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476 Background: Small cell bladder cancer is a rare and aggressive histological variant with a paucity of data to guide the optimal management strategy in non-metastatic disease. NAC-RC and TMT (maximal transurethral resection of bladder tumor + chemoradiation) have been variably employed based on institutional preferences, and we aim to compare outcomes between these two approaches. Methods: We queried the National Cancer Database for adult patients with small cell bladder cancer diagnosed during the years 2004 to 2018. Patients with small cell histology and early-stage clinically node-negative bladder cancer (cT1-4N0M0) were included and divided into two groups based on the treatment strategy employed – NAC-RC or TMT. Patients who did not receive any definitive local therapy and those who received chemotherapy or radiation in the adjuvant setting were excluded. Fisher’s exact and Mann Whiney U tests were used to compare frequency distributions. Cox Proportional Hazards regression was employed for multivariate analysis of factors associated with overall survival. Models were adjusted for age, sex, race, income, educational level, clinical T stage, insurance status, and the Charlson Comorbidity Index. Results: A total of 1262 patients were identified – 629 (49.8%) underwent NAC-RC while 633 (50.2%) received TMT. Patients in the NAC-RC group were younger (median 67 vs. 74 years, P

530 Background: Sarcomatoid bladder cancer is an extremely rare and aggressive histological variant with poor prognosis and limited consensus regarding its management given rarity and lack of high-quality data. Radical cystectomy (RC) is the mainstay of treatment in muscle-invasive disease and adjuvant therapy is often offered to eligible patients with high-risk features. Data regarding the role of neoadjuvant chemotherapy (NAC) for this variant is limited. Methods: The National Cancer Database was queried to identify patients diagnosed with sarcomatoid bladder cancer from 2004 to 2018. Patients older than 18 years with cT2-4aN0-1M0 sarcomatoid bladder cancer who received curative-intent surgery were included in the analyses. Clinical T4b/N2-3/M1 disease and receipt of adjuvant chemotherapy were employed as exclusion criteria. The population was divided into two cohorts based on the receipt of NAC. Chi-Square and Mann Whitney U tests were used to compare frequency distributions. Cox Proportional Hazards regression was employed to adjust for confounding factors associated with overall survival. Models were adjusted for age, race, sex, income, stage, insurance status, and the Charlson Comorbidity Index. Results: A total of 573 patients were identified - 70% were males and 93% were White; 139 (25%) received NAC (NAC+) while 434 (75%) did not (NAC-). NAC+ patients were younger (65 vs 71 years, p < 0.001). Downstaging to pT0-1N0 at the time of RC was significantly more frequent in the NAC+ group compared to the NAC- group (32 (24.5%) vs. 28 (6.8%), p = 0.001). Overall survival (OS) was also significantly longer in the NAC+ group (median of 40.8 vs. 19.4 months, log-rank p = 0.003). On multivariable analysis, NAC+ (Hazard Ratio (HR) = 0.73, 95% CI 0.56-0.91, p = 0.02), pathological downstaging to pT0-1N0 (HR = 0.5, 95% CI 0.31- 0.8, p < 0.001), and any pathological upstaging (HR 4.1, 95% CI 1.5-6.6, p < 0.001) were independently associated with all-cause mortality, while other factors were not (Table). Conclusions: In this large retrospective analysis, administration of NAC in muscle-invasive sarcomatoid bladder cancer was associated with higher rates of downstaging to non-muscle-invasive disease at the time of RC and reduced all-cause mortality. [Table: see text]

