COPD With Lung Cancer Among Older United States Adults: Prevalence, Diagnostic Timeliness, and Association With Earlier Stage Tumors.

Rationale: COPD is a common comorbidity among patients with lung cancer, and an important determinant of their outcomes, however it is commonly underdiagnosed. Objective: To estimate the prevalence of COPD among a cohort of U.S. lung cancer patients, the timing of COPD diagnosis relative to their lung cancer diagnosis, and the association between earlier diagnosis of COPD and stage of lung cancer, with consideration of patient sociodemographic modifying factors. Methods: We conducted an analysis of the Medicare-linked Surveillance, Epidemiology and End Results (SEER) database including patients aged 68+ years who were diagnosed with lung cancer between 2008 to 2017. Exposure: Prevalence of COPD was identified using claims and subclassified based on the timing of its diagnosis relative to the lung cancer diagnostic episode: "pre-existing" if diagnosed > 3 months before lung cancer, and "concurrent" if diagnosed around the same time as the lung cancer (+/-3 months). Outcome: Stage of cancer at diagnosis (early vs. late). Results: Among 159,542 patients with lung cancer, 73.5% had COPD. Among those with COPD, 65.6% were diagnosed "early", i.e., > 3 months before their lung cancer. We observed a positive association between pre-existing COPD diagnosis and early-stage lung cancer (Prevalence ratio= 1.27; 95% CI= 1.23 - 1.30), in adjusted models which was stronger for male, Non-Hispanic Black, and Hispanic patients. Conclusions: Seven out of ten patients with lung cancer have COPD, however many don't receive their COPD diagnosis until around the time of lung cancer diagnosis. Among these patients, early COPD diagnosis may improve early detection of lung cancer.

Emergency department involvement in the diagnosis of cancer among older adults: a SEER-Medicare study.

BACKGROUND: Internationally, 20-50% of cancer is diagnosed through emergency presentation, which is associated with lower survival, poor patient experience, and socioeconomic disparities, but population-based evidence about emergency diagnosis in the U.S. is limited. We estimated Emergency Department (ED) involvement in the diagnosis of cancer in a nationally representative population of older US adults, and associations with sociodemographic, clinical, and tumor characteristics. METHODS: We analyzed SEER-Medicare data for Medicare beneficiaries (≥66 years old) diagnosed with female breast, colorectal, lung and prostate cancers (2008-2017), defining their earliest cancer-related claim as their index date, and patients who visited the ED 0-30 days before their index date to have "ED involvement" in their diagnosis, with stratification as 0-7 or 8-30 days. We estimated covariate-adjusted associations of patient age, sex, race/ethnicity, marital status, comorbidity score, tumor stage, diagnosis year, rurality, and census tract poverty with ED involvement using modified Poisson regression. RESULTS: Among 614,748 patients, 23% had ED involvement with 18% visiting the ED in the 0-7 days before their index date. This varied greatly by tumor site: breast 8%, colorectal 39%, lung 40%, prostate 7%. In adjusted models, older age, female sex, non-Hispanic Black and Native Hawaiian/Other Pacific Islander race, being unmarried, recent diagnosis year, later-stage disease, comorbidities, and poverty were associated with ED involvement. CONCLUSIONS: The ED may be involved in the initial identification of cancer for 1 in 5 patients. Earlier, system-level identification of cancer in non-ED settings should be prioritized, especially among underserved populations.

Development and Evaluation of a Multisource Approach to Extend Mortality Follow-Up for Older Adults With Advanced Cancer Enrolled in Randomized Trials.

