Received Hormone Therapy Research Articles

Effects of omega-3 and vitamin D supplementation in patients with breast cancer: a systematic review

Breast cancer (BC) is the leading cause of death among women with cancer worldwide. Nevertheless, key challenges must be addressed, as new therapies can be employed to support the main treatment and enable a better quality of life, survival and prognosis. In this paper, we described the role of omega-3 and vitamin D supplementation in patients during the main treatment. This is a systematic review of the literature from randomized clinical trials, following the PRISMA and PICOS guidelines for elaborating the guiding question and constructing the results. Our findings in this review reveal and support that omega-3 and vitamin D supplementation can help women with metastatic disease who are not receiving hormone therapy during BC treatment for HR+ (hormone receptor positive). They improve immunity and antioxidant capacity and decrease cardiometabolic effects. This intervention is safe and can be employed as an adjuvant to the other main treatments.

Relationship of physical activity and cognitive functioning among breast cancer survivors: a cross-sectional analysis.

Cancer related cognitive decline is a common long-term side effect of cancer and its treatments among breast cancer survivors. Physical activity is a modifiable risk factor related to cognitive decline. However, existing research lacks consensus regarding the relationship between cognition and exercise as well as the impact of cancer treatments on this relationship. Baseline data from an ongoing randomized clinical trial was utilized to examine the relationship between self-reported and objectively measured cognition with physical activity. Exploratory analyses examined cancer treatments as potential moderators. Breast cancer survivors (N = 253) completed a battery of neurocognitive tests, the PROMIS Cognitive abilities questionnaire, medical charts abstracted for treatment information, and wore an ActiGraph accelerometer at the waist for 7 days. Data were analyzed using multiple linear regression models. Participants were on average 58.5 (SD = 8.88) years old, diagnosed 3 years prior to enrollment (SD = 1.27) with 57% treated with chemotherapy and 80% receiving hormone therapy at baseline. Better self-reported cognitive ability was significantly associated with greater min of moderate to vigorous physical activity (MVPA; β = 0.070, se = 0.028, p = 0.012). There were no significant associations with any objectively measured cognitive domains. Time since diagnosis (years) was a significant moderator of MVPA and Processing Speed (β = -0.103, se = 0.043, p = 0.017). Treatment with chemotherapy and/or hormones did not significantly moderate the relationship between MVPA and any of the cognitive measures or domains. Findings suggest that physical activity is related to self-reported cognition but not objectively measured cognition. Greater physical activity was associated with faster processing speed in participants closer in time to their cancer diagnosis. These results emphasize the need for more research to understand when cancer survivors may benefit from physical activity and what aspects of cognition may be improved.

Abstract PO2-12-02: Frailty among long-term breast cancer survivors

Abstract Background Cancer and its associated treatments may accelerate aging, resulting in increased frailty in survivors. However, the effect of breast cancer (BC) and treatment on frailty among long-term BC survivors has not been well investigated. This study aims to evaluate frailty prevalence and its association with clinical characteristics and treatment among 5-year BC survivors. Methods This study included 353 5-year BC survivors and 214 non-cancer control women aged ≥40 who were recruited to an ongoing breast health study at Vanderbilt University Medical Center between 2004 and 2017, and completed an online survey between May, 2022 and June 2023. Information collected includes demographics, lifestyle, disease history, and current health/functional status. A 26-item cumulative deficit index (CDI) was calculated as the proportion of deficits presented, including aging-related diseases, physical and mental health, activities of daily living, and social well-being, based on survey responses. CDI was categorized as robust (≤0.2), pre-frail (0.2-≤0.35), and frail ( >0.35). Cancer characteristics and treatment information was gathered from tumor registry. Multinomial logistic regression models were used to assess the association of CDI levels with case-control status, and BC clinical characteristics and cancer treatment among BC cases, with adjustment for age at survey (years), follow-up duration (5-≤10 and >10 years), and baseline Charlson comorbidity index (0, 1, and ≥2), and additional adjustment for BC stage and subtype in the analysis of treatment. Results The median time interval from BC diagnosis to survey was 12 years (range 5-34 years) for BC survivors. 90% of the participants were White. On average, BC patients were 3.8 years older at survey than controls [mean±SD (range) 64.5±9.2 (40-88) vs 60.7±10.3 (40-87), p< 0.001]. Among BC survivors, 41% had stage I, 39% stage II, and 8% stage III-IV cancer; 62% had a hormone receptor+/HER2- BC, followed by 22% HER2+ and 16% triple-negative BC. The majority of BC survivors underwent surgical resection (97%), and >50% received hormone therapy (59%), radiation therapy (53%), and chemotherapy (51%). BC survivors had a higher CDI score than controls (median 0.23 vs 0.19, p=0.01), with 34% and 18% of BC survivors being pre-frail and frail, compared with 25% and 16% in controls. After multivariable adjustment, BC survivors had a non-significantly increased prevalence of pre-frailty with odds ratio (OR) and 95% confidence interval (CI) of 1.49 (0.98-2.25), but a similar prevalence of frailty [OR (95% CI) = 1.08 (0.65-1.79)] compared to controls. BC survivors aged 40-65 had significantly elevated odds of pre-frailty [OR (95% CI) = 2.59 (1.44-4.63)]. Among BC survivors, frailty was significantly associated with stage [stage III-IV vs I: OR (95% CI) = 4.03 (1.27-12.78)] and chemotherapy [OR (95% CI) = 4.39 (1.71-11.30)], particularly among survivors aged ≥65 and 10-year survivors, but not BC subtype. Radiation therapy was associated with increased odds of pre-frailty among BC survivors aged 40-65. Conclusions This study suggests that long-term BC survivors younger than 65 are at increased odds of pre-frailty than non-cancer women. Frailty is associated with BC stage and chemotherapy among BC survivors, and radiotherapy among survivors younger than 65. More research is needed to investigate whether specific cancer treatment regimen is associated with frailty and other factors (e.g. lifestyle and genetics) that may modify the risk of frailty. The associations of frailty with cancer characteristics and treatments among breast cancer survivors Citation Format: Cong Wang, Jill De Vis, Kirsten Nguyen, Mason Alford, Brigitte Jia, Bapsi Chakravarthy, Xiao-Ou Shu. Frailty among long-term breast cancer survivors [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 PO2-12-02.

