Characterization of time toxicity in older patients with metastatic breast cancer.

PURPOSE: Recognizing that receiving healthcare can be time intensive and burdensome, time toxicity has been conceptualized as the time spent by patients seeking healthcare. This study investigates the association between age at diagnosis and time toxicity for patients with Metastatic Breast Cancer (MBC) and identifies major components of care that confer the greatest time toxicity. METHODS: We conducted a retrospective cohort study among patients with MBC aged 67 or older using the SEER-Medicare database. We assessed time toxicity using the number of encounter days patients interacted with the healthcare system per 100 days, within the first year of starting cancer treatment. We used a Poisson model to analyze the association between age and encounter days, adjusting for clinical and sociodemographic factors. We stratified the mean encounter days for each age cohort by treatment types. FINDINGS: The final sample included 2949 patients; 51.4% were between 70 and 79 years old, and 81.3% were white. Although unadjusted analysis showed an association between older age and more encounter days (Rate Ratio (RR) 1.12; 95% CI 1.02, 1.22), there was no significant association after adjusting for comorbidities and treatment type. Patients with more than three comorbidities had significantly higher encounter days compared to those without comorbidities [RR 1.36 (95% CI 1.26, 1.46)]. Receipt of radiotherapy [RR: 1.45 95% CI (1.37, 1.54)] was associated with more encounter days compared to not receiving radiotherapy, while receipt of bone-modifying agents was associated with fewer encounter days compared to not using Bone modifying agents [RR 0.75 (95% CI 0.70, 0.79)]. CONCLUSION: Our study identified comorbidities and cancer treatment modality, including radiotherapy, as the factors affecting time toxicity in older patients with MBC. Assessment of an individual's comorbid medical conditions and types of treatment planned are crucial to understanding age-related impacts on encounter days and to support shared decision making in older patients.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Genetic testing in privately insured women with surgically treated breast cancer.

PURPOSE: Rates of BRCA1 and BRCA2 prevalence among women with breast cancer vary by age, hormone receptor status, and family history. Recommendations for genetic testing have varied between overlapping guidelines, payor coverage policies, and have evolved over time, resulting in unclear implications for adoption into routine breast cancer care. METHODS: Using a large, private insurer database, we examined rates of BRCA1/BRCA2 genetic testing in women with newly diagnosed invasive breast cancer undergoing surgery from 2015 through 2019. RESULTS: Testing increased among women 50 years or older from 26 to 38%, remained stable at 66% in both 2015 and 2019 in the under 50 population, and was slightly decreased in women under age 45 years. CONCLUSION: Among privately insured patients with breast cancer, rates are increasing in older women, but appear persistently underused in younger women.

Concurrent prescribing of opioids with other sedating medications after cancer diagnosis: a population-level analysis.

PURPOSE: Cancer is a major reason for concurrent prescription of opioids with other sedating medications-particularly benzodiazepines and gabapentinoids-yet population-based assessments of the extent and predictors of concurrent prescribing among clinically and demographically diverse patients with cancer are lacking. METHODS: We conducted a retrospective cohort study of patients with non-metastatic cancer using North Carolina cancer registry data linked with Medicare and private insurance claims (2013-2016). We used modified Poisson regression to assess associations of patient characteristic with adjusted relative risk (aRR) of new concurrent prescribing of opioids with benzodiazepines or gabapentinoids after diagnosis. RESULTS: Overall, 15% of patients were concurrently prescribed opioids with benzodiazepines or gabapentinoids. Characteristics independently associated with an increased risk of concurrent prescribing included cancer type (e.g., aRR cervical vs. colorectal cancer: 1.55, 95% CI: 1.12-2.14); prior use of opioids (aRR: 2.43, 95% CI:2.21-2.67), benzodiazepines (aRR: 4.08, 95% CI: 3.72-4.48), or gabapentinoids (3.82, 95% CI: 3.31-4.39), and premorbid mental health conditions, including substance use disorder (aRR: 1.27, 95% CI: 1.05-1.54). Black and Hispanic patients were less likely to experience concurrent prescribing (aRR, Black vs. White: 0.35, 95% CI: 0.15-0.83; aRR, Hispanic vs. White: 0.75, 95% CI: 0.66-0.85). CONCLUSION: Approximately 1 in 7 patients with cancer was concurrently prescribed opioids with other sedating medications. Associations between patient characteristics and risk of concurrent prescribing highlight predictors of concurrent prescribing and suggest a rationale for systematic assessment of substance use history at diagnosis. Future research could explore inequitable pain and symptom management and investigate risk of adverse medication-related events.

Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial.

BACKGROUND: As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. METHODS/DESIGN: The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. DISCUSSION: As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. TRIAL REGISTRATION: This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

Chemotherapy Costs and 21-Gene Recurrence Score Genomic Testing Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005 to 2011.

BACKGROUND: This study examined whether associations between 21-gene recurrence score (RS) genomic testing and lower costs among patients with early-stage, estrogen receptor-positive breast cancer are observable in real-world data from the Medicare population. METHODS: A retrospective cohort study was conducted using SEER-Medicare data for a nationally representative sample of Medicare beneficiaries diagnosed from 2005 through 2011. The main outcomes were associations between RS testing and overall and chemotherapy-specific costs. The primary analysis was restricted to patients aged 66 to 75 years. RESULTS: The primary analysis comprised 30,058 patients. Mean costs 1 year after diagnosis were $35,940 [SD, $28,894] overall, $51,127 [33,386] for clinically high-risk disease, $33,225 [$27,711] for intermediate-risk disease, and $26,695 [$19,532] for low-risk disease. Chemotherapy-specific costs followed similar trends. In multivariable analyses, RS testing was associated with significantly lower costs among high-risk patients in terms of both relative costs (cost ratio, 0.88; 99% CI, 0.82-0.94) and absolute costs ($6,606; 99% CI, $39,223-$9,290). Higher costs among low-risk and intermediate-risk patients were mainly caused by higher noncancer costs. In sensitivity analyses that included all patients aged ≥66 years (N=64,996), associations between RS testing and costs among high-risk patients were similar but less pronounced because of lower overall use of chemotherapy. CONCLUSIONS: RS testing was associated with lower overall and chemotherapy-related costs in patients with high-risk disease, consistent with lower chemotherapy use among these patients. Higher overall costs for patients with intermediate-risk and low-risk disease were driven largely by non-treatment-related costs.

Low-Risk Thyroid Cancer in Elderly: Total Thyroidectomy/RAI Predominates but Lacks Survival Advantage.

BACKGROUND: Papillary thyroid cancer (PTC) is the fastest increasing cancer in the United States; incidence increases with age. It generally has a favorable prognosis but may behave more aggressively in older patients. This study aims to describe national treatment patterns for low-risk PTC in older adults. MATERIALS AND METHODS: The Surveillance, Epidemiology, and End Results-Medicare database was used to identify patients ≥66 y treated for clinical T1N0M0 PTC between 1996 and 2011. Multivariable logistic regression was used to identify factors associated with extent of surgery (total thyroidectomy versus lobectomy) and radioactive iodine (RAI) administration. Cox proportional hazards modeling was used to estimate the effect of treatment type on disease-specific survival (DSS). RESULTS: Three thousand two hundred and fourteen patients met inclusion criteria; 77.6% were women, median age was 72 y, and mean tumor size was 0.7 cm. 42.7% had preoperatively diagnosed PTC (versus incidental). 65.4% underwent total thyroidectomy, 29.0% lobectomy, and 5.6% lobectomy followed by completion thyroidectomy; 33.4% received postoperative RAI. Five- and 10-year DSS were 98.9% and 98.3%, respectively. After adjustment, larger tumor size (1.1-2 cm), multifocality, and a preoperative PTC diagnosis were associated with greater odds of undergoing more extensive surgery and receiving RAI (P < 0.0001). DSS was not associated with extent of surgery or RAI administration (P > 0.05). CONCLUSIONS: Most older adults with PTC underwent total thyroidectomy and a third received RAI; neither treatment improved DSS. In the growing elderly population, less extensive interventions for PTC may reduce morbidity and improve quality of life while preserving an excellent prognosis.

