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PurposeIn the construction sector, site excavation is one of the most dangerous and challenging activities. Proper training can be an effective way to mitigate excavation hazards. Virtual reality (VR) has been used as an effective training tool to enhance safety performance in various industries. However, little attention has been paid to the potential of this technology for construction excavation safety training.Design/methodology/approachThis study proposes an immersive VR training system for excavation safety and hazard identification. The proposed VR training system was compared with a health and safety manual via a controlled experiment.FindingsResults based on scores obtained immediately after training indicate that VR training significantly enhanced practical performance, knowledge acquisition and self-efficacy. Results also show that knowledge was retained four weeks after training. In addition, VR training outperformed health and safety manuals regarding knowledge retention.Originality/valueThis study measures the practical performance to evaluate the effectiveness of the proposed VR training system. Also, this study compares the VR training system with a traditional training method by measuring knowledge acquisition and retention. The results demonstrate the potential of VR as a training tool for excavation safety and hazards.

Background Glucocorticoids, particularly dexamethasone, are often used in combination with novel agents in multiple myeloma. This study compared the safety, rate, and extent of absorption of a single dose of an orally administered 20-mg dexamethasone tablet to five 4-mg tablets (total, 20 mg). Patients and Methods This was a single-center, open-label, randomized, 3-way crossover comparative study. Thirty-six volunteers received at least 1 dose of either a single 20-mg dexamethasone tablet, under fasting or fed conditions, or five 4-mg dexamethasone tablets (total, 20 mg). Blood samples were collected before study drug administration and at 21 time points for up to 36 hours after drug administration. Results Mean area under the concentration-time curve from time zero to the time of last non-zero concentration (AUC0–t), mean area under the concentration-time curve from time zero to infinity (extrapolated) (AUC0–∞), and maximum observed concentration (Cmax) were 1314.38 ng × h/mL, 1329.24 ng × h/mL, and 257.22 ng/mL, respectively for fasting test formulation (single dexamethasone 20-mg tablet), 1339.74 ng × h/mL, 1358.07 ng × h/mL, and 194.56 ng/mL, respectively, for the fed test formulation (single dexamethasone 20-mg tablet), and 1325.12 ng × h/mL, 1342.12 ng × h/mL, and 244.12 ng/mL, respectively, for the reference formulation (5 dexamethasone 4-mg tablets). The median time of observed Cmax was 0.997 hours for the fasting and 2.502 hours for the fed test formulation, compared with 1.495 hours for the reference. Mean plasma elimination half-lives (t1/2) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference). The point estimates and 90% confidence intervals (CIs) for AUC0-t, AUC0-∞, and Cmax were 99.37% (90% CI, 95.65%-103.24%), 99.24% (90% CI, 95.47%-103.16%), and 106.28% (90% CI, 97.69%-115.62%), respectively, satisfying the bioequivalence criteria of the United States Food and Drug Administration guidelines. Conclusion The 2 formulations were well-tolerated, and one 20-mg tablet or five 4-mg tablets of dexamethasone are bioequivalent under fasting conditions and thus may be prescribed interchangeably.

The BELIEF trial was an international study of belinostat in patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) that led to FDA-approval for the disease. Herein, we present a subset analysis of patients with angioimmunoblastic T-cell lymphoma (AITL). Patients with R/R PTCL received belinostat 1000mg/m(2) intravenously every 21 days. The primary study endpoint was ORR by Cheson 2007 criteria. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Of 129 patients treated, 22 patients were diagnosed with AITL. The ORR for AITL patients was 45.5%, with 18% achieving compete response. After a median follow up of 21.5 months, the median DOR, PFS, and OS were 13.6 months, 4.2 months, and 9.2 months, respectively. Common grade 3/4 adverse events were asthenia, fatigue, cytopenias, and septic shock. Single-agent belinostat induces clinically meaningful duration of response in patients with AITL and warrants further investigation in studies.

Single agents have demonstrated activity in relapsed and refractory (R/R) peripheral T-cell lymphoma (PTCL). Their benefit relative to combination chemotherapy remains undefined. Patients with histologically confirmed PTCL were enrolled in the Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment (COMPLETE) registry. Eligibility criteria included those with R/R disease who had received one prior systemic therapy and were given either a single agent or combination chemotherapy as first retreatment. Treatment results for those with R/R disease who received single agents were compared to those who received combination chemotherapy. The primary endpoint was best response to retreatment. Fifty-seven patients met eligibility criteria. At first retreatment, 46% (26/57) received combination therapy and 54.5% (31/57) received single agents. At median follow up of 2 years, a trend was seen towards increased complete response rate for single agents versus combination therapy (41% vs 19%; P = .02). There was also increased median overall survival (38.9 vs 17.1 months; P = .02) and progression-free survival (11.2 vs 6.7 months; P = .02). More patients receiving single agents received hematopoietic stem-cell transplantation (25.8% vs 7.7%, P = .07). Adverse events of grade 3 or 4 occurred more frequently in those receiving combination therapy, although this was not statistically significant. The data confirm the unmet need for better treatment in R/R PTCL. Despite a small sample, the analysis shows greater response and survival in those treated with single agents as first retreatment in R/R setting, while maintaining the ability to achieve transplantation. Large, randomized trials are needed to identify the best strategy.

Traditional Pacific diets have many health benefits, including maintenance of a healthy weight and prevention of various diseases. Few studies have evaluated the frequency at which traditional diets are consumed in the Pacific, especially among children.This study examined the frequency of traditional and acculturated fruit and vegetable (FV) intake among children in the US-affiliated Pacific (USAP) region.Diet records of 3319 children ages 2 to 8 y old were analyzed for frequency of traditional or acculturated FV intake within USAP jurisdictions of American Samoa, Commonwealth of the Northern Mariana Islands (CNMI), Federated States of Micronesia (FSM; FSM island states include Chuuk, Kosrae, Pohnpei, and Yap), Guam, Hawaii, Republic of the Marshall Islands (RMI), and Republic of Palau.Of the 95,304 food items recorded among participating children in the USAP jurisdictions, 15.2% were FVs. Of the 10 jurisdictions, children in the islands of Chuuk, Kosrae, Yap, and Pohnpei recorded the highest frequencies of traditional FV intake relative to their total FV intake (67.8%, 64.8%, 56.7%, and 52.5%, respectively). American Samoa and RMI recorded moderate frequency of traditional FV intake (38.9% and 46.4%, respectively), whereas children in Hawaii, Guam, and CNMI recorded the lowest frequencies of traditional FV intake relative to their total FV intake (10.4%, 12.4%, and 15.3%, respectively). Children in Hawaii, Guam, Palau, and CNMI recorded high frequencies of acculturated FV intake (37.8%, 31.2%, 34.5%, and 27.9%, respectively).Overall, children in the USAP jurisdictions participating in this study recorded a low frequency of FV intake. The differences in traditional FV intake found between the USAP islands may be due to variation in economic income level and external influences on social and cultural norms among the island populations and variations of cost, accessibility, and convenience of each category of food to each island's population.