Abstract PS04-03: Survival benefit of regional nodal irradiation in clinically node-positive breast cancer following neoadjuvant chemotherapy and breast-conserving surgery

Abstract Introduction: In recent years, there has been increasing use of neoadjuvant chemotherapy (NAC) and pathologic complete response (pCR) rates for certain breast cancer phenotypes (40-70%). Although encouraging, this has resulted in uncertainties in traditional axillary management. Meanwhile, clinically node-positive (cN+) patients who have a low burden of disease downstaged to node-negative (ypN0) after NAC and get breast-conserving surgery (BCS) may avoid an axillary lymph node dissection (cALND) but still have regional nodal irradiation (RNI) recommended regardless of axillary surgery. Those who remain node-positive (ypN+) undergo cALND and RNI with an increased risk of lymphedema. In this study, we evaluated the survival benefit of RNI in cN+ patients after NAC and BCS. Methods: We reviewed (cN+) stage I-III non-inflammatory female breast cancer patients who underwent NAC followed by BCS between 2010 and 2020 in the National Cancer Database (NCDB). Patients having a history of another malignancy who received hormone therapy or radiotherapy before surgery or whose pathologic nodal status (ypN) was unknown were excluded. Overall survival (OS) from surgery was compared between those who did and did not receive RNI. Patient and tumor characteristics were compared across subgroups using chi-square and Wilcoxon rank sum tests. Weighted Kaplan-Meier curves and log-rank tests were used to assess the effect of RNI on OS. As a sensitivity analysis, analyses were stratified based on yPN status. Finally, multivariable logistic regression was used to determine predictors of receiving RNI. Results: The 8,250 cN+ patients had a mean age of 54.6±11.1 years. In total, 69.1% of patients were White, 23.9% were Black, and 10.2% were Hispanic. The mean number of removed and positive nodes were 10.0 ±7.8 and 2.3±3.8. The most common histology and phenotype were invasive ductal carcinoma (IDC) in 94.3% and hormone-positive (HR+) in 41.0%. Breast and nodal pCR rates were 25.9% and 34.7%, with nodal pCR achieved in 20.7%, 46.0%, and 44.4% of HR+, HER2+, and triple-negative tumors. RNI was performed in 52.1% of the patients (45.3% of the yPN0 and 55.9% of the yPN+). The mean number of nodes removed was 10.4±7.8 in the RNI+ and 9.6±7.7 in the RNI- groups (P < 0.01). The mean number of positive nodes was 2.6±4.0 in the RNI+ and 1.9±3.6 in the RNI- groups (P < 0.01). On multivariable analysis, the predictors of RNI administration included the number of positive nodes (p < 0.01), cN stage (p < 0.01), cT3 (p < 0.01), and tumor phenotype (p < 0.01). Grade I tumors (p=0.04) and Medicare beneficiaries (p=0.01) were less likely to get RNI. The survival rates were 79.9% and 81.9% in the RNI+ and RNI– groups, with a median follow-up of 62.1±31.4 and 62.8±32.2 in the RNI+ and RNI- groups. In the entire cohort, ypN0 patients had improved OS when compared with ypN+ patients (p < 0.001), but in adjusted analyses, there was no difference in OS between those who did and did not receive RNI (p=0.6). There was also no difference in OS comparing those who did and did not receive RNI in the ypN0 (p=0.96) or ypN+ (p=0.76) groups. Conclusion: For breast cancer patients having a modest nodal burden of disease and BCS after NAC, traditional prognostic factors such as stage and nodal status, as well as phenotype, grade, and the presence or absence of pCR, impact overall survival. Although some such factors appear to bias practitioners into giving RNI for patients undergoing NAC and BCS, RNI after NAC and BCS does not improve OS, regardless of pCR status, even at a mean follow-up time of 5.5 years. Further studies evaluating the impact on local control and longer-term outcomes should be pursued to enable the creation of specific guidelines surrounding indications for RNI based on the initial burden of disease and the final response from NAC administration. Citation Format: Mahtab Vasigh, Richard Bleicher, Austin Williams, Allison Aggon, Mary Pronovost, Andrea Porpiglia, Matthew Pierotti, Christian Cruz Pico. Survival benefit of regional nodal irradiation in clinically node-positive breast cancer following neoadjuvant chemotherapy and breast-conserving surgery [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 PS04-03.

