cohort. We estimated odds ratios (OR) and 95 % confidence intervals (CI) using a logistic regression with inverse probability weighting to account for potential selection bias, adjusted for potential confounders identified a priori. We estimated associations between self-reported psoriasis and multiple aspects of mental health (self-rated health, life satisfaction, mental well-being, loneliness, overall and internalizing behavioral difficulties, depressive symptoms, and anxiety symptoms). In sensitivity analyses, we examined doctor-diagnosed psoriasis and psoriasis with and without joint pain. ResultsOf the 44,838 included in this study, 1147 (2.6 %) reported psoriasis. Adolescents with psoriasis had a higher risk of nearly all outcomes, including depressive symptoms (OR 1.38; 1.19–1.58) and panic/agoraphobia among both males (OR 1.72; 1.33–2.19) and females (OR 1.60; 1.33–1.92). Associations attenuated when restricted to doctor-diagnosed psoriasis. Associations with poor mental health were mainly observed for adolescents with psoriasis also reporting joint pain. LimitationsWe could not establish temporality and lacked data on joint pain in referents. ConclusionPsoriasis is associated with poor mental health in adolescents. This appears to be driven by adolescents with psoriasis also reporting joint pain and is less evident in those with a doctor-confirmed diagnosis.

Association between NUDT17 polymorphisms and breast cancer risk.

Breast cancer (BC) is the leading cause of cancer death among women worldwide. The nudix hydrolase 17 (NUDT17) may play notable roles in cancer growth and metastasis. In this study, we explored the importance of NUDT17 gene polymorphism in patients with BC. In our study, 563 BC patients and 552 healthy controls participated. We used logistic regression analysis to calculate odds ratios (OR) and 95% confidence intervals (CI), and multifactor dimension reduction (MDR) analysis of SNP-SNP interactions. Finally, UALCAN and THPA databases were used for bioinformatics analysis. The rs9286836 G allele was associated with a decreased the BC risk (p = 0.022), and the carriers of rs2004659 G allele had a 32% decreased risk of BC than individuals with allele A (p = 0.004). In the four genetic models, rs9286836 and rs2004659 reduced the risk of BC. Additionally, we found that the NUDT17 SNPs were associated with BC risk under age, tumor size, and clinical stage stratification. The MDR analysis showed that the five-locus interaction model was the best in the multi-locus model. Our study found that NUDT17 single nucleotide polymorphisms are associated with BC susceptibility in Chinese Han population.

Abstract PO2-07-07: The role of PET imaging with [18F]16α-fluoro-17β-fluoroestradiol in predicting response to endocrine therapies in patients with breast cancer

