French-Canadian validation of the Traumatic Grief Inventory-Self Report (TGI-SR).

The Traumatic Grief Inventory Self-Report (TGI-SR), which aims to assess both Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, has been validated in several languages. This study sought to validate the French-Canadian version. We conducted an online survey exploring the impact of the COVID-19 pandemic on grief. With data from 728 participants, the scale demonstrated high internal consistency, correlated significantly with three other scales known to measure similar concepts, and distinguished between groups known to be different. This study supports the use of the TGI-SR French-Canadian version by clinicians and researchers to assess complications of grief.

Fracture rates and economic outcomes in patients with osteoporosis prescribed risedronate gastro-resistant versus other oral bisphosphonates: a claims data analysis.

Patients with osteoporosis prescribed risedronate gastro-resistant had a lower incidence of fractures versus those prescribed other oral bisphosphonates. Administration of risedronate gastric-resistant does not require fasting, and this more convenient dosing administration may explain its improved efficacy. PURPOSE: Up to half of patients do not follow complex dosing instructions of immediate-release bisphosphonates used for the prevention of osteoporotic fractures, which can result in suboptimal effectiveness. Risedronate gastro-resistant (GR) offers a more convenient dosing option by eliminating the need for fasting. This study compares fracture rates and outcomes between osteoporosis women treated with risedronate GR (GR cohort) versus other oral bisphosphonates (other cohort). METHODS: Claims from women with osteoporosis in the USA were analyzed. Patients were classified into the two cohorts based on the first oral bisphosphonate observed (index date) and matched 1:1 based on patient characteristics. Patients were observed for ≥ 2 years following the index date. Fracture rates, health care resource utilization and costs, and treatment persistence were compared. RESULTS: In total, 2,726 patients were selected in each cohort (median age: 60.0 years). The incidence of fractures was lower in the GR versus the other cohort for any fracture sites (incidence rate ratio, 95% CI: 0.83, 0.70-0.97) and spine fractures (0.71, 0.54-0.95), although the respective rate of medication discontinuation at 2 years was 80.5% and 74.4%. Time to first fracture was delayed for the GR cohort, reaching statistical significance after 36 months. The GR cohort incurred fewer hospitalizations (incidence rate per 1,000 patient-years: GR = 106.74; other = 124.20, p < 0.05) translating into lower hospitalization costs per patient per year (GR = $3,611; other = $4,603, p < 0.05). CONCLUSIONS: Patients prescribed risedronate GR versus other bisphosphonates had a lower incidence of fractures, which may be explained by the fact that the GR formulation is absorbed even when taken with food.

Predictive Factors of Spiritual Quality of Life during the COVID-19 Pandemic: A Multivariate Analysis.

COVID-19 has led to the implementation of various social and sanitary measures, impacting populations' quality of life. Aims: Documenting the spiritual quality of life (SQoL) of university employees and students in Quebec, Canada. A survey of 2,202 employees and students was conducted using health measurement tools, including the short version of the WHOQoL-SRPB. We ran a multiple linear regression to determine which variables promote the SQoL. SQoL was very low (2.92/5). Positive mental health, religion, and age are the main predictors of the SQoL. Some dimensions of spirituality contribute more than others to the respondents' quality of life and health during the COVID-19 pandemic.

Treatment patterns, healthcare resource utilization, and costs following first-line antidepressant treatment in major depressive disorder: a retrospective US claims database analysis.