Abstract PO2-14-05: COMPARISON OF HER2 mRNA PCR LEVELS AND IMMUNOHISTOCHEMISTRY (IHC) IN HORMONE RECEPTOR POSITIVE (HR+)/HER2 NEGATIVE (HER2-) EARLY BREAST CANCER

Abstract BACKGROUND IHC assays were developed to identify HER2-positive breast cancers deemed to be treated with trastuzumab-based therapies. However, these assays lack sensitivity to reliably identify tumors with low levels of HER2 protein on the cell surface. HR+/HER2-low may benefit from Trastuzumab Deruxtecan (TDxd) and therefore accurate quantification of HER2 expression levels becomes a critical issue. As a result, additional technologies are needed to achieve a quantitative and reproducible detection of HER2 in the low range expression compared with the standard IHC testing. METHODS We conducted a retrospective study of all incident stage I-II HR +/HER2- breast cancer patient whose genomic risk was assessed with the Oncotype 21 gene assay from 2009 to 2022 in Hospital Clínico San Carlos (Spain). Local HER2 expression (IHC w/wo cerbB2 FISH) was performed in all patients according to ASCO/CAP guidelines available during the different periods. HER2 mRNA expression levels by RT-PCR were obtained from OncotypeDx patient reports. The primary objective was to determine the distribution of HER2 mRNA levels across the different HER2 expression groups. Other objectives were to compare the clinicopathological characteristics, management and OncotypeDX Recurrence Score (RS) in the different HER2 expression groups. Qualitative variables are presented with their frequency distribution. Quantitative variables are summarized in their mean and standard deviation (SD). Welch’s F-test ANOVA was used to measure association between the two HER2 measuring methods. RESULTS 500 early breast cancer patients with HER2 IHC 0, 1+ and 2+ (FISH negative) and HER2 mRNA expression by RT-PCR tumors were included. Among them, 169 (34%) were IHC 0, 211(42%) were IHC 1+ and 120 (24%) were IHC 2+ (FISH negative). The distribution of clinicopathological characteristics was similar between different IHC HER2 expression groups, and the distribution of chemotherapy treatment was also similar among them (Table 1). All patients had undergone surgery, and most of them had received hormone therapy (487, 97%) and radiotherapy when indicated (375, 77%). The mean OncotypeDx® recurrence score across HER2 IHC 0, 1, 2 showed not significant difference between groups (16,85, 17,36 and 17,89 respectively). The mean OncotypeDx® HER2 gene score expression across the different levels of HER2 (0, 1+, 2+) determined by IHC were 9.07, 9.25 and 9.51, respectively. One-way ANOVA and Games-Howell post-hoc test revealed that differences between all the groups were significant. The ranges of HER2 gene score data for the 3 IHC groups were widely overlapped, with IQR of [8,5-9,5], [8,83-9,7] and [9,07-10] respectively. CONCLUSIONS Our data show statistically significant differences between HER2 mRNA expression levels and IHC groups. This suggests that RT-qPCR could complement the data obtained by IHC. However, the wide range and dispersion of mRNA expression within groups limits its clinical utility. Clinicopathological characteristics and management between different IHC HER2 expression groups. Citation Format: Julia Tejerina-Peces, Marta Amann-Arévalo, Pablo Ballestín, Beatriz González-Diez, Mateo Paz-Cabezas, Alejandro Pascual, Alicia de Luna, Vanesa García-Barberán, Alfonso López de Sá, Jose Angel García-Sáenz, Fernando Moreno. COMPARISON OF HER2 mRNA PCR LEVELS AND IMMUNOHISTOCHEMISTRY (IHC) IN HORMONE RECEPTOR POSITIVE (HR+)/HER2 NEGATIVE (HER2-) EARLY 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 PO2-14-05.

Abstract PO2-17-08: A RETROSPECTIVE ANALYZES OF 4,885 PATIENTS OF HORMONAL RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER TREATED IN A REFERENCE CENTER, A REAL-WORLD DATA

Abstract Background: Hormonal receptor positive Her2 negative also described as luminal breast cancer (LBC) is the most frequent tumor corresponding to about 60-65% of cases. There is great heterogeneity in these tumors and a great difference between treatments due to lack of access, mainly in developing countries. Clinical trials are important to understand the benefit of the treatments but only 5% of the breast cancer patients are enrolled in these trials and is because of that that Real World Data (RWD) is It's becoming more and more frequent. Objectives: To evaluate LBC and describe treatments and overall survival (OS) of patients treated in public hospital in São Paulo Brazil. Methods: This was a retrospective, single cohort study, that included female patients over 18 years of age, with a diagnosis of LBC. Clinical and pathological data was collected (date of diagnose, first treatment, type of treatment, stage, type of surgery, DFS and OS). This study was approved by our local ethics committee. Results: We’ve enrolled 5,510 patients in Perola Byington ’database from 2010 to 2021. After excluding patients without minimal complete records, a total of 4,885 patients were analyzed. Most patients were diagnosed in stage I (26,9%) and II (38,2%). There was 23,4% in stage III, 3,1% in stage IV and 5,7% in stage 0. In 2,6% the of the patient’s information was not complete. Mean age at diagnosis was 57.6 years. We identified 4,761 (86.4% of 5510) patients who underwent 4,848 surgical procedures. Of the total, 47.2% were mastectomies, 50.9% partial mastectomies and 1.9% were skin sparing mastectomy. Immediate reconstruction was done in 470 patients (69.8% underwent reconstruction with an expander, 22.3% with flap rotation and 7.9% reconstruction with implants). The mean and median time between diagnosis and the beginning of treatment was analyzed, in the sample it was observed that patients who were diagnosed in stages I, II and IV had the same mean of 2.6 months, but stage IV had the lowest median 1 ,9 months. 474 patients were treated in the first line setting during the follow up, 43 % received hormone therapy (HT) and 57% received chemotherapy (CT) as first line. The duration of the treatment in first line was 17,7 months for HT and 7,7 months for CT (p < 0,01). OS for patients diagnosed in stages I and II did not reach the median in the available period, for patients in stages III and IV, a median of 80.4 months and 41.2 months of overall survival was identified, respectively. Conclusions: These are the first results of this large cohort of luminal patients treated in the public reference center. Most patients are diagnosed in stage I or II and more than half undergo conservative surgery. Immediate reconstruction is not routinely performed. In the public setting CDK4/6 inhibitors are not available and that led to more chemotherapy use in first line (57%) and worse survival when compared to clinical trials. Discussions on the incorporation of drugs consolidated in the literature are important to improve the treatment of advanced cancer. Citation Format: Andre Mattar, Marcelo Antonini, Marina Diogenes, Andressa Amorim, Francisco Pimentel Cavalcante, Luiz Henrique Gebrim. A RETROSPECTIVE ANALYZES OF 4,885 PATIENTS OF HORMONAL RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER TREATED IN A REFERENCE CENTER, 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 PO2-17-08.

