Administration Of Hormone Therapy Research Articles

Participation of transgender and gender diverse persons in cardiovascular clinical trials

Study objectiveTransgender persons face increased risk in developing cardiovascular diseases due to administration of hormonal therapy used for gender expression, or due to the presence of other risk factors, such as minority stress and difficulty to have full access to health care. Even though the need for gender diversity in research has been identified, the number of clinical trials including transgender persons remains low. The aim of this study was to highlight gaps in inclusion of transgender individuals in cardiovascular clinical research. Design, settingA search in the pubmed.com database, as well as in the clinicaltrials.gov repository, was performed with search terms regarding transgender persons and cardiovascular diseases. Main outcome measure(s)The inclusion of transgender persons in cardiovascular clinical trials was evaluated. Results and conclusionsThis study revealed that there is only a small number of cardiovascular clinical trials including or studying transgender persons. This finding demonstrates the overall lack of clinical trials regarding cardiovascular health in transgender individuals and is indicative of their under-representation in clinical research.

Clinical differences and management trends of localized breast cancer in the advanced geriatric population.

e12543 Background: Breast cancer remains the most common cancer diagnosis in women and, with the aging Baby Boomer population, is poised to represent an even larger volume of oncologic care in the United States over the coming decades. Combined with limited evidence-based guidelines for geriatric patients, particularly those above the age of 80, there exists the potential for unnecessary morbidity and mortality. This study aims to shed light on the characteristics of this population, including disparities, with an aim to identify subsets of patients who may benefit from more aggressive treatment. Methods: This was a retrospective cohort study to examine key clinical differences between the advanced geriatric breast cancer population (≥80 years) and those of younger age, comparing comorbidities, tumor characteristics, and management trends. The Charleston Area Medical Center cancer registry was queried from 2009-2022 for females diagnosed with invasive breast cancer who had surgery for localized disease, excluding those with previous malignancies. Data were analyzed with SAS 9.4 using student’s t-test for continuous variables, Chi-square or Fisher’s exact for categorical variables, and 5-year survival rates attained via Cox regression models. Results: The analysis involved 1041 female patients, divided into two age groups: 969 who were < 80 years old and 72 who were ≥80 years old at time of breast cancer diagnosis. The ≥80 group had significantly more individuals with hypertension, 83.3% v 63.7% (p < .001), osteoporosis, 26.8% v 9.5% (p < .001), cardiac arrhythmia, 18.1% v 7.3% (p = .001), and CVA, 11.1% v 4.5% (p = .014), than the < 80 group. Looking at overall trend, tumor grade was significantly (p = .040) lower in the ≥80 group than the < 80 group, G1 34.7% v 24.9%, G2 44.4% v 45.4%, G3 20.8% v 29.7%, respectively. Her2neu positivity was significantly (p = .010) lower in the ≥80 group at 0.0% compared to the < 80 group at 8.4%. There was no difference in the rate of endocrine therapy between the two groups (p = 0.320). Only 26.4% of the ≥80 group received radiotherapy compared to 79.0% of the < 80 group (p < .001). None of the ≥80 group received chemotherapy compared to 22.5% of the < 80 group (p < .001). Overall, 5-year survival for those < 80 and ≥80 was 92% and 84%, respectively (p < .001). Conclusions: In summary, patients 80 years of age or older were more likely to have hypertension, osteoporosis, cardiac arrhythmia, and history of CVA. Regarding tumor characteristics, both grade and Her2neu positivity were significantly higher in the < 80 group. There was no difference in the administration of endocrine therapy. Radiotherapy and chemotherapy, however, were used at significantly lower rates in the advanced geriatric population, likely in adherence with current NCCN guidelines for adjuvant therapy in patients ≥70. Further investigation may help to elucidate subgroups amenable to more aggressive adjuvant therapies.

Menopausal hormone therapy and breast cancer risk: a population-based cohort study of 1.3 million women in Norway

BackgroundIt is important to monitor the association between menopausal hormone therapy (HT) use and breast cancer (BC) risk with contemporary estimates, and specifically focus on HT types and new drugs.MethodsWe estimated hazard ratios (HR) of BC risk according to HT type, administration route and individual drugs, overall and stratified by body mass index (BMI), molecular subtype and detection mode, with non-HT use as reference.ResultsWe included 1,275,783 women, 45+ years, followed from 2004, for a median of 12.7 years. Oral oestrogen combined with daily progestin was associated with the highest risk of BC (HR 2.42, 95% confidence interval (CI) 2.31–2.54), with drug-specific HRs ranging from Cliovelle®: 1.63 (95% CI 1.35–1.96) to Kliogest®: 2.67 (2.37–3.00). Vaginal oestradiol was not associated with BC risk. HT use was more strongly associated with luminal A cancer (HR 1.97, 95% CI 1.86–2.09) than other molecular subtypes, and more strongly with interval (HR 2.00, 95% CI: 1.83–2.30) than screen-detected (HR 1.33, 95% CI 1.26–1.41) BC in women 50–71 years. HRs for HT use decreased with increasing BMI.ConclusionsThe use of oral and transdermal HT was associated with an increased risk of BC. The associations varied according to HT type, individual drugs, molecular subtype, detection mode and BMI.