PURPOSE: Mortality data can complement primary end points from cancer clinical trials. Yet, identifying deaths after trial completion is challenging, as timely and comprehensive vital status data are unavailable in the United States. We developed and evaluated a multisource approach to capture death data after clinical trial completion. METHODS: Individuals age 70 years and older with incurable solid tumors or lymphoma and ≥1 aging-related condition were enrolled from October 2014 to March 2019 (ClinicalTrials.gov identifier: NCT02107443 and NCT02054741). Participants provided consent to link trial information to external sources. We developed a stepped approach for extended death capture using (1) active trial follow-up up to 1 year, (2) linkage to the National Death Index (NDI), and (3) obituary searches, thus generating a 5-year survival curve. In a random sample of 50 participants who died during trial follow-up, we estimated sensitivity of death data using NDI and obituary sources and computed survival times by data source. RESULTS: The two trials enrolled 1,169 participants; mean age was 76 years; 46% were female; and gastrointestinal cancer (30%) and lung cancer (26%) were the most common cancer types. Across data sources, maximum follow-up was >7 years; 5-year survival was 18%. In total, there were 841 deaths: 603 identified during trial follow-up; 199 from the NDI; and 39 from obituary searches. The sensitivity for death capture was 92% for the NDI and 94% for the obituary searches compared with the trial data, and computed survival times were similar across data sources. CONCLUSION: Extending clinical trial mortality follow-up through linkage with external data sources was feasible and accurate. Future cancer clinical trials should collect necessary consent and patient identifiers for vital status linkages that can enhance understanding of longer-term outcomes.

Commercial Versus Medicaid Insurance and Use of High-Priced Anticancer Treatments.

BACKGROUND: Because the markups on cancer drugs vary by payor, providers' financial incentive to use high-price drugs is differential according to each patient's insurance type. We evaluated the association between patient insurer (commercial vs Medicaid) and the use of high-priced cancer treatments. MATERIALS AND METHODS: We linked cancer registry, administrative claims, and demographic data for individuals diagnosed with cancer in North Carolina from 2004 to 2011, with either commercial or Medicaid insurance. We selected cancers with multiple FDA-approved, guideline-recommended chemotherapy options and large price differences between treatment options: advanced colorectal, lung, and head and neck cancer. The outcome was a receipt of a higher-priced option, and the exposure was insurer: commercial versus Medicaid. We estimated risk ratios (RRs) for the association between insurer and higher-priced treatment using log-binomial models with inverse probability of exposure weights. RESULTS: Of 812 patients, 209 (26%) had Medicaid. The unadjusted risk of receiving higher-priced treatment was 36% (215/603) for commercially insured and 27% (57/209) for Medicaid insured (RR: 1.31, 95% CI: 1.02-1.67). After adjustment for confounders the association was attenuated (RR: 1.15, 95% CI: 0.81-1.65). Exploratory subgroup analysis suggested that commercial insurance was associated with increased receipt of higher-priced treatment among patients treated by non-NCI-designated providers (RR: 1.53, 95% CI: 1.14-2.04). CONCLUSIONS: Individuals with Medicaid and commercial insurance received high-priced treatments in similar proportion, after accounting for differences in case mix. However, modification by provider characteristics suggests that insurance type may influence treatment selection for some patient groups. Further work is needed to determine the relationship between insurance status and newer, high-price drugs such as immune-oncology agents.

The Carolina hysterectomy cohort (CHC): a novel case series of reproductive-aged hysterectomy patients across 10 hospitals in the US south.