Abstract Background Fluoroestradiol F18 is a radioactive diagnostic agent (18F-FES) used with positron emission tomography (PET) imaging to detect estrogen-receptor (ER)-positive lesions in patients with breast cancer. Convened by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), an expert working group published appropriate use criteria (AUC) for 18F-FES PET including, but not limited to, use of 18F-FES for selection of endocrine therapies. Quantitative determination of ER status, and thus treatment response, has the potential to prevent ineffective courses of endocrine therapies and associated therapeutic/financial burden. This meta-analysis reviewed the AUC-cited studies to assess the utility of 18F-FES in predicting treatment response to endocrine therapies. Methods Eight studies cited in the AUC were selected based on having comparable 18F-FES PET standardized uptake values (SUV) and progression-free survival (PFS) measures, and one additional study was included upon further systematic search of the same selected parameters defined in the AUC. With the nine studies (n = 327), we conducted three investigations to explore the association between: (1) the patient baseline 18F-FES PET SUVmean, across all lesions or across up to seven of the most intense lesions, and patient response to endocrine therapy (response/no response); (2) in the same population as investigation 1, the change (%) in 18F-FES PET SUV from baseline to at 7 to 10 days post-treatment; (3) the 18F-FES interlesional heterogeneity and PFS (months). Interlesional heterogeneity was qualitatively defined as patients displaying both 18F-FES positive and negative lesions versus those with all FES-positive lesions. Results A fixed effects model was used to analyze three studies (n = 102). Findings reveal that patients who responded to endocrine therapy had a significantly higher baseline SUVmean versus non-responders (mean difference 0.91; CI 95% 0.49 to 1.34; P &amp;lt; 0.001); a sensitivity analysis was conducted via random effects modelling and revealed similar results (mean difference 0.92; CI 95% 0.48 to 1.36; P &amp;lt; 0.001). This was consistent with findings from an additional analysis performed on two papers (n = 62), whereby odds ratio estimates indicated that a response to therapy is 89% less likely to occur when baseline 18F-FES SUVmax is &amp;lt; 1.5 (OR 0.11; CI 95% 0.02 to 0.72 P = 0.02). Findings from the analysis of mean percentage change in 18F-FES SUV from baseline to 7-10 days post-treatment initiation showed no significant difference in the percentage change of SUV observed between responders and non-responders (mean difference -0.22; 95% CI -0.69 to 0.26; P = 0.37). The final heterogeneity analysis revealed higher median PFS in all FES-positive cohort, suggesting that this group may respond better to endocrine therapy (Table 1). Conclusion The AUC states that the presence of ER by immunohistochemistry may not be the optimal predictive biomarker for the success of endocrine therapies. Our findings support this statement, as a significantly higher baseline SUVmean of 18F-FES may serve as a predictive biomarker for endocrine therapy response. Patients with a 18F-FES lesion SUVmax &amp;lt; 1.5 are 89% less likely to respond to endocrine therapies; patients demonstrating heterogeneity (FES+/FES- lesions) have a lower median PFS, reinforcing the predictive value of 18F-FES. Table 1. Median PFS scores from FES heterogeneity analysis *Patients with all FES positive lesions were categorised by the median ratio of FES/FDG SUVmax into low FES/FDG ( &amp;lt;0.96), and high FES/FDG (&amp;gt;0.96); only patients with FES/FDG of &amp;gt;0.96 were included in the positive lesions arm. Citation Format: Nicholas DiGregorio, Christine Brand, Dustin Dunham, Eleanor McManus. The role of PET imaging with [18F]16α-fluoro-17β-fluoroestradiol in predicting response to endocrine therapies in patients with breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-07-07.

Abstract PO5-02-11: Is There A Survival Benefit With Adjuvant Chemotherapy Use In Elderly Breast Cancer Patients? A Retrospective Study Using The National Cancer Database

Abstract Background Geriatric patients (Age &amp;gt;=65 years) with Breast Cancer (BC) face a unique challenge due to the relatively lower functional status, as well as co-existing comorbidities. Studies like the recently published meta-analysis by the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) group provide irrefutable evidence for the recurrence free survival benefit of anthracycline and taxane based adjuvant chemotherapy (ACT) regimes in early-stage BC patients. However, the age range of the trials analyzed ranged between 46-55 years, with underrepresentation of the geriatric group. The question on whether ACT results in an overall survival (OS) benefit for the elderly remains at large, which we hope to answer through our study. Methods The 2019 National Cancer Database (NCDB) was used to extract patients aged &amp;gt;= 65 years with breast cancer. We included stage 1-3 patients and stratified them into those who received ACT (ACT+) and those who did not (ACT-). Patients who received ACT were identified from the columns that specified the times of events from diagnosis or from the column for systemic therapy-surgery sequence. Patients should have had definitive surgery for their BC management to be included. Odds Ratio (OR) from logistic regression was used to analyze the utility of ACT based on various factors. Kaplan Meier (KM) survival curves and Hazard Ratio (HR) estimates from multivariate cox model was used to compare OS outcomes. Results Our cohort had 866,071 (ACT+: 642721, ACT-:223350) patients. The age distribution showed that ACT+ had 86.45% in the 65-80 years group and 13.55% in the &amp;gt;80 years group. ACT- had 68.32% aged 65-80 and 31.68% &amp;gt;80 years. The distribution of various demographic, pathologic and clinical factors by ACT use are shown in Table 1. Factors associated with ACT use based on OR estimates are shown in Table 2. ACT use is more likely in younger age group (65-80), lower comorbidity score, poorly differentiated and undifferentiated tumors, ER/PR negativity, T2 and lymph node positivity, those who underwent partial mastectomy and regional lymph node surgery, and HER2 positivity. Both 5-year (86.3 vs 74.2%) and 10-year (66 vs 50.8) OS were better with ACT+ (Table 2). The HR using propensity score (PS) weighted cox model revealed a higher hazard rate on omitting ACT [1.436, 95% Confidence Interval (CI) 1.417,1.456, p&amp;lt; .0001] (Table 2). HR estimates between ACT- vs ACT+, stratified by subgroups [Age (65-80, &amp;gt;80), T stage, grade (G), HER2] favored ACT use in all groups except G1 tumors (Table 3). Discussion Our study using a large national database, supports the use of ACT in the geriatric BC population by showing a clear OS advantage of 15.2% at 10 years. This benefit was observed even in BC patients aged more than 80 years with a HR of 1.683 when compared to ACT-, as represented in Table 3. While the existing literature provides robust evidence for ACT use in situations such as a high oncotype recurrence score, our study provides real-world evidence from a population-based dataset to supports its use in the elderly, including those above 80 years. The geriatric assessment recommended by the American Society of Clinical Oncology guideline for geriatric oncology should be followed in this setting. Utilization of geriatric assessment tools among oncologists has been poor with a survey revealing that 60% of providers did not utilize these tools in making treatment decisions. Limitations of our study include the potential for missing confounding factors and the retrospective nature of the study using a large database. Table 1 Demographic, pathological, and clinical characteristics of the study population and their distribution based on ACT use. Table 2 Odds Ratio for ACT use, KM survival curves and HR estimates of ACT use Table 3 HR estimates of mortality for ACT- vs ACT+ stratified by various subgroups Citation Format: Prashanth Ashok Kumar, Metlapalli Venkata Sravanthi, Dongliang Wang, Danning Huang, Abirami Sivapiragasam. Is There A Survival Benefit With Adjuvant Chemotherapy Use In Elderly Breast Cancer Patients? A Retrospective Study Using The National Cancer Database [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-02-11.

