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Background: OncotypeDx is a prognostic and predictive genomic assay used in early-stage hormone receptor-positive, HER2- (HR+/HER2-) breast cancer. It is used to inform adjuvant chemotherapy decisions, but not all eligible women receive testing. We aimed to assess variation in testing by demographics and geography, and to determine whether testing was associated with chemotherapy. Methods: For 1,615 women in the Carolina Breast Cancer Study with HR+/HER2-, Stage I-II tumors, we estimated prevalence differences (PD) and 95% confidence intervals (CI) for receipt of OncotypeDx genomic testing in association with and sociodemographic characteristics. We assessed associations between testing and chemotherapy receipt overall and by race. Finally, we calculated the proportion of eligible women receiving OncotypeDx by county-level rurality, census tract-level socioeconomic status, and Area Health Education Center regions. Results: 38% (N = 609) of potentially eligible women were tested, with lower testing prevalences in Black (31%; PD, -11%; 95% CI, -16%-6%) and low-income women (24%; PD, -20%; 95% CI, -29% to -11%) relative to non-Black and higher income women. Urban participants were less likely to be tested than rural participants, though this association varied by region. Among women with low genomic risk tumors, tested participants were 29% less likely to receive chemotherapy than untested participants (95% CI, -40% to -17%). Racial differences in chemotherapy were restricted to untested women. Conclusions: Both individual and area-level socioeconomics predict likelihood of OncotypeDx testing. [ABSTRACT FROM AUTHOR]

Background: Studies evaluating the effects of cancer treatments are prone to immortal time bias that, if unaddressed, can lead to treatments appearing more beneficial than they are. Methods: To demonstrate the impact of immortal time bias, we compared results across several analytic approaches (dichotomous exposure, dichotomous exposure excluding immortal time, time-varying exposure, landmark analysis, clone-censor-weight method), using surgical resection among women with metastatic breast cancer as an example. All adult women diagnosed with incident metastatic breast cancer from 2013-2016 in the National Cancer Database were included. To quantify immortal time bias, we also conducted a simulation study where the "true" relationship between surgical resection and mortality was known. Results: 24,329 women (median age 61, IQR 51-71) were included, and 24% underwent surgical resection. The largest association between resection and mortality was observed when using a dichotomized exposure [HR, 0.54; 95% confidence interval (CI), 0.51-0.57], followed by dichotomous with exclusion of immortal time (HR, 0.62; 95% CI, 0.59-0.65). Results from the time-varying exposure, landmark, and clone-censor-weight method analyses were closer to the null (HR, 0.67-0.84). Results from the plasmode simulation found that the time-varying exposure, landmark, and clone-censor-weight method models all produced unbiased HRs (bias -0.003 to 0.016). Both standard dichotomous exposure (HR, 0.84; bias, -0.177) and dichotomous with exclusion of immortal time (HR, 0.93; bias, -0.074) produced meaningfully biased estimates. Conclusions: Researchers should use time-varying exposures with a treatment assessment window or the clone-censor-weight method when immortal time is present. Impact: Using methods that appropriately account for immortal time will improve evidence and decision-making from research using real-world data. [ABSTRACT FROM AUTHOR]

Background: Breast cancers in recently postpartum women may have worse outcomes, but studies examining tumor molecular features by pregnancy recency have shown conflicting results. Methods: This analysis used Carolina Breast Cancer Study data to examine clinical and molecular tumor features among women less than 50 years of age who were recently (=10 years prior) or remotely (>10 years prior) postpartum, or nulliparous. Prevalence odds ratios (POR) and 95% confidence intervals (CI) were estimated using multivariable models. Results: Recently postpartum women (N = 618) were more frequently lymph node-positive [POR (95% CI): 1.66 (1.26-2.19)], estrogen receptor (ER)-negative [1.37 (1.02-1.83)], and IHC-based triple negative [1.57 (1.00-2.47)] compared with nulliparous (N = 360) women. Some differences were identified between recent versus remotely postpartum; smaller tumor size [0.67 (0.52-0.86)], p53 wildtype [0.53 (0.36-0.77)], and non-basal-like phenotype [0.53 (0.33-0.84)] were more common among recently postpartum. Recently postpartum (vs. nulliparous) had significant enrichment for adaptive immunity, T cells, B cells, CD8 T cells, activated CD8 T cells/natural killer (NK) cells, and T follicular helper (Tfh) cells and higher overall immune cell scores. These differences were attenuated in remotely (compared with recently) postpartum women. Conclusions: These results suggest a dominant effect of parity (vs. nulliparity) and a lesser effect of pregnancy recency on tumor molecular features, although tumor immune microenvironments were altered in association with pregnancy recency. [ABSTRACT FROM AUTHOR]