INITIAL ADOPTION OF RECOMBINANT HUMAN THYROID-STIMULATING HORMONE FOLLOWING THYROIDECTOMY IN THE MEDICARE THYROID CANCER PATIENT POPULATION.

OBJECTIVE: Recombinant human thyroid-stimulating hormone (rhTSH) has been approved for diagnostic (1998) and therapeutic (2008) indications in conjunction with radioactive iodine (RAI) administration post-thyroidectomy. Potential benefits of rhTSH, including avoidance of hypothyroidism side effects and shorter, less costly hospital stays, have not been assessed at the population level within the United States. In this study we quantify utilization, outcomes, and associated costs of rhTSH within the nationally representative Surveillance, Epidemiology, and End Results (SEER)-Medicare patient population. METHODS: We conducted a retrospective analysis of beneficiaries aged >65 years diagnosed within the SEER-Medicare data with differentiated thyroid cancer. Endpoints examined included ( 1) rhTSH utilization in the 2 years post-thyroidectomy (patients diagnosed 1996-2011 [utilization cohort]) and ( 2) comparison of resource utilization and costs as a function of rhTSH receipt in the 30 days prior to and 1 year following therapeutic RAI administration (patients diagnosed 2008-2011 [resource use cohort]). All costs were adjusted to reflect 2013 dollars. RESULTS: A total of 6,482 patients met inclusion criteria, of which, 1,363 (21.0%) received rhTSH. Receipt varied by region and was higher in the South (18%), Northeast (28%), and West (44%) compared to the Midwest (10%), and lower in census tracts in the bottom quartile of high school education rates (odds ratio 0.68, 95% confidence interval [CI] 0.55-0.83). rhTSH receipt was not associated with patient sex, age, comorbidities, or stage. Post-therapeutic RAI, 1,444 patients were assessed for resource utilization (2008-2011). The average cost of rhTSH was $905 per patient, with $2,483 being spent on average among patients who received rhTSH in association with therapeutic RAI. rhTSH receipt was not significantly associated with total inpatient days or number of outpatient and emergency department visits. Multivariable analyses showed similar overall costs among patients who did versus did not receive rhTSH (cost ratio [CR] 0.96, 95% CI 0.86-1.09), partially due to increased mean outpatient costs ($5,213 vs. $4,190) being offset by lower inpatient costs ($3,493 vs. $6,143). Overall costs were significantly higher in multivariable analyses among patients with distant metastatic disease (CR 1.92, 95% CI 1.58-2.32) and multiple comorbidities (CR 2.15, 95% CI 1.83-2.53). CONCLUSION: rhTSH recipients had higher outpatient, lower inpatient, and similar total Medicare payments as those not receiving rhTSH in conjunction with RAI, lending support to the use of rhTSH as a cost-neutral treatment option from the payer perspective. ABBREVIATIONS: CI = confidence interval; CMS = Centers for Medicare & Medicaid Services; CR = cost ratio; HCPCS = Healthcare Common Procedure Coding System; IQR = interquartile range; mCi = millicurie; OR = odds ratio; PET = positron emission tomography; RAI = radioactive iodine; rhTSH = recombinant human thyroid-stimulating hormone; RR = risk ratio; SEER = Surveillance, Epidemiology, and End Results.

Association between physician characteristics and the use of 21-gene recurrence score genomic testing among Medicare beneficiaries with early-stage breast cancer, 2008-2011.