Abstract PO2-17-02: Can body mass index be a complete pathological response predictor in breast cancer patients submitted to neoadjuvant chemotherapy? A real-world data trial

Abstract Background: Breast cancer is a prevalent disease, and Its incidence has increased annually worldwide. The prognosis depends on several factors, such as patient characteristics, tumor characteristics and treatment efficacy. In this scenario, neoadjuvant chemotherapy (NAC), previously used only to make surgical approach possible in advanced cases, has been increasingly used in more aggressive initial tumors such as HER 2 positive and triple negative and, in these tumors, the presence of pathological complete response is directly correlated with survival and the disease-free interval. Obesity is very common in Brazil and in the world, and its incidence grows annually. There is a direct relationship between the risk of breast cancer and obesity, especially in postmenopausal women. Justification: Many authors suggest that obese patients are less likely to achieve this pathological complete response (pCR). Real-world data is important to evaluate how patients behave in the real world, only 5% of the patients are enrolled in clinical trials. Most of the clinical trials have strict inclusion and exclusion criteria that ends up selecting a patient that almost doesn't exist in the real world. Objective: To correlate complete pathological response with Body Mass Index (BMI) and, secondarily, to evaluate the relationship between overall and disease-free survival with BMI. Methods: This was a retrospective observational study that has evaluated patients with invasive breast cancer in two Brazilian hospitals. Clinical and pathological characteristics were extracted from the database, being eligible the patients diagnosed with invasive breast cancer, stages I to III, and who underwent neoadjuvant chemotherapy (NAC). Patients were categorized using the World Health Organization (WHO) definition: BMI 18.5 to &amp;lt; 25 kg/m2: normal weight; BMI 25 to &amp;lt; 30 kg/m2: overweight; BMI ≥30kg/m2: obesity. pCR was defined as the absence of breast and axillary invasive tumor. The t test or chi-square test were used to individually analyze the association of each variable between the groups with and without RPc. Univariate and multivariate analyzes to calculate odds ratios (OR) and 95% confidence intervals (CI) of the independent variables BMI, age, clinical stage, histological type, and subtype of cancer, correlated with pCR. where p value &amp;lt; 0.05 was considered statistically significant. Results: 1,779 records were included in the analyses, with a mean age of 50 years at diagnosis and a mean BMI of 28.08 kg/m2. Most patients had stage III cancer (68.1%) at diagnosis and the invasive carcinoma nonspecial type was predominant (95.2%). Immunohistochemistry allowed us to divide the groups into Luminal A like (12.4%), Luminal B like (31.1%), HER2+ like (25.3%) and triple negative like (31.2%). After NAC, 1461 had residual disease and 390 (22.3%) had a pCR. Regarding stages, 2% of the patients were in stage I, 30% in stage II and 68% in stage III. No correlation was found between BMI categories and pCR (p=0.7607). In the multivariate analysis, the results were also not significant for the correlation between the BMI categories after adjusting for age, clinical stage, tumor histology and subtype of breast cancer. We observed, however, that the most aggressive types of cancer were predictors of pathologic complete response. The estimated average overall survival (OS) was 102 months for those of normal weight, 99 months for the overweight ones and 101 months for the obese ones. As for recurrence-free survival, the data were immature. Conclusion: This study with Brazilian real-world data found no correlation between BMI and pCR after NAC and BMI and OS in patients with breast cancer. As an additional finding, most patients were obese or overweight at diagnosis (69%) and public policies should be encouraged to act in this scenario. Trials considering stratification of patients between different regions of the country or specific subtype of cancer can elucidate this finding. Citation Format: Fernanda Grace Bauk Richter, Andre Mattar, Marcelo Antonini, Juliana Real, Luis Henrique Gebrim, Reginaldo Coelho Lopes. Can body mass index be a complete pathological response predictor in breast cancer patients submitted to neoadjuvant chemotherapy? A real-world data trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-17-02.