Evaluating the effects of hormone therapy termination on skeletal muscle and physical independence in postmenopausal women.

In women, the age-related decline in skeletal muscle structure and function is accelerated after menopause, which implicates the role of decreased circulating estrogen levels. Indeed, boosting estrogen, by means of postmenopausal hormone therapy (HT), generally proves beneficial to skeletal muscle. The evidence regarding whether these benefits persist even after cessation of HT is limited, nor is it clear how physical behavior (PB) impacts on benefits. Hence, this exploratory study focused on the interplay between HT administration/cessation, PB and in vivo skeletal muscle structure and function. Fifty healthy women (≥60 y) were included; 19 had an HT administration history (≥9 mo, with now ~8-y hiatus in treatment) and 31 no such history. On seven continuous days, PB data were collected using triaxial accelerometry and analyzed using compositional data analysis. Gastrocnemius medialis muscle volume, architecture, and function were determined using ultrasonography, electromyography, dual x-ray absorptiometry, and dynamometry. Current serum estradiol levels were measured using ELISA. Only fascicle length and duration of HT administration were positively associated. With respect to PB levels, we found a pattern suggesting greater vitality (higher physical activity and lower sedentarism) in previous HT users, compared with nonusers, despite the two groups currently no longer exhibiting significantly different levels of circulating estradiol. After an 8-year hiatus in treatment, HT provides limited advantages in gastrocnemius medialis muscle properties. Interestingly, it perhaps enhances vitality despite prolonged cessation, which in the longer term would facilitate greater physical independence, especially considering the association of sedentary behavior with greater frailty.

Nomogram for Predicting Hypoglycemia in Type 2 Diabetes Mellitus Patients Treated with Insulin Pump During Enteral Nutrition.

To develop a prediction model for hypoglycemia in type 2 diabetes mellitus (T2DM) patients treated with an insulin pump during enteral nutrition. This retrospective study included T2DM patients treated with an insulin pump during enteral nutrition at the First Affiliated Hospital of Jinan University, Guangzhou Red Cross Hospital, Foshan First People's Hospital, and Guangdong Provincial Hospital of Traditional Chinese Medicine between January 2016 and December 2023. The patients were randomized 3:1 to the training and validation sets. The risk factors for hypoglycemia were analyzed. A prediction model was developed. This study included 122 patients, and 57 patients had at least one hypoglycemic event during their hospitalization (46.72%). The multivariable logistic regression analysis showed that the time to reach the glycemic targets (odds ratio (OR)=1.408, 95% confidence interval (CI)=1.084-1.825, P=0.006), average glycemia (OR=0.387, 95% CI=0.233-0.643, P=0.010), coronary heart disease (OR=0.089, 95% CI=0.016-0.497, P<0.001), and the administration of hormone therapy (OR=6.807, 95% CI=1.128-41.081, P=0.037) were independently associated with hypoglycemia. A nomogram was built. The receiver operating characteristics analysis showed that the area under the curve of the model was 0.872 (95% CI=0.0.803-0.940) for the training set and 0.839 (95% CI=0.688-0.991) in the validation set. A nomogram was successfully built to predict hypoglycemia in T2DM patients treated with an insulin pump during enteral nutrition, based on the time to reach the glycemic targets, average glycemia, coronary heart disease, and the administration of hormone therapy.

Impact of Post-Mastectomy Radiotherapy on Cosmesis and Quality of Life after Deep Inferior Epigastric Perforator Flap Breast Reconstruction: A Single Institution Experience

