Oral Hormone Therapy Research Articles

Barriers to endocrine therapy adherence: perspectives of Black breast cancer survivors and their providers.

Adherence to oral endocrine therapy (ET) remains an issue for up to half of women prescribed these medications. There is emerging data that Black breast cancer survivors (BCS) have lower rates of ET adherence. Given the disparities in breast cancer recurrence and survival for Black BCS compared to their White counterparts, the goal of this study is to better understand barriers to ET adherence among Black BCS from the patient and provider perspectives. In this qualitative study, we conducted semi-structured interviews between October 29, 2021, and March 1, 2023. Interviews were recorded and transcribed, and coded data were organized into primary and secondary themes. Participants were recruited from a single academic cancer center. A convenience sample of 24 Black BCS and 9 medical oncology providers was included. Eligible BCS were 18years or older, English-speaking, diagnosed with stage I-III hormone receptor-positive breast cancer, who had initiated ET. Mean age of the BCS was 55years (interquartile range, IQR 17years). About one-fourth had a high school diploma or less (26.1%) and 47% completed a college education or higher. Approximately one-third of participants had annual household incomes of $40,000 or less (30.4%) or more than $100,000 (30.4%). Forty-three percent of the patient participants had private insurance; 11% were insured through Medicaid or the federal healthcare exchange; 26.1% had Medicare; and 13% were uninsured. Of the 9 medical oncology providers interviewed, 2 were advanced practice providers, and 7 were medical oncologists. We found 3 major themes: (1) Black BCS often had concerns about ET before initiation; (2) after initiation, both BCS and providers reported side effects as the most impactful barrier to ET adherence; and (3) survivors experienced challenges with managing ET side effects. Our results suggest that multifaceted support interventions for managing ET-related symptoms may lead to improved adherence to ET among Black women and may reduce disparities in outcomes. Multifaceted support interventions for managing ET-related symptoms may lead to improved adherence to ET among Black breast cancer survivors.

Effectiveness of nursing intervention designing protocol in Improving knowledge and adherence of women with breast cancer regarding oral hormonal therapy

Effectiveness of nursing intervention designing protocol in Improving knowledge and adherence of women with breast cancer regarding oral hormonal therapy

Risk factors for breast cancer subtypes by race and ethnicity: A scoping review of the literature.

Breast cancer is comprised of distinct molecular subtypes. Studies have reported differences in risk factor associations with breast cancer subtypes, especially by tumor estrogen receptor (ER) status, but their consistency across racial and ethnic populations has not been comprehensively evaluated. We conducted a qualitative, scoping literature review using the Preferred Reporting Items for Systematic Reviews and Meta-analysis, extension for Scoping Reviews to investigate consistencies in associations between 18 breast cancer risk factors (reproductive, anthropometric, lifestyle, and medical history) and risk of ER-defined subtypes in women who self-identify as Asian, Black or African American, Hispanic or Latina, or White. We reviewed publications between January 1, 1990 and July 1, 2022. Etiologic heterogeneity evidence (convincing, suggestive, none, or inconclusive) was determined by expert consensus. Publications per risk factor ranged from 14 (benign breast disease history) to 66 (parity). Publications were most abundant for White women, followed by Asian, Black or African American, and Hispanic or Latina women. Etiologic heterogeneity evidence was strongest for parity, followed by age at first birth, post-menopausal BMI, oral contraceptive use, and estrogen-only and combined menopausal hormone therapy. Evidence was limited for other risk factors. Findings were consistent across racial and ethnic groups, although the strength of evidence varied. The literature supports etiologic heterogeneity by ER for some established risk factors that are consistent across race and ethnicity groups. However, in non-White populations evidence is limited. Larger, more comparable data in diverse populations is needed to better characterize breast cancer etiologic heterogeneity.

The Impact of the COVID-19 Pandemic on Adherence to Endocrine Therapy for Breast Cancer in Catalonia (Spain).