BACKGROUND: Although the symptoms of major depressive disorder (MDD) are often manageable with pharmacotherapy, response to first-line antidepressant treatment is often less than optimal. This study describes long-term treatment patterns in MDD patients in the United States and quantifies the economic burden associated with different treatment patterns following first-line antidepressant therapy. METHODS: MDD patients starting first-line antidepressant monotherapy and having continuous enrollment ≥12 months before and ≥24 months following the index date (i.e., the first documented prescription fill) were selected from the Truven Health Analytics MarketScan (2003-2014) database. Based on the type of first treatment change following initiation, six treatment cohorts were defined a priori ("persistence"; "discontinuation"; "switch"; "dose escalation"; "augmentation"; and "combination"). Treatment patterns through the fourth line of therapy within each cohort, healthcare resource utilization (HCRU), and cost analyses were restricted to patients with adequate treatment duration (defined as ≥42 days) in each line (analysis sub-sample, N = 21,088). HCRU and costs were described at the cohort and pattern levels. Treatment cohorts representing <5% of the analysis sub-sample were decided a priori not to be analyzed due to limited sample size. RESULTS: 39,557 patients were included. Mean age was 42.1 years, 61.1% of patients were female, and mean follow-up was 4.1 years. Among the analysis sub-sample, the discontinuation (49.1%), dose escalation (37.4%), and switch (6.6%) cohorts were the most common of all treatment cohorts. First-line antidepressant discontinuation without subsequent MDD pharmacotherapy (22.9%) and cycling between discontinuation and resumption (11.2%) were the two most common treatment patterns. Median time to discontinuation was 23 weeks. The switch cohort exhibited the highest HCRU (18.9 days with medical visits per-patient-per-year) and greatest healthcare costs ($11,107 per-patient-per-year) following the index date. Treatment patterns representing a cycling on and off treatment in the switch cohort were associated with the greatest healthcare costs overall. CONCLUSION: A high proportion of patients discontinue first-line antidepressant shortly after initiation. Patterns representing a cycling on and off treatment in the switch cohort were associated with the highest healthcare costs. These findings underscore challenges in effectively treating patients with MDD and a need for personalized patient management.

Rater cognition: review and integration of research findings.

BACKGROUND: Given the complexity of competency frameworks, associated skills and abilities, and contexts in which they are to be assessed in competency-based education (CBE), there is an increased reliance on rater judgements when considering trainee performance. This increased dependence on rater-based assessment has led to the emergence of rater cognition as a field of research in health professions education. The topic, however, is often conceptualised and ultimately investigated using many different perspectives and theoretical frameworks. Critically analysing how researchers think about, study and discuss rater cognition or the judgement processes in assessment frameworks may provide meaningful and efficient directions in how the field continues to explore the topic. METHODS: We conducted a critical and integrative review of the literature to explore common conceptualisations and unified terminology associated with rater cognition research. We identified 1045 articles on rater-based assessment in health professions education using Scorpus, Medline and ERIC and 78 articles were included in our review. RESULTS: We propose a three-phase framework of observation, processing and integration. We situate nine specific mechanisms and sub-mechanisms described across the literature within these phases: (i) generating automatic impressions about the person; (ii) formulating high-level inferences; (iii) focusing on different dimensions of competencies; (iv) categorising through well-developed schemata based on (a) personal concept of competence, (b) comparison with various exemplars and (c) task and context specificity; (v) weighting and synthesising information differently, (vi) producing narrative judgements; and (vii) translating narrative judgements into scales. CONCLUSION: Our review has allowed us to identify common underlying conceptualisations of observed rater mechanisms and subsequently propose a comprehensive, although complex, framework for the dynamic and contextual nature of the rating process. This framework could help bridge the gap between researchers adopting different perspectives when studying rater cognition and enable the interpretation of contradictory findings of raters' performance by determining which mechanism is enabled or disabled in any given context.

[Influence of spirituality on health status in times of pandemic]. / Influence de la spiritualité sur l'état de santé en temps de pandémie.

Spirituality is a health protection factor recognised in the scientific literature. However, few studies have evaluated its impact on French-speaking populations, in secularised societies and even fewer in the context of a pandemic. It is therefore interesting to highlight significant relationships between spiritual quality of life and health.

[Development of the concept of positive spirituality in health]. / Élaboration du concept de spiritualité positive en santé.

Positive spirituality has three central attributes: connectedness, meaning of life, and identity. Six factors are likely to contribute to its emergence and it can allow the development of ten positive consequences.

Sociographie des ritualités funéraires en temps de pandémie: des rites empêchés aux rites appropriés.