BACKGROUND: Hysterectomy is a common surgery among reproductive-aged U.S. patients, with rates highest among Black patients in the South. There is limited insight on causes of these racial differences. In the U.S., electronic medical records (EMR) data can offer richer detail on factors driving surgical decision-making among reproductive-aged populations than insurance claims-based data. Our objective in this cohort profile paper is to describe the Carolina Hysterectomy Cohort (CHC), a large EMR-based case-series of premenopausal hysterectomy patients in the U.S. South, supplemented with census and surgeon licensing data. To demonstrate one strength of the data, we evaluate whether patient and surgeon characteristics differ by insurance payor type. METHODS: We used structured and abstracted EMR data to identify and characterize patients aged 18-44 years who received hysterectomies for non-cancerous conditions between 10/02/2014-12/31/2017 in a large health care system comprised of 10 hospitals in North Carolina. We used Chi-squared and Kruskal Wallis tests to compare whether patients' socio-demographic and relevant clinical characteristics, and surgeon characteristics differed by patient insurance payor (public, private, uninsured). RESULTS: Of 1857 patients (including 55% non-Hispanic White, 30% non-Hispanic Black, 9% Hispanic), 75% were privately-insured, 17% were publicly-insured, and 7% were uninsured. Menorrhagia was more prevalent among the publicly-insured (74% vs 68% overall). Fibroids were more prevalent among the privately-insured (62%) and the uninsured (68%). Most privately insured patients were treated at non-academic hospitals (65%) whereas most publicly insured and uninsured patients were treated at academic centers (66 and 86%, respectively). Publicly insured and uninsured patients had higher median bleeding (public: 7.0, uninsured: 9.0, private: 5.0) and pain (public: 6.0, uninsured: 6.0, private: 3.0) symptom scores than the privately insured. There were no statistical differences in surgeon characteristics by payor groups. CONCLUSION: This novel study design, a large EMR-based case series of hysterectomies linked to physician licensing data and manually abstracted data from unstructured clinical notes, enabled identification and characterization of a diverse reproductive-aged patient population more comprehensively than claims data would allow. In subsequent phases of this research, the CHC will leverage these rich clinical data to investigate multilevel drivers of hysterectomy in an ethnoracially, economically, and clinically diverse series of hysterectomy patients.

Risk Factors for Return to the Emergency Department and Readmission in Patients With Hospital-Diagnosed Advanced Lung Cancer.

BACKGROUND: Advanced lung cancer (ALC) is a symptomatic disease often diagnosed in the context of hospitalization. The index hospitalization may be a window of opportunity to improve care delivery. OBJECTIVES: We examined the patterns of care and risk factors for subsequent acute care utilization among patients with hospital-diagnosed ALC. RESEARCH DESIGN, SUBJECTS, AND MEASURES: In Surveillance, Epidemiology, and End Results-Medicare, we identified patients with incident ALC (stage IIIB-IV small cell or non-small cell) from 2007 to 2013 and an index hospitalization within 7 days of diagnosis. We used a time-to-event model with multivariable regression to identify risk factors for 30-day acute care utilization (emergency department use or readmission). RESULTS: More than half of incident ALC patients were hospitalized around the time of diagnosis. Among 25,627 patients with hospital-diagnosed ALC who survived to discharge, only 37% ever received systemic cancer treatment. Within 6 months, 53% had been readmitted, 50% had enrolled in hospice, and 70% had died. The 30-day acute care utilization was 38%.Small cell histology, greater comorbidity, precancer acute care use, length of index stay >8 days, and prescription of a wheelchair were associated with higher risk of 30-day acute care utilization. Age >85 years, female sex, residence in South or West regions, palliative care consultation, and discharge to hospice or a facility were associated with lower risk. CONCLUSIONS: Many patients with hospital-diagnosed ALC experience an early return to the hospital and most die within 6 months. These patients may benefit from increased access to palliative and other supportive care during index hospitalization to prevent subsequent health care utilization.

Comparison of Approaches for Measuring Adherence and Persistence to Oral Oncologic Therapies in Patients Diagnosed with Metastatic Renal Cell Carcinoma.

BACKGROUND: Adherence and persistence studies face several methodologic difficulties, including short-term mortality. We compared approaches to quantify adherence and persistence to first line (1L) oral targeted therapy (TT) in patients diagnosed with metastatic renal cell carcinoma (mRCC). METHODS: Patients with mRCC ages 66 years or more who initiated TTs within 4 months of diagnosis were identified in the Surveillance, Epidemiology, and End Results Medicare-linked database (2007-2015). Adherence [proportion of days covered (PDC) >80%] was calculated using (i) PDC with a fixed 6-month denominator including then excluding patients who died within the 6 months and (ii) PDC with a denominator measuring time on treatment. Risk of nonpersistence was obtained by censoring death or treating death as a competing risk using cumulative incidence functions. RESULTS: Among 485 patients with mRCC initiating a 1L oral TT (sunitinib, 64%; pazopanib, 25%; other, 11%), 40% died within 6 months. Adherence was higher after restricting to patients who survived (60%) compared with including those patients and assigning zero days covered after death (47%). Risk of nonpersistence was higher when censoring patients at death, 0.91 [95% confidence interval (CI), 0.88-0.94], compared with treating death as a competing risk, 0.75 (95% CI, 0.71-0.79). CONCLUSIONS: Different approaches to handling death resulted in different adherence and persistence estimates in the metastatic setting. Future studies should explicitly report the proportion of patient deaths over time and explore appropriate methods to account for death as competing risk. IMPACT: Use of several approaches can provide a more comprehensive picture of medication-taking behavior in the metastatic setting where death is a major competing risk.