Purpose. To assess the impact of the COVID-19 pandemic on adherence to oral endocrine therapy in patients diagnosed with breast cancer in the public healthcare system in Catalonia (Spain). Methods. Retrospective cohort study in patients starting endocrine therapy from 2017 to 2021. Adherence was measured during the first year of treatment, and the impact of the pandemic was calculated according to the calendar year and whether the first year of treatment included the peak period of the pandemic in our setting (March-September 2020). Analyses were performed using a chi-square test and multivariable logistic regression, with results stratified by year, age group, and drug type. Results. Mean overall adherence during the first year of treatment was 89.6% from 2017 to 2021. In contrast, the patients who started treatment in 2019 and 2020 and whose treatment included the peak pandemic period presented an adherence of 87.0% and 86.5%, respectively. Young age and tamoxifen or combination therapy were predictors of low adherence. An increase in neoadjuvant therapy was also observed in 2020. Conclusions. The COVID-19 pandemic had only a modest impact on adherence to endocrine therapy (≈3%), despite the enormous disruptions for patients, the healthcare system in general, and cancer care in particular that were occurring in that period.

Interventions to improve oral endocrine therapy adherence in breast cancer patients.

Oral endocrine therapy (OET) is recommended in prevention and treatment of hormone receptor-positive breast cancer (HR+ BC). Despite the reduced incidence, recurrence, and mortality, OET adherence is poor in this patient population. The aim of this study was to review the latest literature to identify effective interventions to improve medication adherence in patients taking OET for prevention or treatment of HR+ BC. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) framework was used to perform this review. We utilized PubMed, SCOPUS, EMBASE, Cochrane, and Web of Science to acquire articles using search terms including breast cancer, adherence, persistence, and acceptability. Inclusion criteria included publication in peer-reviewed journal, primary data source, longitudinal, patients on OET such as aromatase inhibitors (AIs) or selective estrogen receptor modulators (SERMs), measuring adherence, persistence, or acceptability. Out of 895 articles identified, 10 articles were included. Majority of patients had early-stage HR+ BC. Two out of two studies incorporating technological intervention, two out of three studies with text communication-based intervention, and three out of five studies with verbal communication-based intervention reported significant improvement in OET adherence and/or persistence. While the interventions tested so far have shown to improve OET adherence in HR+ BC patients in some studies, there is a need to design combination interventions addressing multiple barriers in this population. This study showcases effectiveness of novel interventions to improve OET adherence and the need to further develop patient-centered strategies to benefit all patients with HR+ BC.

Supraglottic myxoedema successfully treated orally.

Myxoedema coma is a severe form of hypothyroidism with multiple organ dysfunction, characterised by an altered state of consciousness and hypothermia. Intravenous thyroid hormone replacement therapy is the preferred treatment for myxoedema. The mortality rate associated with this disease is high, and early detection and intervention are essential. Supraglottal myxoedema is a rare form of periglottic oedema and can be fatal. A previously healthy 66-year-old man presented with impaired consciousness, hypothermia, and nonpitting oedema. Blood tests revealed the presence of hypothyroidism and respiratory acidosis. He was intubated for type 2 respiratory failure; however, severe laryngeal oedema made the procedure difficult to perform. Oral thyroid hormone therapy was initiated under the diagnosis of myxoedema coma. Tracheostomy was performed because of prolonged type 2 respiratory failure and laryngeal oedema. Three weeks after admission, the patient was weaned off the ventilator. Approximately a week later, laryngeal oedema improved, and the tracheostomy tube was removed. The patient was discharged and remained stable for 3 months. This case report describes a patient with comatose myxoedema and supraglottic oedema who was successfully treated with oral medication alone. This case shows that supraglottic oedema should be considered even in the absence of wheezing or other signs of upper airway obstruction. Myxoedema coma is a differential diagnosis of respiratory acidosis. In myxoedematous coma, the possibility of difficult intubation due to supraglottic oedema should be considered. Tracheostomy should be considered for supraglottic myxoedema, which often results in prolonged ventilator use. Supraglottic myxoedema can be treated with oral medications.