Abstract PO4-16-10: Overall survival in sentinel node biopsy and axillary dissection: a real-world data

Abstract Background: Information about the status of the axilla (presence or absence of lymph node disease) is important for breast cancer (BC) treatment decision-making. Axillary dissection (AD) has been gradually substituted by sentinel node biopsy (SLNB) in clinical node negative patients and intraoperative evaluation became a routine. Most of the patients with a positive node in an intraoperative evaluation were submitted to AD, and when a negative intraoperative evaluation but a positive paraffin evaluation was found a new axillary surgery was a routine. Both approaches were gradually abandoned with the publication of the ACOSOG Z011 study showing no difference in local recurrence or overall survival (OS). Objective: To evaluate the number of patients with BC who meet the criteria of Z011 trial and could be spared of AD and compare the outcomes of the SLNB only and those that had AD. Methods: Patients with BC that were submitted to upfront surgery and had at least one positive node in SLNB were included in these retrospective analyses at Pérola Byington Hospital database, diagnosed between 1992 and 2019. Clinical and pathological characteristics were extracted from the database and patient medical records. T-test or chi-square test was used to individually analyze the association of each variable between the groups. Multivariate analysis was used to calculate odds ratio (OR) and 95% confidence intervals (CI) for independent variables correlated with positive AD. Cox regression was used for survival analysis, and survival curves were plotted using the Kaplan-Meier method, analyzing the difference between curves using the Log-rank test. R software version 4.1.1 was used for all analyses, with a p-value &amp;lt; 0.05 considered statistically significant. Results: A total of 729 patients were analyzed, with a mean age of 54.1 (±11.6) years at diagnosis. Most patients (n=633, 86.8%) underwent AD after a positive SLNB and 40,3% of the patients that were submitted to AD the only positive node was the sentinel node. After AD, 63,3% of these patients had 1 or 2 lymph nodes positive and met the Z011 criteria trial. The mean number of lymph node in AD was 12.2. Most patients (72.7%) were diagnosed at clinical stage II, 62% had nuclear grade 2 tumors, 52.9% had Luminal B subtype, and 63% were postmenopausal. Furthermore, 58.5% of patients underwent breast-conserving surgery, and 5.2% of patients experienced recurrence. The chance of AD was observed 2,2 times for the luminal B (OR 2.163, 95% CI 1.104-4.239, p=0.025), 2,1 times HER2-positive with receptor positive (OR 2.125, 95% CI 1.160-3.893, p=0.015), and 2,8 times for triple-negative (OR 2.806, 95% CI 1.013-7.757, p=0.047) compared to Luminal A. Patients that were submitted to AD had worse outcome when compared to SLNB, the overall survival showed a 94.4% higher risk of death with a median survival of 11 years (HR 1.944, 95% CI 1.20-3.14, p=0.006). Conclusion: These retrospective analyses showed 63,3% of the patients that had a positive node in a SLNB could be spared from AD (based on Z011 trial). Patients submitted to AD had worse outcome and these findings needs to be clarified. Citation Format: Renata Pares, Andre Mattar, Juliana de Lima, Marcelo Antonini, Francisco Pimentel Cavalcante, Luiz Henrique Gebrim. Overall survival in sentinel node biopsy and axillary dissection: a real-world data [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-16-10.

