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Objective: Adjuvant endocrine therapy (AET) is increasingly being prescribed for up to 10 years to people diagnosed with hormone receptor‐positive breast cancer. AET intake is often accompanied by side effects that significantly impact the well‐being of people. The way individuals cope with medication‐related side effects might play a pivotal role in their emotional adaption. Methods: This intensive‐longitudinal study investigated the association between self‐reported coping strategies (Brief COPE) and psychological well‐being (Patient Health Questionnaire‐4) among women undergoing AET. A multilevel factor analysis resulted in the identification of four coping factors, namely, problem‐focused, support‐focused, meaning‐focused, and avoidance‐focused coping. Daily coping efforts and experienced side effects were analyzed as predictors of psychological well‐being using multilevel modeling. Results: A total of 215 women (Mage = 56.5 ± 10.9 years) participated, resulting in a total of n = 2080 daily surveys (M = 9.67 ± 1.08). On average, women reported 3.7 ± 2.2 different side effects per day. Days characterized by an elevated frequency of side effects and increased burden were associated with diminished well‐being. Using more problem‐ and meaning‐focused strategies than usual to cope with side effects correlated positively with well‐being. Conversely, employing more support‐ and avoidance‐focused coping strategies than usual was linked to reduced psychological well‐being. Exploratory analyses focusing on individual coping strategies provided nuanced insights into coping behaviors. Conclusion: The present findings underscore the relationship between women's coping efforts concerning medication‐related side effects during AET and their daily well‐being. Psychosocial education (e.g., cognitive behavioral therapy) may offer valuable benefits for patients by helping them develop adaptive coping strategies to manage side effects. [ABSTRACT FROM AUTHOR]

Purpose: Weight gain after breast cancer poses health risks. We aimed to identify factors associated with weight gain during adjuvant endocrine therapy (AET). Methods: Women initiating AET enrolled in a prospective cohort. Participants completed FACT-ES plus PROMIS pain interference, depression, anxiety, fatigue, sleep disturbance and physical function measures at baseline, 3, 6, 12, 24, 36, 48 and 60 months. Treatment-emergent symptoms were defined as changes in scores in the direction indicative of worsening symptoms that exceeded the minimal important difference at 3 and/or 6 months compared to baseline. We used logistic regression to evaluate associations of clinicodemographic features and treatment-emergent symptoms with clinically significant weight gain over 60 months (defined as ≥ 5% compared to baseline) in pre- and post-menopausal participants. Results: Of 309 participants, 99 (32%) were pre-menopausal. The 60 months cumulative incidence of clinically significant weight gain was greater in pre- than post-menopausal participants (67% vs 43%, p < 0.001). Among pre-menopausal participants, treatment-emergent pain interference (OR 2.49), aromatase inhibitor receipt (OR 2.8), mastectomy, (OR 2.06) and White race (OR 7.13) were associated with weight gain. Among post-menopausal participants, treatment-emergent endocrine symptoms (OR 2.86), higher stage (OR 2.25) and White race (OR 2.29) were associated with weight gain while treatment-emergent physical function decline (OR 0.30) was associated with lower likelihood of weight gain. Conclusions: Weight gain during AET is common, especially for pre-menopausal women. Clinicodemographic features and early treatment-emergent symptoms may identify at risk individuals. Implications for cancer survivors: Patients at risk for weight gain can be identified early during AET. Clinical trials.gov identifier: NCT01937052, registered September 3, 2013. [ABSTRACT FROM AUTHOR]

Background: Electronic patient-reported outcomes (ePRO) monitoring is a useful communication tool for cancer patients and healthcare providers. In this study, we examined the impact of symptom monitoring using an ePRO app on quality of life (QoL) in postmenopausal breast cancer patients receiving adjuvant endocrine therapy. Methods: The free app "Welby My Carte ONC" was used in the study. Patients with breast cancer starting adjuvant endocrine therapy were randomly assigned in a 1:1 ratio to ePRO monitoring (ONC) and control groups. The ONC group reported five symptoms extracted from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) (insomnia, joint pain, headache, anxiety, and hot flashes) weekly for 3 months through the app. Reported symptoms were shared with medical personnel. When serious symptoms were reported, these personnel ascertained the patient's health status and provided advice over the phone. The primary endpoint was QoL measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 3 months from enrollment. Differences between groups were tested using analysis of covariance. Results: The study included 125 subjects with mean age of 64 years in the ONC group (n = 61) and 63 years in the control group (n = 64). In the ONC group, the response rate to PRO-CTCAE was about 70% or higher until week 10. The item missing rate was 0. The ONC group reported more symptoms related to joint pain and insomnia. The difference in FACT-B total score between the groups was − 1.55 (95% confidence interval: − 5.91, 2.81), indicating no significant difference. Conclusions: Symptom monitoring using ePRO early after initiation of adjuvant endocrine therapy after surgery did not improve QoL of breast cancer patients. [ABSTRACT FROM AUTHOR]

Background: Most premenopausal patients with early breast cancer (eBC) are diagnosed with hormone receptor-positive disease and therefore candidate for adjuvant endocrine therapy (ET). Patients and methods: The Gruppo Italiano Mammella (GIM) 23-POSTER (GIM23) is a multicenter, prospective, observational study conducted in 26 Italian institutions, aiming to evaluate ET choices for premenopausal patients affected by hormone receptor-positive eBC in a real-world setting. Here we report also the results in terms of type of ET prescribed according to the definition of high-risk patients by monarchE and NATALEE trials. Results: Between October 2019 and June 2022, 600 premenopausal patients were included, with a median age of 46 years. Almost half (271, 45.2 %) of the patients had stage I disease, while 254 (42.3 %) and 60 (10.0 %) patients had stage II and III, respectively. Overall, 149 (25.1 %) patients received tamoxifen alone, 83 (14.0 %) tamoxifen with ovarian function suppression (OFS), while 361 (60.9 %) received aromatase inhibitor (AI) with OFS. Patients treated with AI and OFS had higher number of metastatic axillary nodes, higher grade and more often received chemotherapy (all p

Purpose: Although younger age has been negatively associated with persistence to adjuvant endocrine therapy (ET), factors contributing to non-persistence remain poorly understood. We assessed factors associated with non-persistence to ET and described the 5-year trajectories of quality of life (QoL) and symptoms in young women (≤40 years) with hormone receptor-positive breast cancer (BC). Methods: We retrieved data on clinical characteristics and non-persistence from the medical annual records in the European cohort of the “Helping Ourselves, Helping Others: The Young Women's BC Study” (IBCSG 43-09 HOHO). Women completed surveys at baseline, biannually for three years, and annually for another seven years. Data collection included sociodemographic information, QoL aspects assessed by the Cancer Rehabilitation Evaluation System-Short Form and symptoms assessed by the Breast Cancer Prevention Trial symptom scales. Cox regression models were applied to identify factors associated with non-persistence. Results: The cumulative risk of interrupting ET within 5 years was 27.7 % (95 % CI, 21.5–35.2). The QoL subscale scores remained stable over 5 years, with slight improvements in the physical subscale. Hot flashes decreased (p

This review presents the evolution of adjuvant endocrine therapy for early hormone-dependent HER2-negative breast cancer, describes late relapse phenomenon, provides clinical rationale for escalation of treatment, analyzes the key stages of the metastatic cascade, and provides a scientific rationale for the introduction of CDK4/6 inhibitors into adjuvant treatment regimens. The main results of two large randomized studies of therapy including abemaciclib (MonarchE) and ribociclib (NATALEE) in patients with early stages of hormone-dependent HER2-negative breast cancer are presented; the oncological results of escalation of treatment and the safety of therapy are assessed.

Abstract Introduction Patients with hormone receptor positive breast cancer are recommended at least five years of adjuvant endocrine therapy, but adherence to this treatment is often suboptimal. We investigated longitudinal trends in adjuvant endocrine therapy (AET) adherence among premenopausal breast cancer patients and identified clinical characteristics, including baseline comorbidities and non-cancer chronic medication use, associated with AET adherence. Methods We included stage I–III premenopausal breast cancer patients diagnosed during 2002–2011 and registered in the Danish Breast Cancer Group clinical database who initiated AET. We used group-based trajectory modeling to describe AET adherence patterns. We also linked patients to Danish population-based registries and fit multinomial logistic models to compute odds ratios (ORs) and 95% confidence intervals (95% CIs) associating clinical characteristics with AET adherence patterns. Results We identified three adherence patterns among 4,353 women—high adherers (57%), slow decliners (36%), and rapid decliners (6.9%). Women with stage I disease (vs. stage II; OR: 1.9, 95% CI 1.5, 2.5), without chemotherapy (vs. chemotherapy; OR: 4.3, 95% CI 3.0, 6.1), with prevalent comorbid disease (Charlson Comorbidity Index score ≥ 1 vs. 0; OR: 1.6, 95% CI 1.1, 2.3), and with a history of chronic non-cancer medication use (vs. none; OR: 1.3, 95% CI 1.0, 1.8) were more likely to be rapid decliners compared with high adherers. Conclusions Women with stage I cancer, no chemotherapy, higher comorbidity burden, and history of chronic non-cancer medication use were less likely to adhere to AET. Taking steps to promote adherence in these groups of women may reduce their risk of recurrence.

