Received Hormone Therapy Research Articles

MiRNAs profile as a signature for cardiovascular disease in long-term breast cancer female survivors: a pilot study

Abstract Background/Introduction Cardiovascular diseases (CVD) is a matter of immediate concern among long term breast cancer (BC) survivors. An early identification of those patients who are at higher risk of developing CVD is warranted to tailor prevention strategies and improve their quality of life. Purpose To identify whether a specific miRNA signature exists in breast cancer female survivors who develop CVD in a long term follow up. Methods We performed cross-sectional comparison of miRNA expression between female BC survivors (i.e. individual with a diagnosis of invasive ductal carcinoma who were free from cancer at 10-year follow up and without known CVD before BC diagnosis) with CVD (n=11) and without CVD (n=11) matched for age, BC grade, treatment received and traditional cardiovascular risk factors. CVD was defined as the incidence of established atherosclerotic cardio- or cerebro-vascular diseases (i.e., ischemic heart disease, carotid endarterectomy, stroke, heart failure), atrial fibrillation or venous thromboembolism. Thirteen miRNAs were selected since they were involved in either BC and CVD. On plasma derived samples, miRNAs expression profile analysis was performed by retro-transcription and real-time PCR assays, using miRNA-specific probes. Results The BC female survivors (mean age 73 years, 70% hypertension, 60% histological grade 2 and 3) were treated with surgery. The majority (76%) received hormone therapy after surgery according to the BC receptor expression. In half of the cohort, radiotherapy was performed. Those female BC survivors developing CVD experienced more commonly cerebral or cardiovascular atherosclerotic events (70%). As reported in Figure 1, some miRNAs analyzed (miR-19a; miR-21; miR-24; miR-125b; miR-195) are upregulated in BC survivors who developed CVD. Of note miR-19a, miR-21 (and miR-195) increase is so significantly relevant to consider these miRNAs as candidate biomarkers. Conclusion(s) In this discovery cohort, a specific miRNA profile signature identified female BC survivors experiencing CVD. Validation of such signatures is needed in a larger cohort as well as mechanistic studies to understand what is the pathophysiological link between the miRNAs identified and vascular health. Nevertheless these miRNAs in both cancer and cardiac diseases are mainly associated with promotion of cell proliferation and inhibition of apoptotic processes. The clinical implications of using a specific miRNA profile as a likely early biomarker of adverse cardiovascular events are indeed of great interest to better preserve BC survivors' health.Figure 1

Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016–01)

BackgroundGranulosa cell ovarian tumors (GCT) are orphan disease with limited treatments. Hormone therapy is a potential treatment, due to the overexpression of hormone receptors in most tumors. This study explores the activity of the antiandrogen, enzalutamide, in metastatic cases. MethodsWe designed a phase II clinical trial under the Spanish Collaborative Group for Transversal Oncology and Rare and Orphan Tumors (GETTHI). Eligible participants were adult women with advanced GCT. Primary endpoint was objective response rate. Secondary endpoints included clinical benefit rate, progression-free survival, overall survival, and safety profile. Patients received enzalutamide 160 mg once daily. ResultsFrom April 2018 to March 2020, eighteen patients were screened, and sixteen were included across nine institutions. Median age was 56.4 years (range 45–71), and most were Caucasian (14 cases), one Arabian and one Latin. ECOG performance status was zero in 13 cases (81 %) and one in three (19 %). Six patients (38 %) had previously received hormone therapy as adjuvant treatment or for advanced disease, and 15 (94 %) chemotherapy. Median time from metastasis to study entry was 96 months (range 4.5–198).No objective response was observed, but the clinical benefit rate reached 68.8 % (95 % CI [46 %–91.5 %]). Median progression-free survival was 3.8 months (95 % CI [1.36–6.14]). Median overall survival was not reached, with a median follow-up of 6 months (range 2.2–19).At the time of database closure, 14 patients had discontinued treatment, 13 due to disease progression and one by personal choice. Two deaths attributed to disease progression were recorded.Five grade 3 adverse events were reported, with only one (asthenia) deemed related to the therapy. ConclusionsAlthough enzalutamide demonstrated modest activity in GCT, durable stabilization was observed in some cases.Trial Registration:ClinicalTrials.gov Identifier: NCT03464201

Abstract C037: Inflammatory breast cancer by metastatic status: Racial and ethnic and socioeconomic disparities in receipt of treatment