Abstract PO2-11-07: Early Integration of Exercise into Breast Cancer Care: The MSK Healthy Living Program

Abstract Background: In patients with early-stage breast cancer, quality of life (QoL) worsens within 3-6 months following diagnosis. Physical activity (PA) can mitigate the adverse effects of treatment and improve QoL, and low PA level is associated with cancer recurrence and mortality. However, PA interventions are not included in standard cancer care. Early intervention to increase PA levels may improve QoL during active cancer therapy. The Healthy Living Program (HLP) at Memorial Sloan Kettering Cancer Center (MSK) is a lifestyle and survivorship program that engages early-stage breast cancer patients at the time of diagnosis using lifestyle risk stratification and matched referrals. We investigated whether early exercise intervention through the MSK HLP impacts QoL within the first months after cancer diagnosis. Methods: At the time of diagnosis, patients complete a lifestyle questionnaire (LQ), which is a composite of validated instruments, including the Godin Leisure Time Exercise Questionnaire (GLTEQ). Patients not meeting PA guidelines per the GLTEQ are offered a referral to an exercise physiologist (EP). The EP creates an individualized, home-based exercise program using the FITT Principle (Frequency, Intensity, Time, and Type). Patients meet with the EP every 4 weeks for 16 weeks; if exercise recommendations continue to be unmet, the program is extended. The Functional Assessment of Cancer Therapy-Breast (FACT-B) and 36-Item Short Form Survey Instrument (SF-36) were completed at baseline and the 16-week follow-up. Results: 252 patients enrolled between April 2020 – February 2023, of whom 92 volunteered to complete the QoL assessments. Median age was 53 years [range 23-84]; 12/252 (13.0%) of patients had ductal carcinoma in situ, 60/252 (65.2%) had Stage 1 disease, 17/252 (18.5%) had Stage 2 disease, and 3/252 (3.1%) had Stage 3 disease. 29/252 (31.5%) received chemotherapy, 62/252 (67.4%) received radiation, and 79/252 (85.9%) received hormone therapy. The mean baseline FACT scores were FACT-B: 116, FACT-G: 87, and FACT-B Trial Outcome Index (TOI): 73. At the 16-week follow-up, all QOL scores remained stable from baseline (means FACT-B: 118, FACT-G: 89, and TOI: 75). Improvements were observed among the subscales of the SF-36 from baseline to follow-up. The largest improvements were observed in physical and emotional role function scores, with 22% and 13% improvements from baseline to follow-up, respectively. Conclusions: A clinically implemented exercise intervention embedded in standard of care prevented decreases in QoL and improved physical and emotional functioning during the initial course of adjuvant breast cancer therapy. These findings support early implementation of lifestyle modification after a breast cancer diagnosis. Citation Format: Kylie Rowed, Sherry Shen, Andrea Smith, Bridget Kelly, Rocco Magnoli, Stacie Corcoran, Melissa Emerzian, Cynthia Cruz, Erica Salehi, Cara Anselmo, Mark Robson, Neil Iyengar. Early Integration of Exercise into Breast Cancer Care: The MSK Healthy Living Program [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 PO2-11-07.

Rapidly expanding gender-affirming care based on consensus instead of evidence justifies rigorous governance and transparency.

Public services offering gender-affirming care to minors have rapidly expanded across Australia. Despite limited evidence of safety and efficacy, no public information about these services is routinely available. Data from freedom of information requests sent to Australian public gender services for minors is summarised. Gender service numbers increased rapidly in Queensland (2017:190 - 2022:922) and in Victoria (2019:472 - 2023:1290). Limited transparency prevented strong confidence in the number of patients receiving hormone therapy. Staff FTE employed by gender services jumped after 2020 in NSW (to 16.7 across two sites in 2023), Queensland (to 11.4 in 2023), Victoria (to 9.4 in 2022), and WA (to 10.2 in 2023). Despite low confidence in their safety and efficacy, the number of patients seen by public gender services has expanded rapidly since 2018. Limited transparency makes it difficult to judge the number of patients seen, treatments provided, and outcomes achieved. Safe, effective care of this vulnerable group requires clear treatment goals, and annual reporting.

