Treatment Characteristics Research Articles

Person-Centred Hepatitis C Virus Treatment In Community Settings

The World Health Organization (WHO) has set a target to eliminate the Hepatitis C virus (HCV) as a public health threat by 2030. To achieve this, HCV treatment needs to be accessible through primary health care providers in community settings. In Australia, general practitioners and nurse practitioners can prescribe nearly free direct-acting antiviral (DAA) medication. However, there are still many barriers to the provision of HCV treatment in community settings. Considering the characteristics of HCV infection, people with HCV, and the Australian primary health system, person-centred HCV treatment is suggested to improve treatment uptake and adherence. Although the provision of person-centred HCV treatment in community settings is emphasised, the characteristics of these models are not well described. This short report describes the characteristics of person-centred HCV treatment in community settings to inform policy and practices in supporting HCV elimination. The characteristics were developed based on the analysis of findings of studies conducted by the author using person-centred care framework. The studies included a mixed methods systematic literature review, a Delphi study, and a mixed methods case study on a community-based model of care for treating HCV.

Реализация междисциплинарного подхода в психолого-педагогическом сопровождении детей, нуждающихся в длительном лечении в медицинских стационарах

<p style="text-align: justify;">This article is aimed at updating the specifics of implementing an interdisciplinary approach in psychological and pedagogical support for children in need of long-term treatment in medical hospitals. The publication describes the importance and possibilities of team interaction between specialists of helping professions in providing psychological and pedagogical support for children in need of long-term treatment with chronic somatic diseases. To implement an interdisciplinary approach, it was found that it is important to take into account the special needs of children in need of long-term treatment, their psychological and social characteristics. An approach to determining the current emotional state, higher mental functions, and personal characteristics of young patients studying in hospital schools is presented. Based on identified current needs, a comprehensive system of pedagogical rehabilitation and psychological and pedagogical support in a hospital school was formed, and the specifics of correctional and developmental, educational, advisory and preventive work of employees of the psychological and pedagogical support service were determined.</p>

Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial.

To assess efficacy of Chinese medicine (CM) on insomnia considering characteristics of treatment based on syndrome differentiation. A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo (n=20) or the CM group (n=96) for a 4-week treatment and a 4-week follow-up. Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation. The primary outcome was change in total sleep time (TST) from baseline. Secondary endpoints included sleep onset latency (SOL), wake time after sleep onset (WASO), sleep efficiency, Pittsburgh Sleep Quality Index (PSQI) and CM symptoms. The CM group had an average 0.6 h more (95% confidence interval (CI): 0.3-0.9, P<0.001) TST and 34.1% (10.3%-58.0%, P=0.005) more patients beyond 0.5 h TST increment than that of the placebo group. PSQI was changed -3.3 (-3.8 to -2.7) in the CM group, a -2.0 (-3.2 to -0.8, P<0.001) difference from the placebo group. The CM symptom score in the CM group decreased -2.0 (-3.3 to -0.7, P=0.003) more than the placebo group. SOL and WASO changes were not significantly different between groups. The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes. Prescriptions for these clinicians displayed relative stability, while the herbs varied. All adverse events were mild and were not related to study treatment. CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia. It is effective and safe for primary insomnia. In future studies, the long-term efficacy validation and the exploratory of eutherapeutic clinicians' fixed herb formulas should be addressed (Registration No. NCT01613183).

Self-reported depression and its risk factors among hypertensive patients, Morocco: a cross-sectional study.

Hypertensive patients are at an elevated risk of developing mental diseases such as depression, which can impair their quality of life. The purpose of this study is to measure the prevalence of self-reported depression among hypertensive patients treated at primary health care facilities in Marrakech. Between May 2021 and December 2022, a cross-sectional study of 1053 hypertensive patients attending primary health care facilities in Marrakech was conducted. A face-to-face questionnaire was used to collect socio-demographic, behavioral, and clinical data, as well as hypertension treatment characteristics and the care-patient-physician triad. The Patient Health Questionnaire-9 was used to assess self-reported depression. To identify self-reported depression risk factors, multivariate logistic regression was used. Depressive symptoms were reported by 56.1% of hypertensive patients. The patients' average age was 63.2 ± 9.5years, and 508 (85.9%) were female. Female sex, stress, a low-salt diet, pain and physical discomfort, an urban living environment, a lack of self-monitoring of hypertension, an unsatisfactory relationship with the healthcare system, a family history of hypertension, and the perception of adverse effects of the antihypertensive drug were all associated with self-reported depression. Self-reported depression is prevalent among hypertensive patients in Marrakech. The mental health component should be emphasized while addressing hypertensive patients in primary health care facilities.

Effect of Rurality in Head and Neck Cancer: A Scoping Review.