TPS406 Background: Most patients with high or very high risk localized prostate cancer (PCa) experience disease recurrence after radical prostatectomy (RP). Neoadjuvant androgen ablation has not improved high-risk pathological features or recurrence rates after RP.1 We reported the association between high intratumoral CD8+ T lymphocyte (CTL) density and improved survival post-RP, suggesting clinical benefit from neoadjuvant immunomodulation (NI).2 Analysis of the tumor immune microenvironment after NI may also provide key insights into potential therapeutic strategies in PCa. CTL/NK/Th1-recruiting chemokines (CCL5, CXCL9 and CXCL10) are downregulated while MDSC/Treg-attracting chemokines (CCL2, CCL22, and CXCL12) are upregulated in human PCa tissue.3 A large proportion of T cells in PCa are Tregs or dysfunctional CTLs and this immunosuppressive profile may be partly driven by COX-2 upregulation.4,5 A chemokine modulating regimen (CKM) of rintatolimod (TLR-3 ligand), aspirin (COX-2 inhibitor), and IFN-α favorably reprogrammed the chemokine profile and CTL/Treg ratio in human PCa explants.3 This combination has demonstrated safety in phase I/II trials across other tumor types, though it is unclear if IFN-α can be omitted without compromising efficacy.7-8 Methods: This is a three-arm, phase II trial where patients with localized PCa scheduled to undergo RP are randomized in 1:1:1 ratio to a 2-week regimen of neoadjuvant CKM triplet (rintatolimod + aspirin + IFN-α) vs CKM doublet (rintatolimod + aspirin) vs no CKM. Thirty patients will be enrolled to assess CD8+ T cell density in the RP specimen as the primary endpoint. Pathological and PSA responses, surgical margin positivity, and safety/toxicity of the CKM combinations will be secondary endpoints. Pre- and post-treatment density of various infiltrating T cell subtypes, MDSCs, chemokine and chemokine receptor profiles, immune checkpoint expression, immune-regulatory gene expression signatures, and peripheral blood immune cell landscape will be key exploratory endpoints. The trial is currently open with 11 patients enrolled. Clinical trial ID: NCT03899987 . References: 1) Scolieri MJ, J Urol 2000, 2) Clin Oncol 36, 2018: suppl; abstr 5068, 3) Muthuswamy R, Prostate 2016, 4) Sfanos KS, Prostate 2009, 5) Gupta S, Prostate 2000, 6) NCT01545141, 7) NCT02151448, 8) NCT02432378.

486 Background: UTUC is less common and associated with poorer stage-for-stage prognosis compared to urothelial bladder cancer. AC is regarded as a standard-of-care in high-risk UTUC based on superior disease-free survival compared to observation in the POUT trial, though fewer than 10% of patients in this trial had lymph node involvement.1 CheckMate 274 revealed lesser magnitude of benefit with adjuvant nivolumab in UTUC compared to bladder cancer on post hoc analysis.2 The preferred sequence of perioperative systemic therapy in node positive UTUC remains unclear. Methods: We queried the National Cancer Database for adult patients with clinically node positive (cTanyN1-3M0) UTUC diagnosed between 2004 and 2018. Patients were divided into two groups based on the perioperative treatment strategy - NAC or AC. Patients who did not undergo RNU were excluded from analyses. Fisher’s exact and Mann Whiney U tests were used to compare frequency distributions. Cox Proportional Hazards regression was employed for multivariate analysis of factors associated with overall survival. Models were adjusted for age, sex, race, income, educational level, clinical T stage, insurance status, and the Charlson Comorbidity Index. Results: A total of 862 patients were identified - 362 (42%) underwent NAC while 500 (58%) received AC. No significant differences were noted between the groups regarding age, sex, or insurance status. Patients with cT1-2 UTUC more often received NAC (27.9% vs 11.8%, P

113 Background: The prognosis of refractory mCRPC remains poor despite advancements in therapeutic options. KeyNote-199 demonstrated modest activity of Pem in mCRPC with expected safety profile. We present our real-world experience with Pem in mCRPC. Methods: We conducted a retrospective review of mCRPC patients treated with Pem at our institution from 1/1/2017 to 10/1/22. Baseline demographic, clinicopathologic, and genomic characteristics were recorded. PSA and radiographic responses were assessed by the study team, and survival distributions estimated using the Kaplan-Meier method. Results: A total of 39 patients were identified – 97% (37) were White, median age was 71 years, 4% (19/35) had a Gleason Score ≥8; 80% (31) had skeletal and 74% (29) had soft tissue metastases at Pem initiation. Overall, patients were heavily pre-treated (median of 7 prior therapies, range 0-8) - 87% (34) had received taxanes, 82% (32) novel antiandrogens, 23% (9) Ra-223, 21% (8) Sipuleucel-T, and 2% (1) Olaparib. Median duration on Pem was 7 months (range = 1-29). Among the 34 evaluable patients, 2 (6%) achieved CR, 2 (6%) had PR, 5 (15%) had stable disease (SD), and 25 (73%) had progressive disease (PD) on radiographic assessment. PSA reduction ≥ 50% was noted in 7/32 (22%) patients. The 4 patients who had radiographic CR/PR had positive predictive biomarkers – Patient 1: CR – MSI-H, high TMB (17.5/Mb); Patient 2: CR – MSI-indeterminate, germline MSH6 mutation; Patient 3: PR – MSI-H, high TMB (28.8/Mb), germline MSH2 mutation; and Patient 4: PR – MSI-S, high TMB (18.3/Mb), PDL1 TPS 100%, positive neuroendocrine markers. Interestingly, patient 3 was switched to ipilimumab + nivolumab after PD on Pem, and subsequently had a CR. None of the evaluated patients with SD or PD had high MSI, TMB, or PDL1 levels. The median overall survival from Pem initiation was 4.4 months (95% CI 3.0-10.2 months). Three (8%) patients discontinued Pem due to immune-related adverse effects (IRAEs); no treatment-related deaths were reported. The most frequent Gr 3 IRAEs are shown. Conclusions: Single-agent Pem demonstrated modest overall efficacy in mCRPC, restricted only to patients with predictive biomarkers. Given the non-trivial risk of IRAEs, financial toxicity, and potential QoL implications, we suggest using checkpoint inhibitors only in appropriately biomarker-selected patients with mCRPC. [Table: see text]

