Racial differences in venous thromboembolism: A surveillance program in Durham County, North Carolina

BACKGROUND: Venous thromboembolism (VTE) affects approximately 1–2 individuals per 1000 annually and is associated with an increased risk for pulmonary hypertension, postthrombotic syndrome, and recurrent VTE. OBJECTIVE: To determine risk factors, incidence, treatments, and outcomes of VTE through a 2‐year surveillance program initiated in Durham County, North Carolina (population approximately 280,000 at time of study). PATIENTS/METHODS: We performed a retrospective analysis of data actively collected from three hospitals in Durham County during the surveillance period. RESULTS: A total of 987 patients were diagnosed with VTE, for an annual rate of 1.76 per 1000 individuals. Hospital‐associated VTE occurred in 167 hospitalized patients (16.9%) and 271 outpatients who were hospitalized within 90 days of diagnosis (27.5%). Annual incidence was 1.98 per 1000 Black individuals compared to 1.25 per 1000 White individuals (p < 0.0001), and Black individuals with VTE were younger than White individuals (p < 0.0001). Common risk factors included active cancer, prolonged immobility, and obesity, and approximately half were still taking anticoagulant therapy 1 year later. A total of 224 patients died by 1 year (28.5% of patients for whom outcomes could be confirmed), and Black patients were more likely to have recurrent VTE than White patients during the first 6 months following initial presentation (9.4% vs. 4.1%, p = 0.01). CONCLUSIONS: Ongoing surveillance provides an effective strategy to identify patients with VTE and monitor treatment and outcomes. We demonstrated that hospital‐associated VTE continues to be a major contributor to the burden of VTE and confirmed the higher incidence of VTE in Black compared to White individuals

Workup and Management of Immune-Mediated Colitis in Patients Treated with Immune Checkpoint Inhibitors.

As the use of immune checkpoint inhibitors for several different malignancies becomes more mainstream, their side-effect profile raises new challenges. In 2011, the Food and Drug Administration approved the first checkpoint inhibitor for the treatment of advanced melanoma, and since then, checkpoint inhibitors have demonstrated efficacy in many other tumor types. Given the frequent use of immune checkpoint inhibitors in a wide range of cancers today, the diagnosis and management of their immune-mediated toxicities need special attention. One of the most common is immune-mediated colitis. Workup and management of immune-mediated colitis can be challenging and is the purpose of this review. KEY POINTS: Rate of immune mediated colitis differ from different kind of immune checkpoint inhibitor treatment. To work up immune-mediated colitis, tests to rule out infectious etiologies of diarrhea, colonoscopy and abdominal image will help to differentiate immune mediated colitis from colitis from other etiology. Patients with mild colitis can be managed with supportive therapies alone, but more severe cases may require immunomodulators such as steroid. Refractory cases may require tumor necrosis factor (TNF) inhibitors, such as infliximab in addition to steroid treatment

Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial.

OBJECTIVES: To determine whether a 1-year community health worker intervention improves access to care and service utilization among Latinos with diabetes. METHODS: We conducted a single-blind randomized trial of 300 adults with poorly controlled diabetes treated in 2 public hospital clinics in Miami, Florida. We began enrollment in 2010 and completed follow-up in 2015. We examined access and utilization using self-reported measures and data from electronic medical records. RESULTS: Participants randomized to the community health worker intervention self-reported fewer problems accessing needed care and prescriptions than did those in the usual care group (30% vs 43% and 28% vs 41%, respectively; P \u3c .05 for both). Adjusting for age, gender, education, depression, and comorbidities showed similar results (odds ratio [OR] = 0.52; 95% confidence interval [CI] = 0.29, 0.93 and OR = 0.45; CI = 0.24, 0.82, respectively). We found no significant utilization differences in primary care visits, emergency department utilization, or hospitalization between the 2 groups. CONCLUSIONS: Among Latinos with poorly controlled diabetes, a 1-year community health worker intervention was associated with improvements in self-reported access to care but not service utilization

Outcomes and toxicity of stereotactic radiosurgery for melanoma brain metastases in patients receiving ipilimumab.

PURPOSE: Patients with melanoma treated with ipilimumab and radiosurgery (stereotactic radiosurgery [SRS]) were reviewed for efficacy/safety. METHODS: Patients who received ipilimumab and SRS for brain metastases were analyzed for control of SRS-treated metastasis and overall survival. RESULTS: We identified 27 patients, 26 were assessable for outcomes. Median time-to-treated metastasis progression was 6.3 months (95% CI: 3.1-12.2). Overall survival was 23.4 months (95% CI: 5.7-not estimable) for SRS prior to/during ipilimumab (n = 14), and 10.4 months (95% CI: 1.9-not estimable) for SRS after ipilimumab (n = 12). Overall, no unexpected toxicities were seen: 11% of patients experienced grade 3 CNS toxicity and 7% developed radionecrosis. CONCLUSION: SRS for melanoma brain metastases with ipilimumab was well-tolerated. There may be improved survival for patients receiving SRS prior to/during ipilimumab

Design and Implementation of a Comprehensive Surveillance System for Venous Thromboembolism in a Defined Region Using Electronic and Manual Approaches.