PURPOSE: We sought to determine whether physician-level characteristics were associated with 21-gene recurrence score (RS) genomic testing to evaluate recurrence risk and benefit of adjuvant chemotherapy in patients with estrogen receptor-positive, node-negative breast cancer. METHODS: Retrospective cohort study of a nationally representative sample of Medicare beneficiaries using Surveillance, Epidemiology, and End Results program-Medicare data linked with the American Medical Association physician master file. The main outcome was receipt of genomic testing within 1 year of diagnosis as a function of physician-level factors. RESULTS: A total of 24,463 patients met the study criteria; they received care from 3172 surgeons and 2475 medical oncologists. Of 4124 tests ordered, 70% were ordered by a medical oncologist and 16% by a surgeon. In multivariable regression models, multiple variables were associated with receipt of testing, including having a medical oncologist (odds ratio [OR] 2.77; 95% CI 2.00-3.82), a surgeon specializing in surgical oncology (OR 1.20; 95% CI 1.09-1.31), and a female medical oncologist (OR 1.10; 95% CI 1.02-1.20). Having a medical oncologist with 5 or more years in practice was associated with lower odds of testing (OR 0.83; 95% CI 0.76-0.92). Surgical procedures performed at academic centers were associated with higher odds of testing (OR 1.11; 95% CI 1.02-1.20). CONCLUSIONS: Although most RS testing was ordered by medical oncologists, physicians in other specialties ordered roughly one-third of the tests. Physician characteristics, including gender and time in practice, were associated with receiving testing, creating opportunities for targeting interventions to help patients receive optimal care.

Advanced imaging and hospice use in end-of-life cancer care.

INTRODUCTION: Advanced imaging can inform prognosis and may be a mechanism to de-escalate unnecessary end-of-life care in patients with cancer. Associations between greater use of advanced imaging and less-aggressive end-of-life care in real-world practice has not been examined. METHODS: We conducted a retrospective analysis of SEER-Medicare data on patients who died from breast, lung, colorectal, or prostate cancer between 2002 and 2007. Hospital referral region (HRR)-level use of computerized tomography (CT), magnetic resonance imaging, and positron emission tomography was categorized by tertile of imaging use and correlated with hospice enrollment overall and late hospice enrollment using multivariable logistic regression. RESULTS: A total of 55,058 patients met study criteria. Hospice use ranged from 50.8% (colorectal cancer) to 62.1% (prostate cancer). In multivariable analyses, hospital referral regions (HRRs) with high rates of CT imaging were associated with lower odds of hospice enrollment (odds ratio, 0.80; 95% CI, 0.70-0.90) and late enrollment among those who did enroll (odds ratio, 1.49; 95% CI, 1.26-1.76). HRRs with the highest rates of CT use were predominantly located in the Midwest and Northeast and associated with higher percentage population of black patients (14.5 vs 5.6%), greater comorbidity (28.4 vs 23.7%), metropolitan residence (93.9 vs 78.5%), and less than high school education (26.4 vs 19.3%). CONCLUSION: In this population-based retrospective study, we did not observe evidence that overall and timely hospice are associated with higher rates of imaging near the end of life. An observed association between higher rates of imaging, particularly CT, may be explained in part by HRR-level differences in practice patterns and patient demographic characteristics. Further research is warranted to explore the ability of oncologic imaging to appropriately de-escalate care.

Algorithms for prediction of the Oncotype DX recurrence score using clinicopathologic data: a review and comparison using an independent dataset.