This scoping review sought to evaluate the current literature regarding the following outcomes in relation to rurality: stage at diagnosis, clinical characteristics, treatment characteristics, and survival outcomes of head and neck cancer (HNC). A literature search was performed using PubMed (MEDLINE), Science Direct, EMBASE, SCOPUS, and Web of Science databases. A 20-year study cutoff from the initial search was used to increase the comparability of the studies regarding population and standards of clinical care. These searches were designed to capture all primary studies reporting HNC incidence, presenting characteristics, treatments, and treatment outcomes. Two reviewers independently screened abstracts, selected articles for exclusion, extracted data, and appraised studies. Critical appraisal was done according to the Joanna Briggs Institute Quality Assessment Tool for Cohort Studies. Twenty eligible original articles were included. Stage at diagnosis, clinical characteristics, treatment characteristics, and survival outcomes were measured. Our review indicates that although this relationship is unclear, there may be variations in treatment choice for laryngeal cancer based on geographic location and rural residency status. The studies assessing HNC outcomes related to stage at diagnosis, clinical characteristics, treatment characteristics, and overall survival demonstrated conflicting findings, indicating a need for further research examining HNC outcomes with a focus on rurality as the main exposure. The relationship between HNC and rural-urban status remains unclear. More studies are needed, along with a consistent metric for measuring rurality and recruitment of comparable populations from both rural and urban areas. Laryngoscope, 2024.

Has the COVID-19 pandemic resulted in more advanced breast cancer? A hospital-based retrospective study.

The suspension of breast cancer screening during the COVID-19 pandemic altered patient diagnosis and management. This study investigates the impact of the COVID-19 lockdowns, screening delays and reduced healthcare attendance on changes in tumour and treatment characteristics, particularly for biologically more aggressive breast cancers. This retrospective single-hospital analysis utilized data from a prospective cancer database between July 2019 and June 2022. Patient, tumour and treatment factors were compared across pre-pandemic, pandemic and post-pandemic groups. Symptomatic breast cancer increased from 42.3% in the pre-, 53.1% in the pandemic and 57% in the post- respectively (P ≤ 0.05). Compared to the pre-pandemic group (4.6%), an increase in stages 3 or 4 breast cancers in the pandemic (8.5%) and post-pandemic (7.1%) was found. Increased node-positivity in Ki67 > 20%, grade 3 or ER- tumours post-pandemic (+5.4%, +14.8%, +33.4%, respectively) was identified. More neoadjuvant chemotherapy was found in both the pandemic (+4.3%) and post-pandemic (+11.3%, P = 0.0261) groups. An increase in hypofractionated radiotherapy in the post-pandemic group (+9.4%) was also identified. Our study identified a decrease in early-stage cancers and an increase in node positivity, particularly for biologically more aggressive tumours. An increase in the number of patients receiving neoadjuvant chemotherapy or hypofractionated radiotherapy during the pandemic and post-pandemic periods was also identified.

Tracking social-economic system nitrogen flow in China for emissions reduction and efficiency improvement

The increasing human demand have driven intensive reactive nitrogen (Nr) use, leading to high emissions and low efficiency in entire social-economic system. Herein, we accomplished a social-economic Nr flow model to trace the multi-sectorial Nr use, efficiency, and emissions in China from 1980 to 2020. The results showed that Nr use intensity increased 3.1-fold within four decades, with the decreasing proportions of Nr recovery from 32.7 % to 16.8 %. The Nr use pathways of production, consumption and waste management stages showed low resources use efficiency in agriculture and industrial production, high degree of consumption loss, insufficient waste treatment characteristics currently. Nr emissions peaked in 2012 and declined 12.7 % to 2020 owing to the nitrogen oxides control and mitigating overuse of fertilizers, and will continuously decrease under strategies in 2040 (41.7 % compared with 2012), indicating the large potential for emission reduction and efficiency improvement in next few decades.

Subchondral rafting wires reduce tibial plateau fracture subsidence.

To determine if subchondral rafting wires retained as adjunctive tibial plateau fracture fixation affect postoperative articular subsidence. A retrospective cohort study was conducted at one Level 1 trauma center and one academic university hospital. Consecutive adults with closed, displaced OTA/AO 41B/C tibial plateau fractures treated between 2018 and 2023 with open reduction internal fixation were included. Patients who were not ambulatory, with contralateral injuries limiting weight bearing, and without follow-up radiographs of the injured extremity were excluded.The intervention was retention of subchondral rafting wires as definitive fixation. The primary outcome was linear articular surface subsidence between postoperative and follow-up AP knee radiographs. Linear subsidence was compared between groups using Welch's two sample t test. Associations of linear subsidence with patient, injury, and treatment characteristics were assessed by multivariable linear regression. We identified 179 patients of a mean age of 44 ± 14years, of whom 15 (8.4%) received subchondral rafting wires. Median follow-up was 121days. No patients who received rafting wires as definitive implants experienced linear subsidence ≥ 2mm, while 22 patients (13.4%) who did not receive rafting wires experienced linear subsidence ≥ 2mm (p = 0.130). Subchondral rafting wires were associated with less linear subsidence (0.3mm [95% confidence interval - 0.3-0.9mm] vsersus 1.0mm [- 0.9-2.9mm], p < 0.001). The depth of linear subsidence was significantly associated on multivariable regression with male sex, depressed plateau area, active smoking, and retained rafting wires. Subchondral rafting wires were associated with a small reduction in articular subsidence after internal fixation of tibial plateau fractures. Routine rafting wires may be useful for patients and fractures at high risk of articular subsidence.