Immediate breast reconstruction (IBR) yields better cosmetic results and reduce psychological distress than delayed (DBR). Literature data showed better local cosmesis after reconstruction autologous flaps than prothesis. Our aim is to compare cosmetic results and quality of life (QoL) after PMRT delivered either after IBR or DBR with DIEP flap. We reviewed files of 99 patients (100 DIEPs) treated in our department from January 2000 to December 2019. Patients were divided into 2 groups depending on the treatment sequence: IBR (n = 22) versus DBR (n = 78) followed by PMRT. All the patients had their DIEP flap by the same surgical team. All patients had cosmetic evaluation using Harvard/RTOG cosmesis grading scale. Fifty percent (32 in IBR and 14 in DBR group) of the patients responded to the QoL evaluation using auto questionnaires and BREAST-Q to evaluate breast specific HRQoL and satisfaction. The analysis of cosmetic scores was carried out with a Chi2 test and the analysis of QoL scores with a student test. Kaplan Meier (log-rank test) is used for recurrence-free and overall survival. Median follow-up was 56 months. Median age of the patients was 48 (28-71). In terms of disease stage: T1-2 (52%), N0 (38%). 86% of the patients had chemotherapy either in neo-adjuvant (26%) or adjuvant (60%) settings. Radiation therapy (RT) delivered a total dose ranged between 45 Gy and 50 Gy using 1.8-2.5 Gy/per fraction. Supra-clavicular and internal mammary chain irradiation was performed in 67% and 33% of the patients respectively. After surgery, 15% had post-operative complications such as DIEP necrosis (n = 8) that delayed RT delivery. Among the 99 patients, 3 died from metastatic evolution and were not included in the cosmetic and QoL analyses. Local recurrence rate was slightly higher after DBR (12.5%) as compared to IBR (3.8%). Loco-regional and metastatic recurrence rates were 4.5% and 4.5% after IBR versus 1.3% and 9% after DBR (p = NS). Disease free and overall survival were 88% and 98% at 5y and 66% and 96% at 10y.Good-to-excellent results were observed in 57% in the IBR vs 67% in the DBR (p = 0.92). There was no impact of previous chemotherapy (p = 0.21), tobacco use at diagnosis (p = 0.27), diabetes (p = 0.86), RT timing (p = 0.53) and endocrine therapy administration (p = 0.67). QoL was evaluated with the BREAST-Q self-evaluation for 5 post operative items: psycho-social, physical, sexual well-being and satisfaction with breast and global cosmetic results. Out of the 99 patients, 46% had responded to the QoL evaluation. We found no statistical difference between the two groups for all the BREAST-Q evaluation items. Our center is considered expert for DIEP reconstructions since its development in end of the nineties. Our data showed no impact PMRT using conventional fractionation (with mainly 1.8 Gy/fraction) on cosmetic results, QoL, and patients' satisfaction regardless of the timing of the breast reconstruction. Additional studies are in progress with updates.

A national questionnaire survey of Japanese urologists on treatment perspectives for elderly prostate cancer patients.

This study conducted a national questionnaire survey of Japanese urologists from a treatment perspective for older patients with prostate cancer. A questionnaire was distributed to 922 teaching hospitals of the Japanese Urological Association. Questionnaire items included years of urologist experience, gender, workplace, treatment equipment owned, daily specialty practice area, urological cancer specialty, treatment reference items for older adults, upper age limit for radical treatment, medication, and two hypothetical cases of Gleason grade group 2 prostate cancer with or without oligometastasis. In total, 1732 questionnaires were analyzed, with responses evenly distributed across all age groups. Workplaces included general hospitals (49.4%), university hospitals (40.3%), and cancer centers (4.2%). Performance status was the most frequently mentioned treatment-related item, followed by comorbidities and cognitive function. In addition, geriatric assessment was used by only 13.3% of respondents. No upper age limit was found for total prostatectomy, brachytherapy, and external beam radiation. Anti-androgens, androgen receptor-axis-targeted agents, chemotherapy, poly ADP ribose polymerase inhibitors, and immune-checkpoint inhibitors were selected by 6.8%, 35.6%, 47.3%, 89%, 62.8%, 24.7%, 41.9%, and 41.7% of the respondents, respectively. Response rates for administration of hormone therapy for hypothetical cases of Gleason grade group 2 prostate cancer with or without oligometastases were 96.8% and 61.2%, respectively. Less than 15% of urologists used geriatric assessments. Several responded that they would set age limits for highly invasive radical and systemic therapies.

Association Between the Route of Administration and Formulation of Estrogen Therapy and Hypertension Risk in Postmenopausal Women: A Prospective Population-Based Study.

Hypertension is the leading global cause of cardiovascular disease and premature mortality in women. The effects of postmenopausal hormone therapy (HT) on blood pressure are uncertain but may be related to route of estrogen administration and formulation of estrogen. We sought to determine the association between route of administration and formulation of estrogen HT and hypertension risk in postmenopausal women. Population-based cohort study with women aged ≥45 years who filled ≥2 consecutive prescriptions for estrogen-only HT, identified from linked provincial health administrative data from Alberta, Canada, between 2008 and 2019. The primary outcome, incident hypertension, was identified using standardized International Classification of Diseases, Ninth and Tenth Revision. Cox proportional hazard models were used to calculate hazard ratios (HRs) for hypertension in women using oral HT compared with nonoral HT (transdermal, vaginal, or intramuscular). In total, 112 240 women used an estrogen-only form of HT. Oral estrogen was associated with a higher risk of hypertension compared with both transdermal (HR, 1.14 [95% CI, 1.08-1.20]) and vaginal (HR, 1.19 [95% CI, 1.13-1.25]) estrogens. Conjugated equine estrogen was associated with an increased risk of hypertension compared with estradiol (HR, 1.08 [95% CI, 1.04-1.14]) but not estrone (HR, 1.00 [95% CI, 0.93-1.10]). Duration of estrogen exposure and cumulative dose of estrogen was positively associated with risk of hypertension. Oral estrogen-only HT use was associated with an increased risk of hypertension in women. In women using estrogen-only HT, nonoral estradiol at the lowest dose and for the shortest time-period is associated with the lowest risk of hypertension.