Purpose: Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality; however, adherence is suboptimal. Interventions exist, yet few have improved adherence. Patient characteristics may alter uptake of an intervention to boost adherence. We examined moderators of the effect of a virtual intervention (STRIDE; #NCT03837496) on AET adherence after breast cancer. Methods: At a large academic medical center, patients taking AET (N = 100; Mage = 56.1, 91% White) were randomized to receive STRIDE versus medication monitoring. All stored their medication in digital pill bottles (MEMS Caps) which captured objective adherence. Participants self-reported adherence (Medication Adherence Report Scale) at 12 weeks post-baseline. Moderators included age, anxiety, and depressive symptoms (Hospital Anxiety and Depression Scale), AET-related symptom distress (Breast Cancer Prevention Trial Symptom Scale), and AET-specific concerns (Beliefs about Medications Questionnaire). We used hierarchical linear modeling (time × condition × moderator) and multiple regression (condition × moderator) to test the interaction effects on adherence. Results: Age (B = 0.05, SE = 0.02, p = 0.003) and AET-related symptom distress (B = −0.04, SE = 0.02, p = 0.02) moderated condition effect on self-reported adherence while anxiety (B = −1.20, SE = 0.53, p = 0.03) and depressive symptoms (B = −1.65, SE = 0.65, p = 0.01) moderated objective adherence effects. AET-specific concerns approached significance (B = 0.91, SE = 0.57, p = 0.12). Participants who received STRIDE and were older or presented with lower anxiety and depressive symptoms or AET-related symptom distress exhibited improved adherence. Post hoc analyses revealed high correlations among most moderators. Conclusions: A subgroup of patients who received STRIDE exhibited improvements in AET adherence. The interrelatedness of moderators suggests an underlying profile of patients with lower symptom burden who benefitted most from the intervention. Study registration: NCT03837496. [ABSTRACT FROM AUTHOR]

Introduction: Patients with hormone receptor positive breast cancer are recommended at least five years of adjuvant endocrine therapy, but adherence to this treatment is often suboptimal. We investigated longitudinal trends in adjuvant endocrine therapy (AET) adherence among premenopausal breast cancer patients and identified clinical characteristics, including baseline comorbidities and non-cancer chronic medication use, associated with AET adherence. Methods: We included stage I–III premenopausal breast cancer patients diagnosed during 2002–2011 and registered in the Danish Breast Cancer Group clinical database who initiated AET. We used group-based trajectory modeling to describe AET adherence patterns. We also linked patients to Danish population-based registries and fit multinomial logistic models to compute odds ratios (ORs) and 95% confidence intervals (95% CIs) associating clinical characteristics with AET adherence patterns. Results: We identified three adherence patterns among 4,353 women—high adherers (57%), slow decliners (36%), and rapid decliners (6.9%). Women with stage I disease (vs. stage II; OR: 1.9, 95% CI 1.5, 2.5), without chemotherapy (vs. chemotherapy; OR: 4.3, 95% CI 3.0, 6.1), with prevalent comorbid disease (Charlson Comorbidity Index score ≥ 1 vs. 0; OR: 1.6, 95% CI 1.1, 2.3), and with a history of chronic non-cancer medication use (vs. none; OR: 1.3, 95% CI 1.0, 1.8) were more likely to be rapid decliners compared with high adherers. Conclusions: Women with stage I cancer, no chemotherapy, higher comorbidity burden, and history of chronic non-cancer medication use were less likely to adhere to AET. Taking steps to promote adherence in these groups of women may reduce their risk of recurrence. [ABSTRACT FROM AUTHOR]

Purpose: Oral adjuvant endocrine therapy (AET) is an effective treatment for hormone receptor positive breast cancer to decrease recurrence and mortality, but adherence is poor. This study explored post-menopausal women’s experiences with AET, with a particular focus on adherence to AET as well as distress and symptoms experienced prior to and during AET treatment. Methods: Participants were recruited from a hospital registry, stratified by adherence to/discontinuation of AET. Telephone interviews followed a semi-structured interview guide and were recorded and transcribed verbatim. Transcripts were systematically coded using team-based coding, with analysis of themes using a grounded theory approach. Results: Thirty-three participants were interviewed; ages ranged from 57 to 86 years. Participants included 10 discontinued patients and 23 patients who completed their AET course or were adherent to AET at the time of interviewing. Both adherent and discontinued patients reported symptoms throughout their AET treatment course, and both attributed symptoms to factors other than AET (e.g., older age and pre-existing comorbidities). However, discontinued patients were more likely to attribute symptoms to AET and to describe difficulty managing their symptoms, with some directly citing symptoms as the reason for discontinuing AET therapy. Conversely, adherent patients were more likely to describe the necessity of taking AET, despite symptoms. Conclusions: AET adherence was associated with beliefs about AET, symptom attribution, and symptom management. Routine symptom monitoring during AET and addressing both symptoms and patients’ understanding of their symptoms may promote adherence to AET. [ABSTRACT FROM AUTHOR]

This observational, cross-sectional study conducted at the University Hospital Centre Zagreb (UHC Zagreb) aimed to explore patients’ beliefs about adjuvant endocrine therapy (AET) as well as their association with non-adherence and sociodemographic and clinical factors. Out of 420 early breast cancer (BC) patients included in the study, 79.5 % perceived AET necessary and important for their health, as measured by the Belief About Medicines Questionnaire (BMQ), with the mean necessity score (20.4 ± 3.68) significantly higher than the mean concerns score (13 ± 4.81) (p < 0.001). Based on the Medication Adherence Report Scale (MARS-5), 44.4 % (n = 182) of the participants were non-adherers, out of which 63.2 % (n = 115) were unintentional and 36.8 % (n = 67) intentional non-adherers. Significantly higher concern beliefs were found among patients that were younger (p < 0.001), employed (p < 0.001), intentionally non-adherent to AET (p = 0.006), had a lower body-mass index (p = 0.005) and a higher level of education (p < 0.001), were premenopausal at the time of diagnosis (p < 0.001), taking tamoxifen treatment (p = 0.05) and receiving ovarian suppression (p < 0.001). Younger patients should be recognized as being at risk of non-adherence as they hold greater concern beliefs about medicines.

This mixed method study developed multiple question types to understand and measure women’s perceived benefit from adjuvant endocrine therapy. We hypothesis that patients do not understand this benefit and sought to develop the questions needed to test this hypothesis and obtain initial patient estimates. From 8/2022 to 3/2023, qualitative interviews focused on assessing and modifying 9 initial varied question types asking about the overall survival (OS) benefit from adjuvant endocrine therapy. Subsequent focus groups modified and selected the optimal questions. Patients’ self-assessment of their OS benefit was compared to their individualized PREDICT model results. Fifty-three patients completed the survey; 42% Hispanic, 30% rural, and 47% with income < $39,999 per year. Patients reported adequate health care literacy (61.5%) and average confidence about treatment and medication decisions 49.4 (95% CI 24.4–59.5). From the original 9 questions, 3 modified questions were ultimately found to capture patients’ perception of this OS benefit, focusing on graphical and prose styles. Patients estimated an OS benefit of 42% compared to 4.4% calculated from the PREDICT model (p < 0.001). In this group with considerable representation from ethnic minority, rural and low-income patients, qualitative data showed that more than one modality of question type was needed to clearly capture patients’ understanding of treatment benefit. Women with breast cancer significantly overestimated their 10-year OS benefit from adjuvant endocrine therapy compared to the PREDICT model. [ABSTRACT FROM AUTHOR]

Patients with breast cancer taking adjuvant endocrine therapy (AET) experience significant symptoms impacting mood, quality of life (QOL), and AET adherence and satisfaction. The aim of this study was to examine the extent to which coping ability and self-efficacy for symptom management moderate the relationships between patients' symptom distress and their mood, QOL, and AET adherence and satisfaction. As part of a randomized controlled trial, participants completed baseline measures including: sociodemographics, symptom distress (breast cancer prevention trial symptom checklist), coping skills (measure of current status), self-efficacy (self-efficacy for managing symptoms), anxiety and depression (hospital anxiety and depression scale), QOL (functional assessment of cancer therapy - general), AET adherence (medication adherence report scale), and AET satisfaction (cancer therapy satisfaction questionnaire). We conducted moderated regression analyses to examine whether coping and self-efficacy moderated the associations of symptom distress with baseline measures. Coping skills moderated the associations of symptom distress with depression and QOL. Among those with lower coping, higher symptom distress was associated with worse depression symptoms (p =.04) and worse QOL (p < 0.001). Self-efficacy moderated the associations of symptom distress with depression symptoms and AET adherence and satisfaction. Among those with higher self-efficacy, higher symptom distress was associated with worse depression symptoms (p < 0.001), worse AET adherence (p < 0.001), and less AET satisfaction (p = 0.01). Coping skills may buffer the effect of AET symptom distress. Findings indicate the relationship between symptom distress and self-efficacy is more nuanced and requires further research to better understand. [ABSTRACT FROM AUTHOR]