Abstract Background: Inflammatory breast cancer (IBC) is a relatively rare but aggressive type of breast cancer. Racial and ethnic minority patients are disproportionately affected by IBC and often face barriers to accessing cancer care and services. However, racial and ethnic disparities in receipt of treatment are not well defined among patients with IBC by metastatic status. Methods: We analyzed data from patients with IBC in the 2004-2020 U.S. National Cancer Database. Five treatment modalities were assessed: hormone therapy, chemotherapy, radiotherapy, surgery, and trimodal therapy. Metastatic status was dichotomous as “metastatic/non-metastatic.” Racial and ethnic groups included Asian or Pacific Islander, American Indian, Alaska Native, or Other, Black, Hispanic, and White. Separate logistic regression models were fit, adjusting for sociodemographic and clinicopathological characteristics, stratified by metastatic status. Adjusted odds ratios (aOR) and 95% CIs were calculated. Results: Of 33,376 patients with IBC (mean age 58 years [SD=14]), most (70.6%) identified as White, followed by 18.1% as Black, 7.0% as Hispanic, 2.5% as Asian or Pacific Islander, 1.8% as American Indian, Alaska Native, or Other; and 32.5% were metastatic. In the non-metastatic cohort, Black (72.7%; aOR 0.79, 95% CI: 0.63-0.98) or Asian or Pacific Islander (74.8%; aOR 0.59, 95% CI: 0.38-0.90) patients had lower odds of receiving hormone therapy than White patients (78.0%). Compared with White patients, Black patients had a lower likelihood of receiving chemotherapy (89.1% vs. 89.5%; aOR 0.67, 95% CI: 0.53-0.86), surgery (78.4% vs. 85.3%; aOR 0.65, 95% CI: 0.55-0.77), or trimodal therapy (81.5% vs. 87.3%; aOR 0.61, 95% CI: 0.49-0.76). American Indian, Alaska Native, or Other (65.0%; aOR 0.64, 95% CI: 0.42-0.97) and Black (63.6%; aOR 0.71, 95% CI: 0.61-0.82) patients had lower odds of receipt of radiotherapy than White patients (70.6%). In the metastatic cohort, Black patients had a lower likelihood of receiving hormone therapy (55.2% vs. 63.5%; aOR 0.61, 95% CI: 0.48-0.78), chemotherapy (78.7% vs. 78.2%; aOR 0.75, 95% CI: 0.60-0.95), surgery (28.2% vs. 35.1%; aOR 0.68, 95% CI: 0.56-0.82), or trimodal therapy (30.4% vs. 40.4%; aOR 0.63, 95% CI: 0.48-0.82) than White patients. There were no statistically significant differences in receipt of treatment between White and other racial and ethnic patients with metastatic IBC. Furthermore, we observed significantly differential rates of treatment receipts by socioeconomic factors including median household income quartile, insurance coverage, and facility type. Conclusions: In this study of a large U.S. national IBC patient cohort, racial and ethnic minority patients were less likely than White patients to have received treatment for IBC, with Black patients being the most affected. Our findings highlight racial and ethnic disparities and socioeconomic inequities in treatment receipts, suggesting the need for oncology programs to improve equitable care access and reduce these disparities in the IBC population. Citation Format: Jincong Q. Freeman, Jared H. Hara, Olasubomi J. Omoleye. Inflammatory breast cancer by metastatic status: Racial and ethnic and socioeconomic disparities in receipt of treatment [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr C037.

The burden of chronic pain in transgender and gender diverse populations: Evidence from a large US clinical database

AbstractBackgroundChronic pain, affecting approximately 20% of the global population, is the leading cause of disability worldwide. Transgender individuals are disproportionately exposed to chronic pain risk factors compared with the cisgender population. This study compares the incidence of chronic pain between transgender and cisgender individuals and examines the impact of gender affirming hormone therapy, anxiety, and depression on chronic pain.MethodsThe study analysed medical records data of 56,470 transgender men and 41,882 transgender women in the TrinetX database. Six cohorts were created: transgender women either receiving oestrogen or no intervention, transgender men receiving testosterone or no intervention and cohorts of cisgender males and females. Unmatched age‐adjusted incidence rates were calculated. Then cohorts were matched on 22 chronic pain‐associated covariates and the rate of new chronic pain diagnoses was compared between those receiving hormone therapy and those without.ResultsWe observed significantly higher rates of chronic pain among transgender individuals compared with cisgender counterparts. Transgender men on testosterone therapy and transgender women on oestrogen therapy exhibited an increased likelihood of chronic pain diagnoses compared with those not receiving hormone therapy. Individuals with anxiety and depression were more likely to be diagnosed with chronic pain.ConclusionThis study demonstrates a significant burden of chronic pain in transgender individuals, with an increased risk among those receiving hormone therapy. Our study, the first to assess chronic pain in a large cohort of transgender patients, provides support for a potential association between hormone therapy and risk of chronic pain diagnosis. Further research is required to understand causal mechanisms and to develop improved screening and management of chronic pain in transgender populations.Significance StatementOur study, featuring the largest cohort of Transgender and Gender Diverse (TGD) individuals assembled to date, reveals critical disparities in chronic pain among TGD populations, notably those on hormone therapy, compared with the cisgender population. It highlights the urgent need for specialized screening and treatment for this vulnerable population, and research into hormone therapy's impact on pain. These insights aim to foster more effective, personalized healthcare, enhancing the well‐being and quality of life for the TGD community.

