Prescreening to Increase Therapeutic Oncology Trial Enrollment at the Largest Public Hospital in the United States.

PURPOSE: The recruitment of underserved patients into therapeutic oncology trials is imperative. The National Institutes of Health mandates the inclusion of minorities in clinical research, although their participation remains under-represented. Institutions have used data mining to match patients to clinical trials. In a public health care system, such expensive tools are unavailable. METHODS: The NYU Clinical Trials Office implemented a quality improvement program at Bellevue Hospital Cancer Center to increase therapeutic trial enrollment. Patients are screened through the electronic medical record, tumor board conferences, and the cancer registry. Our analysis evaluated two variables: number of patients identified and those enrolled into clinical trials. RESULTS: Two years before the program, there were 31 patients enrolled. For a period of 24 months (July 2017 to July 2019), we identified 255 patients, of whom 143 (56.1%) were enrolled. Of those enrolled, 121 (84.6%) received treatment, and 22 (15%) were screen failures. Fifty-five (38.5%) were referred to NYU Perlmutter Cancer Center for therapy. Of the total enrollees, 64% were female, 56% were non-White, and overall median age was 55 years (range: 33-88 years). Our participants spoke 16 different languages, and 57% were non-English-speaking. We enrolled patients into eight different disease categories, with 38% recruited to breast cancer trials. Eighty-three percent of our patients reside in low-income areas, with 62% in both low-income and Health Professional Shortage Areas. CONCLUSION: Prescreening at Bellevue has led to a 4.6-fold increase in patient enrollment to clinical trials. Future research into using prescreening programs at public institutions may improve access to clinical trials for underserved populations.

Racism and hypertension: a review of the empirical evidence and implications for clinical practice.

BACKGROUND: Despite improved hypertension (HTN) awareness and treatment, racial disparities in HTN prevalence persist. An understanding of the biopsychosocial determinants of HTN is necessary to address racial disparities in the prevalence of HTN. This review examines the evidence directly and indirectly linking multiple levels of racism to HTN. METHODS: Published empirical research in EBSCO databases investigating the relationships of three levels of racism (individual/interpersonal, internalized, and institutional racism) to HTN was reviewed. RESULTS: Direct evidence linking individual/interpersonal racism to HTN diagnosis is weak. However, the relationship of individual/interpersonal racism to ambulatory blood pressure (ABP) is more consistent, with all published studies reporting a positive relationship of interpersonal racism to ABP. There is no direct evidence linking internalized racism to BP. Population-based studies provide some evidence linking institutional racism, in the forms of residential racial segregation (RRS) and incarceration, to HTN incidence. Racism shows associations to stress exposure and reactivity as well as associations to established HTN-related risk factors including obesity, low levels of physical activity and alcohol use. The effects vary by level of racism. CONCLUSIONS: Overall the findings suggest that racism may increase risk for HTN; these effects emerge more clearly for institutional racism than for individual level racism. All levels of racism may influence the prevalence of HTN via stress exposure and reactivity and by fostering conditions that undermine health behaviors, raising the barriers to lifestyle change.

Phase I dose-escalating study of biweekly fixed-dose rate gemcitabine plus pemetrexed in patients with advanced solid tumors.

PURPOSE: To determine the maximum tolerated dose (MTD) and the recommended phase II dose and to identify the dose-limiting toxicities (DLTs) of gemcitabine, administered by fixed-dose rate (FDR) infusion, combined with the antifolate agent pemetrexed in patients with advanced solid tumors. METHODS: Eligible patients were entered into this open label, phase I trial. Using a 3 + 3 dose escalation design, patients received intravenous pemetrexed 300-800 mg/m(2) followed by FDR gemcitabine 900-1,500 mg/m(2) at 10 mg/m(2)/min on Day 1 every 2 weeks. All patients received folic acid and vitamin B(12) supplementation. Patients continued until DLT or disease progression. RESULTS: A total of 33 patients were treated at 7 dose levels with a total of 230 cycles (median: 4 cycles; mean: 7 cycles; range: 1-35 cycles). The MTD of the combination was pemetrexed 800 mg/m(2) and gemcitabine 1,500 mg/m(2) over 150 min. DLTs were febrile neutropenia and grade 3 renal failure. Of the 28 patients evaluable for response, 3 patients experienced a partial response (10.7%) and 13 patients had stable disease (46.4%); the disease control rate was 57.1%. CONCLUSIONS: The recommended phase II dose for biweekly pemetrexed with FDR gemcitabine is 800 mg/m(2) and 1,200 mg/m(2) × 120 min, respectively. This regimen allows good dose intensity of both drugs to be administered on a simple schedule with an excellent tolerability profile. This regimen showed moderate activity in a diverse phase I population, possibly greater than either single agent. Further assessment of the combination in a phase II setting is suggested.