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Objectives: Rural women are underrepresented in cancer research. We hypothesized that providing access to a research study to rural, medically underserved women who were receiving their breast cancer screening using a mobile mammography unit would increase the representation of rural women in a cancer cohort study. Design: This study is a cross-sectional study using a cohort of women who have been recruited to a breast cancer study in Arkansas. Setting: Recruiters accompanied a mobile mammography unit, the MammoVan, to implement a novel method for reaching and recruiting underrepresented rural Arkansas women into the study. Participants include 5850 women recruited from 2010 through 2012 as part of the Arkansas Rural Community Health (ARCH) study. Results: Participants recruited during their mammography screening on the MammoVan tended to be more rural, less educated, and more likely to be non-Hispanic than those recruited in other venues. A significant difference was not noted for race or age. Conclusion: Collaboration with the MammoVan greatly aided the recruitment of rural participants. These strategies can facilitate the representation of this historically underserved and understudied rural population in future research studies.

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.

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.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.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 (p0.001) 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.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 (ALAL) is a rare leukemia with sparse data availability about the survival and management strategies in elderly patients.We used the Surveillance Epidemiology and End Results (SEER)-Medicare database to describe the overall survival (OS) and treatment pattern of elderly patients (age65 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.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 aged80 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.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.

562Background: Background:A plethora of studies have failed to define a group of patients that can forgo radiation to complete BCS without a significant increase in recurrence rate. This has result...

7573Background: HIV+ individuals are at increased risk for developing aggressive NHL that are often EBV+ or HHV-8+. We recently reported a phase I study using the HDAC inhibitor vorinostat (V) with...

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.

Purpose To determine whether exercise at low intensity (LO; 50% of peak VO2) or high intensity (HI; 85% of peak VO2) results in improvement of the ventilatory threshold (VT), 186 men with coronary artery disease (CAD) were enrolled in an exercise study for 1 year. Methods A symptom-limited exercise test was performed at baseline and the heart rate corresponding to 50% and 85% of peak VO2 was determined. Subjects were randomized to LO or HI intensity exercise. Exercise sessions included 45 minutes of walking/jogging and/or stationary cycling at the appropriate target heart rate and were conducted 3 days per week. The exercise test was repeated at 3 and 6 months. Target heart rates were revised to adjust for training. Results Both LO and HI resulted in improved VO2 at VT and peak. However, HI resulted in greater improvement than LO. Conclusion Among this population, both HI and LO improve the VO2 at VT and peak, but the improvement is greater with HI. The VT can be a useful adjunct to heart rate and peak oxygen uptake when prescribing exercise.

e18072 Background: CMML is a rare hematological malignancy with characteristics of both myelodysplastic and myeloproliferative disorders. Population level data about its overall survival (OS) in th...

8597 Background: Studies on multiple myeloma demonstrate an improvement in overall survival (OS) and increased risk of second primary malignancy (SPM); Population level data on OS and the risk of S...

Patients with neutropenia and persistent fever are often treated empirically with amphotericin B or liposomal amphotericin B to prevent invasive fungal infections. Antifungal triazoles offer a potentially safer and effective alternative.In a randomized, international, multicenter trial, we compared voriconazole, a new second-generation triazole, with liposomal amphotericin B for empirical antifungal therapy.A total of 837 patients (415 assigned to voriconazole and 422 to liposomal amphotericin B) were evaluated for success of treatment. The overall success rates were 26.0 percent with voriconazole and 30.6 percent with liposomal amphotericin B (95 percent confidence interval for the difference, -10.6 to 1.6 percentage points); these rates were independent of the administration of antifungal prophylaxis or the use of colony-stimulating factors. There were fewer documented breakthrough fungal infections in patients treated with voriconazole than in those treated with liposomal amphotericin B (8 [1.9 percent] vs. 21 [5.0 percent], P=0.02). The voriconazole group had fewer cases of severe infusion-related reactions (P0.01) and of nephrotoxicity (P0.001). The incidence of hepatotoxicity was similar in the two groups. Patients receiving voriconazole had more episodes of transient visual changes than those receiving liposomal amphotericin B (22 percent vs. 1 percent, P0.001) and more hallucinations (4.3 percent vs. 0.5 percent, P0.001). Parenteral voriconazole was changed to the oral formulation in 22 percent of the voriconazole group, with a reduction in the mean duration of hospitalization by one day in all patients (P=0.17) but by two days in patients at high risk (P=0.03).Voriconazole is a suitable alternative to amphotericin B preparations for empirical antifungal therapy in patients with neutropenia and persistent fever.