This study is part of the Children&rsquo, s Healthy Living program in U.S. Affiliated Pacific region. The objectives were to estimate overweight and obesity (OWOB) prevalence and identify possible related risk factors among ethnic groups in Guam. In 2013, 865 children (2&ndash, 8 years) were recruited via community-based sampling from select communities in Guam. Children&rsquo, s demographic and health behavior information, dietary intake, and anthropometric measurements were collected. Logistic regression, odds ratio, t-tests, and chi-square tests were used to determine differences and assess covariates of OWOB. The results indicate that 58% of children were living below the poverty level, 80% were receiving food assistance, and 51% experienced food insecurity. The majority of children surveyed did not meet recommendations for: sleep duration (59.6%), sedentary screen-time (83.11%), or fruit (58.7%) and vegetable (99.1%) intake, and consumed sugar sweetened beverages (SSB) (73.7%). OWOB affected 27.4% of children. Children affected by OWOB in this study were statistically more likely (p = 0.042) to suffer from sleep disturbances (p = 0.042) and consume marginally higher amounts (p value = 0.07) of SSB compared to children with healthy weight. Among Other Micronesians, children from families who considered themselves &lsquo, integrated&rsquo, into the culture were 2.05 (CI 0.81&ndash, 5.20) times more likely to be affected by OWOB. In conclusion, the OWOB prevalence among 2&ndash, 8-year-olds in Guam was 27.4%, and compared with healthy weight children, children with OWOB were more likely to have educated caregivers and consume more SSBs. Results provide a basis for health promotion and obesity prevention guidance for children in Guam.

Introduction We examined patient characteristics, treatments and outcomes of transformed mycosis fungoides (tMF) patients from COMPLETE: a large, multicenter, prospective cohort study of peripheral T-cell lymphoma patients in the US. Methods Patients with tMF were enrolled in COMPLETE at the time of transformation. For this analysis, we identified tMF patients with completed baseline, treatment and follow-up records. Median survival was assessed using Kaplan-Meier methodology. Results Of the 499 patients enrolled in COMPLETE, 17 had tMF. Median age was 61; 53% were male, 9 had elevated lactate dehydrogenase (LDH) and 9 had lymph node involvement. About one-quarter of the patients were African American and 47% had CD30+ disease. Median time to transformation was 53 months. All patients received systemic therapy, with 19% receiving concomitant radiotherapy. Most patients (87%) received single agents, including liposomal doxorubicin, pralatrexate and gemcitabine. Eight patients (50%) had reported responses to therapy. Median survival was 18 months. One- and two-year survival rates were 56% and 44%, respectively. Conclusions tMF often express CD30 and present with lymph-node involvement. Responses have been seen with single agents, but survival remains poor. Novel treatment approaches are urgently needed to improve outcomes.

Background: Outcomes for patients with peripheral T-cell lymphoma (PTCL) who fail to achieve complete response (CR) or relapse after front-line therapy are poor with lack of prospective outcomes data. Objectives: COMPLETE is a prospective registry of 499 patients enrolled at academic and community sites in the United States detailing patient demographics, treatment and outcomes for patients with aggressive T cell lymphomas. We report results for patients with primary refractory and relapsed disease. Methods: Primary refractory disease was defined as an evaluable best response to initial treatment (induction ± maintenance or consolidation/transplant) other than CR, and included a partial response, progressive disease, or no response/stable disease. Relapsed disease was defined as an evaluable best response to initial treatment of CR, followed by disease progression at a later date, irrespective of time to progression. Patients were included in the analysis if initial treatment began within 30 days of enrollment and treatment duration was ≥4 days. Results: Of 420 evaluable patients, 97 met the definition for primary refractory and 58 with relapsed disease. In the second-line setting, relapsed patients received single-agent therapies more often than refractory patients (52 vs. 28%; p = 0.01) and were more likely to receive single-agent regimens (74 vs. 53%; p = 0.03). The objective response rate to second-line therapy was higher in relapsed patients (61 vs. 40%; p = 0.04) as was the proportion achieving a CR (41 vs. 14%; p = 0.002). Further, relapsed patients had longer overall survival (OS) compared to refractory patients, with a median OS of 29.1 versus 12.3 months. Conclusions: Despite the availability of newer active single agents, refractory patients were less likely to receive these therapies and continue to have inferior outcomes compared to those with relapsed disease. PTCL in the real world remains an unmet medical need, and improvements in front-line therapies are needed.

Background With increased understanding of the unique entities, subtype-specific approaches for peripheral T-cell lymphoma (PTCL) are emerging, and more precise diagnoses are becoming increasingly important. Patients and Methods We analyzed the approach to the histopathologic diagnosis of PTCL using data from the comprehensive oncology measures of peripheral T-cell lymphoma (COMPLETE) study. The COMPLETE trial is a large prospective cohort study of patients with newly diagnosed PTCL in the United States. Results A total of 499 patients were enrolled from 40 academic and 15 community-based centers. Baseline assessment forms were collected for 493 patients, of which 435 (88%) were available for analysis. The most common diagnoses were PTCL, not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma, and angioimmunoblastic T-cell lymphoma (AITL). A mean of 10 markers (range, 0-21) was assessed per patient. CD30 was assessed frequently but not uniformly in cases that were not anaplastic large cell lymphoma. Only 17% of PTCL-NOS cases were assessed for PD1. CXCL13 was a relatively sensitive marker in AITL, expressed in 84% of tested cases; however, only 3% of PTCL-NOS cases were tested. T follicular helper cell marker assessment differed between academic and community practices, with PD1 more often evaluated by academic centers in cases of AITL (62% vs. 12%; P = .01). Conclusion The diagnostic workup for PTCL in the United States varies widely and often lacks important phenotypic information to fully characterize the lymphoma. Gaps in testing of selected markers should be filled, given the impending revision to the World Health Organization classification. The accuracy of diagnosis will become increasingly important as we enter the era of targeted treatment for PTCL.