Treatment characteristics of patients with hereditary transthyretin amyloidosis: a cohort study

BackgroundThere are novel medications approved for the treatment of hereditary transthyretin amyloidosis (ATTRv), classified as transthyretin (TTR) stabilizers or gene silencers. While many patients may be on both classes of medications, there is no data available on the safety and efficacy of combination therapy.ObjectivesTo describe ATTRv patient and TTR-targeted therapy characteristics in a US cohort, and compare outcomes with combination therapy versus monotherapy.MethodsWe performed a retrospective cohort study with electronic health record data of patients with ATTRv seen at a single institution between January 2018 and December 2022. We collected data on symptomatology, gene mutation, disease severity, ATTRv treatment, hospitalizations, and mortality.ResultsOne hundred sixty-two patients with ATTRv were identified. The average age at diagnosis was 65 years. 86 patients (53%) had the V122I variant. 119 patients were symptomatic, of whom 103 were started on ATTRv-specific treatment. 41 patients (40%) had cardiomyopathy only, and 53 (51%) had a mixed phenotype of cardiomyopathy and neuropathy. 38 patients (37%) received therapy with both a gene silencer and protein stabilizer. 9 patients (15%) in the monotherapy group had two or more cardiac hospitalizations after starting treatment, compared to 3 patients (9%) on combination therapy (p=0.26). The adjusted hazard ratio of all-cause mortality for the patients on combination therapy compared to monotherapy was 0.37 (0.08-1.8, p=0.21).ConclusionsWhile the efficacy is unproven, over one-third of patients with ATTRv are on both a stabilizer and a silencer. There were no safety issues for combination therapy. There was a trend towards improved hospitalizations and survival in patients in the combination group but this was not statistically significant. Larger studies with longer follow-up are necessary to determine benefit of combination therapy.

Impact of clinical and treatment characteristics on HR-QoL in patients with prolactinoma - cross-sectional analysis of a dutch multicenter prospective cohort study

Impact of clinical and treatment characteristics on HR-QoL in patients with prolactinoma - cross-sectional analysis of a dutch multicenter prospective cohort study

Pathological response to neoadjuvant chemoradiotherapy for oesophageal squamous cell carcinoma in Eastern versus Western countries: meta-analysis.

Locally advanced oesophageal squamous cell carcinoma can be treated with neoadjuvant chemoradiotherapy or chemotherapy followed by oesophagectomy. Discrepancies in pathological response rates have been reported between studies from Eastern versus Western countries. The aim of this study was to compare the pathological response to neoadjuvant chemoradiotherapy in Eastern versus Western countries. Databases were searched until November 2022 for studies reporting pCR rates after neoadjuvant chemoradiotherapy for oesophageal squamous cell carcinoma. Multi-level meta-analyses were performed to pool pCR rates separately for cohorts from studies performed in centres in the Sinosphere (East) or in Europe and the Anglosphere (West). For neoadjuvant chemoradiotherapy, 51 Eastern cohorts (5636 patients) and 20 Western cohorts (3039 patients) were included. Studies from Eastern countries included more men, younger patients, more proximal tumours, and more cT4 and cN+ disease. Patients in the West were more often treated with high-dose radiotherapy, whereas patients in the East were more often treated with a platinum + fluoropyrimidine regimen. The pooled pCR rate after neoadjuvant chemoradiotherapy was 31.7% (95% c.i. 29.5% to 34.1%) in Eastern cohorts versus 40.4% (95% c.i. 35.0% to 45.9%) in Western cohorts (fixed-effect P = 0.003). For cohorts with similar cTNM stages, pooled pCR rates for the East and the West were 32.5% and 41.9% respectively (fixed-effect P = 0.003). The pathological response to neoadjuvant chemoradiotherapy is less favourable in patients treated in Eastern countries compared with Western countries. Despite efforts to investigate accounting factors, the discrepancy in pCR rate cannot be entirely explained by differences in patient, tumour, or treatment characteristics.

Quality of care transition, patient safety incidents, and patients’ health status: a structural equation model on the complexity of the discharge process

BackgroundThe transition of patients between care contexts poses patient safety risks. Discharges to home from inpatient care can be associated with adverse patient outcomes. Quality in discharge processes is essential in ensuring safe transitions for patients. Current evidence relies on bivariate analyses and neglects contextual factors such as treatment and patient characteristics and the interactions of potential outcomes. This study aimed to investigate the associations between the quality and safety of the discharge process, patient safety incidents, and health-related outcomes after discharge, considering the treatments’ and patients’ contextual factors in one comprehensive model.MethodsPatients at least 18 years old and discharged home after at least three days of inpatient treatment received a self-report questionnaire. A total of N = 825 patients participated. The assessment contained items to assess the quality and safety of the discharge process from the patient’s perspective with the care transitions measure (CTM), a self-report on the incidence of unplanned readmissions and medication complications, health status, and sociodemographic and treatment-related characteristics. Statistical analyses included structural equation modeling (SEM) and additional analyses using logistic regressions.ResultsHigher quality of care transition was related to a lower incidence of medication complications (B = -0.35, p < 0.01) and better health status (B = 0.74, p < 0.001), but not with lower incidence of readmissions (B = -0.01, p = 0.39). These effects were controlled for the influences of various sociodemographic and treatment-related characteristics in SEM. Additional analyses showed that these associations were only constant when all subscales of the CTM were included.ConclusionsQuality and safety in the discharge process are critical to safe patient transitions to home care. This study contributes to a better understanding of the complex discharge process by applying a model in which various contextual factors and interactions were considered. The findings revealed that high quality discharge processes are associated with a lower likelihood of patient safety incidents and better health status at home even, when sociodemographic and treatment-related characteristics are taken into account. This study supports the call for developing individualized, patient-centered discharge processes to strengthen patient safety in care transitions.