487 Background: Upper urinary tract cancers (UUTC) are less frequent and associated with poorer stage-for-stage prognosis compared to bladder cancer, with variant histology being an independent predictor of inferior outcomes. The POUT trial included only patients with predominantly urothelial tumors. We aimed to compare outcomes among patients with UUTC-VH who were treated with RNU-AC vs. RNU-O. Methods: We queried the National Cancer Database for adult patients with UUTC-VH diagnosed between 2004 and 2018. Only patients who underwent RNU with node-negative disease on pathological staging (pT2-4N0M0) were included and divided into two groups based on the postoperative treatment strategy - RNU-AC and RNU-O. Patients who received neoadjuvant chemotherapy were excluded from analyses. Fisher’s exact and Mann Whiney U tests were used to compare frequency distributions. Cox Proportional Hazards regression was employed for multivariate analysis of factors associated with overall survival. Models were adjusted for age, sex, race, income, educational level, clinical T stage, insurance status, and the Charlson Comorbidity Index. Results: A total of 522 patients were identified – 133 (25.5%) received RNU-AC while 389 (74.5%) underwent RNU-O. Patients in the RNU-AC group were younger (median 69 vs. 76 years, P

343 Background: The population of prostate cancer (PCa) survivors has grown over the recent decades, with many reporting long-term treatment-related physical, emotional, and financial adverse effects resulting in greater psychological distress compared to males without a history of PCa. This study analyzes the prevalence of psychological distress among PCa survivors and its impact on emergency room (ER) utilization and overall survival. Methods: We identified a cohort of 3,453 PCa survivors from the 2000-2018 National Health Interview Survey (NHIS) linked to the National Death Index Mortality Files through Dec 31, 2019. Deaths that occurred during the first two years of follow-up were excluded from analyses to minimize the likelihood of reverse causation. The Kessler Psychological Distress Scale (K6) was used to quantify psychological distress. Severe, moderate, and none/low mental distress have been validated for thresholds K6≥13, 13> K6 ≥5, and 5> K6 ≥0. Its association with self-reported ER utilization during the 12 months preceding the survey and all-cause mortality was estimated using weighted multivariable logistic regression and Cox proportional hazards regression, respectively. Models were adjusted for age, sex, race, educational attainment, comorbidities, region, year of survey, smoking status, health insurance, functional limitations, and time since cancer diagnosis. Results: Among the 3,453 PCa survivors (mean [SD] age 68.5 [7.2] years; 2479 (77.9%] non-Hispanic White, 655 (14.1%) non-Hispanic Black; median time since cancer diagnosis:5 years), 435 (11.3%) and 96 (2.4%) reported moderate and severe psychological distress respectively. PCa survivors with psychological distress tend to be younger, less educated, single, and with multiple comorbid conditions, and functional limitations. 812(22.8%) of PCa survivors visited the ER during 12 months preceding the survey. During a median follow-up of 81 months, 937(25.5%) of survivors died of all causes. After adjusting for covariates, PCa survivors with severe psychological distress were at a higher risk of ER utilization and all-cause mortality than those with moderate or no distress. Conclusions: Psychological distress was associated with increased risk of ER utilization and all-cause mortality among PCa survivors. Greater efforts are needed to understand, recognize, and alleviate such distress, as well as to enhance social and mental/physical health support in this rapidly growing community of vulnerable cancer survivors. [Table: see text]