The Effect of Socioeconomic Status and Race/Ethnicity on the Risk of Presenting With Advanced Stage at Diagnosis in Embryonal Tumors.

We evaluated whether socioeconomic status (SES), race/ethnicity, and their interaction were associated with the presentation of advanced stage at diagnosis in embryonal tumors. Children 0 to 19 years of age diagnosed with embryonal tumors between 2006 and 2018 were identified from the US Surveillance, Epidemiology, and End Results program database specialized with Census Tract SES/Rurality. SES quintile was derived from a composite index for census tracts. We performed logistic regression to estimate odds ratios (ORs) and 95% confidence intervals by SES and race/ethnicity, adjusting for sex, age, and diagnosis year. Overall, no significant associations were found between either SES or race/ethnicity and the risk of presenting with advanced stage at diagnosis, although patterns of risk reductions were observed in atypical teratoid/rhabdoid tumors and embryonal rhabdomyosarcoma with increasing SES. In the stratified analysis, decreased odds of presenting with advanced-stage embryonal rhabdomyosarcoma were observed for Hispanics with higher SES (OR: 0.24, 95% Confidence Interval: 0.08-0.75) compared with Hispanics with lower SES. Future studies incorporating individual-level SES, cancer-specific staging information, and potential demographic, clinical, epidemiological, and genetic risk factors are warranted to confirm our findings.

Pointwise Nonparametric Estimation of Odds Ratio Curves with R: Introducing the flexOR Package

The analysis of odds ratio curves is a valuable tool in understanding the relationship between continuous predictors and binary outcomes. Traditional parametric regression approaches often assume specific functional forms, limiting their flexibility and applicability to complex data. To address this limitation and introduce more flexibility, several smoothing methods may be applied, and approaches based on splines are the most frequently considered in this context. To better understand the effects that each continuous covariate has on the outcome, results can be expressed in terms of splines-based odds ratio (OR) curves, taking a specific covariate value as reference. In this paper, we introduce an R package, flexOR, which provides a comprehensive framework for pointwise nonparametric estimation of odds ratio curves for continuous predictors. The package can be used to estimate odds ratio curves without imposing rigid assumptions about their underlying functional form while considering a reference value for the continuous covariate. The package offers various options for automatically choosing the degrees of freedom in multivariable models. It also includes visualization functions to aid in the interpretation and presentation of the estimated odds ratio curves. flexOR offers a user-friendly interface, making it accessible to researchers and practitioners without extensive statistical backgrounds.

Abstract PO3-09-02: Identifying risk factors for trastuzumab-induced cardiotoxicity among multi-ethnic women with HER2-positive early-stage breast cancer

Abstract Introduction: While trastuzumab, a HER2-targeted therapy for patients with HER2-positive breast cancer, has been shown to improve disease-free and overall survival rates, it also confers the risk of significant morbidity in the way of trastuzumab-induced cardiotoxicity (TIC). TIC may present as asymptomatic decline in left ventricular ejection fraction (LVEF) or as symptomatic heart failure. Given that racial/ethnic minorities are at higher risk for cardiovascular disease (CVD) compared to non-Hispanic Whites, our objective was to assess racial/ethnic differences in TIC and LVEF recovery among multi-ethnic patients with HER2-positive early-stage breast cancer. Methods: We conducted a retrospective cohort study including patients diagnosed with stage I-III HER2-positive breast cancer between 2007-2022 who had received adjuvant trastuzumab therapy at Columbia University Irving Medical Center (CUIMC) in New York, NY. TIC was defined as &amp;gt;10% decrease in LVEF to an overall LVEF&amp;lt; 50% and was confirmed by a minimum of two serial echocardiograms, whereas LVEF recovery was defined as a return to a LVEF &amp;gt;50%. Descriptive statistics, univariate and multivariate logistic regression analyses were conducted to estimate odds ratios (OR) and 95% confidence intervals (CI) for the associations between sociodemographic factors, tumor characteristics, treatment regimens, and CVD risk factors with the main outcome of TIC. Results: In the final cohort (N=500), median age was 53 years (IQR: 45.0-62.0) with 36.6% non-Hispanic White (NHW), 15.8% non-Hispanic Black (NHB), 27.8% Hispanic, and 19.8% Asian/Pacific Islander/Other. About 68.2% of patients received adjuvant radiation therapy, 30.2% were treated with anthracyclines, 37.8% with pertuzumab, 4.6% with T-DM1 and 69.0% with endocrine therapy. Fifty-three (10.6%) patients developed TIC, half of which experienced LVEF recovery. Compared to NHW, NHB patients had a higher rate of TIC (9.3% vs. 17.7%, respectively) and lower rate of LVEF recovery (70.6% vs. 21.4 % in those with TIC, respectively). On multivariable analysis, increasing age, lower LVEF at baseline, anthracycline exposure, and coronary artery disease (CAD) were associated with TIC (see Table). We found no association between TIC and use of pertuzumab or T-DM1. Discussion: In our racially/ethnically diverse study population, we found an incidence of TIC comparable to previous clinical studies. NHB patients had double the incidence of TIC and a lower incidence of LVEF recovery when compared to NHW patients. Given the observed racial disparities in TIC and LVEF recovery, NHB patients may require closer cardiac monitoring and restricted use of anthracyclines with adjuvant trastuzumab treatment. More research on cardiotoxicity associated with newer forms of HER2-targeted therapies is necessary. Table: Multivariable logistic regression model with outcome of TIC Citation Format: Leila Mishalani, Anna Vaynrub, Katherine Crew. Identifying risk factors for trastuzumab-induced cardiotoxicity among multi-ethnic women with HER2-positive early-stage breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-09-02.