BACKGROUND Long-term survival in patients with aggressive peripheral T-cell lymphoma (PTCL) is generally poor, and there currently is no clear consensus regarding the initial therapy used for these diseases. Herein, the authors analyzed treatment patterns and outcomes in a prospectively collected cohort of patients with a new diagnosis of nodal PTCL in the United States. METHODS Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment (COMPLETE) is a prospective multicenter cohort study designed to identify the most common prevailing treatment patterns used for patients newly diagnosed with PTCL in the United States. Patients with nodal PTCL and completed records regarding baseline characteristics and initial therapy were included in this analysis. All statistical tests were 2-sided. RESULTS Of a total of 499 patients enrolled, 256 (51.3%) had nodal PTCL and completed treatment records. As initial therapy, patients received doxorubicin-containing regimens (41.8%), regimens containing doxorubicin plus etoposide (20.9%), other etoposide regimens (15.8%), other single-agent or combination regimens (19.2%), and gemcitabine-containing regimens (2.1%). Survival was found to be statistically significantly longer for patients who received doxorubicin (log-rank P = .03). After controlling for disease histology and International Prognostic Index, results demonstrated a trend toward significance in mortality reduction in patients who received doxorubicin compared with those who did not (hazard ratio, 0.71; 95% confidence interval, 0.48-1.05 [P = .09]). CONCLUSIONS To the authors' knowledge, there is no clear standard of care in the treatment of patients with PTCL in the United States. Although efforts to improve frontline treatments are necessary, anthracyclines remain an important component of initial therapy for curative intent. Cancer 2017;123:1174–1183. © 2016 American Cancer Society.

Background The role of autologous stem cell transplantation (ASCT) in the first complete remission (CR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1. Methods Patients with newly diagnosed, histologically confirmed, aggressive PTCL were prospectively enrolled into the Comprehensive Oncology Measures for Peripheral T-Cell Lymphoma Treatment (COMPLETE) study, and those in CR1 were included in this analysis. Results Two hundred thirteen patients with PTCL achieved CR1, and 119 patients with nodal PTCL, defined as anaplastic lymphoma kinase-negative anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma (AITL), or PTCL not otherwise specified, were identified. Eighty-three patients did not undergo ASCT, whereas 36 underwent consolidative ASCT in CR1. At the median follow-up of 2.8 years, the median overall survival was not reached for the entire cohort of patients who underwent ASCT, whereas it was 57.6 months for those not receiving ASCT (P = .06). ASCT was associated with superior survival for patients with advanced-stage disease or intermediate-to-high International Prognostic Index scores. ASCT significantly improved overall and progression-free survival for patients with AITL but not for patients with other PTCL subtypes. In a multivariable analysis, ASCT was independently associated with improved survival (hazard ratio, 0.37; 95% confidence interval, 0.15-0.89). Conclusions This is the first large prospective cohort study directly comparing the survival outcomes of patients with nodal PTCL in CR1 with or without consolidative ASCT. ASCT may provide a benefit in specific clinical scenarios, but the broader applicability of this strategy should be determined in prospective, randomized trials. These results provide a platform for designing future studies of previously untreated PTCL.

The US Affiliated Pacific region’s childhood obesity prevalence has reached epidemic proportions. To guide program and policy development, a multi-site study was initiated, in collaboration with partners from across the region, to gather comprehensive information on the regional childhood obesity prevalence. The environmental and cultural diversity of the region presented challenges to recruiting for and implementing a shared community-based, public health research program. This paper presents the strategies used to recruit families with young children (n = 5775 for children 2 – 8 years old) for obesity-related measurement across eleven jurisdictions in the US Affiliated Pacific Region. Data were generated by site teams that provided summaries of their recruitment strategies and lessons learned. Conducting this large multi-site prevalence study required considerable coordination, time and flexibility. In every location, local staff knowledgeable of the community was hired to lead recruitment, and participant compensation reflected jurisdictional appropriateness (e.g., gift cards, vouchers, or cash). Although recruitment approaches were site-specific, they were predominantly school-based or a combination of school- and community-based. Lessons learned included the importance of organization buy-in; communication, and advance planning; local travel and site peculiarities; and flexibility. Future monitoring of childhood obesity prevalence in the region should consider ways to integrate measurement activities into existing organizational infrastructures for sustainability and cost-effectiveness, while meeting programmatic (e.g. study) goals.

Addressing complex chronic disease prevention, like childhood obesity, requires a multi-level, multi-component culturally relevant approach with broad reach. Models are lacking to guide fidelity monitoring across multiple levels, components, and sites engaged in such interventions. The aim of this study is to describe the fidelity-monitoring approach of The Children’s Healthy Living (CHL) Program, a multi-level multi-component intervention in five Pacific jurisdictions. A fidelity-monitoring rubric was developed. About halfway during the intervention, community partners were randomly selected and interviewed independently by local CHL staff and by Coordinating Center representatives to assess treatment fidelity. Ratings were compared and discussed by local and Coordinating Center staff. There was good agreement between the teams (Kappa = 0.50, p