Real-world data of HER2-negative early breast cancer patients treated with anthracycline and/or taxane regimens in Japan

BackgroundAnthracycline- and taxane-based chemotherapy regimens are established treatments for human epidermal growth factor receptor (HER)2-negative early-stage breast cancer with high risk of recurrence. This study examined the prevalence of these chemotherapy regimens as perioperative therapy, the patterns of retreatment, and factors influencing prescription choices in Japan.MethodsThis observational cohort study focused on high-risk early-stage breast cancer patients not undergoing anti-HER2 therapy, utilizing data from a hospital-based claims database in Japan spanning from April 2008 to September 2021.ResultsOf 42,636 high-risk patients who underwent breast cancer surgery, 32,133 (75.4%) were categorized as having luminal-type (received endocrine therapy) and 10,503 (24.6%) as having triple-negative cancer (not receiving any endocrine therapies). Most patients (98.7%) with luminal-type breast cancer received perioperative therapy, and 40.3% of those received anthracycline/taxane. In the triple-negative group, 57.0% of all patients received perioperative therapy and of those, 93.4% received anthracycline/taxane. Being over 40 years old, having an early stage (clinical stage ≤ II), and receiving treatment in non-specialized facilities were associated with less use of anthracycline/taxane in the luminal-type group. For the triple-negative group, associated factors with less use of anthracycline/taxane included being over 60 years old, treatment in small hospital (capacity < 200 beds), and treatment in non-specialized facilities.ConclusionsApproximately half the patients in both the luminal-type and triple-negative groups were prescribed anthracycline and/or taxane for perioperative chemotherapy. The choice was associated with patient age, cancer stage, and the scale and specialization of the treatment facilities. This study sheds light on the current state of breast cancer treatment practices in Japan.

Assessment of Anti-Nuclear Antibodies and Anti-Extractable Nuclear Antigen Levels in Breast Cancer Patients

Anti-nuclear antibodies (ANAs) are autoantibodies synthesized in response to the cell nucleus contents and use as biomarkers of systemic autoimmune diseases. Inflammation, apoptosis and necrosis of the cells are consequences that accompany breast cancer against which autoantibodies will be produced. In this study, we aimed to evaluate the presence of ANAs and anti-extractable nuclear antigens (anti-ENAs) in breast cancer. A total of 33 luminal A and luminal B breast cancer patients were assessed for presence of ANAs and anti-ENAs. All the patients had received hormone therapy at least for 6 months before the tests. Patients were screened to ANAs by indirect immunofluorescence on human epithelial type 2 (HEp-2) cells. AESKUBLOTS® ANA-17 comp kit was used to identify the concentrations of U1-snRNP, snRNP/Sm, SmD1, dsDNA, SS-A/Ro 60, SS-A/Ro 52, SS-B/La antibodies. Fifteen (45.5%) patients were luminal A and 18 (54.5%) patients were luminal B. The median of age was 57 and the median of tumor size was 25. 19 (57.6%) patients had grade I or II and 14 (42.4%) had grade III. 3 patients had ANAs test positive. All the patients who had positive ANA test were luminal A breast cancer and had grade I or II tumors and positive lymph node, whereas, pathological tumor stage were varied. No statistically significant association was found between ANAs positivity and molecular subtype, age, body mass index (BMI), grade, tumor stage or lymph node involvement. Moreover, there were negative correlations between the anti-U1-snRNP and anti-dsDNA with Ki-67 and a correlation between anti-snRNP/Sm and anti-SS-A/Ro 52 was found. Comparing with luminal A, anti-U1-snRNP and anti-snRNP/Sm concentrations were statistically significantly lower in luminal B tumors (p= 0.015 and 0.016 respectively). Patients who had high grade tumors showed low concentrations of anti-snRNP/Sm (p=0.027), whereas patients who had lymph node metastasis showed high concentrations of anti-U1-snRNP (p=0.031). ANAs positivity was more common in luminal A breast cancer patients compared with luminal B. Anti-U1-snRNP and anti-snRNP/Sm concentrations were lower in luminal B. Moreover, patients who had high grade tumors showed low concentrations of anti-snRNP/Sm, whereas those who had lymph node metastasis showed high concentrations of anti-U1-snRNP.

Growth and Adult Height Attainment in Danish Transgender Adolescents Treated With GnRH Analog and Sex Hormones.

Endogenous sex steroids influence the pubertal growth spurt and adult height. However, the impact of puberty suppression and sex steroids on growth in transgender adolescents is sparsely studied. We investigated pubertal growth, serum IGF-I and IGF binding protein-3 (IGFBP-3), and adult height of transgender adolescents receiving hormone therapy. Observational study of a national cohort (2016-2023) comprising 219 transgender adolescents <18 years of age. Treatment consisted of gonadotropin-releasing hormone agonist combined with estradiol or testosterone (adjusted to serum concentrations between 0 and +2 SDs corresponding to the gender identity). Adult height was within ±2 SD for sex assigned at birth.Most trans girls reached adult height within references of girls. For trans girls (bone age ≤15 years before treatment), a growth spurt was observed during estradiol therapy. IGF-I and height SD score (SDS) declined during oral estradiol administration (-0.13 SDS per month, P = .059, and -0.02 SDS, P = .001, respectively). We observed significantly lower adult height compared to target height for trans girls (-2.7 cm, P = .01) and significant differences between height SDS before treatment and at adult height (-0.35 SDS, P < .001).Half of the trans boys remained short (<-2 SD) compared to references for boys, and most completed growth spurt before initiation of treatment. IGFBP-3 declined following testosterone treatment. There was a significant difference between height SDS before treatment and at adult height (-0.17 SDS, P < .001). The minor reduction in adult height of trans girls after hormone treatment may be beneficial to some, whereas trans boys did not experience height gain.

Use of hormones and risk of venous thromboembolism.