This open-label, multicenter trial evaluated the efficacy and safety of a new oral solution formulation of itraconazole in HIV+/AIDS patients with fluconazole-refractory oropharyngeal candidiasis. Seventy-four HIV+/AIDS patients with mycologically confirmed oropharyngeal candidiasis who failed fluconazole therapy (200 mg/day) were treated with 100 mg of itraconazole oral solution administered twice daily (200 mg/day) for 14 days. Patients who demonstrated an incomplete response to treatment were treated for an additional 14 days (28 days total). Clinical responders were eligible for participation in a separate 6-month maintenance protocol. If they declined further treatment, responders were monitored for 6 weeks posttreatment. The primary efficacy parameter was clinical response (i.e., no lesions or symptoms) at end of treatment. Fungal cultures were performed at baseline and at the end of treatment. Among the 74 patients who had mycologically confirmed, fluconazole-unresponsive, oropharyngeal candidiasis at baseline, 41 (55%) achieved a clinical response by day 28. The median time to response was 7 days (range, 7 to 28 days). Candida albicans was the most common pathogen isolated, either alone (62%) or in combination with another Candida species (31%). All 22 patients who entered the optional, off-therapy, 6-week follow-up phase relapsed; mean time to relapse was 13 days. Itraconazole oral solution was well-tolerated; adverse events were predominantly gastrointestinal disturbances. This trial demonstrates that itraconazole oral solution is a useful therapy in the treatment of HIV-infected patients with fluconazole-refractory oropharyngeal candidiasis.

8005 Background: Non-Hodgkin Lymphoma (NHL) remains the most common malignancy in patients with HIV. Outcomes have significantly improved over the last decade, but there is no accepted consensus regarding the optimal initial therapeutic approach. Our objective was to assess the effects of clinical factors on response and survival. Methods: We performed a systematic review to search for prospective clinical phase II or III trials that assessed therapeutic interventions for HIV-associated NHL and assembled individual patient data from 16 trials published between 2000 and 2011 including 1144 patients (median N=62/trial, range 17-195). Treatment factors included type of chemotherapy (CHOP, N=642; EPOCH, N=178; CDE, N=191; intensive regimens, N=155) and rituximab use (N=542). Endpoints included complete response (CR), progression-free survival (PFS), and overall survival (OS). We used logistic regression and Cox proportional hazard models adjusted for age, sex, age-adjusted International Prognostic Index (IPI), baseline CD4 count, baseline HIV viral load, use of concurrent antiretroviral therapy, and histology. Odds ratios (OR) > 1 for CR denote improved CR, and hazard ratios (HR) < 1 indicate reduced risk of progression or death. Results: Among the lymphoma- and HIV-specific covariates evaluated, only a higher IPI score was associated with inferior CR rate, PFS and OS (p

4030 Background: Epidermal growth factor receptor (EGFR) expression and HPV infection are common in SCAC. We therefore initiated 2 phase II studies to evaluate the safety and efficacy of the EGFR inhibitor CX given concurrently with CDDP/5-FU/RT in HIV-positive (AMC045) and immunocompetent (E3205) patients with SCAC. Methods: All patients received CX (400 mg/m2 loading, then 250 mg/m2/wk IV x 6-8 wks) plus CDDP (75 mg/m2 IV q28 days x 2) and 5-FU (1000 mg/m2/day IV infusion days 1-4 q 28 days x 2) concurrently with RT (45-54 Gy) beginning with CX dose 2. Patients in E3205 also received 2 cycles of CDDP/5-FU alone prior to CX/CDDP/5-FU/RT; this was discontinued on recommendation of the NCI Anorectal Task Force after 28 patients. Both trials were powered to detect a reduction in 3-year local-regional failure (LRF) rate from 35% to 17.5% (alpha=0.10, beta=0.10), the primary end point. Other endpoints included progression free survival (PFS) and overall survival (OS). The results below include complete toxicity and preliminary efficacy data (including only the first 28 patients from E3205). Results: Expedited reporting was required for type I (any grade 5, grade 4 cardiac) or II (grade 4 RT skin, diarrhea) adverse events, with prespecified rates of >5% or >20%, respectively defined as unacceptable. Early stopping rules were not invoked for either trial. LRF rates data will be presented after more detailed case review is completed. Conclusions: CX plus CDDP/5-FU/RT is feasible in patients with SCAC, including patients with HIV infection. Preliminary safety and efficacy data appear encouraging, but accrual without neoadjuvant CDDP/5-FU continues in E3205, and additional followup of both study cohorts is required in order to determine whether pre-specified efficacy endpoints were met. [Table: see text]