COVID-19 has led to unprecedented health and social measures in several countries, including major restrictions on funeral rituals. These restrictions concerned pre-mortem, peri-mortem and post-mortem rites. Based on a longitudinal study of 955 French-speaking Canadians bereaved of a loved one during the pandemic, this article describes the reality of these impediments. Through an analysis of the quantitative and qualitative data collected, it is possible to identify the gap between desired and realized funeral rituals during the first year of the COVID-19 pandemic. The results show important hindrances to the various desired rituals, yet some ritual and symbolic creativity by the bereaved.

La Covid-19 a entraîné dans plusieurs pays des mesures sociosanitaires inédites, notamment des restrictions majeures aux rituels funéraires. Ces empêchements ont concerné tant les rites pré-mortem, péri-mortem que post-mortem. À partir d'une étude longitudinale débutée en mars 2021 auprès de 955 personnes francophones canadiennes endeuillées d'un proche pendant la pandémie, cet article propose de décrire la réalité vécue de ces empêchements. Par une analyse des données quantitatives et qualitatives recueillies, il est possible d'identifier l'écart entre les rituels funéraires souhaités et réalisés pendant la première année de la pandémie de Covid-19. Les résultats montrent d'importantes privations des différents rites souhaités, mais également une certaine créativité rituelle et symbolique de la part des personnes endeuillées.

Treatment patterns and sequencing in patients with rheumatic diseases: a retrospective claims data analysis.

OBJECTIVES: Long-term real-world management of inflammatory rheumatic diseases remains unclear, especially with the advent of new treatment options. This study characterizes the number of advanced treatments used by patients with selected rheumatic diseases (rheumatoid arthritis [RA], psoriatic arthritis [PsA], ankylosing spondylitis, juvenile idiopathic arthritis) and provides a contemporary portrait of treatment patterns and therapeutic sequencing among patients with RA and PsA. METHOD: Patients were selected from a large US claims database and classified into disease subsamples based on the latest rheumatic diagnosis recorded before/on the day of initiation of the first advanced treatment (index date). The total number of advanced treatments was assessed within the first 5 years following the index date. Treatment patterns and therapeutic sequencing were assessed over the first 2 years. RESULTS: Approximately 20% of patients received ≥2 distinct advanced treatments during the first year following index date - the proportion increased to almost 50% among patients with 5 years of observation. Most patients (RA: 76.8%; PsA: 88.7%) initiated a tumor necrosis factor as the first advanced treatment. Over the first 2 years after the index date, 1/3 of RA and PsA patients switched to another advanced treatment. More than 50% initiated a second treatment with the same mechanism of action (MOA). A small proportion of patients received a biosimilar. CONCLUSION: Despite advent of treatments with different MOA, cycling between treatments with the same MOA was common. Further studies with longer data follow-up would be needed to assess the impact of higher adoption of biosimilars on treatment patterns/sequencing.

The Effect of Foregrounding Intended Use on Observers' Ratings and Comments in the Assessment of Clinical Competence.

PURPOSE: Some educational programs have adopted the premise that the same assessment can serve both formative and summative goals; however, how observers understand and integrate the intended uses of assessment may affect the way they execute the assessment task. The objective of this study was to explore the effect of foregrounding a different intended use (formative vs summative learner assessment) on observer contributions (ratings and comments). METHOD: In this randomized, experimental, between-groups, mixed-methods study (May-September 2017), participants observed 3 prerecorded clinical performances under formative or summative assessment conditions. Participants rated performances using a global rating tool and provided comments. Participants were then asked to reconsider their ratings from the alternative perspective (from which they were originally blinded). They received the opportunity to alter their ratings and comments and to provide rationales for their decision to change or preserve their original ratings and comments. Outcomes included participant-observers' comments, ratings, changes to each, and stated rationales for changing or preserving their contributions. RESULTS: Foregrounding different intended uses of assessment data for participant-observers did not result in differences in ratings, number or type of comments (both emphasized evaluative over constructive statements), or the ability to differentiate among performances. After adopting the alternative perspective, participant-observers made only small changes in ratings or comments. Participant-observers reported that they engage in the process in an evaluative manner despite different intended uses. CONCLUSIONS: Foregrounding different intended uses for assessments did not result in significant systematic differences in the assessment data generated. Observers provided more evaluative than constructive statements overall, regardless of the intended use of the assessment. Future research is needed to explore whether these results hold in social/workplace-based contexts and how they might affect learners.