Introduction: Melphalan is often part of the standard conditioning regimen for autologous stem cell transplantation (SCT) for multiple myeloma (MM). Due to the short stability time for IV admixtures of traditional propylene glycol-containing melphalan products, careful alignment is required between pharmacy, nursing, and patients to ensure timely dose delivery. Propylene glycol-free (PGF) melphalan (Evomela®) has improved stability that may allow for greater medical staff flexibility for scheduling, reconstitution, admixture delivery, and infusion to patients. The aim of this study was to document the steps, time and resource burden incurred when preparing generic propylene glycol containing melphalan and estimate the benefits of stable PGF melphalan. Methods : A survey was conducted with healthcare providers (HCPs) specializing in the care and management of MM patients. HCPs (5 oncology pharmacists, 5 oncology nurses, 5 oncology pharmacy technicians) included those involved in the preparation, administration and monitoring of melphalan when used as a conditioning agent for SCT. HCPs were selected based on a purposeful sampling design to capture a geographically representative sample among US SCT centers. Part 1 of survey consisted of an exploratory qualitative interview with each HCP to capture insights on preparing oncology treatments for administration as well as melphalan-specific insights related to preparation, administration and monitoring. Part 2 of the survey consisted of a quantitative evaluation based on the insights from part 1 of the survey. The quantitative portion focused on capturing facility characteristics as well as melphalan utilization patterns as well as timing and resource consumption related to the preparation, administration, and monitoring of generic melphalan. Additionally, HCPs provided their attitudes towards the potential time benefits of a more stable form of melphalan as it relates to alignment between the pharmacy and the nurses managing the patients during treatment with melphalan. Results are presented as descriptive statistics with mean and standard deviation for continuous variables and counts and percentages for categorical variables. Results: Sixty percent of those surveyed utilized generic melphalan. The steps involved in the preparation of melphalan (generic or PGF) included 1) verification of melphalan prescription, 2) preparation and release of melphalan admixture, 3) delivery of melphalan to the floor, 4) preparation of the patient for administering melphalan, 5) setup and verification of the melphalan pump and administration, and 6) patient monitoring during administration. The total time from start to finish averaged 75.3 (standard deviation: 46.7) minutes (min). The total time spent varied, but the cumulative total time spent incurred across all provider average times was 108.2 min (Table 1). On average, the time of 2.1 pharmacists, 0.9 technicians and 1.5 nurses were utilized in the preparation, administration and monitoring of a melphalan prescription (Table 1). Forty percent of those surveyed had changed from generic to PGF melphalan for the following reasons: convenience for a more stable product (61.5%); convenience for pharmacy preparation planning (46.2%); convenience for patient scheduling (38.5%); improved safety for staff rushing due to risk of precipitation (30.8%); and to reduce the risk of lost treatment due to precipitation (15.4%). HCPs also estimated the potential time benefits of PGF melphalan, which included reducing preparation time by a mean of 4.96 min for pharmacy and nurse alignment to initiate preparation, 3.77 min for pharmacy and nurse to align on pick up, 8.34 min due to nurse time waiting to pick up and 9.77 min for the pharmacy technician or runner to deliver directly to the floor. Conclusions: In this survey of healthcare providers involved in the preparation, administration and monitoring of melphalan as a conditioning treatment for SCT among MM patients, the total time spent was ~1.8 hours for preparing generic melphalan with a potential opportunity to reduce the time by ~0.45 hours when using a PGF melphalan. There may be a potential time and convenience benefit to oncology pharmacists, technician and nurses. Future comparative effectiveness research is needed to confirm these findings in a larger sample of SCT centers using melphalan as a conditioning regimen for SCT among MM patients. Disclosures Acosta: Acrotech Biopharma: Employment. Darban:BluePath Solutions: Consultancy. Gitlin:BluePath Solutions: Consultancy.