Purpose: Adjuvant endocrine therapy (AET) is pivotal for hormone receptor-positive breast cancer patients, significantly enhancing survival rates. Yet, adherence to AET remains challenging due to side effects. This study delves into the lived experience of breast cancer survivors concerning AET-induced side effects and examines differences in symptom profiles between Tamoxifen and aromatase inhibitors (AIs). Methods: We interviewed 35 breast cancer survivors on AET, conducting qualitative iterative analysis using grounded theory. A codebook was developed to aid data coding and interpretation. NVIVO software facilitated comprehensive transcript analysis. Results: Survivors reported a spectrum of side effects like hot flashes, sexual issues, joint pain, stiffness, mood swings, and fertility concerns. Symptom profiles differed based on AET type. Tamoxifen users experienced more frequent sexual side effects and mood swings, while AIs were linked to joint pain, stiffness, and bone health worries. Those on AET for over 6 months expressed heightened concerns about side effects. Conclusion: Tailored patient education, aligned with AET type, empowers survivors to manage side effects using self-regulatory strategies. Acknowledging distinct symptom profiles enables informed decisions, improving adherence and quality of life. Implications: This study underscores tailored survivorship support, equipping patients with tools to manage side effects, enhancing adherence, and long-term outcomes. The findings inform the integration of comprehensive survivorship programs, emphasizing individualized strategies for managing side effects and promoting better adherence and improved quality of life. [ABSTRACT FROM AUTHOR]

Male breast cancer (BC) represents less than 1% of male tumors. Little is known about male BC characteristics, management, and survival, with many studies based on a small number of cases. Consequently, the treatment of male BC lacks specific guidelines. The aims of the study are to compare male and female breast cancer (FBC) in terms of cancer clinical and anatomopathological features and treatment approach, and to identify differences between male BC and FBC in terms of survival. Patients and methods: Data from 2006 to 2018 were retrospectively acquired. Amounts of 49 males and 680 postmenopausal females with primary non-metastatic BC who underwent breast surgery at Mauriziano Hospital or IRCCS Candiolo (TO—Italy) were included. The mean age at diagnosis for male BC was 68.6 years, and males presented a smaller tumor size than women (p < 0.05) at diagnosis. Most male BC patients received adjuvant endocrine therapy (AET) with tamoxifen (73.5%). AET drop-out rate due to side effects was 16.3% for males compared to 7.6% for women (p = 0.04). Comparing FBC and male BC, no differences have been identified in terms of DFS and OS, with a similar 10-year-relapse rate (12% male BC vs. 12.4% FBC). Propensity Score Matching by age, nodal status, pT, and molecular subtype had been performed and no differences in OS and DFS were seen between male BC and FBC. In conclusion, male BC and FBC have similar prognostic factors and survival outcomes. The drop-out rate of AET was higher in males, and side effects were the main reason for drug discontinuation.

Abstract Background High rates of discontinuation undermine the effectiveness of adjuvant endocrine therapy (AET) among hormone-receptive breast cancer patients. Patient prognosis also relies on the successful management of cardiovascular risk, which affects a high proportion of postmenopausal women. As with AET, adherence with cardiovascular drugs is suboptimal. We examined whether patient adherence with cardiovascular drugs was associated with the rate of AET discontinuation in a French nationwide claims database linked with hospitalisation data. Methods We identified postmenopausal women starting AET between 01/01/2016 and 31/12/2020 and taking at least two drugs for the primary prevention of cardiovascular disease (antihypertensive drugs, lipid-lowering drugs and platelet aggregation inhibitors) before AET initiation. Adherence was assessed for each drug class by computing the proportion of days covered. Women were categorised as fully adherent, partially adherent or fully non-adherent with their cardiovascular drug regimen based on whether they adhered with all, part or none of their drugs. AET discontinuation was defined as a 90-day gap in AET availability. Time to AET discontinuation according to levels of cardiovascular drug adherence was estimated using cumulative incidence curves, accounting for the competing risks of death and cancer recurrence. Multivariate cause-specific Cox regressions and Fine-and-Gray regressions were used to assess the relative hazards of AET discontinuation. Results In total, 32,075 women fit the inclusion criteria. Women who were fully adherent with their cardiovascular drugs had the lowest cumulative incidence of AET discontinuation at any point over the 5-year follow-up period. At 5 years, 40.2% of fully non-adherent women had discontinued AET compared with 33.5% of partially adherent women and 28.8% of fully adherent women. Both partial adherence and full non-adherence with cardiovascular drugs were predictors of AET discontinuation in the two models (cause-specific hazard ratios 1.16 [95% CI 1.10–1.22] and 1.49 [95% CI 1.39–1.58]; subdistribution hazard ratios 1.15 [95% CI 1.10–1.21] and 1.47 [95% CI 1.38–1.57]). Conclusion Clinicians should be aware that patients who do not adhere with their entire cardiovascular drug regimen are also more likely to discontinue AET. This stresses the importance of integrated care, as suboptimal adherence with both treatment components poses a threat to achieving ideal patient outcomes.

Abstract Background Validation studies of the 21‐gene recurrence score (RS) previously demonstrated that adjuvant chemotherapy plus endocrine therapy (CET) was associated with a significant survival benefit in women with node negative breast cancer (BC) and RS >31. However, the TAILORx trial, did not quantify the benefit of adjuvant CET in older women with node negative hormone receptor positive (HR+) BC with RS ≥26. We hypothesized that CET would be associated with improved overall survival (OS) compared to endocrine therapy (ET) in women >50 with HR+/HER2‐node negative BC and RS ≥26. Methods The National Cancer Database (NCDB) was queried to identify women >50 with RS ≥26 ER+/HER2‐BC pT1‐2N0M0. Chi‐square and logistic regression analysis determined the difference between ET and CET. OS was analyzed using a multivariable Cox model. Results We included 16,745 women—4740 (28.3%) received ET and 12,005 (71.7%) received CET. Women who received CET had: moderately (OR = 1.853, p 50 years of age with RS ≥26 pT1 and pT2 N0M0 HR+/HER2‐breast cancer, and which suggests that cytotoxic chemotherapy has an impact on reducing mortality that is independent of induction of premature ovarian failure.

Prior data about the influence of age at diagnosis of breast cancer on patient outcomes and survival has been conflicting. Using the Breast Cancer Outcomes Unit database at BC Cancer, this retrospective population-based study identified a cohort of 24,469 patients diagnosed with invasive breast cancer between 2005 and 2014. Median follow-up was 11.5 years. We analyzed clinical and pathological features at diagnosis and treatment specific variables compared across the following age cohorts:

Background: High rates of discontinuation undermine the effectiveness of adjuvant endocrine therapy (AET) among hormone-receptive breast cancer patients. Patient prognosis also relies on the successful management of cardiovascular risk, which affects a high proportion of postmenopausal women. As with AET, adherence with cardiovascular drugs is suboptimal. We examined whether patient adherence with cardiovascular drugs was associated with the rate of AET discontinuation in a French nationwide claims database linked with hospitalisation data. Methods: We identified postmenopausal women starting AET between 01/01/2016 and 31/12/2020 and taking at least two drugs for the primary prevention of cardiovascular disease (antihypertensive drugs, lipid-lowering drugs and platelet aggregation inhibitors) before AET initiation. Adherence was assessed for each drug class by computing the proportion of days covered. Women were categorised as fully adherent, partially adherent or fully non-adherent with their cardiovascular drug regimen based on whether they adhered with all, part or none of their drugs. AET discontinuation was defined as a 90-day gap in AET availability. Time to AET discontinuation according to levels of cardiovascular drug adherence was estimated using cumulative incidence curves, accounting for the competing risks of death and cancer recurrence. Multivariate cause-specific Cox regressions and Fine-and-Gray regressions were used to assess the relative hazards of AET discontinuation. Results: In total, 32,075 women fit the inclusion criteria. Women who were fully adherent with their cardiovascular drugs had the lowest cumulative incidence of AET discontinuation at any point over the 5-year follow-up period. At 5 years, 40.2% of fully non-adherent women had discontinued AET compared with 33.5% of partially adherent women and 28.8% of fully adherent women. Both partial adherence and full non-adherence with cardiovascular drugs were predictors of AET discontinuation in the two models (cause-specific hazard ratios 1.16 [95% CI 1.10–1.22] and 1.49 [95% CI 1.39–1.58]; subdistribution hazard ratios 1.15 [95% CI 1.10–1.21] and 1.47 [95% CI 1.38–1.57]). Conclusion: Clinicians should be aware that patients who do not adhere with their entire cardiovascular drug regimen are also more likely to discontinue AET. This stresses the importance of integrated care, as suboptimal adherence with both treatment components poses a threat to achieving ideal patient outcomes. [ABSTRACT FROM AUTHOR]