Premature ovarian insufficiency in pediatric cancer patients: a 10 year Rady Children's hospital experience.

To highlight the occurrence of premature ovarian insufficiency in pediatric cancer patients and determine which patient characteristics or treatment modalities are associated with ovarian failure and recovery. Between August 2011-August 2021, 36 of 2,661 patients with cancer were identified to have subsequent ovarian failure. Data collected included cancer type, diagnosis age, types of chemotherapy, bone marrow transplant or radiation treatment, peak FSH, peak AMH, GnRHa treatment, type of hormone replacement therapy, and if ovarian function recovery occurred. The most common cancer type identified was ALL. The mean age of diagnosis was 8.5±4.3 years and mean age of peak FSH value was 12.6±2.8 years. Most patients (97.2 %) were treated with alkylating agents and 72.2 % received radiation. Most patients (72.2 %) received hormone therapy, and 15.8 % of patients received GnRHa Lupron. Ten patients (27.8 %) had ovarian function recovery. Diagnosis age and treatment type were recovery predictors in multivariate regression modeling. Each year older in age was associated with a 30 % decrease in odds of recovery (OR: 0.7, CI: 0.5-0.95, p=0.035), and alkylating agent treatment without transplant was associated with a 3-fold increase in odds of recovery (OR: 3, CI: 2.7-564, p=0.007). This retrospective review demonstrates that POI can occur in pediatric cancer survivors, emphasizing the importance of educating patients on potential long-term effects of cancer treatment and importance of routine surveillance. This study confirmed that recovery of ovarian function is possible, especially when diagnosed at a younger age, making continued monitoring essential.

Recurrence-Free Survival after Postoperative Hormone Therapy for Catamenial Pneumothorax.

Catamenial pneumothorax (CP) is a rare form of spontaneous pneumothorax that is linked to endometriosis; thus, it predominantly manifests in women of reproductive age. Considerable research has explored the potential benefits of postoperative hormone therapy following various surgical interventions. This study was performed to examine the clinical implications of postoperative hormone treatment in patients with CP. The study included patients who underwent surgical intervention for CP between November 2009 and February 2023. These procedures included wedge resection, diaphragm resection, and total pleural coverage. Recurrence-free survival was analyzed using the Kaplan-Meier log-rank test to assess the impact of hormone therapy. Additionally, Cox proportional hazards analysis was employed to identify risk factors associated with postoperative CP recurrence. The study included 41 patients, with a median age of 38.4 years. Among them, 27 individuals received hormone therapy, 8 of whom experienced recurrence during a median follow-up period of 1 year. Patients who received hormone therapy exhibited a lower rate of recurrence than those who did not; however, the difference was not statistically significant, likely due to the small sample size. Side effects of hormone therapy included depression (6.8%), excessive sweating (3.4%), and headache (3.4%). In the analysis of risk factors for postoperative recurrence, diaphragm resection emerged as a protective factor (hazard ratio, 0.16; 95% confidence interval, 0.03-0.77; p=0.022). Hormone treatment combined with surgery did not significantly impact recurrence in patients with CP. The application of diaphragm resection was the sole factor that displayed significance in preventing CP recurrence.

Vaginal microbiota, menopause, and the use of menopausal hormone therapy: a cross-sectional, pilot study in Chinese women.

To compare the vaginal microbiota of premenopausal and postmenopausal women and postmenopausal women undergoing menopausal hormone therapy (MHT) and examine the association between vaginal microbiota and genitourinary syndrome of menopause (GSM). This cross-sectional study classified 94 women aged 40 to 60 years into three groups: premenopausal (Pre, n = 32), postmenopausal (Post, n = 30), and postmenopausal women who received MHT orally (Post + MHT, n = 32). Neither the Pre nor the Post group received hormone therapy within the past 6 months. Postmenopausal women who received vaginal MHT were not included. Vaginal swabs were obtained, and microbial composition was characterized by 16S rRNA gene sequencing targeting the V3 to V4 region. Clinical data were collected and serum sex hormones were measured. The most bothersome symptom approach and vaginal health index were used to evaluate GSM. Mann-Whitney U or Kruskal-Wallis ANOVA followed by multiple comparison tests were performed for comparison between or across groups. The correlations between GSM symptom scores and vaginal microbiota were determined using Spearman's correlation analysis. The vaginal community of postmenopausal women was characterized by a decreased abundance of Lactobacillus (Post 18% vs Pre 69%); an increased abundance of several anaerobic bacteria, including Prevotella, Escherichia-Shigella, and Bifidobacterium; and a higher microbial diversity (P < 0.001 for Shannon and Simpson indexes) than those of premenopausal women. The vaginal community of postmenopausal women who received MHT had an increased abundance of Lactobacillus (54%) and lower microbial diversity (P < 0.001 for Shannon and Simpson indexes) than the postmenopausal women. The vaginal microbial community composition of the Pre group shared more similarity with that of the Post + MHT group (Adonis P = 0.051) than with that of the Post group (Adonis P < 0.001). A decreased abundance of Lactobacillus and high diversity in the vaginal community were found in women with moderate to severe GSM symptoms. Among Chinese postmenopausal women, those receiving MHT had higher Lactobacillus abundance but lower abundance of diverse anaerobes and diversity of the vaginal microbial community compared to non-MHT women. MHT in postmenopausal women may potentially contribute to reestablishing vaginal microbiota homeostasis. Findings in this pilot study, however, need to be examined in larger, prospective studies.