Adult Acne: Its Response to Therapy

Abstract Background: Although acne is principally a disorder of adolescence, the prevalence of adult acne is increasing. Adult acne has been defined as presence of acne beyond the age of 25 years. Various studies have shown that a significant percentage of adult women with acne failed to respond to treatment with systemic antibiotics and isotretinoin which indicates a need for treatment alternatives with improved effectiveness and acceptable side effects for resistant acne. Aim: This study aims to study the response of oral antibiotic therapy and oral hormonal therapy in Adult Acne. Objective: The objective of the study is to examine the response of oral antibiotic and oral hormonal therapy along with their side effects in cases diagnosed with adult acne. Material and Methods: (i) Study design: Interventional study, (ii) Basis of adequate sample size: All patients diagnosed with adult acne will be considered for study. Seventy-two adult female patients presenting with acne fulfilling the inclusion and exclusion criterias were enrolled for the study. (iii) Sampling frame and method: Written informed consent will be obtained and identity of the participants will be kept confidential. Sequential photographs will be taken after patient’s consent to check the response rate. Data will be analyzed using ‘Friedman test”. Result: Based on the results of our study, it can be concluded that although both antibiotics and hormonal therapy improved acne lesions, but results were statistically significant with hormonal therapy as compared to antibiotic therapy. Conclusion: Both antibiotic and hormonal therapies are safe and effective options for treating adult acne. All patients of adult acne may not have an underlying hormonal imbalance or hyperandrogenism, thus the role of oral antibiotics in the treatment should not be underestimated.

Randomized phase III trial evaluating motivational interviewing and text interventions to optimize adherence to breast cancer endocrine therapy (Alliance A191901): the GETSET protocol

BackgroundHormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ET medications are typically prescribed for 5 to 10 years, depending on the risk of recurrence, and must be taken daily. One limiting factor to ET efficacy is nonadherence, with high-risk groups for nonadherence including younger women and Black women.MethodsThe Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm (text message reminder (TMR), motivational interviewing (MI), TMR plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of two interventions (TMR and/or MI) on improved ET adherence, patient-reported outcomes (PROs), and resource use requirements among HR + breast cancer survivors. Participants are randomized in a 1:1:1:1 ratio to the four arms. With an assumed loss to follow-up of approximately 11%, we plan to recruit 1180 participants. Randomization is stratified based on age and race to ensure balance between the arms, and we oversample younger and Black women, with each group representing 30% of the study population. Participants randomized to an intervention will actively participate in the intervention for 9 months, and all participants will be followed for adherence data and PRO endpoints, through the use of the Pillsy cap medication event monitoring system and Alliance ePRO survey app (i.e., Patient Cloud). The primary analysis will compare Pillsy-measured ET adherence among study arms at 12 months.DiscussionThis multisite study will not only define strategies to improve adherence to breast cancer oral therapies, but it will also potentially support strategies in large cooperative research groups that can increase delivery and tolerability of ET, involve diverse patient populations in clinical research, and engage patients effectively in interventional studies, using remote and cost-effective delivery methods.Trial registrationClinicaltrials.gov NCT04379570. Registered on 7 May 2020.

Exogenous hormone therapy and non-melanoma skin cancer (keratinocyte carcinoma) risk in women: a systematic review and meta-analysis

Previous studies reported inconsistent results regarding the association between keratinocyte carcinoma (KC) and exogenous hormone therapy. This study aimed to investigate the association between the use of exogenous sex hormones and the risk of KC among women. The databases of PubMed, Ovid Medline, Cochrane, and Web of Science were searched until May 2023. A total of 5293 patients with KC and 106,424 controls were included for analysis. The meta-analysis indicated that oral contraceptives (OC) and hormonal replacement therapy (HRT) use were associated with an increased risk of squamous cell carcinoma (SCC) (OR/RR = 1.25, 95% CI 1.10 to 1.43, I2 = 41.6%, p = 0.080). Subgroup analysis showed that OC use increased the risk of SCC (OR/RR = 1.37, 95% CI 1.15 to 1.63), whereas no significant association was shown between HRT use and risk of SCC (OR/RR = 1.13, 95% CI 0.93 to 1.37). Additionally, OC and HRT use were linked to an increased risk of basal cell carcinoma (BCC) (OR/RR = 1.16, 95% CI 1.09 to 1.25, I2 = 30.1%, p = 0.188). Further subgroup analysis suggested both OC and HRT use were associated with an increased risk of BCC (OC: OR/RR = 1.13, 95% CI 1.01 to 1.25; HRT: OR/RR = 1.19, 95% CI 1.09 to 1.30). In conclusion, our findings support the hypothesis that the risk of KC among women may be affected by the use of exogenous hormones.

Relative search popularity of five advanced prostate cancer medications using Google Trends.