To evaluate the cost-effectiveness of endocrine therapy (ET), radiation therapy (XRT), and combination ET + XRT as post-surgical treatment for older women with early-stage breast cancer from the societal perspective. We constructed a Markov state-transition model consisting of three mutually exclusive health-states: Disease-Free, Recurrence, or Death. Osteoporotic fracture, radiation-induced breast fibrosis, and radiation pneumonitis were modeled as treatment-related adverse events (AEs). Cancer registry-linked-Medicare data were used to assess probability of recurrence and total costs, after propensity adjustment to account for treatment selection, among women aged >65 years diagnosed with estrogen receptor positive or progesterone receptor positive (ER+/PR+) breast cancer receiving ET, XRT, or ET + XRT in 2007–2011. Following randomized controlled trials, overall survival was assumed equivalent, but locoregional recurrence varied. Indirect costs and health-state utilities were literature-driven and varied in sensitivity analyses. Costs and outcomes were discounted at 3% annually. In a cohort of 10,000 women over ten years, we estimated 1620 total recurrences in the ET-only group, 1296 in the XRT-only group, and 1076 with ET + XRT. Compared to ET-only, the base-case incremental cost-effectiveness ratio (ICER) was $10,826 per quality-adjusted life-year (QALY)-gained for XRT-only and $26,834/QALY-gained for ET + XRT. Similarities in cost and effectiveness between treatments led to highly sensitive results. We also present clinically-relevant patient preference scenarios for recurrence risk-averse patients and near-term AE risk-averse patients. The cost-effectiveness of regimens including ET and/or XRT in older women with early-stage breast cancer is sensitive to small differences in costs, as well as risk of, and utilities associated with, locoregional recurrence, suggesting that patient preferences concerning treatment benefits and risks should be considered by physicians. [ABSTRACT FROM AUTHOR]

Recent clinical trials support de-escalation of adjuvant radiation therapy following lumpectomy in some older women with low-risk HR+ breast cancers planning to take endocrine therapy. The adoption of these findings into clinical practice, and the effectiveness of de-escalated therapy in real-world populations, remain under investigation. We evaluated use of adjuvant radiation therapy and/or endocrine therapy among older women with T1-2 node-negative, HR+ breast cancer in the United States between 2007 and 2011. The study included patients from the Surveillance, Epidemiology and End Results-Medicare linked database and the North Carolina Cancer Information and Population Health Resource database. Radiation therapy was received by 65.5% of patients, with no decrease over time. Older women and those with T2 (compared to T1) tumors were less likely to receive radiation therapy. In propensity-adjusted analyses, both radiation therapy alone (HR 0.75, 95% CI 0.67–0.84) and radiation + endocrine therapy (HR 0.62, 95% CI 0.54–0.69) were associated with significantly lower recurrence risk compared to endocrine therapy alone. Non-adherence to endocrine therapy was common (37%) and similar across groups. With a median follow-up of 48 months (range 13–84), we were not able to detect an association of non-adherence with recurrence risk in endocrine therapy-containing treatment arms. Most older women with stage I HR+ breast cancers continue to receive radiation, at higher rates than patients with node-negative stage II tumors. These findings suggest that while multiple evidence-based treatment options exist in these patients, improvements are needed to ensure that radiation therapy is applied equitably and rationally. [ABSTRACT FROM AUTHOR]

