Jeanette Y. Lee

Associations Between Improvements in Lower Urinary Tract Symptoms and Sleep Disturbance Over Time in the CAMUS Trial

PURPOSE We recently reported an association between the bother and severity of lower urinary tract symptoms secondary to benign prostatic hyperplasia and the severity of sleep disturbance. However, few studies have examined whether alterations in the severity of urinary symptoms influence the degree of sleep problems over time. MATERIALS AND METHODS The severity of lower urinary tract symptoms in men enrolled in CAMUS (Complementary and Alternative Medicine for Urological Symptoms), a clinical trial of saw palmetto (Serenoa repens), was evaluated using AUASI (American Urological Association symptom index) and quality of life scores. Sleep disturbance was evaluated by the Jenkins sleep scale at 0, 24, 48 and 72 weeks. Statistical analyses were used to assess the relationship(s) between changes in lower urinary tract symptoms and sleep disturbance. RESULTS The baseline characteristics of the 339 men (172 placebo arm and 167 saw palmetto arm) enrolled in the CAMUS trial with assessment of sleep disturbance and urinary symptoms were similar. There were no differences between improvements in the severity of sleep disturbance or urinary symptoms between the 2 experimental arms. Combined analyses of the entire cohort revealed significant associations (p <0.001) between the AUASI score and sleep disturbance severity with time. Multivariate analyses demonstrated that improvements in lower urinary tract symptoms other than nocturia were the most significant predictors of improvements in sleep disturbance. Specific analyses adjusting for other baseline characteristics demonstrated that a 3-point improvement in AUASI score was associated with a 0.73-point improvement in the Jenkins sleep scale with time. CONCLUSIONS Improvements in lower urinary tract symptoms correlate with changes in sleeping abilities with time in men with benign prostatic hyperplasia. While nocturia is significantly associated with sleep disturbance, other changes in overall lower urinary tract symptoms are better predictors of changes in sleep dysfunction.

Acute Leukemia of Ambiguous Lineage in Elderly Patients – Analysis of Survival Using Surveillance Epidemiology and End Results-Medicare Database

&NA; We used the Surveillance Epidemiology and End Results‐Medicare database to study the overall survival and treatment pattern of elderly patients with acute leukemia of ambiguous lineage in the United States. Overall survival of this leukemia remains poor, but is improved significantly with chemotherapy. Background: Acute leukemia of ambiguous lineage (ALAL) is a rare leukemia with sparse data availability about the survival and management strategies in elderly patients. Methods: We used the Surveillance Epidemiology and End Results (SEER)‐Medicare database to describe the overall survival (OS) and treatment pattern of elderly patients (age > 65 years) with ALAL. OS analysis was done using the Kaplan‐Meier method, and its determinants were analyzed using the Cox proportional hazard regression method with a significant P < .05. Results: We included 705 patients with ALAL and a median age of 80 years. The 2‐year OS was 16.4% for patients aged 66 to 70 years, 8.1% for patients aged 71 to 75 years, 5.5% for patients aged 76 to 80 years, and 3.7% for patients aged > 80 years (P < .01). Two‐year OS did not significantly vary by race or gender. Among the study cohort, 151 patients received chemotherapy. Two‐year OS was 17% in the chemotherapy group and 3% in the no‐chemotherapy group (P < .001). On multivariate analysis, age less than 80 years (Age 66‐70 years: hazard ratio [HR]; 0.66, 95% confidence interval [CI], 0.52‐0.85; age 71‐75 years: HR, 0.80; 95% CI, 0.65‐0.99; age 76‐80 years: HR, 0.80; 95% CI, 0.66‐0.98; P = .004) and chemotherapy (HR, 0.51; 95% CI, 0.42‐0.62; P = .001) significantly reduced the hazard for mortality. Conclusion: Our study suggests that the OS of elderly patients with ALAL remains poor. Although treatment improved the OS, only 21.5% of patients received therapy. The optimal choice of therapy needs to be determined by prospective studies.