The Effect of Bilateral Orchiectomy on Total Prostate Specific Antigen (TPSA) Levels in Prostate Adenocarcinoma Patients

AbstractBackground: Hormonal therapy is one treatment option for prostate cancer. There are two main categories of hormone therapy: surgical therapy and non-surgical therapy. Orchiectomy is the surgical method of hormone therapy; medication supplementation is the non-surgical method. Many kinds of indicators are used to track the advancement of patients with prostate cancer receiving hormone therapy. tPSA levels are one of the markers that are regularly evaluated.Methods: In this retrospective study, PSA levels in patients with prostate adenocarcinoma cancer were evaluated before and after bilateral orchiectomy. Use the search terms "prostate cancer" and "orchiectomy" to find research subject data in the UGM Academic Hospital's medical records installation between 2020 and 2023. The study's findings will be shown in a graphic and statistical analysis while protecting the subjects' anonymity.Results: Most of the participants (n=18, 60.0%) have pre-orchiectomy tPSA level of more than 30 ng/mL, while only almost a quarter (n=7, 23.3%) of participants have post-orchiectomy tPSA level of more than 30 ng/mL. The two research groups (p&lt;0.0001) before and after the orchiectomy procedure, significantly differ between the two research groups based on Wilcoxon paired sample test analysis.Conclusion: TPSA levels are considerably decreased by bilateral orchiectomy.

Pulmonary adverse reaction caused by furazolidone: Two case reports and a literature review.

As one of the drugs used to treat Helicobacter pylori, furazolidone has been reported to cause gastrointestinal reactions, allergies, dizziness, and more. However, its related drug-induced lung injury has been rarely reported. Furthermore, there have been no reports of the timing for initiating hormone therapy when a pulmonary adverse reaction occurs. We report 2 cases, both of them showed interlobular septal thickening and nodules on the chest computed tomography. One had more discomfort symptoms and had a higher eosinophil count than the normal range, while the other only had fever symptoms and had an eosinophil count within the normal range. Pulmonary adverse reaction caused by furazolidone was diagnosed. Furazolidone was discontinued, and the person with increased eosinophils received hormone therapy, while the other person did not. After discontinuation of medication and treatment, the symptoms of the 2 patients gradually improved. This report suggests that furazolidone may cause pulmonary adverse reactions to raise clinical awareness, and for the first time indicates that hormone therapy is needed for patients whose eosinophils continue to increase after discontinuation.

Real-World Analysis of Breast Cancer Patients Qualifying for Adjuvant CDK4/6 Inhibitors

BackgroundAdjuvant CDK4/6 inhibitors abemaciclib and ribociclib improved disease-free survival (DFS) added to endocrine therapy in hormone receptor (HR)-positive HER2-negative early breast cancer (EBC), in monarchE (NCT03155997) and NATALEE (NCT03701334) trials respectively. We assessed the proportion and outcome of EBC patients qualifying for adjuvant CDK4/6 inhibitors in the real-world. MethodsConsecutive female patients with HR-positive HER2-negative EBC between 1997 and 2017 from the Australian Capital Territory and South-East New South Wales Breast Cancer Treatment Group registry were analyzed. Patients eligible for abemaciclib had ≥4 axillary nodes involved or 1-3 nodes plus primary >5 cm or grade 3. Ribociclib eligibility was defined as node-positive and node-negative with primary >5 cm or >2 cm grade 3. ResultsOf 3840 patients, 671 (17.5%) were abemaciclib-eligible and 1587 (41.3%) ribociclib-eligible . The 5-year DFS was 77% and 94% in abemaciclib-eligible and noneligible registry patients respectively (HR 2.6, 95% CI 2.26-3.05, P < .001). The 5-year DFS was 86% and 97% in ribociclib-eligible and noneligible registry patients respectively (HR 1.92, 95% CI 1.67-2.19, P < .001). Compared with monarchE trial patients, abemaciclib-eligible registry patients were older (median 55 years in registry vs. 51 years in trial), with lower nodal burden (≥4 nodes in 44% in registry vs. 60% in trial). There were more stage III cancers in NATALEE trial patients (60%) than ribociclib-eligible registry patients (24%). ConclusionsMany women with EBC will qualify for adjuvant CDK4/6 inhibitors (17.5% abemaciclib, 41.3% ribociclib) with resource and workforce implications. In the real-world setting, a greater proportion of adjuvant CDK4/6-eligible patients have lower stage disease, therefore the absolute benefit from treatment may be smaller than estimated by the trials.