Comparison of Assessment by a Virtual Patient and by Clinician-Educators of Medical Students' History-Taking Skills: Exploratory Descriptive Study.

BACKGROUND: A virtual patient (VP) can be a useful tool to foster the development of medical history-taking skills without the inherent constraints of the bedside setting. Although VPs hold the promise of contributing to the development of students' skills, documenting and assessing skills acquired through a VP is a challenge. OBJECTIVE: We propose a framework for the automated assessment of medical history taking within a VP software and then test this framework by comparing VP scores with the judgment of 10 clinician-educators (CEs). METHODS: We built upon 4 domains of medical history taking to be assessed (breadth, depth, logical sequence, and interviewing technique), adapting these to be implemented into a specific VP environment. A total of 10 CEs watched the screen recordings of 3 students to assess their performance first globally and then for each of the 4 domains. RESULTS: The scores provided by the VPs were slightly higher but comparable with those given by the CEs for global performance and for depth, logical sequence, and interviewing technique. For breadth, the VP scores were higher for 2 of the 3 students compared with the CE scores. CONCLUSIONS: Findings suggest that the VP assessment gives results akin to those that would be generated by CEs. Developing a model for what constitutes good history-taking performance in specific contexts may provide insights into how CEs generally think about assessment.

Economic burden of relapse/recurrence in patients with major depressive disorder.

Objective: This study was conducted to determine the incremental healthcare resource utilization (HRU) and costs associated with relapse or recurrence (R/R) in patients with major depressive disorder (MDD) treated with antidepressants (AD) in US clinical practice. Methods: In this retrospective cohort study, adult patients with MDD treated with a branded AD were selected from the Truven Health Analytics MarketScan Databases (January 1, 2004-March 31, 2015). Time to first indicator of R/R was described. Characteristics, HRU, and costs were compared between patients with and without R/R. Among patients with R/R, HRU and costs were also compared between the pre- and post-R/R period. Results: From the 22,236 selected patients, 5,541 had ≥ 1 indicator of R/R and 16,695 did not. The 3-year R/R rate varied between 21.3% and 36.4% based on pattern of AD use (continuous, switch/augmentation, or early discontinuation). Patients with and without R/R presented different characteristics-notably, more intensive prior AD use and a higher comorbidity burden. HRU and costs were high in both patients with and without R/R but substantially higher among those with R/R ($20,590 vs $12,368 per-patient-per-year (PPPY); adjusted difference [aDiff] = $7,037), mainly driven by increased inpatient (IP) services (adjusted incidence rate ratio IP days = 3.95; aDiff IP costs = $3,433 PPPY). Among patients with R/R, emergency department visits, IP days, and IP admissions were over 2-times higher during the post-R/R period and total costs increased by over 50% from $19,267 to $29,419 in the post-R/R period. Conclusions: The economic burden in MDD patients is substantial, but is significantly higher among those who experience R/R.

Drivers of treatment patterns in patients with chronic lymphocytic leukemia stopping ibrutinib or idelalisib therapies.

Novel therapies including kinase inhibitors (KI) have led to high and durable response in patients with chronic lymphocytic leukemia (CLL), however, some patients stop therapy. This study evaluates reasons for treatment changes among CLL patients who stopped KI in real-world practice. Sixty-nine US oncologists/hematologists provided patient-level data abstracted from charts of CLL adult patients who initiated a KI and later (1) switched to another anti-neoplastic regimen (Switched cohort), (2) discontinued the KI and remained untreated (Discontinued cohort), or (3) restarted the same KI after an interruption of ≥60 days (Restarted cohort). Demographics, clinical/treatment characteristics, and reasons for stopping, restarting, and switching the KI therapy were described. In the Switched cohort, reasons for stopping included disease progression (72.5%), low/no disease activity (3.9%), adverse event [AE]/ intolerance/comorbidity (15.7%), and planned cellular therapies (7.9%). In the Discontinued cohort, approximately half (46.0%) of patients stopped KI therapy because they were terminally ill/died, or were moved to best supportive care - these patients were older, had more severe disease, and high comorbidity burden. The other half (54.0% of patients) stopped due to low/no disease activity (24.0%), AEs/toxicity (12.0%), or patient-requested drug holiday (18.0%). In the Restarted cohort, the most common reasons for stopping KIs were patient request (37.3%), AEs/intolerance (31.4%), and economic reasons (10%). Patients restarted when disease progressed (60.8%) or when they recovered from the AE (33%). Reasons for KI stop and subsequent treatment patterns were varied and multifactorial, suggesting heterogeneous disease management and a need for more evidence around supporting strategies and physician education.