•The risk of venous thromboembolism (VTE) is not increased in women using long-acting reversible contraceptive methods (LARCs) with progestogens. •Oral contraceptives with levonorgestrel or norgestimate confer half the risk of VTE compared to oral contraceptives containing desogestrel, gestodene or drospirenone. •Progestogen-only pills do not confer an increased risk of VTE. •Women using transdermal contraceptive patches and combined oral contraceptives (COCs) are at an approximately eight times greater risk of VTE than non-users of hormonal contraceptives (HCs), corresponding to 9.7 events per 10,000 women/years. •Vaginal rings increase the risk of VTE by 6.5 times compared to not using HC, corresponding to 7.8 events per 10,000 women/years. •Several studies have demonstrated an increased risk of VTE in transgender individuals receiving hormone therapy (HT). •Hormone therapy during menopause increases the risk of VTE by approximately two times, and this risk is increased by obesity, thrombophilia, age over 60 years, surgery and immobilization. •The route of estrogen administration, the dosage and type of progestogen associated with estrogen may affect the risk of VTE in the climacteric. •Combined estrogen-progesterone therapy increases the risk of VTE compared to estrogen monotherapy. •Postmenopausal HT increases the risk of thrombosis at atypical sites.

Summary of the 2023 Thai Menopause Society Clinical Practice Guideline on Menopausal Hormone Therapy.

The Thai Menopause Society is an academic organization consisting of healthcare professionals engaged in menopause medicine. The position statement was first issued in 1994 and updated in 2003 and 2023. Herein, we reviewed the important updates of the 2023 position statement on menopausal hormone therapy (MHT) as an international reference for healthcare professionals in Thailand. An advisory panel of clinicians and research experts in the field of menopause reviewed the recommendation of published International Consensus Statements and updated the evidence using the MEDLINE database through PubMed. The evidence-based information and relevant publications were assessed, and a consensus on recommendations was subsequently achieved using the level of evidence to determine the recommendation strength and evidence quality. MHT remains the most effective treatment for vasomotor symptoms and genitourinary syndromes of menopause even after 20 years. Additionally, it is effective in preventing bone loss and fractures in postmenopausal women. The cardiovascular risk of MHT increased in women who initiated MHT after 60 years of age. Hormone therapy should be individualized following the hormone type, dose, administration route, use duration, and progestogen inclusion. The necessary pretreatment evaluation and appropriate follow-up recommendations were added for improved MHT standard care. The updated 2023 Clinical Practice Guideline on MHT is useful for gynecologists, general physicians, endocrinologists, and other healthcare professionals in treating menopausal women receiving hormone therapy in Thailand.

(265) Self-Image after Breast Cancer

Abstract Introduction Breast cancer is currently the first cancer diagnosed among women. The impact of its local treatments such as surgery and radiation and its systemic treatments such as chemotherapy, hormone-suppressant therapies and targeted therapies on women's bodies anatomically and physiologically and on their body image and body esteem are the major factors altering their sexual health and the quality of their spousal relationships. Objective We aim to evaluate the qualitative impact of breast cancer on its survivors' body-image. Methods We ran a prospective qualitative study using semi-structured interviews until saturation of findings. The patients included were women diagnosed, treated for breast cancer, and followed up in our institution. All participants were sexually active and no older than 55. The study enrolled 20 participants over a 6-month period (February 2022-July 2022). Results All participants had a history of breast surgery either lumpectomy or mastectomy (70%) with (one case) or without reconstructive surgery. All patients reported a history of radiation and chemotherapy. 60% had received hormone therapy with medically induced menopause. The majority of participants explained how their bodies had changed not only physically and anatomically on the outside but also on the inside especially in relation to the adverse effects of chemotherapy and hormone therapy. They also reported body emotional changes. This required an adaptation to their new body for them and their partners and entourage. The main themes emerging from their discourse were: physical and emotional adaptation to breast cancer per se and its local and systematic treatments, fear of others judgment and comments on their physical changes and loss or gain of self-esteem. Breast reconstruction was also an important theme it the participants verbatim. Conclusions The words and themes that characterized the participants' speeches highlighted the impact of cancer diagnosis and oncological therapies on breast cancer survivors. Being part of a psychological intervention focused on self-compassion and body acceptance helps breast cancer survivors develop a better perception and acceptance of their new bodies. Disclosure No.

(180) Female Sexuality of Tunisian Women with Treated Breast Cancer

Abstract Introduction Breast cancer is a major health problem. Several treatment strategies are used to treat it such as lumpectomy or mastectomy surgery, chemotherapy, radiotherapy, and hormone therapy, which leads us to ask the following question: what impact does breast cancer and its treatments have on female sexuality? Objective The aims of our study were to assess the sexuality of Tunisian women with breast cancer in remission, and to determine the prevalence and nature of sexual dysfunction in this population. Methods We carried out a descriptive cross-sectional study, involving women aged under 60, followed up for treated non-metastatic breast cancer currently in remission, and having a regular sexual partner during the last month. Outpatients in the surgery and radiotherapy department of the "Salah-Azaiez" Institute were interviewed using a questionnaire including a validated Arabic version of FSFI (Female sexual function desire). Our study was carried out throughout a period of 3 months, from January 1st, 2023 to March 31st, 2023, this period allowed us to collect our necessary data. Results We included 120 women in our study. The majority were between 40 and 49 years with an average of 46.53. One-third (33.3%) had a university degree and 16.7% were senior executives. More than half of our population (56.7%) were menopausal and 12% were smokers. 85% of the women had children, and only 36% had breastfed their children exclusively. Half of the women had discovered the disease at stage II, and 52% of them had discovered it during breast self-examination. Surgical treatment was radical in 61.7% of women and conservative in 38.3%. Thus, 75% of the population had undergone chemotherapy, 93.3% had undergone radiotherapy and 71.7% were receiving hormone therapy. Only 5% of our study population had a sexual dysfunction prior to the disease and 78% of women had reported a change in their sex life after breast cancer, with the frequency of intercourse as the main parameter affected. Among the most common sexual complaints were decreased or absent sexual desire in 68.1% of cases, lack of sexual initiative (74.4%), vaginal dryness (48.9%), and dyspareunia (42.6%). The majority of interviewed women (83.3%) had presented with global sexual dysfunction, i.e. a total FSFI score ≤26.55 and the areas most affected were pain, lubrication, and orgasm. Radical surgical treatment, chemotherapy, and hormone therapy were significantly associated with impaired female sexuality (respectively p=0.0036; p=0.047 and p=0.001). Conclusions Our study highlighted the impact of breast cancer treatment on women's sex lives. Healthcare providers should acquire the necessary skills in order to explore female sexual disorders and suggest suitable management. Disclosure No.