Influence of adherence to adjuvant endocrine therapy in early breast cancer: Results from a large German real-world claims data analysis.

551 Background: In hormone-receptor positive (HR+) early breast cancer (EBC) adjuvant endocrine therapy (ET) significantly reduces recurrence and mortality. The most common way to estimate therapy adherence is the use of patient reported outcome measures. Yet, this method is inaccurate due to the social-desirability bias. We therefore aimed to analyze adherence to ET over the first 5 years of treatment by using claims data from a large German health insurance provider (AOK Baden-Wuerttemberg). Methods: Female patients diagnosed with HR+ EBC between July 1st 2010 and December 31st 2019 were included into the analysis. Adherence to ET was defined as the ratio of the summed number of pills of filled prescriptions for ET (either aromatase inhibitors or tamoxifen) and the duration of endocrine therapy in days (from the start of the first prescription after completion of surgery and chemotherapy, if applicable). ET administration was observed over 5 years. High/low adherence was defined as a ratio between 0.8 – 1 and 0 – 0.8, respectively. ET duration was divided into yearly intervals and adherence was calculated as above. Continuous high/low adherence was then defined as an adherence between 0.8 – 1 and 0 – 0.8 in each year. Distant recurrence-free survival (DRFS) was calculated from the day of the first diagnosis of EBC until onset of distant metastatic disease. Overall survival (OS) was defined as the period between first diagnosis of EBC until death. Results: In total, 20998 patients were included. 17006 patients (81%) were HR+. Regarding overall adherence during the first 5 years, average adherence was 0.81 ± 0.26, with 72% of all HR+ patients showing high adherence to ET. Of 17006 HR+ EBC patients, 8363 (49%) showed a continuous high adherence to ET and 1731 (10%) showed a continuous low adherence to ET over 5 consecutive years. Continuous adherence to endocrine therapy had a significant impact on DRFS (HR: 0.61; 95% CI: 0.52 - 0.71; p &lt; 0.0001) and OS (HR: 0.52; 95% CI: 0.46 -0.59; p &lt; 0.0001). The 10-year OS rate was 79% / 64% for patients with continuous high / low adherence to endocrine therapy. Conclusions: As measured by the number of prescribed pills, adherence during the first 5 years of endocrine therapy was higher than expected by literature. Continuous adherence to ET over 5 years has a significant impact on OS and DRFS. Future research should focus on identifying factors that influence therapy adherence in HR+ EBC patients.

Trends in Medicare utilization and reimbursement for hematology/oncology procedures.

e13641 Background: Medicare Part B pays for physician services such as office visits and procedures based on the Medicare Physician Fee Schedule which is re-evaluated annually to maintain budget neutrality. Moreover, national cancer-attributed medical care costs in 2015 were $183 billion and projected to increase 34% to $246 billion by 2030 (Green et al: J Clin Oncol, PMID: 31804856). The aim of this study is to evaluate trends in Medicare reimbursement for procedures in hematology/oncology between 2012-2022. Methods: The data analyzed were extracted from the Physician Fee Schedule Look-Up Tool. CPT Codes were obtained from the Medicare Coverage Database. The following CPT codes were extracted: antineoplastic chemotherapy administration (96405, 96406, 96401, 96409, 96411, 96413, 96415, 96416, 96417, 96420, 96422, 96423, 96425, 96440, 96446, 96450, 96542), antineoplastic hormone therapy administration (96402), non-chemotherapy infusion (96360, 96361, 96365, 96366, 96367, 96368, 96369, 96370, 96371, 96372, 96373, 96374, 96375, 96376 ), bone marrow sampling (38220, 38221, 38222), bone marrow harvest (38230, 38232) and bone marrow transplant (38240, 38241, 38242). Consumer Price Index (CPI) obtained from the U.S. Department of Labor's Bureau of Labor Statistics was used to adjust reimbursement rates for cumulative inflation to 2022 U.S. dollars. The T-test was used to compare the mean prices for each procedure. This research contains publicly available data and as such is exempt from the IRB according to the Institutional Review Board at LSU Health Sciences Center in New Orleans, Louisiana. Results: The procedure with the highest reimbursement rate in 2012 was bone marrow harvest and the procedure with the lowest reimbursement rate in the same year was antineoplastic hormone therapy administration. The procedure with the highest reimbursement rate in 2022 was bone marrow harvest. The procedure with the lowest reimbursement rate in 2022 was antineoplastic hormone therapy. All procedure reimbursement fell significantly (p value of &lt;0.001) over the timer period studied. Conclusions: Between 2012 and 2022 the reimbursement rates for common hematology oncology services fell significantly when adjusted for inflation due to reforms in Medicare part B. [Table: see text]