Economic burden following allogeneic hematopoietic stem cell transplant in patients with diffuse large B-cell lymphoma.

This study describes short-term and long-term healthcare resource utilization (HRU) and costs following an allogeneic hematopoietic stem cell transplant (HSCT) in adult patients with diffuse large B-cell lymphoma (DLBCL) in a real-world setting. Among 101 patients with DLBCL receiving an allogeneic HSCT, HRU and direct healthcare costs for up to three years after the allogeneic HSCT are described. HRU and costs were substantial, with the most intensive HRU and highest healthcare costs observed during the first year after HSCT (38 inpatient days; 68 days with office visits and average healthcare costs of $455,741). Although HRU and costs decreased over time, they remained high even in the third year after HSCT (four inpatient days; 27 days with office visits and average healthcare costs of $72,957). Overall, this study showed that the economic burden following an allogeneic HSCT in DLBCL patients is significant.

Economic Burden of HR+/HER2- Metastatic Breast Cancer Among Adult Premenopausal Women.

INTRODUCTION: Premenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) have complex treatment needs and may receive sequential combinations of endocrine therapy (ET) or chemotherapy. This study describes healthcare utilization (HRU) and costs among premenopausal women with HR+/HER2- mBC in real-world settings from a payer's perspective. METHODS: In this retrospective cohort study, premenopausal women with HR+/HER2- mBC who received ET or chemotherapy were identified from the Truven Health Analytics MarketScan database (1 January 2006-31 December 2015). The main HRU outcomes per patient per 6 months (PPP6 M) were measured during each line of therapy and included number of days in inpatient (IP) and outpatient (OP) services. Healthcare costs per patient per month (PPPM) included medical and pharmacy costs. RESULTS: A total of 3203 patients received first-line, 2194 received second-line, and 1242 received third-line therapy for mBC. Mean number of IP days PPP6 M were 1.6, 1.3, and 1.5 days in the first, second, and third lines, respectively. Mean number of days with OP services PPP6 M was 31.4, 30.9, and 23.3 in the first, second, and third lines, respectively. Among patients receiving ET, mean total healthcare costs were $6521, $4440, and $4555 PPPM in the first, second, and third line, respectively. Among patients receiving chemotherapy, mean total healthcare costs were $16,842, $12,868, and $16,129 PPPM in the first, second, and third line, respectively. These costs were mainly driven by treatment and OP costs. CONCLUSION: Real-world HRU and costs among premenopausal women with HR+/HER2- mBC are extensive. Patients who received chemotherapy incurred approximately twice the costs of patients treated with ET. FUNDING: Novartis Pharmaceutical Corp.

Treatment and Monitoring Patterns Among Premenopausal Women with HR+/HER2- Advanced Breast Cancer.