Background: Angioimmunoblastic T-cell lymphoma (AITL) is a relatively common subtype of peripheral T-cell lymphoma (PTCL) that typically presents with lymphadenopathy, extranodal disease, including rash, and is associated with frequent infections due to immune dysregulation. Patients with AITL generally have a poor prognosis, even with aggressive chemotherapy as responses to standard chemotherapy are often suboptimal. Recent advances in cancer biology suggest that AITL is derived from T-follicular helper cells and is often characterized by gross epigenetic dysregulation. Histone deacetylase (HDAC) inhibitors have demonstrated significant activity in T-cell neoplasms. The BELIEF trial established an overall response rate of 25% in patients with relapsed/refractory PTCL who were treated with belinostat, with a duration of response of about 1 year, leading to accelerated approval. Herein, we present a subset analysis of the data for patients with AITL. Methods: Patients with histologically confirmed PTCL (N = 129) who experienced failure with or refractory to ≥ 1 prior systemic therapy received belinostat 1,000 mg/m(2) as daily 30-minute infusions on days 1 to 5 every 21 days. Central assessment of response used International Working Group criteria. Primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DoR) and progression-free and overall survival (PFS). Results: Of 129 patients, 22 patients had AITL; most had advanced disease (91% stage III/IV; 36% with bone marrow involvement). The median number of prior therapies was 2 (range, 1-5), and 3 (14%) patients were refractory to their last line of therapy. The ORR for patients with AITL was 46% (10/22; 95%CI: 24 - 68%), with a complete response (CR) in 4 of 22 patients (18%). Of the ten responders, the median time to response of 11.3 weeks (range, 4.7 - 24.4 weeks) in the AITL subgroup. After a median follow up of 21.5 months, the median PFS was 4.2 months (95%CI: 1.5 -13.9) and the median DOR was 13.6 months (95%CI: 1.4 - 29.4) as shown in Figure 1. For all patients with AITL treated with belinostat, the median OS was 9.2 months (95%CI: 6.8 - 21.5). The most common grade 3 to 4 adverse events were asthenia (n=2), fatigue (n=2), anemia (n=2), thrombocytopenia (n=2), neutropenia (n=2), and septic shock (n=2). Conclusions: Single-agent belinostat induced rapid and durable responses in patients with relapsed/refractory AITL. At the end of the study, there were 37% patients with ongoing responses at 2 years. Patients with clinical benefit from belinostat continued treatment until progression of disease. These results support the use of belinostat in relapsed/refractory AITL as a single agent and provide rationale for combination therapies in clinical trials. Disclosures Sawas: Seattle Genetics, Gilead, Daiichi Sanko: Consultancy; Affimed: Research Funding. Shustov:Spectrum Pharmaceuticals: Consultancy, Research Funding. Hsu:Spectrum Pharmaceuticals: Employment. Bhat:Spectrum Pharmaceuticals: Employment. Acosta:Acrotech Biopharma: Employment. Horwitz:Astex: Consultancy; Kyowa Hakko Kirin: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Innate Pharma: Consultancy; Kyowa Hakko Kirin: Consultancy; Trillium: Research Funding; Affimed: Consultancy; ADCT Therapeutics: Research Funding; Kura: Consultancy; ADCT Therapeutics: Research Funding; Aileron: Research Funding; Seattle Genetics: Consultancy, Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Trillium: Research Funding; Aileron: Research Funding; Trillium: Research Funding; Miragen: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Kura: Consultancy; Forty-Seven: Research Funding; Millennium/Takeda: Consultancy, Research Funding; ADCT Therapeutics: Research Funding; Mundipharma: Consultancy; Kura: Consultancy; Miragen: Consultancy; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Mundipharma: Consultancy; Astex: Consultancy; Seattle Genetics: Consultancy, Research Funding; Astex: Consultancy; Portola: Consultancy; Celgene: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Aileron: Research Funding; Trillium: Research Funding; Forty-Seven: Research Funding; Infinity/Verastem: Consultancy, Research Funding; Innate Pharma: Consultancy; Miragen: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Mundipharma: Consultancy; Portola: Consultancy; Mundipharma: Consultancy; Portola: Consultancy; Aileron: Research Funding; Forty-Seven: Research Funding; Kura: Consultancy; Kyowa Hakko Kirin: Consultancy; Seattle Genetics: Consultancy, Research Funding; Portola: Consultancy; ADCT Therapeutics: Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Astex: Consultancy; Innate Pharma: Consultancy; Kyowa Hakko Kirin: Consultancy; Miragen: Consultancy; Affimed: Consultancy; Affimed: Consultancy; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Innate Pharma: Consultancy; Seattle Genetics: Consultancy, Research Funding; Forty-Seven: Research Funding; Affimed: Consultancy; Millennium/Takeda: Consultancy, Research Funding. O'Connor:Mundipharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; ADCT Therapeutics, Affimed, Agensys, Merck, Seattle Genetics, Spectrum, Trillium, and Verastem Oncology.: Research Funding; TG Therapeutics: Other: Travel Support, Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Introduction: Patients with aggressive peripheral T-cell lymphoma (PTCL) often undergo induction with anthracycline-based chemotherapy followed by autologous stem cell transplantation in fit patients. Up to 40% of patients have primary refractory disease, and even for those who respond to induction, 5-year overall survival (OS) is 32% with the exception of ALCL. This results in a significant number of patients who need treatment in the relapsed and refractory (R/R) setting. While there is no standard approach for this group, multiagent chemotherapy regimens are often used, particularly in those who may be transplant candidates. Several novel single agents have shown activity in R/R PTCL and can often be given in a more continuous fashion than combination chemotherapy. In order to explore the potential benefits of single agents in comparison to combination chemotherapy in R/R PTCL, we examined treatment outcomes in a prospectively enrolled cohort of PTCL patients. Methods: Patients were enrolled in the Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment (COMPLETE), a multinational prospective cohort of 500 newly diagnosed PTCL patients. Demographics, treatments, and outcomes were recorded until death or for at least 5 years. Analysis was restricted to 6 subtypes of PTCL: PTCL-NOS, AITL, ALCL, EATL, NKT, HSTCL. Primary refractory was defined as lack of a complete response (CR) to initial treatment. Relapsed was defined as a CR to initial treatment with progression at a later date. Patients in whom initial treatment was ≤4 days, unreported, or began >30 days before or after informed consent were excluded. Single agents were pralatrexate, romidepsin, brentuximab vedotin (BV), bendamustine, alisertib, denileukin diftitox, and lenalidomide. Combinations were any multiagent chemotherapy regimen excluding the above agents. Results: Of 462 patients with locked records, 57 met the above eligibility criteria and had treatment and followup data available for analysis. As first treatment in R/R disease, 26 patients received combination therapy (by subtype: PTCL-NOS [10], AITL [6], ALCL [3], EATL [1], NKT [5], HSTCL [1]) and 31 received single agents (by subtype: PTCL-NOS [13], AITL [5], ALCL [7], EATL [2], NKT [2], HSTCL [2]). The most common combination regimens had an ifosfamide-, gemcitabine-, or platinum-based backbone. Single agents used were: BV (12), romidepsin (8), pralatrexate (5), alisertib (3), bendamustine (1), denileukin diftitox (1), and lenalidomide (1). The objective response rate (ORR) for single agents was higher than for combination therapy (59% [17/29] vs. 46% [12/26], P=0.36), as was the CR rate (41% [12/29] vs. 19% [5/26], P=0.02). In those with R/R ALCL who received BV, ORR was 83% (5/6) and CR was 67% (4/6). Given these expected high response rates of BV in R/R ALCL, a subtype analysis excluding ALCL patients who received BV (ALCL-BV) was conducted and showed similar ORR between single and combination therapy (52% [12/23] vs. 46% [12/26], P=0.26), though CR still favored single agents (35% [8/23] vs. 19% [5/26], P=0.07). Excluding the ALCL-BV group, CRs were observed with BV (3/6), romidepsin (2/8), pralatrexate (1/5), bendamustine (1/1), and alisertib (1/3). Median progression-free survival (PFS) favored single over combination therapy (11.2 vs. 6.7 months, P=0.02). PFS in the ALCL-BV group was comparable at 11 months. Stem-cell transplantation occurred more frequently after single agent use than combination therapy (25% [8/31] vs. 7% [2/26]). Conclusion: Our analysis confirms the unmet need for better therapies in R/R PTCL. This data shows a trend towards increased CR and PFS with single agents in comparison to combination therapy, while maintaining the potential to bridge to transplantation. It is unclear whether the differences were driven by reduced toxicity and longer treatment duration with single agents, increased efficacy from BV in CD30-expressing cancers, or patient factors that led to therapy selection. However, despite the small size and exploratory nature of this analysis, single agents do not appear inferior to combination therapy with respect to disease control or ability to bridge to transplant with intent to cure. Our data can serve as a foundation for larger datasets or randomized trials which are needed to identify the truly superior strategy. In the meantime, the optimal approach for R/R PTCL remains unclear. Disclosures Schwartz: MS Biostatistics, LLC: Employment. Acosta:Spectrum: Employment. Pro:Seattle Genetics: Consultancy, Other: Travel expenses, Research Funding; kiowa: Honoraria; portola: Honoraria; Takeda Pharmaceuticals: Honoraria, Other: Travel expenses. Shustov:Seattle Genetics: Research Funding. Horwitz:Aileron Therapeutics: Consultancy, Research Funding; Millennium/Takeda: Consultancy, Research Funding; Mundipharma: Consultancy; ADC Therapeutics: Consultancy, Research Funding; Spectrum: Research Funding; Trillium: Consultancy; Corvus: Consultancy; Forty Seven: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Innate Pharma: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Portola: Consultancy; Kyowa-Hakka-Kirin: Consultancy, Research Funding. Foss:Seattle genetics: Consultancy; Miragen: Consultancy, Speakers Bureau; Mallinkrodt: Consultancy; Spectrum: Consultancy.