A national questionnaire survey of Japanese urologists on the treatment perspective for elderly patients with prostate cancer.

327 Background: Physicians' attitudes toward elderly prostate cancer patients in Japan remain unknown. So, we conduct a national questionnaire survey of Japanese urologists from a treatment perspective for elderly patients with prostate cancer. Methods: A questionnaire was sent to 922 Japanese urological association teaching base hospitals. The following items were included: years of experience as a urologist, gender, workplace, treatment equipment owned, specialty area of daily practice, specialty area of urological cancer, reference items for treatment of the elderly, upper age limit for radical treatment, medication, and two hypothetical cases of Gleason grade Group 2 prostate cancer with or without oligometastasis. For examined the correlation between experience for urological practice and the answer, “not considering the upper age limit”, Cochran-Armitage trend test was used. For comparison of the rate of answering with “not considering the upper age limit” between variables, z-tests were conducted repeatedly and Bonferroni adjustments were made. In this analysis, the statistical significance was set at a P-value &lt;0.05. Results: Altogether, 1,732 questionnaires were analyzed. The responses were almost equally distributed among all age groups. Workplaces included general hospitals (49.4%), university hospitals (40.3%), and cancer centers (4.2%). Performance status was the most frequently referenced item in treating the elderly, followed by the presence of comorbidities and cognitive function. Furthermore, 13.3% of respondents used the geriatric assessment. There was no upper age limit for total prostatectomy, brachytherapy, and external radiation therapy. Antiandrogens, androgen receptor-axis-targeted agents, chemotherapy, PARP inhibitors, and immune-checkpoint inhibitors were selected by 6.8%, 35.6%, 47.3%, 89%, 62.8%, 24.7%, 41.9%, and 41.7% of the respondents, respectively. The answers for the administration of hormone therapy for hypothetical cases of Gleason grade Group 2 prostate cancer with or without oligometastasis were 96.8% and 61.2%, respectively. The answers for the administration of hormone therapy for hypothetical cases of Gleason grade Group 2 prostate cancer with or without oligometastasis were 96.8% and 61.2%, respectively. Conclusions: Fewer than 10% of urologists used geriatric assessments. Many urologists responded that they would set age limits for highly invasive radical and systemic therapies. [Table: see text]

CLINICO-HISTOPATHOLOGICAL STUDY OF ENDOMETRIUM WITH AND WITHOUT HORMONE THERAPY IN PATIENTS WITHABNORMAL UTERINE BLEEDING

Background: Abnormal uterine bleeding (AUB) is one of the most common problem for the patients and the gynecologists. Histological characteristics of endometrial biopsy material as assessed by light microscopy remains the diagnostic standard for the diagnosis of endometrial pathology. Material and Methods: In our prospective study of 100 patients of the age between 24-75 years, clinical characteristics and the pattern of endometrial histopathology and their association with hormone therapy administration were studied. Results: Total of 100 patients were divided into two subgroups one that received hormone therapy prior to endometrial biopsy and Group II in which hormone therapy was not administered prior to the said procedure. In both groups proliferative phase was the commonest followed by secretory endometrium in both groups. Pill change, Arias Stella reaction, tubercular endometritis, endometrial carcinoma was exclusively noted in the group in hormone therapy was administered prior to endometrial biopsy. Pill change endometrium was only significantly correlated with Group I (p=0.05). Simple hyperplasia, endometrial polyp, chronic endometritis, endocervical polyp, atrophic endometrium was noted in Group II of which simple hyperplasia (p=0.10) was not found to be clinically significant. Conclusions: The study of the endometrium in AUB revealed many structural and non-structural causes manifest in the form of different endometrial histopathological patterns in two groups with or without hormone therapy. Endometrial study gives significant etiological information in AUB when interpreted with relevance to age and other clinical data, thus guiding the appropriate management.