Abstract B042: Analysis of predictive indicators of invasive breast cancer: Modeling survival rates

Abstract Objective: We aim to investigate indicators of risk for invasive breast cancer (IBC) and to predict and assess the impact of these risk indicators on survival rates in breast cancer (BC) patients who received various therapies. Background: It has been identified that several indicators including BC subtypes, age at diagnosis, history of breast disease, menopausal status, estrogen receptor (ER) status, progesterone receptor (PR) status, human epidermal growth receptor (HER2) status, tumor stage, tumor size, among others, can cause genomic alterations and driver mutations in BC, leading to invasive carcinogenesis. To assure improved BC outcomes, we investigate the influence of BC indicators on survival rates in patients receiving hormone therapy, chemotherapy and radiotherapy. Methods: This study uses the Molecular Taxonomy of Breast Cancer International Consortium (METABRIC) dataset, which included 31 clinical indicators, m-RNA levels z-score for 331 genes, and mutation in 175 genes for 1904 BC patients. Both bivariate and multivariate associations were examined using logistic regression and Cox proportional hazard models. The multivariate logistic regression analysis is used to determine predictors of IBC. The Cox proportional hazard model was also used to evaluate the magnitude of the impacts of clinical and demographic variables on IBC, as well as the effects of therapy on survival. All analyses for this investigation were carried out using SAS. A p-value &amp;lt; 0.05 was considered statistically significant. Results: We examined 1,043 patients (with the median age 61±13.1 years) from a total of 1904 for this study: 78.8% of patients had breast invasive ductal carcinoma; 87.4% were HER2 negative; 22.8%, 60.7%, and 67.6% received chemotherapy, hormone therapy, and radiotherapy treatments, respectively; 56.9% died but only 34.6% died from the disease; the average overall survival months was 127.3±77.6 months; and the most common age group was "65+ years" (39.4%). Chemotherapy (p=0.0474), neoplasm histologic grade (p=0.0015), Nottingham prognostic index (p&amp;lt;.0001), radiation (p=0.0068), and BReast CAncer gene 1 (BRCA1) (p=0.0251) were all associated with IBC. Overall survival was also correlated to age at diagnosis (p=0.0002), neoplasm histologic grade (p&amp;lt;.0001), lymph nodes (p&amp;lt;.0001), mutation count (p&amp;lt;.0001), Nottingham prognostic index (p&amp;lt;.0001), radiotherapy (p=0005), tumor size (p&amp;lt;.0001), tumor stage (p&amp;lt;.0001), BRCA1 (p=0.250), PTEN (p&amp;lt;.0001), and TP53 (p=0.0248). The overall accuracy of the model for each IBC and survival status was 82.1% and 74.2%, respectively. Conclusion: Our analysis demonstrated the importance of predictive analysis using the logistic regression model and survival analysis using the Cox proportional hazard model in cancer research. Predictive and survival analysis results aided in predicting the invasiveness and survival rate of BC among the study participants. In general, predictive and survival analyses are more accurate and may be used to make more realistic treatment decisions and precision oncology. Citation Format: Olumide Arigbede, Gebre-Egziabhe Kiros. Analysis of predictive indicators of invasive breast cancer: Modeling survival rates [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Translating Cancer Evolution and Data Science: The Next Frontier; 2023 Dec 3-6; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(3 Suppl_2):Abstract nr B042.

Complications and Influential Perioperative Factors Associated with SpaceOAR Hydrogel Placement.

To examine one academic institution's experiences with SpaceOAR placement, its associated complications, and periprocedural characteristics that affect outcomes for the purpose of quality improvement. We conducted a retrospective review of 233 patients who received SpaceOAR from four surgeons and one radiation oncologist between 2018 and 2021. Variables such as demographics, oncologic parameters, radiation plan, and radiographic assessment of hydrogel placement were recorded. The Charlson Comorbidity Index (CCI) was used to assess comorbidity risk. Mann-Whitney and Fisher's exact tests were performed to compare patients with and without complications. Of the 233 patients who received SpaceOAR, 24 (10.3%) experienced toxicity. All complications were Clavien I or II, such as pelvic pain postplacement, pelvic fullness, bleeding, and lower urinary tract symptoms. 16 patients (6.9%) had some portion of the hydrogel injected into the rectal wall, but it was never clinically significant. The average CCI was 3.2 ± 0.95 for patients who experienced complications; the average CCI was 3.6 ± 1.6 (p=0.48) in the group without complications. Of the physicians with higher procedure volumes, Physician #1 had the highest rate of patient-reported complications at 11 out of 68 (16.2%) and Physician #2 had the lowest rate of complications at 4 out of 96 placements (4.2%). Multivariate analysis found that patients who had received hormone therapy previously had less odds of reporting complications after SpaceOAR placement. The listed attending on the procedure had a significant correlation to complications with SpaceOAR placement on univariate analysis, and hormone therapy had some benefits to the tolerance for the procedure on multivariate analysis. Overall, the hydrogel placement was well tolerated with low incidence of mild and transient procedure-related toxicity.