Purpose This phase III, placebo-controlled, randomized trial was designed to investigate efficacy and safety of two doses of denileukin diftitox (DD; DAB389–interleukin-2 [IL-2]), a recombinant fusion protein targeting IL-2 receptor–expressing malignant T lymphocytes, in patients with stage IA to III, CD25 assay–positive cutaneous T-cell lymphoma (CTCL), including the mycosis fungoides and Sézary syndrome forms of the disease, who had received up to three prior therapies. The primary end point was overall response rate (ORR). Patients and Methods Patients (N = 144) with biopsy-confirmed, CD25 assay–positive CTCL were randomly assigned to DD 9 μg/kg/d (n = 45), DD 18 μg/kg/d (n = 55), or placebo infusions (n = 44), administered for 5 consecutive days every 3 weeks for up to eight cycles. Patients were monitored for drug efficacy, clinical benefit, and safety of DD. Results ORR was 44% for all participants treated with DD (n = 100; 10% complete response [CR] and 34% partial response [PR]) compared with 15.9% for placebo-treated patients (2% CR and 13.6% PR). ORR was higher in the 18 μg/kg/d group versus the 9 μg/kg/d group (49.1% v 37.8%, respectively), and both doses were significantly superior to placebo. Progression-free survival (PFS) was significantly longer (median, > 2 years) for both DD doses compared with placebo (median, 124 days; P < .001). Rates of moderately severe and severe adverse events (AEs) were slightly higher in the DD groups, whereas moderate and mild AEs were similar to placebo. No statistical differences were observed for drug-related serious AEs. Conclusion DD had a significant and durable effect on ORR and PFS with an acceptable safety profile in patients with early- and late-stage CTCL.

Many studies support the influential role that the community food environment (CFE) has on children’s weight status. The purpose of this study is to determine if the CFE is associated with early childhood body mass index (BMI) in 3 communities on Guam. CFE factors, including fruit/vegetable availability, store advertising, and community readiness (CR) for change, were assessed using tools amended for the Children’s Healthy Living (CHL) Program community randomized trial. Anthropometry data of children (2 to 8 years; n=536) were collected across all communities and BMI z-scores calculated using the 2000 CDC growth curves. Mean differences between BMI z-score and CFE factors were examined using a general linear model and Spearman correlations evaluated associations. A total of 42 stores were surveyed of which a majority were small markets (74%) and the remaining were convenience stores (17%) and large grocery stores/supermarkets (9%). At the community level, there was a significant difference in mean BMI z-...

Introduction: Outcomes for patients with aggressive T cell lymphomas who are not cured by frontline therapies are poor. A Canadian retrospective analysis showed median overall survival (OS) to be 6.5 months combined for peripheral T-cell lymphoma (PTCL) patients in first relapse (Rel) and patients with primary refractory (Ref) disease (Mak, et al. JCO 2013). There have been no prospective studies that have examined the differences between Rel and Ref patients. In this analysis, we examined clinical features and outcomes for 285 patients prospectively enrolled in the COMPLETE Registry who completed frontline therapy and identified 119 patients with either Rel or Ref disease. We describe differences in clinical features, treatment, and outcomes between Rel and Ref patients. Methods: Patients with all subtypes of PTCL from 72 sites in the US were prospectively enrolled in the COMPLETE registry at initial diagnosis. Clinical and histopathologic features, treatment regimens, goals of therapy, toxicities, and outcomes were recorded. For this analysis, Ref disease was defined as no response to initial treatment or progression during or within 1 month of completing frontline therapy. Rel disease was defined as progression at least 1 month from completion of frontline therapy in patients who achieved a complete response (CR) or partial response (PR). Results: Of 285 patients in COMPLETE who had locked treatment and follow-up records required for this analysis, 50 met the criteria for Rel and 69 for Ref PTCL. Demographics (age, gender, race) and key clinical characteristics at initial diagnosis (histology [Table 1], bone marrow involvement, LDH, ECOG performance status) did not significantly differ between Rel and Ref patients. According to the treating physician, the primary goal of second-line therapy was cure in over half of both groups (52% for Rel, 60% for Ref); the remainder were managed with palliative intent. Rel patients received novel therapies (see Table 2 for definition) more frequently than Ref patients (58% vs. 28%) (P = 0.005) and were less likely to receive multi-agent regimens (24% vs. 45%; P = 0.04) [Table 2]. In the 55 Rel and Ref patients who received single-agent therapy, the most common agents were brentuximab vedotin (20%), romidepsin (15%), pralatrexate (9%) and gemcitabine (7%). In the 30 patients who received multi-agent therapy, the most common regimens were ICE (ifosfamide, carboplatin and etoposide) (17%), GemOx (gemcitabine and oxaliplatin) (17%), and CHOP or CHOP-like plus etoposide (13%). Despite similar frontline therapy with combination chemotherapy regimens, more Rel patients underwent high dose therapy and transplant compared to the Ref group (30% vs. 4%; P = 0.0005). Although single agent versus combination therapy showed similar objective response rates (ORR= CR+PR), the ORR of novel vs. traditional chemotherapy showed a trend favoring novel agents for the entire cohort (57% vs. 38%; P = 0.07). The ORR to second-line therapy was higher in Rel patients (63% vs. 38%; P = 0.02) as was the proportion achieving a CR (38% vs. 15%; P = 0.02). Further, Rel patients had longer OS compared Ref patients, with a median OS of 31 months (95% CI: 22.1 months to not reached) versus 10.2 months (95% CI: 6.5 - 15.9 months) from first diagnosis (Figure 1a) and 14.6 months versus 6.1 months (P = 0.048) from the time of relapse or progression (Figure 1b). For both Rel and Ref patients, there was no difference in survival by PTCL subtype. In both the Rel group and Ref groups, survival was significantly longer in patients treated with curative vs. palliative (as determined by the treating physician) intent (P = 0.01). Conclusions: Our analysis of real world outcomes in patients with aggressive T cell lymphomas demonstrates that outcomes are significantly worse for patients with Ref compared to those with Rel disease. Interestingly, novel single agent therapies were used most often as second-line therapy in Rel patients while multi-agent chemotherapy was used more frequently in Ref patients, despite the demonstration of activity of novel single agents in the Ref setting in other studies. The high proportion of patients with Rel or Ref disease in COMPLETE, and the demonstrated activity of novel agents in the Rel and Ref settings, supports initiatives to incorporate novel agents into frontline therapy for PTCL. Download : Download high-res image (122KB) Download : Download full-size image Download : Download high-res image (156KB) Download : Download full-size image Download : Download high-res image (109KB) Download : Download full-size image Disclosures Lansigan: Spectrum: Consultancy, Research Funding; Pharmacyclics: Consultancy; Teva: Research Funding; Celgene: Consultancy. Horwitz: Huya: Consultancy; Celgene: Consultancy; Takeda: Consultancy, Research Funding; Infinity: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy; Kyowa Hakka Kirin: Consultancy, Research Funding; Spectrum: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; ADCT Therapeutics: Research Funding. Pinter-Brown: Celgene: Consultancy; Spectrum Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy. Carson: American Cancer Society: Research Funding. Pro: Seattle Genetics: Honoraria; Takeda: Honoraria; Celegene: Honoraria. Hsi: Onyx Pharmaceuticals: Honoraria; Seattle Genetics: Honoraria; Eli Lilly: Research Funding; Cellerant: Honoraria, Research Funding; Abbvie: Honoraria, Research Funding; HTG Molecular Diagnostics: Consultancy. Federico: MedNet Solutions: Consultancy. Gisselbrecht: Roche/Genentech: Research Funding, Speakers Bureau. Schwartz: MedNet Solutions: Employment. Bellm: Merck: Equity Ownership; Johnson & Johnson: Equity Ownership; BMS: Equity Ownership; MedNet Solutions: Consultancy, Other: Reimbursement of travel-related expenses. Acosta: Spectrum Pharmaceuticals: Employment, Equity Ownership. Foss: Celgene: Consultancy, Research Funding, Speakers Bureau; Seattle Genetics: Consultancy, Speakers Bureau; Spectrum Pharmaceuticals: Consultancy; Eisai: Consultancy.