A cancer diagnosis can influence medication adherence for chronic conditions by shifting care priorities or reinforcing disease prevention. This study describes changes in adherence to medications for treating three common chronic conditions – diabetes, hyperlipidemia, and hypertension – among older adults newly diagnosed with non-metastatic breast, colorectal, lung, or prostate cancer. We identified Medicare beneficiaries aged ≥66 years newly diagnosed with cancer and using medication for at least one chronic condition, and similar cohorts of matched individuals without cancer. To assess medication adherence, proportion of days covered (PDC) was measured in six-month windows starting six-months before through 24 months following cancer diagnosis or matched index date. Generalized estimating equations were used to estimate difference-in-differences (DID) comparing changes in PDCs across cohorts using the pre-diagnosis window as the referent. Analyses were run separately for each cancer type-chronic condition combination. Across cancer types and non-cancer cohorts, adherence was highest for anti-hypertensives (90–92%) and lowest for statins (77–79%). In older adults with colorectal and lung cancer, adherence to anti-diabetics and statins declined post-diagnosis compared with the matched non-cancer cohorts, with estimates ranging from a DID of −2 to −4%. In older adults with breast and prostate cancer cohorts, changes in adherence for all medications were similar to non-cancer cohorts. Our findings highlight variation in medication adherence by cancer type and chronic condition. As many older adults with early stage cancer eventually die from non-cancer causes, it is imperative that cancer survivorship interventions emphasize medication adherence for other chronic conditions. [ABSTRACT FROM AUTHOR]

Background: The pharmacy reference database, Micromedex, lists concomitant hydrochlorothiazide and cyclophosphamide use as a potential, major drug-drug interaction (DDI), although only one small, single-center study supports this claim. Our objective was to estimate associations between this potential DDI and two adverse chemotherapy-related events, neutropenia-related hospitalizations and treatment regimen discontinuation, among a cohort of women with breast cancer initiating adjuvant chemotherapy containing cyclophosphamide. Methods: Using linked Surveillance, Epidemiology, and End Results Program (SEER)-Medicare data, we included women 66 years and older with breast cancer diagnosis between 2007 and 2011, who initiated a regimen containing cyclophosphamide. Risk ratios (RR) and 95% confidence intervals for adverse outcomes comparing women exposed versus unexposed to the potential DDI were assessed using modified multivariable Poisson regression adjusting for potential confounders. Results: In total, 27% of women receiving cyclophosphamide treatment were exposed to concomitant hydrochlorothiazide, of which 11% experienced a neutropenia-related hospitalization and 21% discontinued their chemotherapy regimen prior to completion. Adjusted risks of both adverse events were similar between those exposed and unexposed to the potential DDI [neutropenia-related hospitalization: adjusted RR (aRR) = 0.92 (0.70-1.21); treatment discontinuation: aRR = 1.00 (0.96-1.05)]. Conclusions: Our results do not support an association between concomitant hydrochlorothiazide use and two clinically relevant adverse chemotherapy-related events. [ABSTRACT FROM AUTHOR]

Background: The implementation science literature has contributed important insights regarding the influence of formal policies and practices on health care innovation implementation, whereas informal implementation policies and practices have garnered little attention. The broader literature suggests that informal implementation policies and practices could also influence innovation use. Purpose: We used the Organizational Theory of Innovation Implementation to further understand the role of formal and informal implementation policies and practices as determinants of implementation effectiveness. We examined their role within the context of initiatives to increase palliative care consultation in inpatient oncology. Methods: We used a case study design in two organizational settings within one academic medical center: medical and gynecologic oncology. We completed semistructured interviews with medical (n = 12) and gynecologic (n = 10) oncology clinicians using questions based on organizational theory. Quantitative data assessed implementation effectiveness, defined as aggregated palliative care consult rates within oncology services from 2010 to 2016. Four palliative care clinicians were interviewed to gain additional implementation context insights. Results: Medical oncology employed multiple formal policies and practices including training and clinician prompting to support palliative care consultation and a top-down approach, yet most clinicianswere unaware of the policies and practices, contributing to a weak implementation climate. In contrast, gynecologic oncology employed one formal policy (written guideline of criteria for initiating a consult) but also relied on informal policies and practices, such as spontaneous feedback and communication; they adopted a bottom-up approach, contributing to broader clinician awareness and strong implementation climate. Both services exhibited variable, increasing consult rates over time. Practice Implications: Informal policies and practices may compensate or substitute for formal policies and practices under certain conditions (e.g., smaller health care organizations). Further research is needed to investigate the role of formal and informal policies and practices in shaping a strong and sustainable implementation climate and subsequent effective innovation implementation. [ABSTRACT FROM AUTHOR]

Date Presented 04/21/2023 This cross-sectional study compares scores on three versions of the Caregiver Strain Questionnaire (CGSQ) using repeated-measures analysis of variance. Practitioners should consider the balance of respondent burden and scale validity when using clinical questionnaires. Primary Author and Speaker: Ho Ching Lam Additional Authors and Speakers: Emily Campi Contributing Authors: Katherine Hayes, Grace Baranek [ABSTRACT FROM AUTHOR]