PURPOSE: Given the potential savings in cost and resource utilization, several algorithms have been proposed to predict Oncotype DX recurrence score (ODX RS) using commonly acquired histopathologic variables. Although it is promising, additional independent validation of these surrogate markers is needed prior to guide the patient management. METHODS: In this retrospective study, we analyzed 305 patients with invasive breast cancer at our institution who had ODX RS available. We selected five equations that provide a surrogate measure of ODX as previously published by Klein et al. (Magee equations 1-3), Gage et al., and Tang et al. All equations used estrogen receptor status and progesterone receptor status along with different combinations of grade, proliferation indices (Ki-67, mitotic rate), HER2 status, and tumor size. RESULTS: Of all surrogate scores tested, the Magee equation 2 provided the highest correlation with ODX both with regard to raw score (Pearson's correlation coefficient = 0.66 95% CI 0.59-0.72) and categorical correlation (Cohen's kappa = 0.43, 95% CI 0.33-0.53). Although Magee equation 2 provided a way to reliably identify high-risk disease by assigning 95% of the patients with high ODX RS to either the intermediate- or high-risk group, it was unable to reliably identify the potential for patients to have intermediate- or high-risk disease by ODX (66% of such patients identified). CONCLUSIONS: Although commonly available surrogates for ODX appear to predict high-risk ODX RS, they are unable to reliably rule out the presence of patients with intermediate-risk disease by ODX. Given the potential benefit of adjuvant chemotherapy in women with intermediate-risk disease by ODX, current surrogates are unable to safely substitute for ODX. Characterizing the true recurrence risk in patients with intermediate-risk disease by ODX is critical to the clinical adoption of current surrogate markers and is an area of ongoing clinical trials.

Patient-Centered Communication for Discussing Oncotype DX Testing.

Oncotype DX testing (ODX), a tumor gene expression test, may improve breast cancer care, however, communicating results remains challenging. We identified patient-centered communication strategies/gaps for discussing ODX results. We applied a patient-centered communication framework to analyze qualitative interviews with oncologists about how they communicate about ODX with patients, using template analysis in Atlas.ti. Overall, providers discussed four patient-centered communication domains: exchanging information, assessing uncertainty, making decisions and cross-cutting themes. Providers did not report discussing emotional aspects of managing uncertainty, assessing decision-making preferences, and evaluating decisions. A patient-centered approach may be a model for communicating about tumor gene expression tests.

ONCOLOGISTS' BARRIERS AND FACILITATORS FOR ONCOTYPE DX USE: QUALITATIVE STUDY.

BACKGROUND: Oncotype DX (ODX), a tumor gene profiling test, has been incorporated into clinical guidelines to aid in adjuvant chemotherapy decision making for early-stage, hormone receptor positive breast cancer patients. Despite United States (U.S.) guidelines, less than half of eligible women receive testing. Reasons for low usage are unclear: Our objective was to better understand U.S. oncologists' ODX uptake and how they use ODX during adjuvant chemotherapy decision making. METHODS: We conducted semi-structured, ~30-minute phone interviews with medical and surgical oncologists in one U.S. State using purposive sampling. Oncologists were included if they saw greater than or equal to five breast cancer patients per week. Recruitment ended upon thematic saturation. Interviews were recorded, transcribed, and double-coded using template analysis. RESULTS: During analysis, themes emerged across three domains. First, organizational factors (i.e., departmental structure, ODX marketing, and medical/insurance guidelines) influenced ease of ODX use. Second, oncologists referenced the influence of interpersonal factors (e.g., normative beliefs and peer use of ODX) over their own practices and recommendations. Third, intrapersonal factors (e.g., oncologist attitudes, perceived barriers, and research gaps) were discussed: although oncologists largely held positive attitudes about ODX, they reported challenges with interpreting intermediate scores for treatment decisions and explaining test results to patients. Finally, oncologists identified several research gaps. CONCLUSIONS: As more tumor gene profiling tests are incorporated into cancer care for treatment decision making, it is important to understand their use in clinical practice. This study identified multi-level factors that influence ODX uptake into clinical practice, providing insights into facilitators and modifiable barriers that can be leveraged for improving ODX uptake to aid treatment decision making.

Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients.