INTRODUCTION: Premenopausal women with hormone receptor positive (HR+) and human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (aBC) often present with aggressive tumor types that lead to poor prognosis, high rates of recurrence, and mortality. Although clinical guidelines provide evidence-based recommendations for optimal treatment and monitoring, there is a dearth of information regarding treatment and monitoring patterns in clinical practice. In this study, we describe treatment and monitoring patterns among premenopausal women with HR+/HER2- aBC in real-world practice. METHODS: A large US claims database was used to describe treatment patterns for patients in first, second, and third lines of therapy. Treatment monitoring included complete blood count (CBC), liver function test (LFT), and electrocardiogram (EKG) monitoring, described for the first three lines of therapy, and separately for patients receiving endocrine monotherapy (ET) and chemotherapy. RESULTS: Among 3203 patients, chemotherapy was the most common treatment used in first-line (63.6%) and second-line therapy (66.9%). ET was used in 34.4, 30.1, and 73.6% of patients in first, second, and third lines of therapy, respectively. The two most common treatment sequences were a single line of ET (27.3%), and two consecutive lines of chemotherapy followed by a line of ET (19.3%). Patients receiving chemotherapy were monitored with CBC on average more than two times per month, and for LFT one to two times per month. Patients receiving ET were monitored with CBC and LFT on average once every 2-3 months. Overall, approximately 20% of patients were monitored with an EKG at some point during each line of therapy. CONCLUSION: A considerable proportion of premenopausal women with aBC received first- and second-line chemotherapy, which appears inconsistent with current clinical guidelines. The observed treatment heterogeneity points to a lack real-world consensus on the management of premenopausal women with HR+/HER2- aBC. FUNDING: Novartis Pharmaceuticals Corporation.

The Comorbidity Burden of Hidradenitis Suppurativa in the United States: A Claims Data Analysis.

INTRODUCTION: Prior studies have reported that hidradenitis suppurativa (HS) is accompanied by a myriad of physical and mental conditions. However, given the small sample sizes and the limited number of pre-selected comorbidities, these studies do not provide a complete picture of the comorbidity burden of HS in the USA. Moreover, the relationship between HS severity and comorbidity burden has yet to be characterized. Using a large US claims database, we estimated the comorbidity burden associated with HS, stratified by disease severity. METHODS: A retrospective matched cohort design was used. Patients with HS were classified into two severity cohorts (milder and more severe) using an empirical algorithm based on treatments received. The comorbidity burden was compared between each HS cohort and their matched HS-free cohort, and between patients with milder vs. those with more severe forms of HS. RESULTS: Several physical and mental comorbidities were found to be more prevalent in both cohorts of patients with milder and more severe forms of HS than in their matched HS-free cohorts. The comorbidity burden also increased greatly as the disease progressed to more severe forms. CONCLUSIONS: The results of this study highlight the complexity of the comorbidity burden of HS patients and the need for a multidisciplinary approach to optimize the management of HS and its numerous associated comorbidities. FUNDING: AbbVie, Inc.

Dosing Patterns and Economic Burden of Palbociclib Drug Wastage in HR+/HER2- Metastatic Breast Cancer.

INTRODUCTION: Targeted therapies have revolutionized the treatment of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC). However, as for many oncology drugs, the dose of targeted therapies may need to be adjusted over time, leading to drug wastage when a dose modification is needed but the dose cannot be split or saved. This has been shown to be the case for palbociclib and has led to concerns among payers. This study described palbociclib dosing patterns and estimated the economic burden of the drug wastage associated with palbociclib dose modifications in postmenopausal women with HR+/HER2- mBC. METHODS: A large US claims database was used to identify postmenopausal women with HR+/HER2- mBC who received a palbociclib-based therapy during one of their first three lines of therapy for mBC between February 2015 (palbociclib approval) and December 2015. Dosing patterns (dosing modifications and sequences) were reported; a dose modification was defined as an increase/decrease of at least 25 mg daily compared to the preceding dose. Estimates of drug wastage costs were based on days with overlap in prescription fills for different palbociclib doses. RESULTS: A total of 473 postmenopausal palbociclib-treated women with HR+/HER2- mBC were included (first line 214; second line 157; third line 120). Over an average duration of line of therapy of approximately 4 months, dose modification was observed in 17.8%, 31.2%, and 35.0% of patients in first, second, and third line. Average overlap in prescription fills was 9.2, 9.9, and 5.4 days in first, second, and third line. This potential drug wastage resulted in an average cost of $4376, $4740, and $2592 per patient in first, second, and third line. CONCLUSIONS: This study showed that drug wastage due to palbociclib dose modification results in substantial costs. Treatment options with more flexible dosing may help reduce the costs of drug wastage. FUNDING: Novartis Pharmaceuticals Corporation.