Patterns of first-line targeted therapy utilization and adherence among older adults diagnosed with metastatic renal cell carcinoma.

BACKGROUND: Despite the rapid approval of targeted therapies for metastatic renal cell carcinoma (mRCC) evidence on real world treatment patterns remains limited. This study evaluated patterns of first-line targeted therapy utilization and adherence in older adults, a population with a high burden of RCC. METHODS: 2093 patients aged ≥66 years with a primary diagnosis of mRCC were identified from United States (US)-based cancer registry and administrative claims data (2007-2015). We included only patients with de novo disease. We assessed the initiation of first-line targeted therapy within four months of diagnosis and persistence and adherence to targeted therapy, using the proportion of days covered (PDC). Multivariable logistic regression yielded adjusted odds ratios (ORs) and 95% confidence intervals (CIs) to describe characteristics associated with targeted therapy versus no targeted therapy initiation and for high (≥80% PDC) versus low adherence. RESULTS: 28.8% of patients received first-line targeted therapy within four months of diagnosis, with the proportion of patients receiving targeted therapy increasing over time. Older age (one-year increment OR:0.95 95%CI 0.93, 0.97), high comorbidity burden (OR:0.65 95%CI0.46, 0.93) and clear cell histology (OR:1.54 95%CI 1.19, 2.00) were associated with targeted therapy initiation. 48.2% of patients exhibited a high PDC to oral targeted therapy at 120 days, which was attenuated with inclusion of patients who died during the time period (34.2% PDC ≥80%). CONCLUSION: Increasing age, high comorbidity burden and non-clear cell histology were associated with decreased targeted therapy initiation among patients with de novo mRCC. Our findings suggest adherence to oral therapies was low; future research exploring the mechanisms and impact of low adherence in this older patient population is warranted.

Predicting positive outcomes and successful completion in an online parenting program for parents of children with disruptive behavior: An integrated data analysis.

Online delivery of parenting support is steadily increasing, yet the factors that influence program engagement and efficacy are still understudied. This study used an integrated data analysis approach to identify family and program-related factors that influence outcomes. We combined individual data from seven published efficacy trials of the web-based version of the Triple P-Positive Parenting Program. Data were analyzed for 985 families with children aged between 2 and 12 years (M = 4.87; SD = 2.14) using a Latent Change Score approach. At post-intervention, sociodemographic factors were not predictive of changes in child behavior problems, while parents of boys and those with higher education showed greater improvements in dysfunctional parenting. Parents who were initially more confident in their parenting showed more overall gains while parents with more initial adjustment difficulties showed less improvement. Only the effect of baseline child behavior problems on changes in dysfunctional parenting was moderated by treatment condition. At follow-up, program variant and completion were the primary outcome predictors, with completion found to be related to initial parenting confidence, internet usage and program variant. The implications of these findings for reaching and retaining parents in online programs across all phases of the engagement process are discussed.

Evaluating the Contribution of Patient-Provider Communication and Cancer Diagnosis to Racial Disparities in End-of-Life Care Among Medicare Beneficiaries.