There are many FDA-approved drugs for advanced prostate cancer (PC), yet public interest in these drugs is not well understood. We compared public interest and state-level predictors of interest in five common oral adjunctive hormonal therapies. Google Trends™ was queried for: "Enzalutamide", "Abiraterone Acetate", "Bicalutamide", "Apalutamide", and "Darolutamide" in the United States from January 2004 to November 2022. Data are presented as relative search index (RSI) by month. RSI ranges from 0 to 100 with 100 being peak popularity, 50 being half of the peak popularity, and 0 representing insufficient data to be determined. Several drugs abruptly increased in popularity following FDA approval including abiraterone, enzalutamide, and apalutamide. All drugs decreased in popularity from January 2020 to July 2020, corresponding with the COVID-19 pandemic. In the most recent 5 years, enzalutamide and abiraterone were the most common searched drugs, with bicalutamide a close 3rd place. States that did not expand Medicaid were significantly more likely to have bicalutamide as the top search drug vs. states that expanded Medicaid (p = 0.012). Across all states with data (n = 39), higher bicalutamide RSIs were significantly associated with lower household income (r = 0.385, p = 0.02) and greater percent of uninsured adults (r = 0.426, p = 0.007). This is the first study using Google Trends to compare advanced PC drugs by search popularity. Despite the emergence of more effective medications, bicalutamide remains relatively popular, particularly in states with lower household income, more uninsured adults, or those that did not expand Medicaid, possibly due to its lower cost.

Barriers to Adherence to Oral Hormonal Therapy Among Breast Cancer Women

BACKGROUND: Oral hormonal medication is an essential part of the management of breast cancer for hormone receptor-positive patients. OBJECTIVE: This study aimed to evaluate barriers to adherence to oral hormonal therapy among breast cancer women. METHOD: A descriptive study was utilized on 200 adult women diagnosed with metastatic breast cancer, newly received oral hormonal therapy. Those women were admitted to the outpatient clinic at South Egypt Cancer Institute at Assiut University. Using interview questionnaire sheet included, demographics, medical data, patient knowledge assessment, Morisky Medication adherence scale, and factors affecting drug adherence checklist. RESULTS: The highest percentage among the studied sample their age was above 4o years (91%). Around (50%) the duration of illness was more than 5 years. 57% of patients the duration of oral hormonal therapy was more the three years. Our study explores that studied patients nearly had no knowledge regarding all items of oral hormonal therapy. In addition, most of them are not compliant with oral hormonal therapy. The most important predictor factors for medication compliance are psychological/behavioral factors. CONCLUSION: Most of the patients are not compliant with oral hormonal therapy, so, nurses should counsel cancer patients about oral hormonal therapy, addressing reasons for no adherence and handling them.

Evaluation of quality of life using CERVANTES scale-16 items in a menopausal women treated with 17-βE2 + micronized progesterone, sample extended

Background: The availability of an oral menopausal hormone therapy (MHT) consisting of a single capsule with 17βestradiol and micronized natural progesterone has several advantages, both in terms of efficacy (better sleep quality and greater comfort of use) and in safety (fewer thrombotic events and lower risk of breast and endometrial cancer).

Adherence to oral endocrine therapy in racial/ethnic minority patients with low socioeconomic status before and during the COVID-19 pandemic

BackgroundAdherence to oral endocrine therapy (OET) is crucial in ensuring its maximum benefit in the prevention and treatment of hormone receptor-positive (HR +) breast cancer (BC). Medication use behavior is suboptimal especially in racial/ethnic minorities with lower socioeconomic status (SES).AimWe aimed to assess the impact of the coronavirus disease 2019 (COVID-19) pandemic on OET adherence and identify demographic and/or clinical characteristics associated with nonadherence in racial/ethnic minorities with lower SES.MethodA retrospective study was conducted at the Harris Health System in Houston, Texas. Data were collected during the 6 months before and 6 months after the start of the pandemic. The adherence was assessed using the prescription refill data using the proportion of days covered. A multivariable logistic regression model was used to identify demographic/clinical characteristics associated with nonadherence. Eighteen years or older patients on appropriate doses of OET for prevention or treatment of BC were included.ResultsIn 258 patients, adherence was significantly lower during the pandemic (44%) compared to before the pandemic (57%). The demographic/clinical characteristics associated with OET nonadherence before the pandemic were Black/African American, obesity/extreme obesity, prevention setting, tamoxifen therapy, and 4 or more years on OET. During the pandemic, prevention setting and those not using home delivery were more likely to be nonadherent.ConclusionOET adherence was significantly reduced during the COVID-19 pandemic in racial/ethnic minority patients with low SES. Patient-centered interventions are necessary to improve OET adherence in these patients.