Nitric oxide donor increases umbilical vein blood flow and fetal oxygenation in fetal growth restriction. A pilot study

IntroductionTo evaluate the maternal and fetal hemodynamic effects of treatment with a nitric oxide donor and oral fluid in pregnancies complicated by fetal growth restriction. Methods30 normotensive participants with early fetal growth restriction were enrolled. 15 participants were treated until delivery with transdermal glyceryl trinitrate and oral fluid intake (Treated group), and 15 comprised the untreated group. All women underwent non-invasive assessment of fetal and maternal hemodynamics and repeat evaluation 2 weeks later. ResultsIn the treated group, maternal hemodynamics improved significantly after two weeks of therapy compared to untreated participants. Fetal hemodynamics in the treated group showed an increase in umbilical vein diameter by 18.87 % (p < 0.01), in umbilical vein blood flow by 48.16 % (p < 0.01) and in umbilical vein blood flow corrected for estimated fetal weight by 30.03 % (p < 0.01). In the untreated group, the characteristics of the umbilical vein were unchanged compared to baseline. At the same time, the cerebro-placental ratio increased in the treated group, while it was reduced in the untreated group, compared to baseline values. The treated group showed a higher birthweight centile (p = 0.03) and a lower preeclampsia rate (p = 0.04) compared to the untreated group. DiscussionThe combined therapeutic approach with nitric oxide donor and oral fluid intake in fetal growth restriction improves maternal hemodynamics, which becomes more hyperdynamic (volume-dominant). At the same time, in the fetal circuit, umbilical vein flow increased and fetal brain sparing improved. Although a modest sample size, there was less preeclampsia and a higher birthweight suggesting beneficial maternal and fetal characteristics of treatment.

Preference of treatment characteristics among people with haemophilia or their caregivers, and physicians in the Japanese healthcare environment.

Studies of treatment preferences in haemophilia have been conducted in many countries. This study is the first to examine treatment characteristic preferences among people with haemophilia (PWH) and their caregivers, and physicians in Japan. To examine current treatment preferences of PWH and their caregivers, plus those of physicians at haemophilia treatment centres (HTCs) and non-HTCs for different treatment characteristics in Japan. Physicians listed on a survey panel were invited to participate in the survey and to refer PWH and caregivers to participate in the survey. Web-based surveys were conducted to examine physician and PWH/caregiver background, prophylaxis background, prophylaxis goals, understanding of haemophilia treatment products, important information sources, preferences while choosing prophylaxis products, understanding of the patient's condition, and potential product switching. A discrete choice experiment exercise was included in the survey. A total of 107 physicians and 44 PWH/caregivers participated in the study. Key treatment goals of physicians included optimisation of haemophilia management. PWH/caregivers were focused on quality of life and reduced treatment burden. Consistent differences in haemophilia treatment strategies at HTCs and non-HTCs were observed for prescribed treatments, preferences in choosing prophylaxis products, understanding of patients' condition, and reasons for potential product switch. Our study utilises real-world survey data and presents preferences for haemophilia treatment characteristics among physicians, PWH and their caregivers in Japan, which could encourage improvements in individualised treatment and disease management. Alignment between treatment approaches at HTCs and non-HTCs could facilitate improvements in the quality of care for PWH across Japan.

Abstract PO2-10-03: Clinical characteristics and survival trends of male breast cancer in the United States: A propensity score matched analysis