BACKGROUND: The quality of end-of-life (EOL) care in the USA remains suboptimal, with significant variations in care by race and across disease subgroups. Patient-provider communication may contribute to racial and disease-specific variations in EOL care outcomes. OBJECTIVE: We examined racial disparities in EOL care, by disease group (cancer vs. non-cancer), and assessed whether racial differences in patient-provider communication accounted for observed disparities. DESIGN: Retrospective cohort study using the 2001-2015 Surveillance, Epidemiology, and End Results - Consumer Assessment of Healthcare Providers and Systems data linked with Medicare claims (SEER-CAHPS). We employed stratified propensity score matching and modified Poisson regression analyses, adjusting for clinical and demographic characteristics PARTICIPANTS: Black and White Medicare beneficiaries 65 years or older with cancer (N=2000) or without cancer (N=11,524). MAIN MEASURES: End-of-life care measures included hospice use, inpatient hospitalizations, intensive care unit (ICU) stays, and emergency department (ED) visits, during the 90 days prior to death. KEY RESULTS: When considering all conditions together (cancer + non-cancer), Black beneficiaries were 26% less likely than their Whites counterparts to enroll in hospice (adjusted risk ratio [ARR]: 0.74, 95%CI: 0.66-0.83). Among beneficiaries without cancer, Black beneficiaries had a 32% lower likelihood of enrolling in hospice (ARR: 0.68, 95%CI: 0.59-0.79). There was no racial difference in hospice enrollment among cancer patients. Black beneficiaries were also at increased risk for ED use (ARR: 1.12, 95%CI: 1.01-1.26). Patient-provider communication did not explain racial disparities in hospice or ED use. There were no racial differences in hospitalizations or ICU admissions. CONCLUSION: We observed racial disparities in hospice use and ED visits in the 90 days prior to death among Medicare beneficiaries; however, hospice disparities were largely driven by patients without cancer. Condition-specific differences in palliative care integration at the end-of-life may partly account for variations in EOL care disparities across disease groups.

Comparative Effectiveness and Harms of Antibiotics for Outpatient Diverticulitis : Two Nationwide Cohort Studies.

BACKGROUND: Outpatient diverticulitis is commonly treated with either a combination of metronidazole and a fluoroquinolone (metronidazole-with-fluoroquinolone) or amoxicillin-clavulanate alone. The U.S. Food and Drug Administration advised that fluoroquinolones be reserved for conditions with no alternative treatment options. The comparative effectiveness of metronidazole-with-fluoroquinolone versus amoxicillin-clavulanate for diverticulitis is uncertain. OBJECTIVE: To determine the effectiveness and harms of metronidazole-with-fluoroquinolone versus amoxicillin-clavulanate for outpatient diverticulitis. DESIGN: Active-comparator, new-user, retrospective cohort studies. SETTING: Nationwide population-based claims data on U.S. residents aged 18 to 64 years with private employer-sponsored insurance (2000 to 2018) or those aged 65 years or older with Medicare (2006 to 2015). PARTICIPANTS: Immunocompetent adults with diverticulitis in the outpatient setting. INTERVENTION: Metronidazole-with-fluoroquinolone or amoxicillin-clavulanate. MEASUREMENTS: 1-year risks for inpatient admission, urgent surgery, and Clostridioides difficile infection (CDI) and 3-year risk for elective surgery. RESULTS: In MarketScan (IBM Watson Health), new users of metronidazole-with-fluoroquinolone (n = 106 361) and amoxicillin-clavulanate (n = 13 160) were identified. There were no differences in 1-year admission risk (risk difference, 0.1 percentage points [95% CI, -0.3 to 0.6]), 1-year urgent surgery risk (risk difference, 0.0 percentage points [CI, -0.1 to 0.1]), 3-year elective surgery risk (risk difference, 0.2 percentage points [CI, -0.3 to 0.7]), or 1-year CDI risk (risk difference, 0.0 percentage points [CI, -0.1 to 0.1]) between groups. In Medicare, new users of metronidazole-with-fluoroquinolone (n = 17 639) and amoxicillin-clavulanate (n = 2709) were identified. There were no differences in 1-year admission risk (risk difference, 0.1 percentage points [CI, -0.7 to 0.9]), 1-year urgent surgery risk (risk difference, -0.2 percentage points [CI, -0.6 to 0.1]), or 3-year elective surgery risk (risk difference, -0.3 percentage points [CI, -1.1 to 0.4]) between groups. The 1-year CDI risk was higher for metronidazole-with-fluoroquinolone than for amoxicillin-clavulanate (risk difference, 0.6 percentage points [CI, 0.2 to 1.0]). LIMITATION: Residual confounding is possible, and not all harms associated with these antibiotics, most notably drug-induced liver injury, could be assessed. CONCLUSION: Treating diverticulitis in the outpatient setting with amoxicillin-clavulanate may reduce the risk for fluoroquinolone-related harms without adversely affecting diverticulitis-specific outcomes. PRIMARY FUNDING SOURCE: National Institutes of Health.