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.

PCR171 Longitudinal Patterns of Adherence for Oral Endocrine Therapy Among US Women with Breast Cancer: A Group-Based Trajectory Modeling Study

Breast cancer (BC) is one of the leading causes of cancer death among American women. Oral endocrine therapy (OET) including tamoxifen and aromatase inhibitors (AIs) reduces recurrence risk and is associated with better disease-free and overall survival in hormone receptor-positive (HR+) BC patients. However, poor adherence of up to 50-60% contributes to recurrences in about one-third of patients. This study aimed to evaluate longitudinal patterns of adherence to OET using a group-based trajectory model (GBTM).

A novel abiraterone acetate oral suspension for patients with metastatic prostate cancer: An open-label, phase 3, randomized trial.

5052 Background: Abiraterone acetate (AA) is a first-line oral hormone therapy for metastatic prostate cancer (mPC), but the licensed formulation is limited by large tablet size, requirement to take on an empty stomach, and pharmacokinetic variability. TAVT-45, a novel formulation of AA granules for oral suspension, offers improved oral bioavailability (allowing dose reduction), decreased food effect, and may provide an option for the ~20-30% of patients with dysphagia. This Phase 3, open-label global study (NCT04887506) aimed to establish therapeutic equivalence between TAVT-45 granules and reference AA tablets (R-AA). Methods: Patients with castrate-resistant or castrate-sensitive mPC (mCRPC or mCSPC) were randomized 1:1 to receive TAVT-45 (1 sachet of AA granules [250 mg] in water or juice, twice daily) or R-AA tablets (2 x 500 mg once daily ≥1 h before or ≥2 h after food), plus prednisone (5 mg once [mCSPC] or twice [mCRPC] daily) for 84 days. Efficacy (serum testosterone and prostate-specific antigen [PSA]) and safety were assessed. Average serum testosterone concentrations on Days 9 & 10 (primary endpoint, analyzed via analysis of covariance) were compared to show therapeutic equivalence. The key secondary endpoint was PSA-50 response (patients with ≥50% decrease in PSA from baseline at any time). mCRPC was the primary analysis population. Preliminary results are presented. Results: Of 107 randomized patients, 103 received TAVT-45 (n=54) or R-AA (n=49). The TAVT-45 and R-AA groups were well matched (mean [SD] age: 74.5 [8.45] and 74.9 [8.40] years; mCRPC: 61.1% and 61.2%). In mCRPC, serum testosterone concentrations fell rapidly from mean (SD) baseline of 9.7 (5.19) for TAVT-45 and 10.6 (7.32) ng/dL for R-AA, with all <1 ng/dL by Day 9. Therapeutic equivalence between TAVT-45 and R-AA at Days 9 & 10 was also shown in the full study population: Days 9 & 10 average rounded-up least-squares mean serum testosterone levels were comparable (TAVT-45 [n=52]: 1.004 ng/dL; R-AA [n=47]: 1.015 ng/dL), and the geometric mean ratio between groups was 0.990 (90% CI: 0.978-1.002), with the 90% CI falling within 80.0–125.0% equivalence limits. No statistical difference between TAVT-45 vs R-AA was demonstrated for PSA-50 (mCRPC 85% vs 70%; mCSPC 90% vs 95%). The frequency of treatment-emergent adverse events (TEAEs) was similar between groups; most were mild or moderate. Serious TEAEs occurred in 5 TAVT-45 and 3 R-AA patients. There were two deaths in treated patients due to cardiorespiratory arrest (TAVT-45) and prostate cancer (R-AA); neither was considered related to study drug. Conclusions: This Phase 3 study demonstrates that TAVT-45, a novel AA formulation with improved bioavailability, yields similar testosterone/PSA responses and a comparable safety profile to R-AA, and as an oral solution, may be suitable for mPC patients with dysphagia. Clinical trial information: NCT04887506 .