Psoriatic arthritis (PsA) is associated with increased cardiovascular morbidity and mortality. Higher disease activity has been associated with increased rates of mortality in PsA. The objectives of the study were to describe the trends for hospitalisations from acute myocardial infarction (AMI) amongst patients with underlying PsA.All adult hospitalisations for AMI with and without PsA from 2004-2014 in the nationwide in-patient sample (NIS) database were captured. A propensity score-matching model was also developed for comparative outcome analysis and reduce the potential of selection bias.From 2004 to 2014, 4778 unmatched weighted hospitalisations were estimated for AMI with underlying PsA. Mean age for hospitalisations with AMI and PsA was lower (average age in years: 63.1±11.5 vs. 67.5±14.4; p-value0.05), with a higher percentage being males (62.7% vs. 60.4%, p-value0.05). When adjusted for confounding factors, overall mortality was found to be signi cantly lower in hospitalisations with PsA (2.21% vs. 5.8%, p-value0.05). After propensity matching analyses, in-hospital mortality in PsA cohort continued to be signi cantly lower when compared to the matched cohort without PsA (1.79% vs. 5.71%, Odds ratio=0.3, p-value 0.002).The study suggests that overall rates of mortality in AMI with underlying PsA are lower compared to those without PsA. A decrease in cardiovascular mortality from AMI in PsA re ects that even though PsA is associated with an increased prevalence of cardiovascular risk factors, the trends in mortality are similar or even better than those for the general population.

Tumid lupus erythematosus (TLE) is a rare variant of cutaneous lupus erythematosus. Clinically, it lacks typical changes found in discoid lupus and antinuclear antibodies (ANA) levels are elevated in only 10% of the patients. Coexistent systemic lupus erythematosus (SLE) has been reported to be rare, and literature shows only a few case reports. We present a case of coexistent tumid lupus and SLE. We present a case of a 48-year-old Caucasian female who presented with chronic facial rash, photosensitivity, intermittent oral ulcers, joint pain with morning stiffness, and unintentional weight loss. Laboratory studies showed positive ANA at 1:640, elevated erythrocyte sedimentation rate, positive anticardiolipin immunoglobulin (Ig) G, anticardiolipin IgM, and anti-beta-2 glycoprotein IgM. Skin biopsy of the rash showed a superficial and deep dense lymphocytic infiltrate with mucin deposition, histopathology favoring tumid lupus. The patient was diagnosed with TLE with SLE and was started on hydroxychloroquine with improvement in her rash. Ultraviolet light and certain medications have been proven to play a role in the pathogenesis of tumid lupus. It usually responds to photoprotection, topical treatment, or oral antimalarial therapy.

472 Background: Timely initiation of NAC is critical to improve outcomes in MIBC. Medicaid expansion through the Affordable Care Act improved racial disparities in healthcare access for patients with advanced cancers. This study aimed to assess the association of Medicaid expansion with racial disparities in time-to-NAC in MIBC. Methods: This case-control study queried the National Cancer Database for 18-64 years old Black and White adults who were diagnosed with stage II&III bladder cancer and treated with NAC from Jan 1, 2008 to Dec 31, 2018. The primary endpoint was the timely receipt of NAC, defined as initiation within 45 days from the diagnosis of resectable MIBC. Racial disparity was defined as percentage-point (PP) difference for Black vs. White patients, adjusted for age, sex, income level, clinical stage, and year of diagnosis. Results: The study included 5053 patients (7.2% Black, n = 391). In states without Medicaid expansion, Black patients became less likely to receive timely NAC than their White counterparts (2008-2013: Black 59.6% vs White 63.8%, p = 0.53; 2014-2018: Black 47.9% vs White 61.2%, p < 0.01). In contrast, the racial disparity was narrowed in states with Medicaid expansion (2008-2013: Black 35.7% vs White 62.9%, p < 0.01; 2014-2018: Black 53.4% vs White 59.5%, adjusted PP difference -2.4; p = 0.20). The adjusted difference-in-differences estimate revealed a 26.0 PP reduction in racial disparity (95% CI, 8.1%-44.0%; p < 0.01). Conclusions: Medicaid expansion was associated with significant reduction in racial disparity between Black and White patients in the timely receipt of NAC for MIBC.