Hearing Impairment and Physical Activity and Physical Functioning in Older Adults: Baseline Results From the ACHIEVE Trial.

Hearing loss is associated with restricted physical activity (PA) and impaired physical functioning, yet the relationship between severity of hearing impairment (HI) and novel PA measures in older adults with untreated HI is not well understood. Analyses included 845 participants aged ≥70 years (mean = 76.6 years) with a better-hearing ear pure-tone average (PTA) ≥30 and <70 dB in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study who wore an ActiGraph accelerometer for 7 days. Physical functioning measures included grip strength and the Short Physical Performance Battery (SPPB). Linear regression models estimated the association by HI level (moderate or greater [PTA ≥ 40 dB] vs mild [PTA < 40 dB]) and continuous hearing with total daily activity counts, active minutes/day, activity fragmentation, grip strength, and gait speed. Logistic regression models estimated odds ratios (ORs) and 95% confidence intervals (CIs) of poor performance on the SPPB (≤6) and its subtests (≤2). Mixed-effects models estimated differences by HI level in activity by time of day. Participants with moderate or greater HI had poorer physical functioning, particularly balance (OR = 2.17, 95% CI = 1.29-3.67), versus those with mild impairment. There was no association of HI level with activity quantities or fragmentation. For diurnal patterns of activity, participants with moderate or greater HI had fewer activity counts in the afternoon (12:00 pm -05:59 pm). Older adults with worse hearing had shifted diurnal patterns and poorer balance performance. Exercise programs should be tailored to older adults with different levels of HI to maintain PA and physical functioning, particularly balance control.

Cluster Analysis of Fear of Childbirth, Anxiety, Depression, and Childbirth Self-Efficacy

ObjectiveTo identify clusters of women based on anxiety, depression, fear of birth, and childbirth self-efficacy and factors associated with the clusters. DesignCross-sectional survey. SettingOnline in Sweden. ParticipantsPregnant women (N = 1,419). MethodsWe collected data through online questionnaires. We included scales to measure anxiety, depression, worries about and fear of birth, and self-efficacy in a kappa-means cluster analysis. We calculated odds ratios with 95% confidence intervals between clusters and background variables. ResultsWe identified 4 clusters based on severity: Resourceful–Robust, Resourceful–Fearful, Vulnerable–Fearful, and Fragile–Fearful. Participants in the Resourceful–Fearful and Vulnerable–Fearful clusters were more likely to report mental health problems than those in the Resourceful–Robust cluster. Participants in the Vulnerable–Fearful and Fragile–Fearful clusters were more likely to report mental health problems than those in the Resourceful–Robust cluster. Participants in the Fragile–Fearful cluster were more likely to be multiparous, report that their pregnancy was not normal, and prefer cesarean birth than those in the Resourceful–Robust cluster. ConclusionsWomen with childbirth fear may be vulnerable to anxiety and depression during the perinatal period, although the severity might vary. Self-efficacy might be a mediator against mental health problems. Findings demonstrated levels of severity, and the one-size-fits-all approach in Swedish health care may benefit from a more targeted approach for women with fear of childbirth.