A case report: Diagnosis and treatment of idiopathic hypertrophic pachymeningitis

AbstractA 57‐year‐old man who suffered from a headache for 1 year, accompanied by blurred vision for 7 months and numbness in his left face for 1 week was admitted to the Affiliated Hospital of Zunyi Medical University on May 7, 2022. One year ago, the patient had no obvious precipitating factor of paroxysmal stabbing pain in the whole skull with dizziness, which could be relieved by oneself after lasting for 1–2 min each time, with about 20 episodes per day. The cranial magnetic resonance imaging revealed changes in bilateral frontal lobe ischemic foci, bilateral frontal, ethmoid, sphenoid and maxillary sinusitis, and retinal macular degeneration. After hormone shock treatment, the condition improved. He suffered from headaches again with blurred vision in the right eye 7 months ago and was initially diagnosed with multiple sclerosis. He then was discharged after improvement due to hormone shock therapy. Oral hormone therapy was continued outside the hospital, but he stopped it due to drug side effects (details remained unclear). After cutting off, he developed a headache and visited our hospital once more, the relevant tests were performed and the patient was diagnosed with idiopathic hypertrophic pachymeningitis (IHP). The symptoms were slightly abated after hormone therapy. We hope that through this case report, we can deepen the clinicians' understanding of IHP, and improve the diagnosis rate of the disease through relevant examinations in future clinical work, so that patients can receive timely treatment and the mental pressure and economic burden caused by the disease on patients are reduced.

Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients

Oral endocrine therapy (ET) is an inexpensive and effective therapy for hormone receptor-positive (HR+) breast cancer that prevents recurrence but relies upon long-term adherence for up to ten years. More than 80% of breast cancer patients have an HR+ phenotype and are candidates for ET, but approximately half discontinue or become non-adherent by five years. ET underuse is more prevalent in Black and young (<50 yrs) women, which may contribute to outcome disparities in these groups. The objective of this study was to evaluate the feasibility, acceptability, and utility of a patient-centered counseling intervention to enhance ET adherence, with a focus on the needs of Black and younger women. We conducted a single-arm pilot study of a twelve-month motivational interviewing (MI) intervention consisting of five MI counseling sessions, an interactive workbook, a resource guide, and an educational video developed and revised with iterative patient and clinician input. The eligible participants were >18 years old, English speaking, and with stage I-III HR+ breast cancer. Participants were recruited across a large academic medical center and four community sites. Feasibility and acceptability were assessed by measures of participant recruitment, retention, session participation, and patient-reported satisfaction. ET adherence at 12 months was assessed by self-report and medication event monitoring system (MEMS) caps using a continuous measure of the proportion of days covered (PDC) as well as a dichotomous measure of the optimal adherence, defined as >80% PDC. Forty-two women initiated the intervention, of whom thirty-five participants (83%) completed outcome assessments at 12 months, including thirteen Black and twenty-two non-Black participants. The average participant age was 54.8 years (range: 25-73). Overall, 97% completed at least three MI sessions and 83% completed at least four sessions. Participant retention and satisfaction were high, particularly among Black women. Self-reported adherence at 12 months was 88% overall (100% in Black women and 81% in non-Black women). The majority of women also achieved 80% of days adherent using MEMS caps, with a greater adherence in Black women. This study demonstrates the feasibility, acceptability, and early promise of the effectiveness of an MI counseling-based intervention to promote ET adherence and prevent breast cancer recurrence in diverse populations.

Adherence to oral anticancer hormonal therapy in breast cancer patients and its relationship with treatment satisfaction: an important insight from a developing country