Male breast cancer (BC) represents less than 1% of male tumors. Little is known about male BC characteristics, management, and survival, with many studies based on a small number of cases. Consequently, the treatment of male BC lacks specific guidelines. The aims of the study are to compare male and female breast cancer (FBC) in terms of cancer clinical and anatomopathological features and treatment approach, and to identify differences between male BC and FBC in terms of survival. Patients and methods: Data from 2006 to 2018 were retrospectively acquired. Amounts of 49 males and 680 postmenopausal females with primary non-metastatic BC who underwent breast surgery at Mauriziano Hospital or IRCCS Candiolo (TO—Italy) were included. The mean age at diagnosis for male BC was 68.6 years, and males presented a smaller tumor size than women (p < 0.05) at diagnosis. Most male BC patients received adjuvant endocrine therapy (AET) with tamoxifen (73.5%). AET drop-out rate due to side effects was 16.3% for males compared to 7.6% for women (p = 0.04). Comparing FBC and male BC, no differences have been identified in terms of DFS and OS, with a similar 10-year-relapse rate (12% male BC vs. 12.4% FBC). Propensity Score Matching by age, nodal status, pT, and molecular subtype had been performed and no differences in OS and DFS were seen between male BC and FBC. In conclusion, male BC and FBC have similar prognostic factors and survival outcomes. The drop-out rate of AET was higher in males, and side effects were the main reason for drug discontinuation. [ABSTRACT FROM AUTHOR]

Background: Oral complications from cancer treatments are among the adverse effects breast cancer survivors can face. Yet such complications are often overlooked in cancer survivorship care. Many breast cancer survivors are receiving adjuvant endocrine therapy, but there is limited understanding of potential oral complications from this therapy. Purpose: This study aimed to compare aspects of oral health in female breast cancer survivors who were taking adjuvant endocrine therapy with those of survivors not taking such therapy. Methods: National Health and Nutrition Examination Survey data collected from January 2009 through March 2020 were used for the analysis. Female adults ages 20 years and older who had been diagnosed with breast cancer were included. Linear regression and χ2 analyses were conducted to examine aspects of oral health, using IBM SPSS Complex Samples software, version 27. Results: In our sample of 423 female breast cancer survivors, 7.1% were taking tamoxifen, 7.8% were taking anastrozole, 4.3% were taking letrozole, and 2.9% were taking exemestane. Compared with the survivors not taking such therapy, a greater proportion of those taking it had decayed teeth, gum disease/problems, and were recommended for imminent dental care after oral health examination by dentists. The survivors who were not taking adjuvant endocrine therapy had more coronal cavities. Conclusions: Data analysis showed that female breast cancer survivors taking adjuvant endocrine therapy appear more likely to have oral health issues than those not taking such therapy. Improved awareness of these issues is critical. Assessment and management guidelines to address these oral health issues are needed by health care providers. To learn more about the potential oral complications of adjuvant endocrine therapy in breast cancer survivors, the authors aimed to compare aspects of oral health in those who were taking the therapy with those who were not. [ABSTRACT FROM AUTHOR]

Background: Validation studies of the 21‐gene recurrence score (RS) previously demonstrated that adjuvant chemotherapy plus endocrine therapy (CET) was associated with a significant survival benefit in women with node negative breast cancer (BC) and RS >31. However, the TAILORx trial, did not quantify the benefit of adjuvant CET in older women with node negative hormone receptor positive (HR+) BC with RS ≥26. We hypothesized that CET would be associated with improved overall survival (OS) compared to endocrine therapy (ET) in women >50 with HR+/HER2‐node negative BC and RS ≥26. Methods: The National Cancer Database (NCDB) was queried to identify women >50 with RS ≥26 ER+/HER2‐BC pT1‐2N0M0. Chi‐square and logistic regression analysis determined the difference between ET and CET. OS was analyzed using a multivariable Cox model. Results: We included 16,745 women—4740 (28.3%) received ET and 12,005 (71.7%) received CET. Women who received CET had: moderately (OR = 1.853, p < 0.001) or poorly/undifferentiated tumors (OR = 3.875, p < 0.001), pT2 (OR = 1.356, p < 0.001), or lymph‐vascular invasion (OR = 1.206, p = 0.001). After accounting for demographic and oncologic factors, 5‐year OS rates were significantly superior in women receiving CET vs. ET alone (95.4% vs. 92.0%, Hazard Ratio = 0.680, p < 0.001). Conclusions: We observed that CET was associated with a clinically and statistically significant higher OS compared to ET alone in women >50 years of age with RS ≥26 pT1 and pT2 N0M0 HR+/HER2‐breast cancer, and which suggests that cytotoxic chemotherapy has an impact on reducing mortality that is independent of induction of premature ovarian failure. [ABSTRACT FROM AUTHOR]

Introduction: Fear of cancer recurrence (FCR) is one of the most-prevalent psychological problems among cancer survivors, and younger females who have received endocrine therapy are particularly at risk of high FCR. The aim of this study was to determine the relationship between high FCR and factors related to it in South Korean patients with breast cancer who receive adjuvant endocrine therapy (AET). Methods: This cross-sectional study recruited 326 patients with breast cancer who had received AET. All participants were asked to complete a personal information sheet, the short form of the Fear of Progression Questionnaire, and the Menopause Rating Scale. The factors associated with high FCR were analyzed using association-rule analysis. Results: The mean FCR score was 32.24 (SD = 10.22), and 137 of the 326 (42.0%) patients had high scores (≥34). Hot flushes and sweating (moderate to extremely severe), depressed mood (moderate to extremely severe), irritability (moderate to extremely severe), invasive stage, taking tamoxifen, and being married were associated with high FCR. Conclusion: Since FCR was common in patients with breast cancer who received AET, patients at a greater risk of experiencing FCR must be screened and supported. [ABSTRACT FROM AUTHOR]

Prior data about the influence of age at diagnosis of breast cancer on patient outcomes and survival has been conflicting. Using the Breast Cancer Outcomes Unit database at BC Cancer, this retrospective population-based study identified a cohort of 24,469 patients diagnosed with invasive breast cancer between 2005 and 2014. Median follow-up was 11.5 years. We analyzed clinical and pathological features at diagnosis and treatment specific variables compared across the following age cohorts: <35, 35–39, 40–49, 50–59, 60–69, 70–79, and 80 years of age and older. We assessed the impact of age on breast cancer specific survival (BCSS) and overall survival (OS) by age and subtype. There were distinct clinical-pathological and treatment pattern differences at both extremes of age at diagnosis. Patients <35 and 35–39 years old were more likely to present with higher risk features, HER2 positive or triple-negative biomarkers, and more advanced TNM stage at diagnosis. They were more likely to undergo treatment with mastectomy, axillary lymph node dissection, radiotherapy and chemotherapy. Conversely, patients ≥80 years old were generally more likely to have hormone-sensitive HER2-negative disease, and lower TNM stage at diagnosis. They were less likely to undergo surgery or be treated with radiotherapy and chemotherapy. Both younger and elderly age at breast cancer diagnosis were independent risk factors for poorer prognosis after controlling for subtype, LVI, stage, and treatment factors. This work will help clinicians to more accurately estimate patient outcomes, patterns of relapse, and provide evidence-based treatment recommendations. • Young patients are more likely to present with high-risk disease features. • Older adults are more likely to present with indolent disease features. • Both younger and older age at diagnosis are risk factors for poor prognosis. [ABSTRACT FROM AUTHOR]

Background: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence and mortality of women with hormone-receptor-positive tumors, but poor adherence remains a significant problem. The aim of this study was to analyze AET side effects and their impact on adherence to treatment. Methods: A total of 373 breast cancer patients treated with AET filled out a specific questionnaire during their follow up visits at the Breast Unit of our Centre. Results: Side effects were reported by 81% of patients, 84% of those taking tamoxifen and 80% of those taking aromatase inhibitors (AIs). The most common side effect in the tamoxifen group was hot flashes (55.6%), while in the AI group it was arthralgia (60.6%). The addition of GnRH agonists to both tamoxifen and AI significantly worsened all menopausal symptoms. Overall, 12% of patients definitively discontinued AET due to side effects, 6.4% during the first 5 years and 24% during extended therapy. Patients who had previously received chemotherapy or radiotherapy reported a significantly lower discontinuation rate. Conclusions: AET side effects represent a significant problem in breast cancer survivors leading to irregular assumption and discontinuation of therapy. Adherence to AET may be improved by trustful patient–physician communication and a good-quality care network.