Improving Fertility in Non-obstructive Azoospermia: Results from an Autologous Bone Mar-row-Derived Mesenchymal Stromal/Stem Cell Phase I Clinical Trial.

In this phase I clinical trial, our primary objective was to develop an innovative therapeutic approach utilizing autologous bone marrow-derived mesenchymal stromal/stem cells (BM-MSCs) for the treatment of nonobstructive azoospermia (NOA). Additionally, we aimed to assess the feasibility and safety of this approach. We recruited 80 participants in this non-randomized, open-label clinical trial, including patients undergoing NOA treatment using autologous BM-MSCs (n=40) and those receiving hormone therapy as a control group (n=40). Detailed participant characteristics, such as age, baseline hormonal profiles, etiology of NOA, and medical history, were thoroughly documented. Autotransplantation of BM-MSCs into the testicular network was achieved using microsurgical testicular sperm extraction (microTESE). Semen analysis and hormonal assessments were performed both before and six months after treatment. Additionally, we conducted an in-silico analysis to explore potential protein-protein interactions between exosomes secreted from BM-MSCs and receptors present in human seminiferous tubule cells. Our results revealed significant improvements following treatment, including increased testosterone and inhibin B levels, elevated sperm concentration, and reduced levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prolactin. Notably, in nine patients (22.5%) previously diagnosed with secondary infertility and exhibiting azoospermia before treatment, the proposed approach yielded successful outcomes, as indicated by hormonal profile changes over six months. Importantly, these improvements were achieved without complications. Additionally, our in-silico analysis identified potential binding interactions between the protein content of BM-MSC-derived exosomes and receptors integral to spermatogenesis. Autotransplantation of BM-MSCs into the testicular network using microTESE in NOA patients led to the regeneration of seminiferous tubules and the regulation of hormonal profiles governing spermatogenesis. Our findings support the safety and effectiveness of autologous BM-MSCs as a promising treatment modality for NOA, with a particular focus on the achieved outcomes in patients with secondary infertility (registration number: IRCT20190519043634N1).

Relationship between menopausal hormone therapy and colorectal cancer: a cohort study utilizing the health insurance database in South Korea (HISK)-II.

Many studies have demonstrated that menopausal hormone therapy is associated with a reduced risk for colorectal cancer. This study investigated the relationship between specific hormone therapy regimens and colorectal cancer risk in postmenopausal women in South Korea using national insurance claims data. This population-based, retrospective cohort study used insurance data provided by the Health Insurance Review and Assessment Service between 2007 and 2020. The hormone therapy group comprised women ≥40 years of age who underwent hormone therapy for the first time between 2011 and 2014. The control group included women ≥40 years of age who visited medical institutions for menopause-related issues during the same period but did not undergo hormone therapy. After 1:1 propensity score matching, 153,736 women were grouped into either the hormone therapy or nonhormone therapy groups. The incidence of colorectal cancer was 46 and 53 per 100,000 person-years in the nonhormone therapy and hormone therapy groups, respectively. Hormone therapy was associated with an increased risk for colorectal cancer (hazard ratio 1.124 [95% confidence interval 1.002-1.261]). Subgroup analysis, according to hormone therapy type, revealed no significant differences in the risk of colorectal cancer for estrogen plus progestogen or estrogen therapy alone; however, tibolone was associated with an increased risk of colorectal cancer compared to nonhormone therapy (hazard ratio, 1.178 [95% confidence interval, 1.021-1.359]). This study found an increased risk of colorectal cancer in women receiving hormone therapy, and tibolone was significantly associated with an increased risk of colorectal cancer. However, the magnitude of the increase was small and unlikely to be of clinical significance.

Towards improved diagnosis: radiomics and quantitative biomarkers in 18 F-PSMA-1007 and 18 F-fluorocholine PET/CT for prostate cancer recurrence.