Purpose The incidence of treatment-related toxicity for adjuvant chemotherapy in breast cancer is well documented in clinical trials. However, the effect of chemotherapy on functional outcomes in older patients is less well known. We identified a cohort of older women diagnosed with early stage breast cancer to examine the association between exposure to chemotherapy and a claims-based measure of function-related adverse events (FAE). Methods Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset, we identified women aged ≥ 66 diagnosed with stage I or II breast cancer from 2004 to 2011. FAE were defined as one or more claims suggestive of functional impairment within 24 months following chemotherapy including claims for durable medical equipment and skilled care. Women who did not receive chemotherapy were weighted to reflect the covariate distribution of chemotherapy recipients using propensity score weighting for age, stage, baseline healthcare utilization, and comorbidities. Results The cohort included 44,626 patients, 6892 (15%) received chemotherapy. 19% of the population experienced ≥ 1 FAE. After propensity weighting, chemotherapy was associated with a small increased risk of FAEs (HR 1.12, 95% confidence interval: 1.04, 1.20). Results were similar in patients 75 years and older versus younger patients. In the chemotherapy group, the highest risk of FAE occurred in the first 3 months, but persisted through follow-up. Conclusions Exposure to chemotherapy was associated with a small increased risk of FAE which did not vary by age. These data can be used to inform treatment decision making for older patients with breast cancer who are eligible for adjuvant chemotherapy. [ABSTRACT FROM AUTHOR]

Background: Insurance may lengthen or inhibit time to follow-up after positive screening mammography. We assessed the association between insurance status and time to initial diagnostic follow-up after a positive screening mammogram. Methods: Using 1995-2010 data from a North Carolina population-based registry of breast imaging and cancer outcomes, we identified women with a positive screening mammogram. We compared receipt of follow-up within 60 days of screening using logistic regression and evaluated time to follow-up initiation using Cox proportional hazards regression. Results: Among 43,026 women included in the study, 73% were <65 years and 27% were 65+ years. Median time until initial diagnostic follow-up was similar by age group and insurance status. In the adjusted model for women <65, uninsured women experienced a longer time to initiation of diagnostic follow-up [HR, 0.47; 95% confidence interval (CI), 0.25-0.89] versus women with private insurance. There were increased odds of these uninsured women not meeting the Centers for Disease Control and Prevention guideline for follow-up within 60 days (OR, 1.59; 95% CI, 1.31-1.94). Among women ages 65+, women with private insurance experienced a faster time to follow-up (adjusted HR, 2.09; 95% CI, 1.27-3.44) than women with Medicare and private insurance. Approximately 10% of women had no follow-up by 365 days. Conclusions: We found differences in time to initial diagnostic follow-up after a positive screening mammogram by insurance status and age group. Uninsured women younger than 65 years at a positive screening event had delayed follow-up. Impact: Replication of these findings and examination of their clinical significance warrant additional investigation. [ABSTRACT FROM AUTHOR]

Objectives To provide a brief overview of disparities across the spectrum of breast cancer incidence, treatment, and long-term care during the survivorship period. Data Sources Review of the literature including research reports, review articles, and clinically based articles available through PubMed and CINAHL. Conclusion Minority women generally experience worse breast cancer outcomes despite a lower incidence of breast cancer than whites. A variety of factors contribute to this disparity, including advanced stage at diagnosis, higher rates of aggressive breast cancer subtypes, and lower receipt of appropriate therapies including surgery, chemotherapy, and radiation. Disparities in breast cancer care also extend into the survivorship trajectory, including lower rates of endocrine therapy use among some minority groups, as well as differences in follow-up and survivorship care. Implications for Nursing Practice Breast cancer research should include improved minority representation and analyses by race, ethnicity, and socioeconomic status. While we cannot yet change the biology of this disease, we can encourage adherence to screening and treatment and help address the many physical, psychological, spiritual, and social issues minority women face in a culturally sensitive manner. [ABSTRACT FROM AUTHOR]

The article presents information on the challenges to clinical and financial integration in services for dual eligibles prior to passage of the U.S. Patient Protection and Affordable Care Act (PPACA). It explores models used by states to integrate care through contract and waiver authorities available to the U.S. Centers for Medicare and Medicaid Services (CMS). It discusses several new models available for consideration by federal and state policymakers to reduce growing Medicaid costs.