Purpose: Adjuvant endocrine therapy reduces the recurrence and mortality of early hormone receptor-positive breast cancer in both pre- and postmenopausal women. The aim of this study was to investigate adjuvant tamoxifen adherence and associated factors in breast cancer survivors. Methods: This descriptive, prospective study was conducted in 2019–2020 with the participation of 531 women who survived breast cancer and were under follow-up at the Senology Institute of a hospital in Istanbul. Inclusion criteria were having completed treatment for early hormone receptor-positive breast cancer, being prescribed tamoxifen, and being 18 years or older. Data were collected using a patient information form and the Morisky Medication Adherence Scale-8 (MMAS-8). Results: The mean age of the participants was 44.9 ± 6.5 years, and the mean duration of tamoxifen use was 834.4 ± 685.7 days. The women’s mean MMAS-8 score was 6.86 ± 1.39. Medication adherence was significantly positively correlated with current age (p = 0.006) and age at diagnosis (p = 0.002). There was a statistically significant difference between tamoxifen adherence according to participants’ employment status (p = 0.028), chronic disease status (p = 0.018), loss of libido (p = 0.012), treatment-related changes in mood changes (p = 0.004), and having negative effects affecting daily life (p < 0.001). Conclusion: Overall, breast cancer survivors in this study reported moderate adherence to tamoxifen. The women’s individual characteristics and the adverse effects of treatment influenced medication adherence. Healthcare professionals can help increase adherence to this treatment, which reduces the risk of mortality, by explaining the importance of the medication, identifying and eliminating barriers to adherence, and informing women about evidence-based interventions to increase medication compliance. [ABSTRACT FROM AUTHOR]

Aromatase inhibitors (AIs) cause symptoms of musculoskeletal pain, and some mechanisms have been proposed to explain them. However, signaling pathways downstream from kinin B2 (B2R) and B1 (B1R) receptor activation and their possible sensitizing of the Transient Receptor Potential Ankyrin 1 (TRPA1) remain unknown. The interaction between the kinin receptor and the TRPA1 channel in male C57BL/6 mice treated with anastrozole (an AI) was evaluated. PLC/PKC and PKA inhibitors were used to evaluate the signaling pathways downstream from B2R and B1R activation and their effect on TRPA1 sensitization. Anastrozole caused mechanical allodynia and muscle strength loss in mice. B2R (Bradykinin), B1R (DABk), or TRPA1 (AITC) agonists induced overt nociceptive behavior and enhanced and prolonged the painful parameters in anastrozole-treated mice. All painful symptoms were reduced by B2R (Icatibant), B1R (DALBk), or TRPA1 (A967079) antagonists. We observed the interaction between B2R, B1R, and the TRPA1 channel in anastrozole-induced musculoskeletal pain, which was dependent on the activation of the PLC/PKC and PKA signaling pathways. TRPA1 seems to be sensitized by mechanisms dependent on the activation of PLC/PKC, and PKA due to kinin receptors stimulation in anastrozole-treated animals. Thus, regulating this signaling pathway could contribute to alleviating AIs-related pain symptoms, patients' adherence to therapy, and disease control. [ABSTRACT FROM AUTHOR]

Purpose: To validate the prognostic role of urokinase-type plasminogen-activator (uPA) and plasminogen activator inhibitor type-1 (PAI-1) protein expression in FFPE archived tumor samples when assessed by immunohistochemistry. Patients and methods: Fresh-frozen, paraffin-embedded (FFPE) samples from 303 postmenopausal women with hormone receptor-positive, early breast cancer were investigated. The patients had received 5 years of endocrine therapy in the prospectively randomized ABCSG-8 trial. Immunohistochemistry for stromal uPA and PAI-1 protein expression was correlated with distant recurrence-free survival (DRFS) and overall survival (OS). Results: We detected stromal uPA in 132 of 297 tumors (44.4%) and stromal PAI-1 expression in 74 out of 299 samples (24.7%). Co-expression of uPA and PAI-1 was present in 48 of 294 (16.3%) cases. Neither uPA nor PAI-1 expression was associated with tumor size, age, nodal status, grading, or quantitative receptor status. Patients whose tumor stroma expressed uPA protein had a significantly shorter DRFS (adjusted HR for relapse: 2.78; 95% CI 1.31–5.93; p = 0.008 Cox regression analysis) than women without uPA expression. No such association was seen for PAI-1 and the uPA/PAI1 ratio. After a median follow-up of 5.6 years, women with uPA-positive tumors demonstrated significantly shorter DRFS (93.3% vs. 84.8%; p

Purpose: In the genomic era, more women with low-risk breast cancer will forego chemotherapy and rely on adjuvant endocrine therapy (AET) to prevent metastatic recurrence. However, some of these patients will unfortunately relapse. We sought to understand this outcome. Preliminary work suggested that early discontinuation of AET, also known as non-persistence, may play an important role. A retrospective analysis exploring factors related to our breast cancer patients' non-persistence with AET was performed. Methods: Women who underwent Oncotype-DX® testing between 2011 and 2014 with minimum 5 years follow-up were included. 'Low risk' was defined as Oncotype score < 26. Outcomes of recurrence and persistence were determined by chart review. Patient, tumor and treatment factors were collected, and persistent versus non-persistent groups compared using multivariable ANOVA and Fisher Chi square exact test. Results: We identified six cases of distant recurrence among low-risk patients with a median follow-up of 7.7 years. Among them, five of six patients (83%) were non-persistent with AET. The non-persistence rate in our cohort regardless of recurrence was 57/228 (25%). Non-persistent patients reported more severe side effects compared with persistent patients (p = 0.002) and were more likely to be offered a switch in endocrine therapy, rather than symptom-relief (p = 0.006). In contrast, persistent patients were 10.3 times more likely to have been offered symptom-alleviating medications compared with non-persistent patients (p < 0.001). A subset analysis revealed that patients who persisted with therapy had a higher Oncotype-DX® score than patients who discontinued early (p = 0.028). Conclusion: Metastatic recurrence in low-risk breast cancer patients may be primarily due to non-persistence with endocrine therapy. Further work is needed to optimize care for patients who struggle with side effects. To our knowledge, these are the first published data suggesting that Oncotype-DX® score may influence persistence with AET. [ABSTRACT FROM AUTHOR]

Background: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence and mortality of women with hormone-receptor-positive tumors, but poor adherence remains a significant problem. The aim of this study was to analyze AET side effects and their impact on adherence to treatment. Methods: A total of 373 breast cancer patients treated with AET filled out a specific questionnaire during their follow up visits at the Breast Unit of our Centre. Results: Side effects were reported by 81% of patients, 84% of those taking tamoxifen and 80% of those taking aromatase inhibitors (AIs). The most common side effect in the tamoxifen group was hot flashes (55.6%), while in the AI group it was arthralgia (60.6%). The addition of GnRH agonists to both tamoxifen and AI significantly worsened all menopausal symptoms. Overall, 12% of patients definitively discontinued AET due to side effects, 6.4% during the first 5 years and 24% during extended therapy. Patients who had previously received chemotherapy or radiotherapy reported a significantly lower discontinuation rate. Conclusions: AET side effects represent a significant problem in breast cancer survivors leading to irregular assumption and discontinuation of therapy. Adherence to AET may be improved by trustful patient–physician communication and a good-quality care network. [ABSTRACT FROM AUTHOR]

Purpose: Characterizing oral adjuvant endocrine therapy (ET) non-initiation and non-persistence in young women with breast cancer can inform strategies to improve overall adherence in this population. Methods: We identified 693 women with hormone receptor-positive, stage I–III breast cancer enrolled in a cohort of women diagnosed with breast cancer at age ≤ 40 years. Women were classified as non-initiators if they did not report taking ET in the 18 months after diagnosis. Women who initiated but did not report taking ET subsequently (through 5-year post-diagnosis) were categorized as non-persistent. We assessed ET decision-making and used logistic regression to identify factors associated with non-initiation/non-persistence and to evaluate the association between non-persistence and recurrence. Results: By 18 months, 9% had not initiated ET. Black women had higher odds and women with a college degree had lower odds of non-initiation. Among 607 women who initiated, 20% were non-persistent. Younger age, being married/partnered, and reporting more weight problems were associated with higher odds of non-persistence; receipt of chemotherapy and greater hot flash and vaginal symptom burden were associated with lower odds of non-persistence. Adjusting for age and clinical characteristics, non-persistence was associated with lower odds of recurrence. Women who initiated were more likely to report shared decision-making than non-initiators (57% vs. 38%, p = 0.049), while women who were non-persistent were less likely to indicate high confidence with the decision than women who were persistent (40% vs. 63%, p < 0.001). Conclusion: Interventions to improve ET decision-making may facilitate initiation and address barriers to adherence in young breast cancer survivors. Trial registration: www.clinicaltrials.gov, NCT01468246. [ABSTRACT FROM AUTHOR]