Background —Triiodothyronine (T 3 ) supplementation may be a useful adjunct in the management of patients after cardiopulmonary bypass. Limited data are available regarding the use and pharmacokinetics of T 3 in children. The present study was performed to evaluate T 3 pharmacokinetics in a cohort of children undergoing the modified Fontan procedure. Methods and Results —A total of 28 patients were enrolled in this randomized, prospective study. The patients were divided into 4 groups: 1 group received a placebo and 3 groups received intravenous T 3 at dosages of 0.4, 0.6, and 0.8 μg/kg, respectively. All 28 patients survived their operative procedures. Two patients developed low cardiac output, and 3 patients had pleural effusions. The median length of hospital stay was 7 days. The mean free T 3 level was 316±67 pg/dL after then administration of a placebo. Patients who received T 3 had mean peak free T 3 levels of 972±88, 1351±299, and 1869±281 pg/dL for the dosages of 0.4, 0.6, and 0.8 μg/kg, respectively. The calculated half-life of T 3 was 7 hours. Conclusions —The half-life of intravenous T 3 in children is approximately one-third of that reported for adults. These results provide a framework for studying the efficacy of T 3 supplementation in children undergoing open-heart surgery.

OBJECTIVES To compare 2 doses of rectal midazolam, used for pediatric emergency department sedation, with regard to sedative efficacy and frequency of paradoxical agitation. METHODS Children

This paper describes the development of applications for the interactive investigation of three-dimensional geological andgeophysical data, using an Interactive Workbench. The Interactive Workbench is essentially a large (175 cm by 125 cm)light table, on which stereo images are back-projected. The position of the user's head and hands are determined by amagnetic tracking system. The user interacts via a 3D mouse with geoscientific data objects that appear to be placed on orabove the table. A high-end Silicon Graphics Workstation (Onyx2) renders the stereo image 30 times a second for the users current eye position. We have implemented a pen-driven user interface (traditional GUI) as well as virtual tools for positioning, picking and cutting in order to visualize and, in some instances, edit geological objects like horizons, faults,seismic data, well bores, etc.This approach enables geoscientists to more fully exploit three-dimensional geoscientific data by providing them with a trulythree-dimensional display that can be shared (locally or remotely) with others. In addition, the three-dimensional interactivitythat this technology provides can support more productive modeling of geoscientific data and more efficient verification ofthe resulting interpretations.Keywords: Scientific Visualization, Virtual Reality, Geophysical Data, Direct manipulation of virtual objects, ImmersiveDisplay

PTCL are an aggressive group of lymphomas comprising a number of histopathologic subtypes for which CHOP chemotherapy has been the standard first-line regimen at many centers. Denileukin diftitox (Dd) is a recombinant DNA-derived cytotoxic protein composed of diphtheria toxin fragments A and B and the full length sequence of human interleukin-2 (IL-2). Dd targets T-cells expressing the intermediate and high-affinity IL-2 receptor. Because the mechanism of action of Dd is distinct from traditional cytotoxic chemotherapy and Dd has exhibited minimal myelosuppression, we evaluated the safety, tolerability, and efficacy of combining Dd with CHOP as first-line therapy for patients with PTCL according to the REAL classification. (Pts with mycosis fungoides or Sezary syndrome were not included.) Dd was administered at 18 mcg/kg/day on Days 1 and 2 followed by CHOP on Day 3, and G-CSF support starting Day 4, every 3 weeks for up to 6 cycles. Evaluation of response is performed after every 2 cycles of treatment. Results: Forty-one pts, 18 male/23 female, have been enrolled to date, with a median age of 52. Ten pts are not evaluable for response: 5 discontinued due to an adverse event (AE) prior to assessment of response; 3 due to lack of measurable disease at baseline; and 2 are too early to evaluate. For the 31 response-evaluable patients, the overall response rate is 90%, with 71% (22/31) CR or CRu, 19% (6/31) PR, 6% (2/31) SD, and 3% (1/31) PD. Ten of 28 responders (36%) have progressed, with a median duration of response of 13 months. | PTCL subtype | No. of Patients | No. evaluable | Responses | ORR | |:-------------------------------- | --------------- | ------------- | ----------------------------- | ---- | | PTCL-nos | 20 | 15 | 3 CR, 5 CRu, 4 PR, 2 SD, 1 PD | 80% | | Angioimmunoblastic | 10 | 9 | 3 CR, 5 CRu, 1 PR | 100% | | Anaplastic large cell | 6 | 4 | 2 CR, 2 CRu | 100% | | Enteric T-cell | 2 | 1 | 1 CRu | 100% | | Hepatosplenic | 1 | | n/a | n/a | | Nasal/nasal type T/NK cell | 1 | 1 | 1 CRu | 100% | | Subcutaneous panniculitic T-cell | 1 | 1 | 1 PR | 100% | Toxicities have generally been grade 1–2, were transient, and caused few dose modifications. The most common have been fatigue (62%), nausea (44%), anemia (38%), sensory neuropathy (33%), hypoalbuminemia (33%), elevated ALT (30%), dyspnea (28%), thrombocytopenia (30%), leukopenia (28%), fever (25%), elevated AST (25%), lymphopenia (25%), and hyperglycemia (25%). Forty-three percent (17/40) of patients experienced one or more grade 3–4 hematological toxicities and 40% (16/40) of patients experienced one or more grade 3–4 non-hematological toxicities. Five patients discontinued the study due to AEs, all occurring prior to Cycle 2, for: infusion-related anaphylaxis; elevated LFTs; port-related staph sepsis; pneumonia; and a death possibly resulting from tumor lysis syndrome and rhabdomyolysis. Conclusion: The combination of Dd plus CHOP has a generally manageable safety profile and to date has exhibited promising clinical activity in PTCL.