Abstract Introduction Male breast cancer (MBC) is extremely rare and represents less than 1% of breast cancer (BC). There are limited studies investigating clinical outcomes of MBC. Although the survival of female breast cancer (FBC) has increased over the years; there is a substantial knowledge gap regarding survival trends of MBC. Given the rarity of MBC, recommendations on the treatment of MBC are scarce and mainly extrapolated from the data from FBC. We aim to analyze the clinical characteristics and annual trend in the survival of MBC compared to FBC. Methods We queried the National Cancer Database for BC patients (pts) diagnosed during 2004-2020. The demographic, clinicopathological and treatment characteristics were summarized by sex. An inverse-propensity weighted cox regression model was used to assess the association between sex and overall survival. Propensity weights were based on age, race, insurance, T, N, M-stages, subtype, grade, chemotherapy (CT), radiation (RT), hormone therapy (HT), and time to definitive treatment. To compare survival trends over time, year of diagnosis and its interaction with sex were included in the model. All analyses were performed at a significance level of 0.05. Results A total of 24, 055 MBC and 2,532,470 FBC pts were identified. MBC pts were older (mean age: 65.6 vs 61.4 years), Blacks (12.8 vs 11.2%) and had more government insurance (55.7% vs 45.8%) compared to FBC (all p&amp;lt; 0.001). Compared with FBC, more MBC pts had stage IV (7% vs 4.7%), fewer pts had stage I (33.4% vs 44.8%), more pts had larger tumors (cT4: 6% vs 3.7%), and node positive disease (18.5% vs 15.5%) (all p&amp;lt; 0.001). MBC were more likely estrogen (ER) (88.5% vs 78.5%) and progesterone receptor (PR) (79.6% vs 68%) positive and less likely HER2 receptor positive (7.9% vs 9.3%) or triple negative (2.8% vs 7.6%) compared to FBC (all p &amp;lt; 0.001). Male pts with BC received less CT (38.7% vs 41.2%), RT (32% vs 52.6%), HT (59.8% vs 62.5%) compared to females with BC (p &amp;lt; 0.001). The overall survival (OS) rates were lower in MBC compared to FBC (5-year: 73% vs 83%; 10-year: 54% vs 70%, p &amp;lt; 0.001). In the propensity weighted cox-regression model, males had higher mortality compared to females with BC (HR 2.8, 95% CI 2.88 - 2.9, p &amp;lt; 0.001). This difference in OS was observed in TNBC (HR 1.2, 95% CI 1.21 - 1.24) and HER2+ (HR 2, 95% CI 1.9 - 2.0), but not in ER/PR+ HER2- BC (HR 0.78, 95% CI 0.78 - 0.79), all p &amp;lt; 0.001. The 5-year and 10-year OS of early-stage MBC and advanced MBC was lower compared to FBC (Early-stage:- 5-year: 77% vs 86%, 10-year: 57% vs 72%, HR 2.9, 95% CI 2.9-2.92; Advanced: 5-year: 23% vs 28%, 10-year: 8% vs 13%, HR 1.14, 95% CI 1.14 – 1.2, both p &amp;lt; 0.001) The 5-year OS rates increased steadily for FBC from 2004-2015; however, the survival rates were not improved for MBC (Table 1) (p-value for interaction of sex and year of diagnosis was 0.02). Conclusion MBC pts have higher mortality rates and poor clinical outcomes compared to FBC pts. We demonstrate that the survival of MBC pts has not improved over the last decade, even after adjusting for clinicopathological and treatment characteristics. These findings suggest the need to investigate personalized treatment interventions for male breast cancer pts, especially given the disparate trends in survival among male and female BC over a period of time. Table 1: Survival trend by sex - overall BC cohort Citation Format: Arya Mariam Roy, Anthony George, Archit Patel, Malak Alharbi, Kristopher Attwood, Shipra Gandhi. Clinical characteristics and survival trends of male breast cancer in the United States: A propensity score matched analysis [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 PO2-10-03.

Abstract GS02-13: Pregnancy after breast cancer in young women with germline BRCA pathogenic variants: results from an international cohort study

Abstract Background: Oncofertility counseling in BRCA carriers has unique challenges due to a possible negative impact of germline pathogenic/likely pathogenic variants (PVs) on reproductive potential and the indication to undergo risk-reducing bilateral salpingo-oophorectomy. While previous studies demonstrated the safety of pregnancy in women with prior breast cancer (BC) history, limited evidence exists in BRCA carriers specifically. We report the results of the largest study to date investigating likelihood of pregnancy after BC, reproductive and disease outcomes specifically in BRCA carriers. Methods: This was an international, multicenter, hospital-based, retrospective cohort study including young BRCA carriers with history of BC (NCT03673306). Eligible patients were women harboring germline PVs in BRCA1 and/or BRCA2 and diagnosed with stage I-III invasive BC at the age of ≤ 40 years between January 2000 and December 2020. BRCA healthy carriers or patients with BRCA variants of unknown significance, non-invasive BC, lack of follow-up, prior ovarian cancer or other malignancies without history of BC were excluded. Primary endpoints were pregnancy rate and disease-free survival (DFS). Overall survival (OS), BC specific survival (BCSS), pregnancy, fetal and obstetric outcomes were secondary endpoints. To mitigate the impact of guaranteed time bias, two survival analyses were performed: 1) Extended Cox model with occurrence of pregnancy as a time-varying covariate; 2) Case-control analysis by matching 1:3 patients with and without a pregnancy for type of BRCA PV, hormone receptor status, nodal status and year at diagnosis; moreover, each control had to have a disease-free interval longer than the time occurring between BC diagnosis and conception of the matched case. Results: From 78 centers worldwide, 4,732 patients were included, of whom 659 had at least one pregnancy after BC (pregnancy cohort) and 4,073 did not (non-pregnancy cohort). Patients in the pregnancy cohort were significantly more likely to carry BRCA1 PVs, to be younger at BC diagnosis, to have node-negative and hormone receptor-negative (HR-) BC (all p&amp;lt; 0.01). Pregnancy rate at 10 years was 22% (95% CI 21%-24%) overall, 18% (95% CI 16%-21%) and 26% (95% CI 24%-26%) in patients with HR+ and HR- BC, respectively (p&amp;lt; 0.01). Median time from BC diagnosis to conception was 3.5 years (IQR 2.2-5.3 years), significantly longer in patients with HR+ than HR- BC (4.3 vs 3.2 years, p&amp;lt; 0.01). Among 659 patients with a pregnancy after BC, 45 (6.8%) and 63 (9.6%) experienced an induced abortion or a miscarriage, respectively. Of the 517 (78.5%) patients with completed pregnancy, 54 (10.4%) had twins and 406 (78.5%) delivered at term (delivery ≥37 weeks). Among the 571 babies born, 5 (0.9%) had congenital anomalies. Median follow-up was 7.8 years (IQR, 4.5-12.6 years). No significant difference in DFS was observed between the pregnancy and non-pregnancy cohorts (unadjusted HR 0.97, 95% CI 0.82-1.15, p=0.74; adjusted HR [aHR] 0.99, 95% CI 0.81-1.20, p=0.90). Patients in the pregnancy cohort showed significantly better BCSS (HR 0.53, 95% CI 0.38-0.74, p&amp;lt; 0.01; aHR 0.59, 95% CI 0.41-0.86, p&amp;lt; 0.01) and OS (HR 0.52, 95% CI 0.38-0.72, p&amp;lt; 0.01; aHR 0.58, 95% CI 0.40-0.85, p&amp;lt; 0.01). Similar results were obtained in the case-control analysis. Subgroup analyses of survival endpoints according to patient, tumor and treatment characteristics will be presented at the conference. Conclusions: In this global study, 1 out of 5 young BRCA carriers conceived within 10 years after a BC diagnosis, higher than rates previously reported in unselected young BC populations. Pregnancy following BC in BRCA carriers did not appear to adversely impact maternal prognosis or fetal outcomes. These findings should be incorporated into oncofertility counseling of young BRCA carriers with BC. Citation Format: Matteo Lambertini, Eva Blondeaux, Elisa Agostinetto, Anne-Sophie Hamy-Petit, Hee Jeong Kim, Camila Chiodi, Rinat Bernstein-Molho, Florentine Hilbers, Katarzyna Pogoda, Estela Carrasco Lopez, Kevin Punie, Jyoti Bajpai, Michail Ignatiadis, Halle Moore, Kelly-Anne Phillips, Angela Toss, Christine Rousset-Jablonski, Fedro Alessandro Peccatori, Tiphaine Renaud, Alberta Ferrari, Shani Paluch-Shimon, Robert Fruscio, Wanda Cui, Stephanie Wong, Claudio Vernieri, Kathryn Ruddy, Maria Vittoria Dieci, Alexios Matikas, Mariya Rozenblit, Cynthia Villareal Garza, Laura De Marchis, Lucia Del Mastro, Fabio Puglisi, Maria Del Pilar Estevez-Diz, Kenny A. Rodriguez-Wallberg, Bela Mrinakova, Sarah Meister, Luca Livraghi, Florian Clatot, Rinat Yerushalmi, Carmine De Angelis, Rodrigo Sánchez-Bayona, Icro Meattini, Natalia Cichowska-Cwalińska, Martine Berlière, Mahmoud Salama, Ugo De Giorgi, Amir Sonnenblick, Hatem Azim, Ann Partridge. Pregnancy after breast cancer in young women with germline BRCA pathogenic variants: results from an international cohort study [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 GS02-13.