OBJECTIVES: To describe national practice patterns regarding utilization of minimally invasive pancreaticoduodenectomy (MIPD) and compare short-term outcomes with those following open pancreaticoduodenectomy for cancer. BACKGROUND: There is increasing interest in use of MIPD; however, published data are limited to single institutional experiences. METHODS: Adult patients undergoing pancreaticoduodenectomy were identified from the National Cancer Database, 2010-2011. Descriptive statistics and multivariable modeling were employed to characterize use of MIPD (laparoscopic or robotic) and compare short-term outcomes to those following open pancreaticoduodenectomy. RESULTS: A total of 7061 patients underwent pancreaticoduodenectomy: 983 had MIPD and 6078 had open procedures. The use of MIPD increased by 45% (179 cases) from 2010 to 2011. The majority of hospitals (92%) performing MIPD were low volume (≤ 10 cases/2 years). Factors independently associated with undergoing MIPD included fewer comorbidities, treatment at an academic institution, and a neuroendocrine tumor diagnosis (all P < 0.01). The unadjusted 30-day mortality rate was 5.1% for MIPD versus 3.1% after open surgery. For patients with adenocarcinoma, there were no differences between MIPD and open pancreaticoduodenectomy after multivariable adjustment in number of lymph nodes removed, rate of positive surgical margins, length of stay, or readmissions. However, 30-day mortality was higher for patients undergoing MIPD versus open surgery (odds ratio = 1.87, confidence interval: 1.25-2.80, P = 0.002). CONCLUSIONS: While there is increasing interest in employing MIPD for adenocarcinoma, its use is associated with increased 30-day mortality. The majority of hospitals performing MIPD were low volume. These results may suggest that MIPD is a complex procedure for which comprehensive protocols outlining criteria for implementation might be warranted to optimize patient safety.

Racial variation in adjuvant chemotherapy initiation among breast cancer patients receiving oncotype DX testing.

It is unknown whether racial differences exist in adjuvant chemotherapy initiation among women with similar oncotype DX (ODX) risk scores. We examined whether adjuvant chemotherapy initiation varied by race. Data come from the Phase III, Carolina Breast Cancer Study, a longitudinal, population-based study of North Carolina women diagnosed with breast cancer between 2008 and 2014. We used modified Poisson regression and report adjusted relative risk (aRR) and 95% confidence intervals (95%CI) to estimate the association between race and adjuvant chemotherapy initiation across ODX risk groups among women who received the test (n = 541). Among women who underwent ODX testing, 54.2, 37.5, and 8.3% of women had tumors classified as low-, intermediate-, and high-risk groups, respectively. We observed no racial variation in adjuvant chemotherapy initiation. Increasing ODX risk score (aRR = 1.39, 95%CI = 1.22, 1.58) and being married (aRR = 2.92, 95%CI = 1.12, 7.60) were independently associated with an increased likelihood of adjuvant chemotherapy in the low-risk group. Among women in the intermediate-risk group, ODX risk score (aRR = 1.15, 95%CI = 1.11, 1.20), younger age (aRR = 1.95, 95%CI = 1.35, 2.81), larger tumor size (aRR = 1.70, 95%CI = 1.22, 2.35), and higher income were independently associated with increased likelihood of adjuvant chemotherapy initiation. No racial differences were found in adjuvant chemotherapy initiation among women receiving ODX testing. As treatment decision-making becomes increasingly targeted with the use of genetic technologies, these results provide evidence that test results may drive treatment in a similar way across racial subgroups.

Management of chemotherapy-induced neutropenia: measuring quality, cost, and value.

Treatment-associated neutropenia continues to represent the most common dose-limiting toxicity of cancer chemotherapy. It often leads to fever and infection, prompting hospitalization and occasionally resulting in serious morbidity, and even mortality, despite modern broad-spectrum antibiotic treatment and supportive care. Neutropenia and its complications may also lead to chemotherapy dose reductions, treatment delays, or early treatment termination, compromising disease control and the potential for cure. NCCN Clinical Practice Guidelines in Oncology recommend administration of primary prophylaxis with a myeloid growth factor in patients receiving regimens associated with a high risk for febrile neutropenia, and consideration of prophylaxis in patients receiving lower-risk regimens who have other risk factors that might place them at higher risk for febrile neutropenia. Although these agents have been shown to be effective and safe in numerous randomized controlled trials, they are expensive and contribute significantly to increasing health care costs. Regulatory agencies and guideline organizations do not currently address the issue of cost. However, with the relentless increase in health care use and current efforts to reform health care, it has become increasingly important to assess both the cost and the net benefit of interventions related to an episode of care in order to compare the overall value of therapeutic options. This article defines and discusses the intersection of quality, costs, and value in the context of prophylactic myeloid growth factor use in patients with cancer receiving myelosuppressive chemotherapy.