520 Background: The role of RC in patients with CNBC remains unclear since most prospective clinical trials excluded them. Our study aims to evaluate overall survival (OS) in patients with CNBC treated with systemic chemotherapy (SC) with or without RC. Methods: We queried the National Cancer Database for adult patients who received SC for localized CNBC during the years 2004 to 2018. Patients with distant metastases, including to non-regional nodes, and those treated with radiation to the bladder or pelvic nodes were excluded. Chi-square and Mann Whitney U tests were used to compare frequency distributions. Cox proportional hazards analysis was employed for multivariate analysis of factors associated with OS. Results: A total of 8464 patients were identified – 3565 (42.1%) underwent RC + SC (RC+), while 4899 (57.9%) received only SC (RC-). Median age at diagnosis was 65y in the RC+ grp vs. 68y in the RC- grp ( P = 0.006). Majority of patients were Caucasian in both grps – 86.9% and 85.1%, respectively. 5y-OS was 34.1% in the RC+ grp vs. 36.1% in the RC- grp ( P = 0.06). On multivariate analysis, factors independently associated with OS were RC+ status (Hazard ratio (HR) 0.81, 95% CI 0.75-0.88, P < 0.001), advanced age (70-85y vs. 18-35y, HR 1.88, 95% CI 1.18-3.01, P < 0.001), female gender (HR 1.20, 95% CI 1.12-1.28, P = 0.001), African American (vs. Caucasian) race (HR 1.24, 95% CI:1.10-1.40, P = 0.0004), ≥ 2 comorbidities (HR 1.67, 95% CI 1.34-1.92, P = 0.001), annual income ( < $30,000 vs > $45,000, HR 1.24, 95% CI 1.13-1.37, P < 0.001), and insurance status (uninsured vs. private, HR 1.39, 1.15-1.67, P < 0.001). Conclusions: In this large retrospective analysis, among patients with localized CNBC who received SC, 5y-OS rates were comparable with or without RC. However, RC was associated with improved OS on multivariate analysis.[Table: see text]

Walkable bike is a conversion of a conventional bicycle into a treadmill cycle. It is a collaboration of two different things i.e. treadmill and electric bike. This is designed to save our environment from the harmful emissions of the vehicles which is causing a very hazardous impact on the humankind. This is designed keeping in mind that we can commute easily to different places speedily and without getting exhausted by doing some brisk walk or jogging which will eventually help us in burning some calories without leaving any carbon footprints behind , without emitting any other harmful gases , without burning any of the available fossil fuels. It does not take not more than a effort to walk in a park. This paper presents the design of Walkable bike. The idea behind this is making an affordable, eco-friendly, easy to use vehicle and using the treadmill outside the gym making the lives of people healthier and happier.

Background Studies have suggested an increased risk of cardiovascular, cerebrovascular and peripheral vascular disease in patients with history of hematopoietic stem cell transplant (HSCT). (Tichelli et al, Blood 2007). This is attributed cumulative exposure to anthracyclines, total body or chest irradiation during treatment of the primary malignancy as well as the high prevalence of metabolic syndrome reported among HSCT survivors. Data on impact of HSCT on cardiovascular mortality are limited to single center studies. Our study aims to assess impact of HSCT on mortality associated with cardiovascular and cerebrovascular disease in a large national database. Methods We extracted data for all the adult admissions with cardiovascular or cerebrovascular events (myocardial infarction, angina, stroke and transient ischemic attack) from National Inpatient Sample (NIS) database from 2010-2014 and stratified it into two groups based on the status of HSCT; using ICD-9 CM diagnostic codes. The baseline characteristics, total charges per admission, length of stay and mortality were compared. Results A total of 6808386 admissions with primary diagnosis of either a cardiovascular or cerebrovascular event were identified, and amongst those 1254 admissions had underlying history of HSCT. Average age of patients was lower in patients with concomitant HSCT (59.57 yrs vs 69.01 yrs; p=0.00), with higher percentage of male patients (62.34% vs 53.8%, p=0.007). In-hospital mortality was noted in 44 (3.54%) patients in HSCT group, but it was not a clinically significant, when compared to the group without HSCT (in-hospital mortality in 3.84% patients). No significant difference was found in length of stay or average costs per admissions for patients with HSCT. Conclusion Annual cardiovascular risk factor evaluation for all HSCT recipients, with more frequent evaluations for high risk patients. Our study suggests that HSCT does not impact the mortality associated with cardiovascular events. These results support and validates strong efforts to promote healthy lifestyle behaviors and to treat cardiovascular risk factors aggressively in HCT survivors. Educating and reinforcing this published screening and preventive practice recommendations for Metabolic syndrome and cardiovascular disease amongst stakeholders like primary care physicians, oncologists, advanced practice providers may reduce future ischemic heart disease in this high-risk population.