Abstract PO1-09-08: Mammography adherence modifies the relationship between multilevel social deprivation and tumor characteristics in the Carolina Breast Cancer Study

Abstract Objective: To describe associations of individual and community socioeconomic status (SES) with breast cancer tumor and treatment characteristics, and to assess potential modification by mammography receipt. Methods: The Carolina Breast Cancer Study is a population-based cohort of women diagnosed with breast cancer between 2008 and 2013. We restricted this analysis to participants with stage 1-3 cancer (n=2,841). Socio-demographic information was obtained during in-home study interviews, and tumor characteristics were obtained from medical records and pathology reports. Community characteristics were obtained from American Community Survey census-tract level data. SES subgroups were identified using latent class analysis, a method for identifying group membership based on multiple shared characteristics. This was done separately using individual data (e.g. household income) and census-tract level data (e.g. poverty rate). We reported prevalence differences (PDs) and 95% CIs for each outcome. Finally, analyses were repeated with stratification by race (Black/non-Black) and receipt of at least one mammogram every 2 years (yes/no), based on self-reported mammography history. Results: Based on the latent class models, participants were sorted into 4 groups based on their individual/community SES: “high/high”, “high/low”, “low/high”, and “low/low”. Black women made up 81% of the low/low group compared to 26% of the high/high. All high individual-SES participants were combined as one referent group because they had similar clinical characteristics regardless of community status. We found that participants with low/low SES had more aggressive tumor characteristics at diagnosis compared to the referent group, such as stage 3 cancer (PD = 5.7%, 2.4-9.0), grade 3 tumor (PD = 9.9%, 5.3-14.4), and triple negative breast cancer (PD = 5.8%, 2.4-9.1). Low/low participants were also more likely to have an interval of at least 30 days between diagnosis and treatment (PD = 4.6%, 0.2-9.0). However, none of these associations were significant for low/high women. When reported separately by race, Black women with low/low SES had greater frequency of stage 3 cancer (PD = 6.3, 1.9-10.8) and prolonged treatment length (PD = 7.5%, 1.1-13.8) compared to high-SES Black women. Race-stratified SES differences were non-significant for genomic subtype and other tumor characteristics like grade and tumor size. After stratifying by screening status, we found that associations of SES with stage and tumor size were only present among those with &amp;lt; 1 mammogram every 2 years. The low/low PDs were (7.9%, 1.5-14.3) for stage 3 and (7.8%, 2.2-13.3) for tumor size &amp;gt;5 cm. Low/low women also had greater frequency of lump detected cancer (PD = 12.6%, 4.0-21.2). In contrast, these associations were not present among women with biannual mammography. Finally, screening status did not modify PDs for genomic subtype (ER+/HER2-, ER-/HER2+, TNBC). Conclusions: Lower community-level SES is associated with less favorable tumor characteristics at diagnosis, mainly among those with low individual SES. Access to mammography may explain part of the disparity in stage and tumor size, suggesting public health benefit for targeted screening initiatives in disadvantaged communities. Still, screening and SES are only 2 mechanisms that contribute to racial disparities; our future work will explore additional intervention points. Demographic and clinical characteristics of CBCS participants by individual and community socioeconomic status (n=2,841) SES groups were derived from latent class models. P-values were assessed by chi-square tests. Participants with race classified as “other” includes all those not identifying as Black or White, including American Indian/Alaska Native, Asian, or another race not listed on the questionnaire. Urbanicity is defined at the census tract-level Citation Format: Matthew Dunn, Marc Emerson, Louise Henderson, Katherine Reeder-Hayes, Terry Hyslop, Melissa Troester. Mammography adherence modifies the relationship between multilevel social deprivation and tumor characteristics in the Carolina Breast Cancer Study [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 PO1-09-08.