BackgroundHormone-positive breast cancer is the most common type and represents a burden in all countries. Treatment satisfaction might be a predictor for adherence, as higher satisfaction with medication encourages patients to adhere appropriately to the medication and, consequently, successfully achieve the treatment goals. The present study evaluated the adherence of women with hormone-positive breast cancer to oral hormonal drugs and correlated it with treatment satisfaction and other sociodemographic and clinical factors.MethodsA cross-sectional design was applied. This study included two cancer centers. Data were collected from patients through face-to-face interviews and medical record reviews. The Medication Adherence Scale was adapted to assess medication adherence, and the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 was adopted to measure treatment satisfaction.ResultsThe final analysis included 106 patients, with a mean age ± SD of 51.9 ± 1.2. Approximately 35% were hospitalized in the past year. Current hormonal therapy among cancer patients included letrozole (38.7%), tamoxifen (31.1%), exemestane (17%), and anastrozole (13.2%). The median adherence score was 5.0 [4.8–6.0], and 62.3% adhered fully to their oral hormonal drugs in the past week. The median scores of effectiveness, side effects, convenience, and global satisfaction were 66.67 [61.11.0–72.22], 75.00 [48.44–100.00], 66.67 [66.67–72.22], and 71.43 [57.14–78.57], respectively. A significantly lower adherence score was identified in patients living in camps (p = 0.020). Patients with comorbidities and those who continued on the same hormonal therapy had higher adherence scores, although they were not statistically significant. Multiple linear regression analysis showed that two domains of treatment satisfaction, side effects (p = 0.013) and global satisfaction (p = 0.018), were predictors of adherence to oral hormonal drugs.ConclusionsThe current study revealed a significant association between treatment satisfaction and adherence to oral hormonal therapy. We recommend creating a specialized scale to measure adherence, considering the psychosocial factors that affect hormonal anticancer medication adherence.

Association of Plasma Metabolomic Biomarkers With Persistent Tinnitus

Persistent tinnitus is common, disabling, and difficult to treat. To evaluate the association between circulating metabolites and persistent tinnitus. This was a population-based case-control study of 6477 women who were participants in the Nurses' Health Study (NHS) and NHS II with metabolomic profiles and tinnitus data. Information on tinnitus onset and frequency was collected on biennial questionnaires (2009-2017). For cases, metabolomic profiles were measured (2015-2021) in blood samples collected after the date of the participant's first report of persistent tinnitus (NHS, 1989-1999 and 2010-2012; NHS II, 1996-1999). Data analyses were performed from January 24, 2022, to January 14, 2023. In total, 466 plasma metabolites from 488 cases of persistent tinnitus and 5989 controls were profiled using 3 complementary liquid chromatography tandem mass spectrometry approaches. Logistic regression was used to estimate odds ratios (ORs) of persistent tinnitus (per 1 SD increase in metabolite values) and 95% CIs for each individual metabolite. Metabolite set enrichment analysis was used to identify metabolite classes enriched for associations with tinnitus. Of the 6477 study participants (mean [SD] age, 52 [9] years; 6477 [100%] female; 6121 [95%] White individuals) who were registered nurses, 488 reported experiencing daily persistent (≥5 minutes) tinnitus. Compared with participants with no tinnitus (5989 controls), those with persistent tinnitus were slightly older (53.0 vs 51.8 years) and more likely to be postmenopausal, using oral postmenopausal hormone therapy, and have type 2 diabetes, hypertension, and/or hearing loss at baseline. Compared with controls, homocitrulline (OR, 1.32; (95% CI, 1.16-1.50); C38:6 phosphatidylethanolamine (PE; OR, 1.24; 95% CIs, 1.12-1.38), C52:6 triglyceride (TAG; OR, 1.22; 95% CIs, 1.10-1.36), C36:4 PE (OR, 1.22; 95% CIs, 1.10-1.35), C40:6 PE (OR, 1.22; 95% CIs, 1.09-1.35), and C56:7 TAG (OR, 1.21; 95% CIs, 1.09-1.34) were positively associated, whereas α-keto-β-methylvalerate (OR, 0.68; 95% CIs, 0.56-0.82) and levulinate (OR, 0.60; 95% CIs, 0.46-0.79) were inversely associated with persistent tinnitus. Among metabolite classes, TAGs (normalized enrichment score [NES], 2.68), PEs (NES, 2.48), and diglycerides (NES, 1.65) were positively associated, whereas phosphatidylcholine plasmalogens (NES, -1.91), lysophosphatidylcholines (NES, -2.23), and cholesteryl esters (NES,-2.31) were inversely associated with persistent tinnitus. This population-based case-control study of metabolomic profiles and tinnitus identified novel plasma metabolites and metabolite classes that were significantly associated with persistent tinnitus, suggesting that metabolomic studies may help improve understanding of tinnitus pathophysiology and identify therapeutic targets for this challenging disorder.