Therapeutic options for patients (pts) with relapsed/refractory B-NHL and poor bone marrow reserve are limited. Denileukin diftitox (DD), a recombinant fusion protein, which when given at the standard dose, is not myelosuppressive and achieved a response rate of 25% in pts with relapsed/refractory B-NHL (Dang JCO22:4095–4102, 2004). We conducted a phase II, open label, multi-site study to evaluate efficacy and tolerability of DD given weekly in pts with relapsed/refractory B-NHL who had diminished bone marrow reserve. This is the first study of DD in NHL to use a dosing regimen other than the standard 18 mcg/kg/day for 5 days repeated every 21 days. Pts were required to have failed to respond or have progressive disease (PD) after ≥2 prior treatment regimens, bi-dimensional disease of at least 4cm2, and mild to moderate cytopenia defined as one or more of the following: ANC ≥1000 but

Denileukin diftitox, an interleukin-2 (IL-2)-diphtheria toxin fusion protein, binds to and intoxicates cells expressing the medium (CD122, CD132) and high affinity (CD25, CD122, CD132) IL-2 receptor. Because its role in patients whose tumors tested negative for the CD25 component of the receptor had not been prospectively studied, we initiated a prospective, open label, multi-center study to evaluate the safety and efficacy of denileukin diftitox in CTCL patients according to CD25 status (CD25+ and CD25-). Patients with pathologically proven, persistent or recurrent CTCL Stages IB-IVA were treated with denileukin diftitox at a dose of 18 mcg/kg/day x 5 days every 21 days for up to 8 cycles. Expression of CD25 by tumor cells in skin biopsies was determined by IHC or flow cytometry at a central laboratory and investigators were blinded to CD25 status. Response was based on improvement in skin involvement by weighted skin assessment for lesion type (patch, plaque, tumor) and blood involvement based on quantitation of Sezary cells. Safety was evaluated based on reports of Grade 3 and 4 toxicities (NCI CTC version 2.0). Sixty-one pts were enrolled and treated with denileukin diftitox. Disease stages were: I-IIA (n=14), IIB (n=22), III (n=11) and IV (n=14). Eighteen (29.5%) had blood involvement. Fifty-seven pts completed at least one cycle of treatment and were evaluable for response. Four pts were excluded because they had Stage IVB (visceral) disease (n=2), did not have a post baseline skin assessment recorded (n=1), or did not complete the first cycle (n=1). The median number of cycles of denileukin diftitox was 4 (range 1–13). The overall response rate (CR+PR) was 53% (30/57, 95% CI 40–66%), with 2 CR. Of the 57 evaluable pts, tumor was CD25+ in 34 (70%), CD25- in 14 (25%) and unknown in 9. Response rate was similar in patients whose tumor tested CD25+ (56%, 95% CI: 39–73%), and CD25- (43%, 95% CI: 17–69%) (p=0.41). For the 61 patients the most common grade 3/4 toxicities included constitutional symptoms (11%) and metabolic/laboratory abnormalities (36%). One patient with significant cardiopulmonary disease died of myocardial infarction while on therapy. The frequency of grade 3/4 toxicities was similar in CD25+ 64% (23/36), vs CD25- 75% (12/16) (p=0.62). In conclusion, we found that 70% of the CTCL pts evaluated for this study tested CD25+ and that the response rates and safety profile of denileukin diftitox in CD25+ and CD25- patients were similar. These data support a role for denileukin diftitox in the treatment of CTCL regardless of CD25 status.

A grant to construct a “Model Farm” on Guam and the Virgin Islands was approved in 2000 by the USDA/CSREES/Initiative for Future Agriculture and Food Systems Program. The main goal was to establish an integrated model farm that had potential benefits for small agricultural enterprises operated by Asian-Pacific and Caribbean Islanders. University of Guam Triton Farm was established on 3.75 acres (1.5 ha) of the Agricultural Experiment Station. Initially we conducted a soil survey, and established windbreaks/hedgerows. We also built the foundation for aquaculture/aquaponic system, field irrigation systems, and animal production facilities. Then, we planted long-term fruit and ornamental plants while growing short-term vegetable crops for quick returns. Currently we raise tilapia (Oreochromis niloticus), goats (Capra hercus) and layer-chickens (Gallus gallus). We grow banana (Musa spp.), calamansi (X Citrofortunello mitis, hot peppers (Capsicum spp.), cucumbers (Cucumis sativus), lettuce (Lactuca sativa), eggplants (Solanum melongena), and Ti-leaf (Cordyline terminalis). We also try to develop value-added products using local produce. Occasionally we investigate other potential commodities and operational schemes for the farm. These must be suitable for Guam's agro-climate and social and economic structure. We focus on conservation of natural materials, composting, and sustainable agriculture. Education and outreach activity is also an important component of the farm to disseminate technologies and to educate young children about farming.