Risk of Cardiovascular Diseases Among Older Breast Cancer Survivors in the United States: A Matched Cohort Study.

BACKGROUND: It has been suggested that cardiovascular risks are increased in breast cancer survivors, but few studies have quantified the risks of a range of specific clinically important cardiovascular outcomes in detail. PATIENTS AND METHODS: Women aged >65 years with incident breast cancer from 2004 to 2013 in the SEER-Medicare linked database were matched with 5 cancer-free female counterparts (5:1 ratio). Prevalence of specific cardiovascular outcomes at baseline was measured, then Cox regression was used to calculate hazard ratios (HRs) and 95% confidence intervals for the risk of individual cardiovascular outcomes during follow-up. Modification of the effect was investigated by time since diagnosis, race/ethnicity, prior cardiovascular disease (CVD), and age. RESULTS: In all, 91,473 women with breast cancer and 454,197 without breast cancer were included. Women with breast cancer had lower baseline prevalence of all CVDs. Compared with cancer-free controls, breast cancer survivors had substantially increased risks of deep vein thrombosis (adjusted HR, 1.67; 95% CI, 1.62-1.73; 386,484 person-years of follow-up) and pericarditis (HR, 1.43; 95% CI, 1.38-1.49; 390,776 person-years of follow-up); evidence of smaller increased risks of sudden cardiac arrest, arrhythmia, heart failure, and valvular heart disease (adjusted HRs ranging from 1.05-1.09, lower CI limits all ≥1); and evidence of lower risk of incident angina, myocardial infarction, revascularization, peripheral vascular disease, and stroke (adjusted HRs ranging from 0.89-0.98, upper CI limits all ≤1). Increased risks of arrhythmia, heart failure, pericarditis, and deep vein thrombosis persisted >5 years after cancer diagnosis. CONCLUSIONS: Women with a history of breast cancer were at increased risk of several CVDs, persisting into survivorship. Monitoring and managing cardiovascular risk throughout the long-term follow-up of women diagnosed with breast cancer should be a priority.

Endocrine therapy use and cardiovascular risk in postmenopausal breast cancer survivors.

OBJECTIVE: Examine the effect of tamoxifen and aromatase inhibitors (AIs) on the risk of 12 clinically relevant cardiovascular outcomes in postmenopausal female breast cancer survivors. METHODS: We carried out two prospective cohort studies among postmenopausal women with breast cancer in UK primary care and hospital data (2002-2016) and US Surveillance, Epidemiology and End Results-Medicare data (2008-2013). Using Cox adjusted proportional hazards models, we compared cardiovascular risks between AI and tamoxifen users; and in the USA, between users of both drug classes and women receiving no endocrine therapy. RESULTS: 10 005 (UK) and 22 027 (USA) women with postmenopausal breast cancer were included. In both countries, there were higher coronary artery disease risks in AI compared with tamoxifen users (UK age-standardised incidence rate: 10.17 vs 7.51 per 1000 person-years, HR: 1.29, 95% CI 0.94 to 1.76; US age-standardised incidence rate: 36.82 vs 26.02 per 1000 person-years, HR: 1.29, 95% C I1.06 to 1.55). However, comparisons with those receiving no endocrine therapy (US data) showed no higher risk for either drug class and a lower risk in tamoxifen users (age-standardised incidence rate tamoxifen vs unexposed: 26.02 vs 35.19 per 1000 person-years, HR: 0.74, 95% 0.60 to 0.92; age-standardised incidence rate AI vs unexposed: 36.82 vs 35.19, HR: 0.96, 95% CI 0.83 to 1.10). Similar patterns were seen for other cardiovascular outcomes (arrhythmia, heart failure and valvular heart disease). As expected, there was more venous thromboembolism in tamoxifen compared with both AI users and those unexposed. CONCLUSIONS: Higher risks of several cardiovascular outcomes among AI compared with tamoxifen users appeared to be driven by protective effects of tamoxifen, rather than cardiotoxic effects of AIs.