Safety and Preliminary Efficacy of Vorinostat With R-EPOCH in High-risk HIV-associated Non-Hodgkin's Lymphoma (AMC-075)

&NA; We performed a phase I trial of vorinostat (VOR) given on days 1 to 5 with R‐EPOCH (rituximab plus etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin hydrochloride) in patients with aggressive HIV‐associated non‐Hodgkin lymphoma. VOR was tolerable at 300 mg and seemingly efficacious with chemotherapy with complete response rate of 83% and 1‐year event‐free survival of 83%. VOR did not significantly alter chemotherapy steady‐state concentrations, CD4+ cell counts, or HIV viral loads. Introduction: Vorinostat (VOR), a histone deacetylase inhibitor, enhances the anti‐tumor effects of rituximab (R) and cytotoxic chemotherapy, induces viral lytic expression and cell killing in Epstein‐Barr virus‐positive (EBV+) or human herpesvirus‐8‐positive (HHV‐8+) tumors, and reactivates latent human immunodeficiency virus (HIV) for possible eradication by combination antiretroviral therapy (cART). Patients and Methods: We performed a phase I trial of VOR given with R‐based infusional EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin hydrochloride) (n = 12) and cART in aggressive HIV‐associated B‐cell non‐Hodgkin lymphoma (NHL) in order to identify safe dosing and schedule. VOR (300 or 400 mg) was given orally on days 1 to 5 with each cycle of R‐EPOCH for 10 high‐risk patients with diffuse large B‐cell lymphoma (1 EBV+), 1 EBV+/HHV‐8+ primary effusion lymphoma, and 1 unclassifiable NHL. VOR was escalated from 300 to 400 mg using a standard 3 + 3 design based on dose‐limiting toxicity observed in cycle 1 of R‐EPOCH. Results: The recommended phase II dose of VOR was 300 mg, with dose‐limiting toxicity in 2 of 6 patients at 400 mg (grade 4 thrombocytopenia, grade 4 neutropenia), and 1 of 6 treated at 300 mg (grade 4 sepsis from tooth abscess). Neither VOR, nor cART regimen, significantly altered chemotherapy steady‐state concentrations. VOR chemotherapy did not negatively impact CD4+ cell counts or HIV viral loads, which decreased or remained undetectable in most patients during treatment. The response rate in high‐risk patients with NHL treated with VOR(R)‐EPOCH was 100% (complete 83% and partial 17%) with a 1‐year event‐free survival of 83% (95% confidence interval, 51.6%‐97.9%). Conclusion: VOR combined with R‐EPOCH was tolerable and seemingly efficacious in patients with aggressive HIV‐NHL.

P2.05 A silent epidemic: the prevalence, incidence and persistence of mycoplasma genitalium in young asymptomatic women in the united states

Introduction: Mycoplasma genitalium (MG) is an emerging sexually transmitted infection (STI) associated with cervicitis, pelvic inflammatory disease, and adverse pregnancy outcomes in women, yet little is known regarding its natural history. We conducted a secondary analysis of specimens collected from young women enrolled in a multi-centre study of asymptomatic bacterial vaginosis (BV) in order to determine the natural history of MG and associated factors with infection. Methods Sexually active women aged 15–25 years were recruited from 10 US clinical sites. Eligible women had asymptomatic BV at baseline, and >/=2 STI risk factors. Self-collected vaginal swabs were collected at enrollment, and by home-based testing at 2, 4, 6, 8, 10 and 12 months. MG nucleic acid amplification testing was performed using a transcription mediated assay (Hologic Inc, San Diego, California). Prevalent, incident and persistent MG were estimated with 95% confidence intervals (CI). Univariate analyses and logistic regression modelling were performed to assess associations between participants’ baseline demographic, sexual, and clinical characteristics with prevalent MG infection. Results Specimens were tested for MG from 1365 predominantly Black (85.4%) women. At baseline, 233 women were MG+ (prevalence 20.5% [95% CI: 18.2–22.9]); among 204 participants with follow-up specimens, 42 (20.6%) had persistent MG, remaining MG+ on all follow-up testing. Among 801 women who were MG negative at baseline with follow-up testing, 220 had at least one subsequent MG+ test for an incidence of 27.5% (95% CI: 24.4–30.7). Black race (adjusted odds ratio (AOR) 1.92, 95% CI: 1.09–3.38) and younger (15–21 years) age (AOR 1.40, 95% CI: 1.03–1.91) were significantly associated with prevalent MG infection. Conclusions We identified high rates of prevalent, incident, and persistent MG infections among sexually active young women followed over 12 months. As national programs consider the impact of MG as an STI, the implications of asymptomatic infections should be considered among at-risk populations.

CARS temperature measurements in an MHD diffuser

The U.S. Department of Energy is currently conducting proof-of-concept testing of MHD power plant components in the DOE Coal -Fired Flow Facility located at the University of Tennessee Space Institute. As part of this DOE program, Mississippi State University is developing advanced instrumentation for nonintrusive measurements of coal-fired combustion gas properties. This paper presents data from MSU CARS temperature measurements taken in the CFFF diffuser during a recent long duration experiment. Details are given on the CARS system. Comparisons are drawn between the CARS data and the University of Tennessee Space Institute modeling results. These results further define the flow field and heat transfer in the diffuser and provide a basis for interpreting the CARS temperature measurements.