This study compared the radiomic features and quantitative biomarkers of 18 F-PSMA-1007 [prostate-specific membrane antigen (PSMA)] and 18 F-fluorocholine (FCH) PET/computed tomography (CT) in prostate cancer patients with biochemical recurrence (BCR) enrolled in the phase 3, prospective, multicenter BIO-CT-001 trial. A total of 106 patients with BCR, who had undergone primary definitive treatment for prostate cancer, were recruited to this prospective study. All patients underwent one PSMA and one FCH PET/CT examination in randomized order within 10 days. They were followed up for a minimum of 6 months. Pathology, prostate-specific antigen (PSA), PSA doubling time, PSA velocity, and previous or ongoing treatment were analyzed. Using LifeX software, standardized uptake value (SUV) maximum, SUV mean , PSMA and choline total volume (PSMA-TV/FCH-TV), and total lesion PSMA and choline (TL-PSMA/TL-FCH) of all identified metastatic lesions in both tracers were calculated. Of the 286 lesions identified, the majority 140 (49%) were lymph node metastases, 118 (41.2%) were bone metastases and 28 lesions (9.8%) were locoregional recurrences of prostate cancer. The median SUV max value was significantly higher for 18 F-PSMA compared with FCH for all 286 lesions (8.26 vs. 4.99, respectively, P < 0.001). There were statistically significant differences in median SUV mean , TL-PSMA/FCH, and PSMA/FCH-TV between the two radiotracers (4.29 vs. 2.92, 1.97 vs. 1.53, and 7.31 vs. 4.37, respectively, P < 0.001). The correlation between SUV mean /SUV max and PSA level was moderate, both for 18 F-PSMA ( r = 0.44, P < 0.001; r = 0.44, P < 0.001) and FCH ( r = 0.35, P < 0.001; r = 0.41, P < 0.001). TL-PSMA/FCH demonstrated statistically significant positive correlations with both PSA level and PSA velocity for both 18 F-PSMA ( r = 0.56, P < 0.001; r = 0.57, P < 0.001) and FCH ( r = 0.49, P < 0.001; r = 0.51, P < 0.001). While patients who received hormone therapy showed higher median SUV max values for both radiotracers compared with those who did not, the difference was statistically significant only for 18 F-PSMA ( P < 0.05). Our analysis using both radiomic features and quantitative biomarkers demonstrated the improved performance of 18 F-PSMA-1007 compared with FCH in identifying metastatic lesions in prostate cancer patients with BCR.

Relationship of adaptive subtyping and tumour heterogeneity of treatment response to neoadjuvant therapy in hormone receptor–positive HER2-negative early breast cancer: PENELOPE-B.

566 Background: The concept of intrinsic subtyping has been an important step for understanding of breast cancer (BC) as a heterogenous disease. However, these subtypes are not adapted to therapy-induced molecular plasticity. We have evaluated a high-risk luminal BC clinical trial cohort to identify new additional adaptive BC subtypes based on molecular alterations induced during neoadjuvant chemotherapy (NACT). Methods: A total of 1250 ER+/HER2- BC patients (pts) with residual disease after NACT and increased risk (CPS-EG score of ≥3 or 2 with ypN+) were randomized into the PENELOPE-B (NCT01864746) trial to receive palbociclib or placebo. Biomarker analysis was performed in 1411 pre- or postNACT tumor samples including 540 paired samples using the HTG EdgeSeq Oncology Biomarker Panel targeting 2549 genes (HTG Molecular Diagnostics Inc.), with assessment of the absolute assignment of breast cancer intrinsic molecular subtype (AIMS). For a subcohort of 29 pts, we evaluated triplicate samples before and after NACT as well as at the time of metastatic disease. Results: In paired biopsies, a total of 335 genes were significantly different between the pre- and the postNACT cohort. With hierarchical unsupervised clustering of these 335 genes, we characterized five different tumor subtypes with highly significant iDFS survival differences (p&lt;0.0001, n=539). We identified two large groups of tumors with excellent prognosis (adaptive cluster AC1 and AC2, together n=284, 6 events), as well as two groups with a poor prognosis; AC-3 (n=163, 82 events) and AC-4 (n=78, 29 events). The worst prognosis was observed in a small group of tumors with a pre-NACT Basal/HER2E AIMS subtype (n=14, 11 events). AC1 and AC3 are enriched for tumors with an AIMS subtype change from LumB to LumA during NACT, with improved iDFS for AC1. AC2 and AC4 are enriched for tumors with a constant LumA AIMS subtype before and after NACT, with improved iDFS for AC2. The low-risk adaptive subtypes AC1 and AC2 cover a total of 52.7% of pts with a combined event rate of 2.1%. In contrast, the best pretherapeutic conventional AIMS-subtype, preNACT LumA, covers 51.7% of pts, but still has an event rate of 15.4%. This suggests that adaptive subtypes are superior to classical AIMS subtypes for prediction of survival after NACT in luminal BC. Conclusions: Classical approach of intrinsic subtyping relies on constant gene expression, limiting its scope. Adaptive subtyping can complement the classical approach, focusing on those genes that are changed during therapy. Comparison of paired samples before and after therapy is superior to classical subtyping of baseline samples. This approach identified large subgroups of pts with excellent prognosis after NACT despite clinical high risk. This can be an important step to focus on high-risk pts for new neoadjuvant and post-neoadjuvant therapy concepts.