Abstract P4-11-24: Patient's point of view on how to promote adherence to adjuvant endocrine therapy (ET): A large french survey

Abstract Purpose: Non-adherence to adjuvant ET remains a major issue in patients with localized breast cancer (BC) and negatively impacts the long-term recurrence and survival outcomes. Recently, we reported that 16.0% of premenopausal pts had a serum tamoxifen level below the set adherence threshold and had an increased their risk of breast cancer distant recurrences (NCT01993498). Thus, implementation of personalized effective strategies to improve patients adherence remains a topic of active research. As effective approaches must rely upon a comprehensive understanding of the multiple interplaying factors that affect adherence, we performed a survey among French breast cancer survivors that were receiving or had previously received adjuvant ET to explore patients’ expectations and preferences for mitigating ET side effects. Methods: From July 1st to July 31 2020, we addressed a large social media and web-based survey to premenopausal patients who currently or had been treated for a localised BC in collaboration with 2 major French patient advocacy groups “Les Seintinelles” and “ODYSSEA Foundation”. The survey aimed to determine: a. patient’s preferences on ET formulation and administration; b. patient’s opinion on the contents of a mobile application for managing ET. It comprised 3 items: information about the participants and the ET received or currently ongoing; preferences on ET formulation (type of pill, taste, color, shape), dosing and combination with active drugs controlling side effects; opinion on the usefulness of a mobile application and relevance of its possible contents for complementing ET administration. Results: Of the 1,616 survey responses collected, 1,474 were completely filled and could be used in the analysis. 65% of them were aged between 40 and 59 years, 68% were still receiving ET during data collection. Most of the patients considered the presentation of the drug (taste, shapes and colors) to have little impact on adherence to treatment. The preferred pharmaceutical forms were capsules or swallowable tablets (56%). 75% of participants favoured a single pill containing ET plus an active substance controlling side effects. 85% were favourable to the use of a mobile application, in particular to better understand the interest and the expected benefit of ET (15%), to be reminded when to take the treatment (11%), and to obtain advice concerning the management of side effects (29%).Conclusion: This large French survey identified two main leads that could potentially promote or improve adherence to ET: combined treatment formulation including substances. targeting side effects, and a mobile application allowing support throughout treatment duration. Patient’s opinions on ET dosing and management are essential to inform the development of personalized approaches for improving adherence. Keywords: Endocrine therapy, non-adherence, breast-cancer, survey. Citation Format: Sarra Akla, Elie Rassy, Antonio Di-Meglio, Elise Martin, Julie Havas, Andre Rieutord, Angelo Paci, David Combarel, Leonor Fasse, Florian Scotte, Guillemette Jacob, Anne Bergognoux, Suzette Delaloge, Ines Vas Luis, Barbara Pistilli. Patient's point of view on how to promote adherence to adjuvant endocrine therapy (ET): A large french survey [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-11-24.

Trends in incidence, molecular diagnostics, and treatment of patients with breast cancer in Kazakhstan, 2014-2019

Relevance: Globocan reported 4,390 new breast cancer cases and 1,654 deaths from breast cancer in the Republic of Kazakhstan (RK) in 2020. Molecular diagnostics of breast cancer includes the determination of Hormone Receptor (HR), HER2, and Ki-67 status to detect patients&#x0D; with HR-positive tumors and administer effective treatment.&#x0D; Methods: This observational study included a retrospective analysis of incidence, molecular diagnostics, and treatment regimens in women with a confirmed breast cancer diagnosis aged 18 years old and older, registered in the RK Electronic Registry of Cancer Patients (ERCP) from 1 January 2014 till 31 December 2019.&#x0D; Results: In the study period (2014 to 2019), the number of breast cancer cases registered annually has doubled. The incidence increased by 46.9%. The share of locally advanced and advanced forms of breast cancer has decreased. The proportion of Luminal type A (HR+/HER2-)&#x0D; among newly diagnosed patients ranged from 17.9% to 30%. Chemotherapy and endocrine therapy with goserelin, buserelin, leuprorelin, and fulvestrant are standard first- and second-line treatments for HR+ breast cancer. Since fulvestrant indications have been expanded, more&#x0D; than 50% of patients with HR-positive advanced breast cancer receive fulvestrant as the first-line therapy.&#x0D; Conclusion: Breast cancer incidence growth and a decrease in the share of locally advanced and advanced breast cancer cases in the RK could be attributed to increased coverage of eligible women aged 40 to 70 with breast cancer mammographic screening. Although international guidelines support the administration of hormone therapy with or without targeted therapy in women with HR-positive, HER2-metastatic breast cancer, upfront use of chemotherapy remains common in the RK even in the absence of visceral crisis. The use of CDK4/6 inhibitor palbociclib in combination with hormone therapy has become routinely available since 2019

Trends in incidence, molecular diagnostics, and treatment of patients with breast cancer in Kazakhstan, 2014-2019