BACKGROUND: Systematic surveillance for venous thromboembolism (VTE) in the United States has been recommended by several organizations. Despite adoption of electronic medical records (EMRs) by most health care providers and facilities, however, systematic surveillance for VTE is not available. OBJECTIVES: This article develops a comprehensive, population-based surveillance strategy for VTE in a defined geographical region. METHODS: The primary surveillance strategy combined computerized searches of the EMR with a manual review of imaging data at the Duke University Health System in Durham County, North Carolina, United States. Different strategies of searching the EMR were explored. Consolidation of results with autopsy reports (nonsearchable in the EMR) and with results from the Durham Veterans\u27 Administration Medical Center was performed to provide a comprehensive report of new VTE from the defined region over a 2-year timeframe. RESULTS: Monthly searches of the primary EMR missed a significant number of patients with new VTE who were identified by a separate manual search of radiology records, apparently related to delays in data entry and coding into the EMR. Comprehensive searches incorporating a location-restricted strategy were incomplete due to the assigned residence reflecting the current address and not the address at the time of event. The most comprehensive strategy omitted the geographic restriction step and identified all patients with VTE followed by manual review of individual records to remove incorrect entries (e.g., outside the surveillance time period or geographic location; no evidence for VTE). Consolidation of results from the EMR searches with results from autopsy reports and the separate facility identified additional patients not diagnosed within the Duke system. CONCLUSION: We identified several challenges with implementing a comprehensive VTE surveillance program that could limit accuracy of the results. Improved electronic strategies are needed to cross-reference patients across multiple health systems and to minimize the need for manual review and confirmation of results

Safety and Efficacy of Radiation Therapy in Advanced Melanoma Patients Treated With Ipilimumab.

PURPOSE: Ipilimumab and radiation therapy (RT) are standard treatments for advanced melanoma; preclinical models suggest the potential for synergy. However, limited clinical information exists regarding safety and optimal timing of the combination. METHODS AND MATERIALS: We reviewed the records of consecutive patients with unresectable stage 3 or 4 melanoma treated with ipilimumab. Patients were categorized as having received RT or not. Differences were estimated between these 2 cohorts. RESULTS: We identified 88 patients treated with ipilimumab. At baseline, the ipilimumab-plus-RT group (n=44) had more unfavorable characteristics. Despite this, overall survival, progression-free survival, and both immune-related and non-immune-related toxicity were not statistically different (P=.67). Patients who received ipilimumab before RT had an increased duration of irradiated tumor response compared with patients receiving ipilimumab after RT (74.7% vs 44.8% at 12 months; P=.01, log-rank test). In addition, patients receiving ablative RT had non-statistically significantly improved median overall survival (19.6 vs 10.2 months), as well as 6-month (95.1% vs 72.7%) and 12-month (79.7% vs 48.5%) survival rates, compared with those treated with conventionally fractionated RT. CONCLUSIONS: We found that both ablative and conventionally fractionated RT can be safely administered with ipilimumab without a clinically apparent increase in toxicity. Patients who received ipilimumab before RT had an increased duration of irradiated tumor response

TKIs beyond immunotherapy predict improved survival in advanced HCC.

PURPOSE: For patients with advanced HCC, predictors of immunotherapy response are scarce, and the benefits of tyrosine kinase inhibitor (TKI) treatment after immunotherapy are unclear. We explored whether clinical features, such as target lesion response, immune-mediated toxicity, or subsequent TKI therapy predict immunotherapy response. METHODS: We retrospectively studied 77 patients with advanced HCC receiving immunotherapy. Patient characteristics and outcomes were assessed using various statistical methods, including the log-rank test and Kaplan-Meier methods. Cox proportional hazard modeling was used for multivariable survival analysis. RESULTS: For all patients, median overall survival (mOS) was 13 months (95% CI 8-19), and median progression-free survival (mPFS) was 6 months (95% CI 4-10). Patients with partial response (PR) and stable disease (SD) compared to progressive disease (PD) had prolonged mPFS (27 vs. 5 vs. 1 month(s), p \u3c 0.0001) and mOS (not met vs. 11 vs. 3 months, p \u3c 0.0001). Patients with vs. without immune-mediated toxicities trended towards longer mPFS (9 vs. 4 months p = 0.133) and mOS (17 vs. 9 months; p = 0.095). Patients who did vs. did not receive a tyrosine kinase inhibitor (TKI) after immunotherapy had a significantly improved mOS (19 vs. 5 months, p = 0.0024)). Based on multivariate modeling, the hazard ratio (HR) of overall survival (OS) of patients receiving TKI vs. no TKI was 0.412 (p = 0.0043). CONCLUSION: We show that disease control predicts prolonged mOS and mPFS. Furthermore, TKI therapy administered after immunotherapy predicts prolonged mOS in patients with advanced HCC