Effectiveness of adjuvant FOLFOX vs 5FU/LV in adults over age 65 with stage II and III colon cancer using a novel hybrid approach.

PURPOSE: Estimates of cancer therapy effects can differ in clinical trials and clinical practice, partly due to underrepresentation of certain patient subgroups in trials. We utilize a hybrid approach, combining clinical trial and real-world data, to estimate the comparative effectiveness of two adjuvant chemotherapy regimens for colon cancer. METHODS: We identified patients aged 66 and older enrolled in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer. Similar patients were identified in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, initiating adjuvant chemotherapy with either 5-fluorouracil (5FU) alone or in combination with oxaliplatin (FOLFOX). We used logistic regression to estimate the likelihood of trial enrollment as a function of age, sex, and substage. Using inverse odds of sampling weights (IOSW), we compared 5-year mortality in patients randomized to FOLFOX vs 5FU using weighted Cox proportional hazards regression, the Nelson-Aalen estimator for cumulative hazards, and bootstrapping for 95% confidence intervals (CIs). RESULTS: There were 690 trial participants and 3834 SEER-Medicare patients. The SEER-Medicare population was older and had a higher proportion of stage IIIB and IIIC patients than the trial. After controlling for differences between populations, the IOSW 5-year HR was 1.21 (0.89, 1.65), slightly farther from the null than the trial estimate (HR = 1.14, 95%CI: 0.87, 1.49). CONCLUSIONS: This study supports mounting evidence of little to no incremental reduction in 5-year mortality for FOLFOX vs 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.

Use of High-Cost Cancer Treatments in Academic and Nonacademic Practice.

BACKGROUND: Academic physicians, such as those affiliated with National Cancer Institute (NCI)-designated Comprehensive Cancer Centers, may have different practice patterns regarding the use of high-cost cancer drugs than nonacademic physicians. MATERIALS AND METHODS: For this cohort study, we linked cancer registry, administrative, and demographic data for patients with newly diagnosed cancer in North Carolina from 2004 to 2011. We selected cancer types with multiple U.S. Food and Drug Administration-approved, National Comprehensive Cancer Network-recommended treatment options and large differences in reimbursement between higher-priced and lower-priced options (stage IV colorectal, stage IV lung, and stage II-IV head-and-neck cancers). We assessed whether provider's practice setting-NCI-designated Comprehensive Cancer Center ("NCI") versus other location ("non-NCI")-was associated with use of higher-cost treatment options. We used inverse probability of exposure weighting to control for patient characteristics. RESULTS: Of 800 eligible patients, 79.6% were treated in non-NCI settings. Patients treated in non-NCI settings were more likely to receive high-cost treatment than patients treated in NCI settings (36.0% vs. 23.2%), with an unadjusted prevalence difference of 12.7% (95% confidence interval [CI], 5.1%-20.0%). After controlling for potential confounding factors, non-NCI patients remained more likely to receive high-cost treatment, although the strength of association was attenuated (adjusted prevalence difference, 9.6%; 95% CI -0.1%-18.7%). Exploratory analyses suggested potential heterogeneity across cancer type and insurance status. CONCLUSION: Use of higher-cost cancer treatments may be more common in non-NCI than NCI settings. This may reflect differential implementation of clinical evidence, local practice variation, or possibly a response to the reimbursement incentives presented by chemotherapy billing. IMPLICATIONS FOR PRACTICE: Oncology care delivery and practice patterns may vary between care settings. By comparing otherwise similar patients treated in National Cancer Institute (NCI)-designated Comprehensive Cancer Centers with those treated elsewhere, this study suggests that patients may be more likely to receive treatment with certain expensive cancer drugs if treated in the non-NCI setting. These practice differences may result in differences in patient costs and outcomes as a result of where they receive treatment.