Relevance: Globocan reported 4,390 new breast cancer cases and 1,654 deaths from breast cancer in the Republic of Kazakhstan (RK) in&#x0D; 2020. Molecular diagnostics of breast cancer includes the determination of Hormone Receptor (HR), HER2, and Ki-67 status to detect patients&#x0D; with HR-positive tumors and administer effective treatment.&#x0D; Methods: This observational study included a retrospective analysis of incidence, molecular diagnostics, and treatment regimens in&#x0D; women with a confirmed breast cancer diagnosis aged 18 years old and older, registered in the RK Electronic Registry of Cancer Patients&#x0D; (ERCP) from 1 January 2014 till 31 December 2019.&#x0D; Results: In the study period (2014 to 2019), the number of breast cancer cases registered annually has doubled. The incidence increased&#x0D; by 46.9%. The share of locally advanced and advanced forms of breast cancer has decreased. The proportion of Luminal type A (HR+/HER2-)&#x0D; among newly diagnosed patients ranged from 17.9% to 30%. Chemotherapy and endocrine therapy with goserelin, buserelin, leuprorelin,&#x0D; and fulvestrant are standard first- and second-line treatments for HR+ breast cancer. Since fulvestrant indications have been expanded, more&#x0D; than 50% of patients with HR-positive advanced breast cancer receive fulvestrant as the first-line therapy.&#x0D; Conclusion: Breast cancer incidence growth and a decrease in the share of locally advanced and advanced breast cancer cases in the RK&#x0D; could be attributed to increased coverage of eligible women aged 40 to 70 with breast cancer mammographic screening. Although international guidelines support the administration of hormone therapy with or without targeted therapy in women with HR-positive, HER2-metastatic breast cancer, upfront use of chemotherapy remains common in the RK even in the absence of visceral crisis. The use of CDK4/6 inhibitor&#x0D; palbociclib in combination with hormone therapy has become routinely available since 2019.

PD34-02 THE KEY ROLE OF PSA DOUBLING TIME IN PATIENTS TREATED WITH SALVAGE RADIATION THERAPY AFTER RADICAL PROSTATECTOMY: IMPLICATIONS FOR THE EXTENT OF RADIATION AND THE CONCOMITANT USE OF HORMONAL THERAPY

PD34-02 THE KEY ROLE OF PSA DOUBLING TIME IN PATIENTS TREATED WITH SALVAGE RADIATION THERAPY AFTER RADICAL PROSTATECTOMY: IMPLICATIONS FOR THE EXTENT OF RADIATION AND THE CONCOMITANT USE OF HORMONAL THERAPY

Hormone therapy in the postmenopausal years: considering benefits and risks in clinical practice.

Menopausal symptoms can be very distressing and considerably affect a woman's personal and social life. It is becoming more and more evident that leaving bothersome symptoms untreated in midlife may lead to altered quality of life, reduced work productivity and, possibly, overall impaired health. Hormone therapy (HT) for the relief of menopausal symptoms has been the object of much controversy over the past two decades. At the beginning of the century, a shadow was cast on the use of HT owing to the concern for cardiovascular and cerebrovascular risks, and breast cancer, arising following publication of a large randomized placebo-controlled trial. Findings of a subanalysis of the trial data and extended follow-up studies, along with other more modern clinical trials and observational studies, have provided new evidence on the effects of HT. The goal of the following paper is to appraise the most significant clinical literature on the effects of hormones in postmenopausal women, and to report the benefits and risks of HT for the relief of menopausal symptoms. A Pubmed search of clinical trials was performed using the following terms: estrogens, progestogens, bazedoxifene, tibolone, selective estrogen receptor modulators, tissue-selective estrogen complex, androgens, and menopause. HT is an effective treatment for bothersome menopausal vasomotor symptoms, genitourinary syndrome, and prevention of osteoporotic fractures. Women should be made aware that there is a small increased risk of stroke that tends to persist over the years as well as breast cancer risk with long-term estrogen-progestin use. However, healthy women who begin HT soon after menopause will probably earn more benefit than harm from the treatment. HT can improve bothersome symptoms, all the while conferring offset benefits such as cardiovascular risk reduction, an increase in bone mineral density and a reduction in bone fracture risk. Moreover, a decrease in colorectal cancer risk is obtainable in women treated with estrogen-progestin therapy, and an overall but nonsignificant reduction in mortality has been observed in women treated with conjugated equine estrogens alone or combined with estrogen-progestin therapy. Where possible, transdermal routes of HT administration should be preferred as they have the least impact on coagulation. With combined treatment, natural progesterone should be favored as it is devoid of the antiapoptotic properties of other progestogens on breast cells. When beginning HT, low doses should be used and increased gradually until effective control of symptoms is achieved. Unless contraindications develop, patients may choose to continue HT as long as the benefits outweigh the risks. Regular reassessment of the woman's health status is mandatory. Women with premature menopause who begin HT before 50 years of age seem to have the most significant advantage in terms of longevity. In women with bothersome menopausal symptoms, HT should be considered one of the mainstays of treatment. Clinical practitioners should tailor HT based on patient history, physical characteristics, and current health status so that benefits outweigh the risks.