Purpose: To describe medication adherence, to analyze the relationships among medication adherence, illness perception, and beliefs about medicines, and to determine the mediating effects of beliefs about medicines on the relationship in breast cancer patients with adjuvant endocrine therapy (AET) in China.Methods: A cross-sectional study was conducted on 202 breast cancer patients with AET from September 2017 to February 2019 in China. The Medication Adherence Report Scale (MARS-5), the Chinese version of the revised illness perception questionnaire for Breast Cancer (CIPQ-R-BC) and the Beliefs about Medicines Questionnaire (BMQ) were used.Results: The mean MARS-5 score of our participants was 23.72 (SD = 1.62), and 175 (86.6%) patients were adherent to medications. Moreover, medication adherence was negatively correlated with identity, environmental or immune factors, emotional representations, BMQ-specific concerns, BMQ-general overuse, and BMQ-general harm, as well as being positively correlated with coherence and the total BMQ scores. Furthermore, beliefs in the overuse about medicines functioned as mediators for the influencing effects of coherence and emotional representations on medication adherence.Conclusion: Illness perception not only directly affected medication adherence, but also indirectly affected medication adherence through the beliefs about medicines. Necessary interventions that target beliefs in the overuse about medicines in breast cancer patients with AET with low levels of coherence or high levels of emotional representations could be provided to improve the level of their medication adherence. [ABSTRACT FROM AUTHOR]

Purpose: Sexual function problems are common but under-reported among women receiving adjuvant endocrine therapy for breast cancer. Worsening scores on patient-reported outcomes (PROs) may identify those at risk for sexual function problems during treatment. We performed a secondary analysis of prospectively collected PROs in women receiving adjuvant endocrine therapy to identify factors associated with worsening sexual function. Methods: Women with stage 0–III breast cancer initiating adjuvant endocrine therapy participating in a prospective cohort completed PROs at baseline, 3, 6, 12, 24, 36, 48, and 60 months. Sexual function was evaluated by the MOS-SP measure. Other measures included PROMIS pain interference, fatigue, depression, anxiety, physical function, and sleep disturbance and the Endocrine Symptom Subscale of the FACT-ES. We evaluated associations between score worsening of at least the minimal important difference (MID) in PROMIS T-scores (4 points) and FACT-ES scores (5 points) with score worsening of at least the MID in MOS-SP scores (8 points) using logistic regression. Results: Among 300 participants, 45.7% experienced ≥ 8-point worsening of MOS-SP score at any time point compared to baseline. Worsening endocrine symptoms (OR 1.34, 95% CI 1.22–1.49, p < 0.001), worsening physical function (OR 1.09, 95% CI 1.00–1.18, p = 0.06), and prior mastectomy (OR 1.45, 95% CI 0.94–2.23, p = 0.09) were associated with MOS-SP score worsening by at least the MID. Conclusion: Worsening endocrine symptoms and physical function identified on PROs are associated with worsening sexual function during adjuvant endocrine therapy. Routine assessment of these domains with PROs may identify women at risk for sexual function problems. Trial registration number: NCT01937052; Date of Registration: 09/09/2013. [ABSTRACT FROM AUTHOR]

Purpose: Side-effects of adjuvant endocrine therapy (AET) are common in breast cancer survivors, and can affect adherence to treatment. We synthesised the evidence for strategies to self-manage these side-effects. Methods: We searched for systematic reviews and clinical guidelines on self-management strategies for AET side-effects (arthralgia, fatigue, hot flashes, gastrointestinal discomfort, nausea, vulvovaginal symptoms, and sleep disturbance). We searched oncology organisation's websites and eight databases (Inception-November 2020). Screening, data extraction and quality assessment were completed independently in duplicate. PROSPERO: 2019CRD4201914001. Results: We identified 33 systematic reviews and 18 clinical guidelines. 21% of reviews were high quality, and the average quality score for guidelines was 44%. Evidence for most strategies was absent or weak. There was consensus from a low-quality review and multiple guidelines to recommend moisturisers, gels and lubricants for vulvovaginal symptoms. Evidence was weak for physical activity for self-managing most symptoms, although two high-quality reviews indicated yoga and aerobic exercise could reduce fatigue. Primary research was often biased by weak and underpowered study designs. Eleven reviews did not report information on adverse events. Conclusions: Most self-management strategies for breast cancer survivors experiencing side-effects from AET lack evidence. Primary research is needed using high-quality well-powered designs focusing on implementable strategies. Implications for Cancer Survivors: Patients and clinicians should be aware that although the risk of harm is low for these self-management strategies, the likelihood of benefit is often unclear. Women should consider moisturisers, gels or lubricants for self-managing vulvovaginal symptoms, and yoga or aerobic exercise for alleviating fatigue. [ABSTRACT FROM AUTHOR]

Abstract Background Patients undergoing endocrine therapy for breast cancer often suffer from poor psychosocial adaptation, low compliance with endocrine therapy and poor quality of life. However, the relationship among the three is not completely clear. The aims of this study were to investigate the status of psychosocial adaptation (PSA), medication adherence and quality of life (QOL) in breast cancer women with adjuvant endocrine therapy (AET), and to analyze the influencing factors of QOL and explore the relationship among them. Methods 346 breast cancer women were selected who underwent endocrine therapy after surgery, and data collected by the general information questionnaire, the PSA questionnaire among breast cancer women with AET, Morisky Medication Adherence Scale and The Functional Assessment of Cancer Therapy-Breast (FACT-B). The relationship among the variables was investigated by univariate analysis, multiple stepwise regression analysis and mediating effect analysis. Results The scores of PSA, medication adherence and QOL were slightly above the medium level. Univariate analysis showed that there were significant differences in QOL among breast cancer women of AET with different types of exercise, medical payment methods, discomfort symptoms (headache, hypomnesis, arthralgia, perturbation), type of discomfort symptoms, medication adherence and PSA; Multi-factor analysis showed that PSA and medication adherence were the influential factors of QOL; mediating effect showed that medication adherence played a partial mediating role in PSA and QOL. Conclusion The QOL of breast cancer women with AET will be directly affected by PSA. Medication compliance has a weak mediating effect in the indirect impact of PSA on the QOL. In the future, clinical nursing work should take targeted measures to improve the PSA level of patients, and effectively improve the compliance of patients with medication, so as to better improve the QOL of breast cancer women.

Most premenopausal patients with early breast cancer (eBC) are diagnosed with hormone receptor-positive disease and therefore candidate for adjuvant endocrine therapy (ET). The Gruppo Italiano Mammella (GIM) 23-POSTER (GIM23) is a multicenter, prospective, observational study conducted in 26 Italian institutions, aiming to evaluate ET choices for premenopausal patients affected by hormone receptor-positive eBC in a real-world setting. Here we report also the results in terms of type of ET prescribed according to the definition of high-risk patients by monarchE and NATALEE trials. Between October 2019 and June 2022, 600 premenopausal patients were included, with a median age of 46 years. Almost half (271, 45.2 %) of the patients had stage I disease, while 254 (42.3 %) and 60 (10.0 %) patients had stage II and III, respectively. Overall, 149 (25.1 %) patients received tamoxifen alone, 83 (14.0 %) tamoxifen with ovarian function suppression (OFS), while 361 (60.9 %) received aromatase inhibitor (AI) with OFS. Patients treated with AI and OFS had higher number of metastatic axillary nodes, higher grade and more often received chemotherapy (all p < 0.001). According to the inclusion criteria of the monarchE and NATALEE trials, 81 patients (15.6 %) were considered high-risk for the monarchE and received AI with OFS in 88.9 % of the cases, while 231 patients (44.4 %) were considered high-risk for the NATALEE trial and received AI with OFS in 74.5 % of cases. AI with OFS is the most prescribed adjuvant ET among premenopausal patients, especially in the presence of high-risk features. • GIM23 is a prospective study including premenopausal patients with early breast cancer. • Main objective is to assess the choices of adjuvant endocrine therapy. • Aromatase inhibitor with ovarian function suppression is the most prescribed strategy. • Less prescribed strategy is tamoxifen with ovarian function suppression. • Almost half of premenopausal patients could be candidate to adjuvant CDK4/6 inhibitors. [ABSTRACT FROM AUTHOR]

Although younger age has been negatively associated with persistence to adjuvant endocrine therapy (ET), factors contributing to non-persistence remain poorly understood. We assessed factors associated with non-persistence to ET and described the 5-year trajectories of quality of life (QoL) and symptoms in young women (≤40 years) with hormone receptor-positive breast cancer (BC). We retrieved data on clinical characteristics and non-persistence from the medical annual records in the European cohort of the "Helping Ourselves, Helping Others: The Young Women's BC Study" (IBCSG 43-09 HOHO). Women completed surveys at baseline, biannually for three years, and annually for another seven years. Data collection included sociodemographic information, QoL aspects assessed by the Cancer Rehabilitation Evaluation System-Short Form and symptoms assessed by the Breast Cancer Prevention Trial symptom scales. Cox regression models were applied to identify factors associated with non-persistence. The cumulative risk of interrupting ET within 5 years was 27.7 % (95 % CI, 21.5–35.2). The QoL subscale scores remained stable over 5 years, with slight improvements in the physical subscale. Hot flashes decreased (p < 0.001), while vaginal problems intensified (p < 0.001) over time. Being married without children and having difficulties interacting and communicating with the medical team were significantly associated with non-persistence. Discussing the desire to conceive with partnered childless women and establishing a good relationship with the medical team may be important in addressing the non-persistence in young BC survivors. As recent data suggests the safety of pausing ET to conceive, this approach may be a reasonable future option to limit non-persistence. • Persistence to endocrine treatment in young women is poorly understood. • Quality of life remained stable over 5 years. • Hot flashes decreased and vaginal problems intensified over time. • Women being married without children were less likely to persist. • Good communicating with the medical team is important for persistence. [ABSTRACT FROM AUTHOR]