Abstract PO5-11-11: Risk Assessment, Prevention and Early Detection of Breast Cancer Related Lymphedema – Objective Measurements and Patient Reported Outcomes

Abstract Background Breast cancer-related lymphedema (BCRL) affects the quality of life, but there is no consensus regarding early detection and monitoring. Patient-reported outcomes (PROs) are important in assessing cancer survivor outcomes, and different questionnaires have been developed. LYMPHA (Lymphatic Microsurgical Preventive Healing Approach) and S-LYMPHA (Simplified LYMPHA) have reduced BCRL rates. This study aims to identify the most reliable PRO in a South Florida multi-ethnic population and to study correlations between PROs and objective measurements in the first 6 months after axillary surgery. Methods Patients undergoing axillary lymph node dissection (ALND) or axillary radiation were included. L-Dex score (Bioimpedance Spectroscopy) and three validated questionnaires (LyQLI, Lymphedema Quality of Life Inventory; LyQOL, Lymphedema Quality of Life and FACT-B4+ Functional Assessment of Cancer Therapy – Lymphedema) were recorded at baseline, and 6 months post-surgery to assess the agreement between patient-reported symptoms and BCRL. L-Dex score outside the normal range or a 10 unit increase above baseline was considered lymphedema. Additional variables such as demographics, tumor characteristics, and treatment modalities were recorded. Results Out of 40 recruited patients, 39 were analyzed (excluding one deceased patient). Patient and treatment characteristics are described in Table 1. Patients were divided into three cohorts (Figure 1) for analysis: ALND with no axillary radiation (7.69%; n=33), Sentinel Lymph Node Biopsy (SLNB) with axillary radiation (7.69 %; n=3), and ALND with axillary radiation (85%; n=3). In the first cohort, LYMPHA or S-LYMPHA were associated with lower rates of lymphedema (19% vs, 50%) (p=0.116). No patients in the second or third cohort developed lymphedema. There were 4 out of 20 (20%) patients with lymphedema with scores above the median for FACT B4+ (p= 0.480) and a lower score (higher quality of life) correlated with lower L-Dex (p=0.76). The higher value in the physical domain of LyQLI showed higher L-Dex (p=0.826). There was a significant inter-domain correlation in LyQLI and LyQOL (p= &amp;lt; 0.001). Conclusion These results validate the use of PROs alongside objective measurements to assess BCRL. In addition, LYMPHA and S-LYMPHA significantly reduce lymphedema rates. Larger numbers will be necessary to reach statistical significance and to identify the best PRO. Figure 1 Division of patient population into three cohorts Table 1 Demographic and Treatment Summary Citation Format: Anshumi Desai, Orli-Friedman Eldar, Gili Halfteck, Mecker Moller, Susan Kesmodel, Dido Franceschi, Neha Goel, Jessica Crystal, Laura Huang, Jennifer Hu, Koru-Sengal Tulay, Wei Zhao, Alexis Narvaez-Rojas, Eli Avisar. Risk Assessment, Prevention and Early Detection of Breast Cancer Related Lymphedema – Objective Measurements and Patient Reported Outcomes [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 PO5-11-11.

Abstract PO4-08-04: Comparison of Outcomes and Prognosis between BRCA Pathogenic Variant Carriers Undergoing Breast-Conserving Surgery versus Mastectomy for Breast Cancer