Hormone Replacement Therapy in Endometrial Cancer Survivors: A Meta-Analysis.

The purpose of this study is to investigate the effect of hormone therapy (HT) on the oncological outcomes of endometrial cancer (EC) survivors. A systematic literature review was conducted in July 2021 to identify studies detailing the effect size for the relationship between HT use in EC and oncological outcomes (survival and disease recurrence). This included studies that evaluated the different recurrence rates among women treated for EC who subsequently underwent HT and those who did not. The collected studies were evaluated for quality, heterogeneity, and publication bias, and a pooled odds ratio (OR) or hazard ratio (HR) was calculated with a confidence interval of 95% (95% CI). In total, 5291 studies were collated, and after the review process, one randomized trial and seven observational studies were included, comprising 1801 EC survivors treated with HT and 6015 controls. The time-dependent analysis could be conducted for four studies, and considering the disease-free survival, the pooled HR of 0.90 (95% CI 0.28 to 2.87) showed no significant differences. However, among Black American women treated with continuous estrogen HT, the HR was 7.58 (95% CI 1.96 to 29.31), showing a significantly increased risk of recurrence for women in this ethnic group. Considering the pooled OR of all included studies 0.63 (95% CI 0.48 to 0.83), a significantly reduced risk of recurrence was found among EC survivors treated with HT. Considering the type of HT, the most risk-reducing was combined estrogen and progestin therapy and the cyclic regimen. Although supporting evidence is based mainly upon observational studies, evidence of no increased risk or even decreased risk was generally found, apart from in Black American women where a significantly increased recurrence risk was evident. The data are rather reassuring for the short-term administration of HT to symptomatic EC survivors. Future studies with a longer follow-up are necessary to better clarify the long-term effects of HT.

Does the Time of Day at Which Endocrine Therapy Is Taken Affect Breast Cancer Patient Outcomes?

Background: Non-compliance and non-persistence with endocrine therapy for breast cancer is common and usually related to treatment-induced side effects. There are anecdotal reports that simply changing the time of day when taking endocrine therapy (i.e., changing morning dosing to evening dosing or vice versa) can reduce side effects. Literature review: We conducted a literature review to evaluate whether changing the timing of tamoxifen and/or aromatase inhibitor administration impacted patient outcomes. No randomized control trials or prospective cohort studies that looked at time of day of endocrine therapy were identified through our review of literature from 1947 until August 2020. Conclusions: Given the rates of endocrine therapy non-compliance and non-persistence reported in the literature, ranging from 41–72% and 31–73%, respectively, simply changing the time of day when medications are taken could be an important strategy. We could identify no trials evaluating the effect of changes in timing of administration of endocrine therapy on breast cancer patient outcomes. Randomized control trials are clearly indicated for this simple and cost-effective intervention.

BRCA mutation carriers' perceptions on postmenopausal hormone therapy: An Italian study.

ObjectiveTo evaluate the actual perceptions of postmenopausal hormone therapy (HT) in BRCA mutation carriers (BRCAmc) in comparison with women from the general population.MethodsQuestionnaire‐based study of 83 BRCAmc and a control group of 89 women without a genetic mutation. Perceptions were evaluated by specific questions and Likert scales (−5–+5).ResultsPresent and past users of HT were more frequent in the control group (p = 0.01), with a longer time of use (p = 0.03). The preferred route of administration of HT was ‘oral’ (54.6%). The most frequently reported adverse effect of HT was venous thrombosis (0.8), while a protective effect on bone health was reported. No noticeable beneficial effects of HT have been recognised for hot flushes (0.2) and vaginal dryness (0.1). The most frequently perceived beneficial and adverse effects of HT were not significantly different between BRCA mutation carriers and controls. The greatest oncological fear was breast cancer (1.0). The protective role of HT on colorectal cancer was not known (0.1). These oncological impacts were mostly overestimated in BRCAmc, however this was not significant. Few BRCAmc would think of taking HT after risk‐reducing surgeries.ConclusionsKnowledge of the effects of HT on BRCAmc is relatively poor and they are likely to overstate its negative effects and underestimate its health benefits; however, this is not significant in comparison to the general population. More and better information should be given to BRCAmc to allow them to make informed decisions about the use of HT, especially before undergoing risk‐reducing surgeries.