Multicentric retrospective study on the treatment characteristics, efficacy and safety of eribulin in Slovenian patients with breast cancer.

e13123 Background: Eribulin mesylate (eribulin) is a microtubule inhibitor and a synthetic analog of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin was approved based on the randomized Phase 3 EMBRACE clinical trial, which showed an improvement in survival compared to chemotherapy (CT) of the physician's choice. The efficacy and safety of eribulin treatment in real-world settings has been reported in several studies: Korean and Chinese multicenter retrospective studies and a meta-analysis from 2020. Methods: We included all patients treated with eribulin between January 24, 2013 and September 14, 2022 at the Institute of Oncology Ljubljana (85.4% of patients) and University Medical Centre Maribor (14.6%). Clinical data were collected retrospectively from paper and electronic patient records. The primary endpoints were median progression-free survival (PFS), overall survival (OS), response rates and safety. We performed a descriptive statistical analysis and a survival analysis using the Kaplan-Meier method. Results: 205 patients, whose average age was 58.6 (29-88) years, were included in the study. The majority (79%) had a hormone receptor (HR+) positive tumor, 12.2% were HER2 positive and 16.6% were triple negative. 32/205 (15.6%) were primary metastatic. Of the remaining 173 patients, 160/173 (92.4%) received adjuvant therapy, of which 15% received hormone therapy, 23.1% received CT and 61.9% received both. At the start of treatment with eribulin, 84.9% had visceral tumors and 14.6% had tumors in the CNS. The median number of all treatment lines was 6 (range 2–15) and the median number of CT lines was 4 (0–13). The ECOG performance status was: 0 in 4.9%, 1 in 53.2%, 2 in 35.1% and 3 in 4.9% and 4 in 0.5% of patients. The objective response rate was 7.3% and clinical benefit was achieved in 27.3%. The median CT line in which eribulin was used was the fourth (1–10). Eribulin was used as the last CT line in half of the patients. The median PFS was 3.01 months (95% confidence interval 2.56–3.47) and the median OS was 6.68 months (95% confidence interval 5.60–7.77). Patients who received eribulin in the first 3 lines of treatment had a better OS than those who received eribulin in later lines. Adverse events (AEs) occurred in 52.7%. Eribulin therapy was discontinued due to AEs in 18.5% of patients. The most common AE was fatigue (25.9%), followed by neuropathy and neutropenia (22.9% and 18%). Conclusions: In our retrospective analysis, we found significantly worse results of treatment with eribulin than in previous studies. In our population, eribulin was used in the late stages of treatment and in older patients with poorer performance status. The proportion of patients with visceral and CNS tumors was higher. The side effects were comparable.

The effect of energy from reiki treatments on sleep quality for patients with breast and prostate cancer on hormone therapy.

e24076 Background: Manypatients with cancer receiving hormone therapy experience difficulty with sleeping and insomnia. Reiki is a technique where therapy is delivered to the patient with either no or very light physical touch whereas traditional massage therapy uses pressure and movement by the therapist to manipulate soft tissue. Both Reiki and traditional massage therapy have been shown by others to be effective in providing benefits in sleep quality. This study is the first to compare changes in sleep quality after massage and Reiki treatments in patients with prostate and breast cancer receiving hormone therapy. Methods: Eighty-seven, breast (n = 56) and prostate cancer (n = 31), patients receiving hormone therapy experiencing self-reported fatigue ≥4/10were included in this randomized controlled trial (RCT). Patients were randomized into one of three treatment arms for 4-weeks: Arm 1 received two massage treatments, Arm 2 received two Reiki treatments and Arm 3 received four Reiki treatments. Each treatment session was approximately 75 minutes. . Participants with a baseline score of ( ≥8) on the ISI were included in this analysis. Results: 75% of all enrolled participants (n = 65) met the inclusion criteria for baseline clinically meaningful insomnia. Both Reiki and massage provided improvement in sleep quality from pre to post intervention and there was no difference between 2 and 4 Reiki sessions. Reiki significantly increased sleep quality (p &gt; .01) with a mean decrease in total ISI score of 2.96. Massage therapy showed a trend towards improved sleep quality (p = 0.06) with a mean decrease in ISI score of 1.95. There was a clinically meaningful decrease in total ISI score (≥6) in 15% of those who received massage therapy compared to 25% in the reiki therapy group. Conclusions: Four weeks of Reiki significantly improved sleep quality in patients with breast and prostate cancer receiving hormone therapy. Reiki may be a better non-pharmacologic therapeutic for improving sleep quality. Clinical trial information: NCT02758756 .