Monitoring of Hematologic, Cardiac, and Hepatic Function in Post-Menopausal Women with HR+/HER2- Metastatic Breast Cancer.

INTRODUCTION: In the treatment of metastatic breast cancer (mBC), regular monitoring is key in helping physicians to make informed clinical decisions, managing treatment side effects, and maintaining patients' quality of life. Therefore, we investigated the monitoring frequency in post-menopausal women with HR+/HER2- mBC stratified by first-line regimen. METHODS: Treatment monitoring was assessed using two complementary data sources: a medical chart review (chart review analysis) and a commercial claims database (claims analysis). Women with post-menopausal HR+/HER2- mBC who initiated first-line therapy for mBC were selected and classified under three cohorts, based on treatment received: cyclin-dependent kinase 4/6 (CDK4/6) inhibitor (i.e., palbociclib-the only CDK4/6 approved at the time of the study), endocrine therapy (ET), and chemotherapy. Frequency of monitoring [complete blood count (CBC), electrocardiogram (EKG), and liver function test (LFT)] and laboratory abnormalities detected during the first line of therapy were analyzed. RESULTS: In the chart review analysis, 64 US oncologists abstracted medical information on 401 eligible patients, including 210 CDK4/6 users, 121 ET users, 51 chemotherapy users; 19 patients used other regimens. All patients had ≥ 1 CBC; between 8.3% (ET users) and 39.5% (CDK4/6 users) had ≥ 1 EKG; and over 98% of patients had ≥ 1 LFT across all three cohorts. Among monitored patients, 64.6% had a CBC abnormality, with anemia (39.9%), leukopenia (27.4%), and neutropenia (26.7%) being the most common. Abnormal EKG readings were detected in 8.4, 0.0%, and 7.7% of CDK4/6, ET, and chemotherapy users, respectively. LFT abnormalities were detected in 14.1-26.0% of CDK4/6 and chemotherapy users, respectively. Similar frequency of monitoring was observed in the claims analysis, with the exception of EKG monitoring, for which the proportion of patients tested was higher. CONCLUSION: Post-menopausal women with HR+/HER2- mBC receiving first-line therapy with CDK4/6, ET, or chemotherapy were regularly monitored regardless of the first-line regimen received. FUNDING: Novartis Pharmaceuticals Corporation.

Current Treatment Patterns Among Postmenopausal Women with HR+/HER2- Metastatic Breast Cancer in US Community Oncology Practices: An Observational Study.

INTRODUCTION: Recent approval of novel agents has changed the treatment landscape for post menopausal women with hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC). The objective of this study was to describe contemporary treatment patterns among postmenopausal women with HR+/HER2- mBC in the real-world setting. METHODS: Data were collected from 64 community oncologists in the US between February and June 2017 using an online medical records extraction tool. Physicians reviewed medical records and provided information on patient demographics and disease characteristics, and treatment regimens. Treatment patterns were described overall and separately by line of therapy and type of treatment received. Discontinuation rates were estimated using Kaplan-Meier analyses to account for censoring. RESULTS: Data were collected on 401 patients. Mean age at the time of mBC diagnosis was 67 years. In the first-line setting, 52.4% of patients received a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor-based regimen, most commonly with an aromatase inhibitor (AI) (39.2%) or fulvestrant (10.0%); 30.2% received endocrine therapy, most commonly an AI (21.4%) or fulvestrant (5.2%) in monotherapy, while 12.7% received a chemotherapy-based regimen. In the second-line setting, 42.9% of patients received a CDK4/6 inhibitor-based regimen, 18.4% received endocrine therapy, and 22.4% received a chemotherapy-based regimen. The 18-month discontinuation rate was 34.5% for patients receiving a CDK4/6 inhibitor-based regimen and 45.8% for patients receiving endocrine monotherapy. CONCLUSION: CDK4/6 inhibitor-based regimens were the most commonly prescribed treatment in both first- and second-line settings. A wide variety of treatment sequences were observed which suggests an absence of a standard of care for postmenopausal women with HR+/HER2- mBC in real-world practice.