Extent of surgery for papillary thyroid cancer is not associated with survival: an analysis of 61,775 patients.

OBJECTIVE: To examine the association between the extent of surgery and overall survival in a large contemporary cohort of patients with papillary thyroid cancer (PTC). BACKGROUND: Guidelines recommend total thyroidectomy for PTC tumors >1 cm, based on older data demonstrating an overall survival advantage for total thyroidectomy over lobectomy. METHODS: Adult patients with PTC tumors 1.0-4.0 cm undergoing thyroidectomy in the National Cancer Database, 1998-2006, were included. Cox proportional hazards models were applied to measure the association between the extent of surgery and overall survival while adjusting for patient demographic and clinical factors, including comorbidities, extrathyroidal extension, multifocality, nodal and distant metastases, and radioactive iodine treatment. RESULTS: Among 61,775 PTC patients, 54,926 underwent total thyroidectomy and 6849 lobectomy. Compared with lobectomy, patients undergoing total thyroidectomy had more nodal (7% vs 27%), extrathyroidal (5% vs 16%), and multifocal disease (29% vs 44%) (all Ps < 0.001). Median follow-up was 82 months (range, 60-179 months). After multivariable adjustment, overall survival was similar in patients undergoing total thyroidectomy versus lobectomy for tumors 1.0-4.0 cm [hazard ratio (HR) = 0.96; 95% confidence interval (CI), 0.84-1.09); P = 0.54] and when stratified by tumor size: 1.0-2.0 cm [HR = 1.05; 95% CI, 0.88-1.26; P = 0.61] and 2.1-4.0 cm [HR = 0.89; 95% CI, 0.73-1.07; P = 0.21]. Older age, male sex, black race, lower income, tumor size, and presence of nodal or distant metastases were independently associated with compromised survival (P < 0.0001). CONCLUSIONS: Current guidelines suggest total thyroidectomy for PTC tumors >1 cm. However, we did not observe a survival advantage associated with total thyroidectomy compared with lobectomy. These findings call into question whether tumor size should be an absolute indication for total thyroidectomy.

Robotic thyroidectomy for cancer in the US: patterns of use and short-term outcomes.

BACKGROUND: We describe nationally representative patterns of utilization and short-term outcomes from robotic versus open thyroidectomy for thyroid cancer. METHODS: Descriptive statistics and multivariable analysis were used to analyze patterns of use of robotic thyroidectomy from the National Cancer Database (2010-2011). Short-term outcomes were compared between patients undergoing robotic versus open thyroidectomy, while adjusting for confounders. RESULTS: A total of 68,393 patients with thyroid cancer underwent thyroidectomy; 225 had robotic surgery and 57,729 underwent open surgery. Robotic thyroid surgery use increased by 30 % from 2010 to 2011 (p = 0.08). Robotic cases were reported from 93 centers, with 89 centers performing <10 robotic cases. Compared with the open group, the robotic group was younger (51 vs. 47 years; p < 0.01) and included more Asian patients (4 vs. 8 %; p = 0.006) and privately-insured patients (68 vs. 77 %; p = 0.01). Tumor size was similar between patients undergoing robotic versus open surgery. Total thyroidectomy was performed less frequently in the robotic group (67 vs. 84 % open; p < 0.0001). Patients were relatively more likely to undergo robotic surgery if they were female (odds ratio [OR] 1.6; p = 0.04), younger (OR 0.8/10 years; p < 0.0001), or underwent lobectomy (OR 2.4; p < 0.0001). In adjusted multivariable analysis, there were no differences in the number of lymph nodes removed or length of stay between groups; however, there was a non-significant increase in the incidence of positive margins with robotic thyroidectomy. CONCLUSIONS: Use of robotic thyroidectomy for thyroid cancer is limited to a few institutions, with short-term outcomes that are comparable to open surgery. Multi-institutional studies should be undertaken to compare thyroidectomy-specific complications and long-term outcomes.