Objective: The use of adjuvant endocrine therapy (AET) after primary treatment of hormone receptor‐positive breast cancer reduces the risk of recurrence and mortality. However, non‐adherence is still common. Limited consideration has been given to how users deal with AET and the role of pharmaceutical care. Therefore, this study aims to obtain insight into the needs and wishes of women using AET regarding pharmaceutical care and eHealth. Methods: This is a qualitative explorative study comprising semi‐structured interviews (n = 16) and a focus group (n = 5) among women who use or used AET after primary early‐stage breast cancer (EBC) treatment using a thematic analysis approach. Results: Three themes emerged from the interviews and focus group: (1) experiences with AET use, (2) experiences with provided information and (3) needs and wishes regarding pharmaceutical care. Most women were highly motivated to use AET and indicated to have received useful information on AET. However, many expressed a strong need for more elaborate tailored and timely provided information on AET. They acknowledged the accessibility of pharmacists but reported that currently, pharmacists are hardly involved in AET care. Several women considered eHealth useful to obtain counselling and reliable information. Conclusion: Women need more comprehensive information and follow‐up in primary setting after initial cancer treatments. A more elaborate role for the pharmacy and eHealth/mHealth, especially with regard to counselling on side effects and side effect management, could potentially improve pharmaceutical care. [ABSTRACT FROM AUTHOR]

Objective: Non‐adherence to adjuvant endocrine therapy (AET) for breast cancer leads to increased recurrence and mortality risk and healthcare costs. Evidence on feasible, effective AET adherence interventions is scarce. This paper describes the systematic adaptation of the cost‐effective adherence improving self‐management strategy (AIMS) for patients with HIV to AET for women after breast cancer treatment. Methods: We followed the intervention mapping protocol for adapting interventions by conducting a needs assessment, reviewing target behaviours and determinants, reassessing behaviour change methods and adapting programme content. Therefore, we performed a literature review, consulted behavioural theory and organised nine advisory board meetings with patients and healthcare professionals. Results: Non‐adherence occurs frequently among AET users. Compared to HIV treatment, AET is less effective, and AET side effects are more burdensome. This drives AET treatment discontinuation. However, the key determinants of non‐adherence are largely similar to HIV treatment (e.g. motivation, self‐regulation and patient–provider relationship); therefore, most strategies in AIMS‐HIV also seem suitable for AIMS‐AET. Modifications were required, however, regarding supporting patients with coping with side effects and sustaining treatment motivation. Conclusion: AIMS seems to be a suitable framework for adherence self‐management across conditions and treatments. Intervention mapping offered a transparent, systematic approach to adapting AIMS‐HIV to AET. [ABSTRACT FROM AUTHOR]

Kirsti I Toivonen,1 Linda E Carlson,2,3 Joshua A Rash,4 Tavis S Campbell1 1Department of Psychology, University of Calgary, Calgary, AB, Canada; 2Department of Oncology, University of Calgary, Calgary, AB, Canada; 3Department of Psychosocial Resources, Tom Baker Cancer Centre, Calgary, AB, Canada; 4Department of Psychology, Memorial University of Newfoundland, St. John’s, NL, CanadaCorrespondence: Tavis S CampbellDepartment of Psychology, University of Calgary, 2500 University Dr NW, Calgary, T2N 1N4, AB, CanadaTel +1 403-210-8606Email t.s.campbell@ucalgary.caPurpose: Despite the efficacy of adjuvant endocrine therapy (AET) in reducing breast cancer recurrence and mortality, suboptimal AET adherence is common and hence an important clinical issue among breast cancer survivors. Delineating potentially modifiable patient-level factors associated with AET adherence may support the development of successful adherence-enhancing interventions.Patients and Methods: The present study included 133 breast cancer survivors prescribed AET recruited from a cancer pharmacy. Women completed a baseline questionnaire examining psychosocial factors and self-reported adherence and consented to their prescription records being monitored for the proceeding 12 months to ascertain proportion of days covered (PDC), an objective measure of adherence. Regression analyses were used to identify the factors most strongly associated with both self-reported and objective adherence. Exploratory moderation analyses examined whether factors were differentially associated with adherence based on AET type (aromatase inhibitors or tamoxifen).Results: Adherence was high in this sample (PDC over 12 months was 95%). Side effect severity was most strongly associated with self-reported adherence, followed by self-efficacy, and medication/healthcare system-related barriers. Medication/healthcare system-related barriers was the only factor that uniquely predicted objective adherence. Within medication/healthcare system-related barriers, fear of side effects was most strongly associated with both measures of adherence. There were no significant interactions between AET type and potentially modifiable factors in predicting self-reported or objective adherence.Conclusion: Side effects, reactions to side effects, and self-efficacy may represent modifiable targets through which AET adherence can be improved. Associations between potentially modifiable factors and adherence did not vary by AET type, despite distinct side-effect profiles.Keywords: adjuvant endocrine therapy, breast cancer, adherence, patient reported outcomes, side effects, symptom management

Emilia Montagna,1 Paola Zagami,1,2 Marianna Masiero,3,4 Ketti Mazzocco,3,4 Gabriella Pravettoni,3,4 Elisabetta Munzone1 1Division of Medical Senology, IEO European Institute of Oncology IRCCS, Milan, Italy; 2Division of Early Drug Development for Innovative Therapies, IEO European Institute of Oncology IRCCS, Milan, Italy; 3Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; 4Applied Research Division for Cognitive and Psychological Science, IEO European Institute of Oncology IRCCS, Milan, 20141, ItalyCorrespondence: Emilia MontagnaDivision of Medical Senology, European Institute of Oncology, IRCCS, Via Ripamonti 435, Milan, 20141, ItalyTel +39 02 57489439Fax +39 02 574829212Email emilia.montagna@ieo.itAbstract: Adjuvant endocrine therapy (AET) is generally proposed to all patients with hormone receptor-positive breast cancer to reduce the risk of recurrence and death. Adherence to therapy is crucial. However, non-adherence to AET is common, with estimates of up to 50% of patients not successfully completing a five-year course of treatment, and it is significantly associated with lower survival rates and a higher risk of recurrence. Currently, no gold standard is available to assess adherence. Several studies, most of them retrospective in nature, have used both direct and indirect methods to monitor the adherence to therapy in breast cancer. The indirect method is more widely used, and it is based on pharmacy prescription refills and patient administered questionnaires. On the other hand, direct methods such as a measurement of the level of the drug or its metabolites in blood or urine are much more precise, but more expensive and not routinely implemented. In this review, we analyzed the results of the major studies focused on the adherence to tamoxifen in breast cancer patients. We identified several factors associated with poor adherence, such as the side effects of therapy, the lack of shared decision-making between the physician and patient, the context in which the discussion takes place, and whether the patients are enrolled in a clinical trial. Moreover, we discussed possible methods to improve adherence to adjuvant therapy in breast cancer.Keywords: adherence, adjuvant endocrine therapy, tamoxifen, breast cancer

Objective: The aim of this study was to investigate quality-of-life (QoL) in breast cancer (BC) patients treated with adjuvant endocrine therapy (AET). Methods: We designed a cross-sectional study of 233 BC patients treated with AET and used the Functional Assessment of Cancer Therapy – Breast questionnaire. Results: No significant difference was observed between endocrine agents. Duration of AET did not affect QoL. In the entire cohort, multivariate analysis determined age (p = 0.034) and switching treatment from tamoxifen to aromatase inhibitors (p = 0.049) as significant positive coefficients of QoL, while comorbidity (p = 0.072) tended to be associated with lower scores. Education level (p = 0.001) and chemotherapy (p = 0.04) were significant predictors of QoL in the tamoxifen group, while comorbidity (p = 0.04), surgery type (p = 0.02), radiotherapy (p = 0.006) and stage (p = 0.009) had a significant impact on QoL in aromatase inhibitors group. Conclusion: Evaluating the well-being of BC patients by QoL questionnaires is of great importance to identify particular subgroups that may require supportive care. Breast cancer (BC) remains the most common cancer among women worldwide. Hormone receptor-positive (estrogen receptor- and/or progesterone receptor-positive) BC represents 70% of all cases. Advances in the treatment of disease lead to improved patient survival. As a result, quality-of-life (QoL) becomes a major concern in clinical practice. This study aimed to assess the impact of socio-demographic, clinical and treatment-related factors on QoL among patients with BC treated with adjuvant endocrine therapy. We used the Functional Assessment of Cancer Therapy – Breast questionnaire to evaluate QoL. In the entire cohort, multivariate analysis determined age and switching treatment from tamoxifen to aromatase inhibitors to be significant positive coefficients of QoL, while comorbidity tended to be associated with lower scores. Education level and chemotherapy were significant determinants of QoL in the tamoxifen group, while comorbidity, surgery type, radiotherapy and disease stage had a significant impact on QoL in the aromatase inhibitor group. These findings can be utilized to identify certain subgroups that may need greater supportive care. [ABSTRACT FROM AUTHOR]