background: Invasive aspergillosis is the most common invasive mould infection and a major cause of mortality in immunocompromised patients. Response to amphotericin B, the only antifungal agent licensed in the United States for the treatment of aspergillosis, is suboptimal. methods: A multicenter open study with strict entry criteria for invasive aspergillosis evaluated oral itraconazole (600 mg/d for 4 days followed by 400 mg/d) in patients with various underlying conditions. Response was based on clinical and radiologic criteria plus microbiology, histopathology, and autopsy data. Responses were categorized as complete, partial, or stable. Failure was categorized as an itraconazole failure or overall failure. results: Our study population consisted of 76 evaluable patients. Therapy duration varied from 0.3 to 97 weeks (median 46). At the end of treatment, 30 (39%) patients had a complete or partial response, and 3 (4%) had a stable response, and in 20 patients (26%), the protocol therapy was discontinued early (at 0.6 to 54.3 weeks) because of a worsening clinical course or death due to aspergillosis (itraconazole failure). Twenty-three (30%) patients withdrew for other reasons including possible toxicity (7%) and death due to another cause but without resolution of aspergillosis (20%). Itraconazole failure rates varied widely according to site of disease and underlying disease group: 14% for pulmonary and tracheobronchial disease, 50% for sinus disease, 63% for central nervous system disease, and 44% for other sites; 7% in solid organ transplant, 29% in allogeneic bone marrow transplant patients, and 14% in those with prolonged granulocytopenia (median 19 days), 44% in AIDS patients, and 32% in other host groups. The relapse rates among those who completed therapy and those who discontinued early for possible toxicity were 12% and 40%, respectively; all were still immunosuppressed. conclusion: Oral itraconazole is a useful alternative therapy for invasive aspergillosis with response rates apparently comparable to amphotericin B. Relapse in immunocompromised patients may be a problem. Controlled trials are necessary to fully assess the role of itraconazole in the treatment of invasive aspergillosis.

Invasive pulmonary aspergillosis (IPA) is a major cause of mortality in cancer patients with chemotherapy-induced neutropenia. While duration of neutropenia is a significant risk factor for and an outcome predictor of IPA, many patients with IPA recover from neutropenia and yet fail to respond to therapy. In addition, the duration of neutropenia (absolute neutrophil count; ANC Between November 2003 and February 2008, 78 consecutive myeloma patients developed IPA following chemotherapy-induced neutropenia. This included two populations: recipients of autologous stem cell transplantation (ASCT) (32 patients) and patients treated with non-myeloablative chemotherapy (NMCT) (46 patients). The diagnosis of IPA was based on conventional diagnostic criteria plus ≥ 2 consecutive positive assays for the FDA-approved serum galactomannan index (GMI) (optical density ≥0.5). Following the diagnosis of IPA, GMI testing was repeated to monitor the rapidity of IPA response. Response of IPA was defined as normalization of GMI with survival and was considered rapid if it occurred within 8 days after ANC ≥ 1000/μL. Overall, 664 GMI tests were positive (median of 5 per patient). Univariate and multivariate logistic regression analysis were applied to identify the pretreatment variables that predict IPA outcome. These variables included age, gender, body measurements, myeloma remission status, ANC, platelet and lymphocyte counts, renal and liver function tests, serum albumin and the number of CD34 + cells infused (for 32 ASCT recipients). All patients developed neutropenia which was severe (ANC We conclude that pretreatment platelet count is a strong predictor of the quality and rapidity of response of IPA among neutropenic patients with myeloma. These novel findings, which are available prior to commencing myelosuppressive chemotherapy, allow us to predict, for the first time, the likelihood and rapidity of response of IPA and may be used to individualize antifungal prophylaxis and therapy.

To determine predictors of TNM relapse and survival for 108 patients with epidermoid carcinoma of the pyriform sinus, the histopathologic features of tumor-related and host-related characteristics were correlated with primary and/or cervical nodal failure, distant metastases, and actuarial three-year survival. Patients in this study received preoperative irradiation and partial laryngopharyngectomy (PLP) or total laryngopharyngectomy (TLP) with en bloc radical neck dissection. Higher rates of local failure were observed in patients with keratinizing tumors (34 vs. 15%), with tumors having an "infiltrating" tumor-stromal interface (30 vs. 14%), with positive surgical margins in PLP or TLP specimens (30 vs. 16%), and with extranodal extension of tumor (39 vs. 22%). The development of distant metastases was significantly correlated with nonkeratinizing carcinomas (30 vs 11%, P = 0.02), and was observed more often in patients with positive lymph nodes (17 vs. 7%). Patients with negative surgical margins in PLP or TLP excision (50 vs. 21%, P = 0.01) survived significantly longer.

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8524 Background: Management of ARL evolved in the last 2 decades. We previously reported prognostic factors in a pooled analysis of 1,546 patients with ARL, and here present analysis of these factors over time to determine if their prognostic significance has changed. Methods: Following a systematic review, we assembled individual patient data from 19 prospective phase 2/3 clinical trials (published 1993-2010) for ARL (n=1,546). Factors analyzed include age, sex, histology, CD4 count, prior history of (h/o) AIDS, & age-adjusted (aa) IPI. The endpoint was overall survival (OS) expressed as the hazard ratio (HR) for death. We used separate Cox proportional hazard models adjusted for the other covariates to determine the significance of each variable in the following time periods: pre-cART [combination antiretroviral therapy] (