Changes in Facility Share of Medicaid-insured Patients With Urologic Cancers Following Implementation of the Patient Protection and Affordable Care Act.

OBJECTIVE: To examine Medicaid-insurance acceptance at facilities treating urologic cancers following implementation of the Affordable Care Act (ACA). METHODS: We conducted a retrospective, longitudinal study with a pre-post design. We accessed 2010-2017 data from the National Cancer Database, calculating the facility-level change in proportion of urologic cancer patients with Medicaid following implementation of the ACA. We used multivariable logistic regression to assess baseline clinical and demographic factors associated with changes in the proportion of patients at a facility insured through Medicaid. RESULTS: We identified 630 facilities, including 287 in Medicaid expansion states and 343 in non-expansion states associated with 436,082 urologic cancer patients. The mean facility-level change in proportion of patients with Medicaid was + 5.8% (95% CI 5.0%-6.5%) in expansion states versus + 0.6% (95% CI 0.2%-0.9%) in non-expansion states. There were 179 facilities that experienced a decrease in the post-ACA period, representing 13.6% of facilities in expansion states and 40.8% in non-expansion states (P <.001). Factors associated with a decrease in proportion of urologic cancer patients insured by Medicaid included non-expansion state status (OR 8.9, 95% CI 5.3-15.6, P <.001), higher baseline proportion of patients with Medicaid (highest quartile vs lowest: OR 4.6, 95% CI 2.3-9.4, P <.001) and high-income zip code (highest vs lowest quartile: OR 3.1, 95% CI 1.5-6.6, P <.001). CONCLUSION: Urologic cancer care for Medicaid-insured Americans remains unevenly distributed across cancer care centers, even in states that expanded coverage. Our findings suggest that this variation may reflect the effort of some facilities to reduce their financial exposure to increased numbers of Medicaid patients in the wake of ACA-supported state expansions.

Cost trends of metastatic renal cell carcinoma therapy: the impact of oral anticancer agents and immunotherapy.

BACKGROUND: Immunotherapy (IO) and oral anticancer agents (OAA) have improved outcomes for metastatic renal cell carcinoma (mRCC), but there is a need to understand real-world costs from the perspective of payers and patients. METHODS: We used retrospective fee-for-service Medicare 100% claims data to study patients diagnosed with mRCC in 2015-2019. We identified initial treatment type and costs (the year after diagnosis) and analyzed differences in monthly and 12-month costs over time and between OAA, IO, and combination groups and the association between Out-Of-Pocket (OOP) costs and adherence. RESULTS: We identified 15 407 patients with mRCC (61% male; 85% non-Hispanic White). A total of 6196 received OAA, IO, or combination OAA/IO as initial treatment. OAA use decreased (from 31% to 11%) with a simultaneous rise in patients receiving IO (3% to 26%) or combination IO/OAA therapy (1% to 11%). Medicare payments for all patients with mRCC increased by 41%, from $60 320 (95% confidence interval = 58 260 to 62 380) in 2015 to $85 130 (95% confidence interval = 82 630 to 87 630) in 2019. Payments increased in patients who received OAA, IO, or combination OAA/IO but were stable in those with other/no treatment. Initial higher OOP responsibility ($200-$1000) was associated with 13% decrease in percent days covered in patients receiving OAA in the first 90 days of treatment, compared with those whose OOP responsibility was less than $200. CONCLUSION: From 2015 to 2019, costs for Medicare patients with mRCC rose substantially due to more patients receiving IO or IO/OAA combined therapy and increases in costs among those receiving those therapies. Increased OOP costs was associated with decreased adherence.