Abstract Introduction: While outcomes are similar following breast-conserving surgery (BCS) or mastectomy among patients with sporadic breast cancer, data are still controversial for germline BRCA pathogenic variant carriers. We previously compared outcome following BCS between BRCA pathogenic variant carriers and non-carriers, and reported higher ipsilateral breast recurrence and comparable prognosis in the carriers. The purpose of this current study was to compare outcomes among BRCA pathogenic variant carriers undergoing BCS versus mastectomy in long-term follow-up period. Methods: Women with a BRCA pathogenic variant and a stage 0-III breast cancer who underwent definitive surgery from 1987–2021 were retrospectively identified from institutional database. Factors including clinicopathologic information and treatment characteristics were identified. Subsequent local recurrence, regional recurrence, distant recurrence, contralateral breast cancer (CBC), breast cancer-specific survival (BCSS), and overall survival (OS) rates were compared between BCS and mastectomy using Kaplan-Meier method and log-rank test. The chi-square test and t-test were used to compare patient characteristics between the two groups. Results: A total of 232 BRCA mutation carriers with 257 cancers including 25 patients with synchronous bilateral breast cancer were identified. Surgical treatment included BCS for 82 cancers and mastectomy for 175 cancers including nipple-sparing mastectomy for 51 cancers. Patient age at surgery and cancer stage did not statistically differ between BCS and mastectomy groups. Comparing to patients choosing mastectomy, patients who underwent BCS were less likely to be aware of their genetic status before surgery and were more likely to receive radiation therapy (p &amp;lt; 0.001). Contralateral risk reducing mastectomy was performed in 22.5% (18/80) in the BCS group and 48.7% (74/152) in the mastectomy group (p &amp;lt; 0.001) concurrently or at any time after the first definitive surgery. Risk reducing salpingo-oophorectomy was performed in 40% (32/80) in the BCS group and 49% (75/152) in the mastectomy group (p = 0.17). At 7.5 years median follow-up, local recurrence rate was statistically higher in the BCS group than in the mastectomy group (20.0% in BSC vs. 4.6% in mastectomy, p = 0.043). In patients who underwent nipple-sparing mastectomy, 4.0% (2/51) had local subcutaneous recurrence and no nipple-areolar recurrence was observed. Median duration from the first definitive surgery to ipsilateral local recurrence was 10.0 years in the BCS group and 2.3 years in the mastectomy group. Regional lymph node recurrence (11.2% in BCS vs. 6.4% in mastectomy, p = 0.62), distant recurrence (13.7% vs. 9.2%, p = 0.84), CBC (15.0% vs. 8.6%, p = 0.70), BCSS (88.8% vs. 94.1%, p = 0.65) and OS (87.5% vs. 94.1%, p = 0.49) rates did not statistically differ between two groups. Conclusions: With 7.5 years median follow-up, higher local recurrence rate was observed in BCS than in mastectomy among BRCA pathogenic variant carriers. Our results found no statistical difference between BCS and mastectomy in regional recurrence, distant recurrence, CBC, and prognosis, indicating relatively higher risk in BCS. While BCS could be an option for BRCA pathogenic variant carriers willing to continue high-risk breast surveillance, shared decision making should be carefully performed based on the long-term local recurrence risk. Citation Format: Kumiko Kida, Junko Takei, Misato Suzuki, Megumi Okawa, Sakurako Kazama, Sakiko Kondo, Michiko Yamanaka, Atsushi Yoshida. Comparison of Outcomes and Prognosis between BRCA Pathogenic Variant Carriers Undergoing Breast-Conserving Surgery versus Mastectomy for 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 PO4-08-04.

Abstract PO2-02-04: The Impact of Statins on Breast Cancer Specific Mortality in a Diverse Patient Population with Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

Abstract Hormone receptor-positive (HR+), HER2 negative (HER2−) breast cancer has a long-term risk of recurrence, compared with other breast cancer subtypes, which ultimately impacts mortality outcomes. Although adjuvant endocrine therapy plays an integral role in risk reduction, disparities persist—with Black women experiencing higher mortality rates compared to White women. Multiple studies have demonstrated that statin use can lead to a reduction in breast cancer mortality, but there is limited information in relation to the impact of statins among diverse patient populations in the United States. To assess whether statin use is associated with an improvement in breast cancer-specific mortality (BCSM), we conducted a large, observational study in women aged 66 and older diagnosed with Stage I–IIIC HR+, HER2- breast cancer between 2013 and 2017. We identified eligible women using the SEER-Medicare database and linked them to the BRIDGE (BReast cancer Investigation of Disparities in GEorgia) cohort, a survivorship cohort of the Georgia Cancer Registry. Patients needed to be continuously enrolled in Medicare Parts A, B, and D in the 12 months following a breast cancer diagnosis. We used Cox proportional hazards models to estimate the impact of statin use within 12 months of diagnosis on BCSM with adjustment for age, stage, and race using multivariable-adjusted hazard ratios (HRs). A total of 2483 participants were identified, and of those, 303 (12.2%) were statin users, 383 (15.4%) were non-Hispanic Black women, and 1564 (63%) resided in census tract with greater than or equal to 10% poverty levels at the time of diagnosis. Distribution of age, stage, and race were similar between statin and non-statin users. Of the statin users, 41/303 (13.5%) were non-Hispanic Black women. The majority of statin users were prescribed lipophilic statins alone (169; 55.8%), and atorvastatin was the most commonly prescribed statin. There was no association between statin use and BCSM (HR 1.09; 95% CI 0.62-1.90) in the multivariable-adjusted model. Although preliminary results suggest that there is no association between statin use and BCSM among women with Stage I–IIIC HR+, HER2− breast cancer, further analyses are planned to explore statin use as a time-varying exposure, which may provide additional insights into the potential relationship between statin use and BCSM. In addition, analyses examining potential heterogeneity by race, tumor and treatment characteristics, and comorbidities are forthcoming. Given the low cost and relative accessibility of statins, we anticipate these findings will inform the clinical management of women with operable breast cancer, increasing parity in outcomes and potentially narrowing race disparities. Citation Format: Ruth Sacks, Maya Bliss, Micah Streiff, Leah Moubadder, Maret Maliniak, Tsion Armidie, Lindsay Collin, Kevin Kalinsky, Lauren McCullough. The Impact of Statins on Breast Cancer Specific Mortality in a Diverse Patient Population with Stage I-III Hormone Receptor Positive, HER2 Negative 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 PO2-02-04.