Multimedia-based hormone therapy information program for patients with prostate cancer: the result of a randomized pilot study

Few studies have explored the feasibility and efficacy of a multimedia information intervention for patients with prostate cancer who are undergoing hormone therapy. Thus, the purpose of the study was to assess the feasibility, acceptability, and the preliminary results of a multimedia-based hormone therapy information program (HTIP) on positive thinking and quality of life (QOL; primary outcomes) as well as social support and self-efficacy (secondary outcomes) of patients with prostate cancer. Patients with prostate cancer who were receiving hormone therapy were recruited from hospitals. After completing the pre-test questionnaire, patients were randomly divided into the multimedia information group (MIG; n = 40) and the control group (CG; n = 40). Patients in the MIG received a multimedia-based HTIP once a week for 6 weeks. Data were collected at 8 and 12 weeks after the pre-test. Measurement variables included positive thinking, QOL, social support, self-efficacy, and satisfaction with the program. The recruitment rate and retention rate were calculated for assessment of feasibility. The study had a 96.3% retention rate, and patients in the MIG were satisfied with the program. Preliminary results showed that, compared with those in the CG, patients in the MIG tended to exhibit higher positive thinking, prostate cancer-specific QOL, and social support at 8 weeks and 12 weeks after pre-test; however, the effect did not reach a statistically significant level. A multimedia-based HTIP is considered feasible and acceptable in patients with prostate cancer who underwent hormone therapy. Further research with a larger sample size, patients with high homogeneity in early-stage disease and long-term follow-up is needed to assess the efficacy of the intervention program.Trial registration: ClinicalTrials.gov (NCT04693910); Registered 05/01/2021.

Effects of Hormone Replacement Therapy on Autoimmune Markers and Clinical Outcomes in Pediatric Patients with Hashimoto's Thyroiditis

Objective: Hashimoto’s Thyroiditis (HT), a chronic autoimmune thyroiditis, is the predominant cause of hypothyroidism in regions without iodine deficiency. HT is characterized by the loss of immunological tolerance of the thyroid gland, leading to autoimmune attacks. This study aimed to compare the autoantibody profiles, along with clinical and laboratory findings, of patients diagnosed with Hashimoto’s disease who were either receiving treatment or followed without treatment. Material and Methods: Clinical manifestations, laboratory data, and thyroid ultrasonography (USG) findings of patients diagnosed with Hashimoto’s thyroiditis receiving hormone therapy and those followed without treatment were compared in our clinic. Results: Among a total of 249 patients, 116 received hormone replacement therapy, while 133 were followed without treatment. The mean age of all patients was 13.91±3.71 years, with a mean age at diagnosis of 11.51±3.79 years. After twelve months of follow-up, the untreated group showed an increase in serum fT4 and antiTPO levels (p=0.012 and p=0.001), with no significant difference found in serum TSH, fT3, and antiTG levels. Those receiving treatment exhibited a significant decrease in serum TSH levels and a significant increase in serum fT4 levels (p=0.002 and p&amp;lt;0.001, respectively). Although there was an increase in serum antiTPO and antiTG levels over time, no change was detected in serum fT3 levels. Clinical improvement was significantly greater in the treatment group (p=0.044). Conclusion: It has been concluded that early initiation of hormone replacement therapy in Hashimoto’s thyroiditis can mitigate negative clinical effects during follow-up, contributing to patient comfort and alleviating clinical complaints.

Evaluation of overall survival and disease-free survival of adjuvant chemotherapy and hormone therapy in patients with breast cancer

Background: This study evaluated the effect of adjuvant chemotherapy and hormone therapy on overall survival and disease-free survival in patients with breast cancer with hormone receptor-positive, HER2-negative tumors without lymph node involvement.&#x0D; Methods: Breast cancer patients with hormone receptor-positive, HER2-negative, and no lymph node involvement were included in this retrospective cohort study. Patient records were used to collect data on sex, age, time of disease onset, tumor subtype, tumor size, grade, lymphovascular and perineural involvement, ki67, and treatment protocols. Patients were divided into 2 groups: Patients who received both adjuvant chemotherapy and hormonal therapy and patients who received hormonal therapy only. Disease-free survival index (DFS) and overall survival index (OS) were evaluated.&#x0D; Results: Sixty-seven female patients were enrolled in this study. Of them, 68.2% received both adjuvant chemotherapy and hormonal therapy and 31.6% received hormonal therapy only. During follow-up, recurrences occurred in 8 patients. The 3-year and 5-year DFS were 93.4% and 90%, respectively. The 3-year and 5-year DFS was 94% and 92%, respectively, in patients who received both adjuvant chemotherapy and hormonal therapy, and 91% and 85%, respectively, in patients who received hormonal therapy. None of the factors studied affected the 3-year and 5-year DFS. The 3-year and 5-year DFS OS were 98.6% and 96.9%, respectively&#x0D; Conclusion: Adjuvant chemotherapy in patients with breast cancer with hormone receptor-positive, HER2-negative, and no lymph node involvement compared with similar patients receiving hormone therapy alone had no significant difference in disease-free survival index and overall survival index.