Adenocarcinoma in multiple adenomatous polyps: An analysis of demographic and socioeconomic factors.

e15619 Background: Adenocarcinoma in multiple adenomatous polyps (AMAP) is a form of gastrointestinal cancer characterized by adenomatous polyps in the gastrointestinal mucosa and distinct lesions found outside the intestines. A rare form of cancer, AMAP can be traced back to mutations in the APC gene, with higher rates of mutation correlating with worse prognosis. There is an association with familial adenomatous polyposis, which can lead to colorectal cancer in patients as young as 15. Examining demographic statistics on AMAP from the National Cancer Database (NCDB) sheds light on this rare form of colorectal cancer, unlocking new possibilities for diagnostics and treatment. Methods: A retrospective cohort analysis identified 193 patients with AMAP from the 2004-2020 NCDB using ICD-O-3 Code 8221 to identify them. Demographic factors such as age, sex, treatment type, and Charles/Deyo score were explored with descriptive statistics. Linear regression analysis was utilized to study incidence trends. Results: A total of 193 cases of histologically confirmed AMAP were retrieved from the 2004-2020 NCDB with a slight decline in incidence rates during this time (R² = 0.39). The majority of patients were male (55%), White (86%), privately insured (46%), and resided in metropolitan areas with a population size of at least one million (60%). Most patients also comprised the top two income quartiles based on median household income (64%). The mean age at diagnosis was 56.5 years (SD = 19.15, range = 15 - 90). The top primary sites affected were the Colon (26%), Sigmoid Colon (16%), and Rectum (11%). Furthermore, most patients were treated surgically (88%) with the average tumor size of 35.3 mm (SD = 20.5, range = 5.0 - 77.0). More patients received chemotherapy (28%) than radiation therapy (10.4%), with few patients receiving hormone therapy (0.5%) and none receiving immunotherapy. Over half (51%) of the patients were categorized as experiencing Stage 0 and Stage 1 cancer according to the NCDB Analytic Stage Group. The vast majority of patients (74%) had no comorbidities (Charlson-Deyo = 0) and did not receive any palliative care (97%). Conclusions: Our NCDB analysis on AMAP is a novel examination that provides insight into various demographics to better understand the disease. The majority of patients were males with adenocarcinoma lesions most commonly diagnosed in the colon and rectal areas, consistent with previous studies on multiple adenomatous polyps. Our analysis revealed that the majority of patients diagnosed with AMAP tend to be White, privately insured, reside in metropolitan areas, and hail from the top two quartiles of median household income. Additional research is required to gain a greater understanding of the demographic and socioeconomic factors that are important for accurate diagnosis, effective treatments, and improved outcomes.

The effect of hormone therapy on physiological uptake of the endometrium on [18F]F-FDG PET in postmenopausal women.

The effects of hormonal therapy, estrogen-based hormone replacement therapy (HRT), and anti-tumor hormone therapy, such as tamoxifen, on the physiological uptake of the endometrium on 2-deoxy-2[18F]fluoro-D-glucose ([18F]F-FDG) positron emission tomography (PET) in postmenopausal women have not been determined. We explored the effect of hormone therapy, particularly HRT, on physiological uptake in the endometrium of postmenopausal women. Postmenopausal women receiving hormone therapy who underwent cancer screening using PET/computed tomography (CT) between June 2016 and April 2023 were included in the hormone therapy group (n = 21). Postmenopausal women with no history of hormone therapy were included in the control group (n = 49). First, the physiological endometrial uptake at menopausal age and at least 1year thereafter was compared quantitatively (SUVmax) and qualitatively (4-point scale) in the control group, to assess when the endometrium ceased to show significant physiological [18F]F-FDG uptake after menopause. Endometrial uptake was compared between the hormone therapy and control groups. The association between HRT duration (months) and endometrial uptake (SUVmax) was evaluated. Endometrial thickness, measured using transvaginal ultrasonography, was also compared between the two groups. Endometrial uptake was significantly reduced both qualitatively and quantitatively (P < 0.05) at least 1year after menopause in control patients, by which time most women (89.8%) no longer had significant endometrial uptake. The hormone therapy group (n = 21) showed higher FDG uptake in the endometrium compared to the control group (median SUVmax: 2.3 vs 1.9, P = 0.0011), as well as a higher visual score (P < 0.0001). HRT duration did not correlate with endometrial uptake (P = 0.097). Endometrial thickness in the hormone therapy group was significantly thicker than in the control group (median: 3.9mm vs 1.8mm, P = 0.002). Hormone therapy may affect physiological uptake in the endometrium in postmenopausal women.

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.