To validate the prognostic role of urokinase-type plasminogen-activator (uPA) and plasminogen activator inhibitor type-1 (PAI-1) protein expression in FFPE archived tumor samples when assessed by immunohistochemistry. Fresh-frozen, paraffin-embedded (FFPE) samples from 303 postmenopausal women with hormone receptor-positive, early breast cancer were investigated. The patients had received 5 years of endocrine therapy in the prospectively randomized ABCSG-8 trial. Immunohistochemistry for stromal uPA and PAI-1 protein expression was correlated with distant recurrence-free survival (DRFS) and overall survival (OS). We detected stromal uPA in 132 of 297 tumors (44.4%) and stromal PAI-1 expression in 74 out of 299 samples (24.7%). Co-expression of uPA and PAI-1 was present in 48 of 294 (16.3%) cases. Neither uPA nor PAI-1 expression was associated with tumor size, age, nodal status, grading, or quantitative receptor status. Patients whose tumor stroma expressed uPA protein had a significantly shorter DRFS (adjusted HR for relapse: 2.78; 95% CI 1.31–5.93; p = 0.008 Cox regression analysis) than women without uPA expression. No such association was seen for PAI-1 and the uPA/PAI1 ratio. After a median follow-up of 5.6 years, women with uPA-positive tumors demonstrated significantly shorter DRFS (93.3% vs. 84.8%; p < 0.013 log-rank test), and tended to have a worse OS (83.0% vs. 77.3%; p = 0.106) compared to women with uPA negative tumors. This independent validation in archived tumor samples from a large prospective randomized trial confirms the clinical utility of stromal uPA evaluation by immunohistochemistry. This provides level 1b evidence for the prognostic role of stromal uPA in women with endocrine-responsive early breast cancer. • Prospective trial provides level 1b evidence. • UPA expression associated with better DDFS and OS. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to explore symptom trajectories over 24 months for hot flushes and sweating, sleep problems, joint and muscular discomfort, and physical and mental exhaustion experienced by premenopausal women diagnosed with tamoxifen-treated breast cancer. Methods: A total of 104 patients participated in the study. The menopausal symptoms were examined using the Menopausal Rating Scale at baseline, 3-6, 12, and 18-24 months after initiating tamoxifen. The changes over four time points were analyzed using repeated measures analysis of variance. The chisquare test was used to examine the differences between "no symptom-tomild" and "moderate-to-extremely severe" 3-6 months after initiating tamoxifen according to the patients' chemotherapy treatment experiences. Results: All menopausal symptoms occurred in > 70% of patients with breast cancer and persisted until 24 months. More than 50% of patients experienced four menopausal symptoms, with at least two at a serious severity level after initiating tamoxifen. Hot flushes and sweating occurred in the highest number of patients, recording high scores. Sleep problems and physical and mental exhaustion exhibited relatively high scores, even before tamoxifen initiation. There were significant changes over four time points in all symptoms. Young patients aged < 40 years experienced more severe sleep problems, and patients who had previously received chemotherapy experienced more severe joint and muscular discomfort. Conclusions: This study's findings may assist in alerting healthcare providers to menopausal symptoms that develop during tamoxifen therapy and the need for early and active intervention to minimize symptom occurrence and distress. [ABSTRACT FROM AUTHOR]

Ductal carcinoma in situ (DCIS) is an extremely heterogeneous disease in terms of clinical manifestations, morphological changes, and expression of biomarkers, which determine the risk of subsequent development of an invasive breast cancer (BC). Diagnosis and treatment of DCIS prevents the development of invasive tumors (which reduces the potential risk of death from BC); however, the prognostic value of local treatment depends on the biological characteristics of its. The tumor grade, presence of comedonecrosis and expression of estrogen receptors are the key prognostic factors in DCIS for the treatment tactics and prognosis. The clinical symptoms of DCIS are very scarce, the most of tumors is diagnosed by screening mammography; the typical sign of DCIS is malignant microcalcifications or changes of breast architectonic. The sensitivity of mammography, ultrasound and MRI directly depend on the biological characteristics of DCIS. Surgical treatment (breast-conserving surgery or mastectomy) significantly reduces the risk of BC death in women with DCIS G2/G3, and radiotherapy after breast-conserving surgery reduce the risk of local recurrence of non-invasive and invasive BC. The choice of the local treatment (breast-conserving surgery radiation therapy vs mastectomy) depend on such factors as: tumor size, localization, clear margins, and biological characteristics of DCIS. In contrast to invasive cancers, the negative margin in DCIS is more than 2 mm from the tumor. Regional lymph node involvement in DCIS occurs in less than 1% of cases; however, microinvasion is found in analyze the surgical specimen in 15% of patients, which raises the question about regional staging. Risk factors for microinvasion in DCIS are age less than 55 years, tumor lesion size more than 4.0 cm, DCIS grade G3, and tumor palpability. Adjuvant endocrine therapy with tamoxifen significantly reduces the 10-year risk of invasive recurrence by 51%, the risk of contralateral BC by 50% and the risk of death by 40%, but only for hormone-positive DCIS. HER2 overexpression is found in DCIS significantly often (up to 40% of cases) than in invasive BC, HER2+ status correlates with DCIS high grade G3, the presence of comedonecrosis and with increased risk of relapse (both non-invasive and invasive) but is not a reason for anti-HER2 therapy. DCIS low risk and DCIS high risk have not only different morphological characteristics, but also different models of biological behavior, which must be considered in the different choice of treatment tactics.

Adjuvant endocrine therapy (AET) is recommended after hormone receptor-positive breast cancer to reduce risk of recurrence, but adherence is sub-optimal in many women. Behavioral interventions have been ineffective in improving adherence rates to AET. This qualitative descriptive study investigates factors that support women in AET use and suggestions for interventions to improve AET use and management. Interviews with women who persisted with AET (n = 23), women who discontinued AET (n = 15), and healthcare providers (HCPs; oncologists, oncology residents, and pharmacists; n = 9) were conducted, transcribed, and described using thematic analysis. Data collection stopped once saturation occurred (i.e., no new codes or themes emerged during interviews). Two researchers created codes and developed themes in an iterative process; a third researcher verified the representativeness of final themes. This study was approved by the Health Research Ethics Board of Alberta (ID: HREBA.CC-17-0513). Women who persisted described being prepared for side effects and having self-management strategies, strong rationale for AET use, supportive HCPs, and available resources as relevant factors. Women who discontinued described feeling overwhelmed by side effects, information needs, drawbacks of AET, helpful/unhelpful experiences with HCPs, and contextual factors as relevant to their discontinuation. HCPs described health system-related and patient-related barriers, side effect management, and patient-provider interactions as relevant to supporting AET use. The considerable overlap in themes among the three groups suggests broad recognition of salient factors relevant to AET use and that associated strategies to improve use may be acceptable to patients and providers alike. Factors supporting AET use could include the following: education (which may be necessary but insufficient), developing a strong personal rationale for use, being prepared for side effects, having side effect management strategies, reciprocal communication between patients and HCPs, and accessible resources.

Background: A systematic review and meta-analysis was conducted to assess breast cancer (BC) outcomes among patients with early-stage hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) BC, receiving adjuvant endocrine therapy. Methods: Randomized controlled trials (RCTs) and real-world evidence (RWE) studies were identified using Ovid MEDLINE®, Embase, and Evidence-Based Medicine Reviews. Clinical and methodological similarities including alignment of outcome definitions with standardized definitions for efficacy endpoints criteria were assessed to evaluate feasibility of conducting a meta-analysis. Where feasible, 5-year probabilities of BC recurrence or death were estimated using a Bayesian hierarchical arm-based model. Results: Of 21 included studies, 8 RCTs and 4 RWE studies reported outcome data of interest. There was heterogeneity in outcome reporting, as well as variation in recurrence risk amongst studies with aligned reporting. Of the 12 studies, 10 were considered for inclusion in a meta-analysis of BC recurrence or death. Only a subgroup analysis of node-positive patients (3 studies; n = 7307) was deemed feasible. The 5-year probability of BC recurrence or death was 17.2% (95% credible interval: 14.6%–20.3%). Conclusion: Although studies reporting recurrence outcomes were limited, there remains a high risk of BC recurrence, especially among node-positive patients. Approximately 1 in 6 women with node-positive HR+/HER2- early-stage BC receiving endocrine therapy experience recurrence or death within 5-years of initiating treatment, suggesting a need for novel treatments for this population.