Introduction: Early readmissions are important indicators of quality of health-care. National-level data is currently lacking for patients admitted for induction chemotherapy for acute myeloid leukemia (AML). Our study is to investigate characteristics and predictors of 30-day hospital readmission in patients with AML after receiving induction chemotherapy. Methods: We analyzed the 2016 United States National Readmission Database, the latest and largest readmission database available so far. The authors identified hospitalizations for patients using ICD-10 codes for "encounter for chemotherapy" or a procedure code for administration of antineoplastic agent as the primary diagnosis with a secondary diagnosis of acute myeloid leukemia or myeloid sarcoma. We excluded patients who had a personal history of chemotherapy or those in remission or relapse in order to avoid counting patients admitted for consolidation/ re-induction chemotherapy. A readmission was defined as the first admission to any hospital for any non-traumatic diagnosis within 30 days of discharge after the index admission. Same day admissions and discharges were excluded. The primary outcome was 30-day readmission rate. Secondary outcomes were 30-day mortality rate, most common reasons for readmission, readmission mortality rate and resource utilization (length of stay and hospitalization costs). Independent risk factors for readmission were identified using multivariate regression analysis. Results: A total of 18,140 admissions were identified for induction chemotherapy. The median age was 64.1 years and 45% of patients were female. The all cause 30-day readmission rates were 30.1%. The in-hospital and 30-day mortality rate were 3.9% and 4.8%, respectively. The in-hospital mortality rate for readmitted patients was 3.8%. The top five causes for unplanned readmissions were neutropenia (7.2%), sepsis (6.1%), pneumonia (2.6%), acute kidney injury (2.5%) and neoplasm related pain (2.3%). Mean total charges were higher during index admission than readmission ($118,449 vs $49,087, p=.000). Table 1 shows the base patient characteristics and Table 2 shows the odds ratios of the various factors tested as independent predictors of readmission. Independent predictors of readmission were younger age, low income, Medicaid, uninsured or Private Insurance, co-morbidities, urban hospital and length of stay during index hospitalization. The total hospital days associated with readmission were 102,924 days, with a total healthcare economic burden of $303 million. Conclusions: Our study reveals that there is a significant readmission rate in this study population generating a substantial financial burden. 30-day readmissions are primarily due to neutropenia and infectious etiologies including sepsis and pneumonia. This emphasizes the urgent need for organizing better outpatient follow up for these patients post-hospitalization as well as increased awareness for antibiotic prophylaxis. Further research into development of clinical models for risk stratification is also required. Disclosures Rajeeve: ASH-HONORS Grant: Research Funding.

4559 Background: GC has a high overall response rate (ORR) but a high relapse rate in pts with untreated mUC. Inhibition of programmed death-ligand 1 (PD-L1) with A can lead to long-term survival, but single-agent ORR is modest. We report the outcomes of GC+A in a cohort pts with mUC. Methods: This study was designed to assess the safety of GC + A in 10 pts with untreated mUC prior to testing GC + A in a neoadjuvant study in pts with muscle-invasive disease. The primary endpoint was safety as assessed by a predefined dose limiting toxicity (DLT) rate during the first cycle in the first 6 pts. Total accrual goal was 10 pts to collect preliminary data on ORR and progression-free survival (PFS). RECIST 1.1 assessments were performed every 9 wks. Pts received 6 cycles of GC + A induction and then A maintenance every 3 wks. Results: No DLTs occurred during the first cycle in the first 6 pts. Grades 3-4 neutropenia and anemia occurred in 6/10 and 7/10 pts, respectively. Three pts required gemcitabine dose reductions for hematologic toxicity and 2 pts had febrile neutropenia. One pt discontinued cisplatin after 2 cycles for grade 3 hearing impairment but completed induction with gemcitabine and A. Only 1 pt discontinued study therapy due to treatment-related adverse events (AEs), including A-related grade 4 encephalopathy and grade 3 polyneuropathy. Three of 10 pts had visceral (liver or bone) metastases. Of the 10 pts, 1 pt is completing induction but meets initial criteria for partial response (PR), 8 pts had confirmed PR, and 1 pt had progressive disease (PD). Of 9 pts with confirmatory scans, the median PFS was 10.6 months (95% CI 6.7, N/A). Of 8 pts with confirmed PR, 5 eventually had PD, 1 has just completed induction, 1 remains without PD at 25 months, and 1 had consolidation surgery with a pathologic complete response and remains disease-free at 21 months. Conclusions: This 10 pt study met its primary safety endpoint. The neoadjuvant study is ongoing (NCT02989584). Although there were a substantial number of grade 3-4 toxicities, therapy was discontinued due to treatment-related AEs in only 1 pt. Immune correlative studies are ongoing. Clinical trial information: NCT02989584.

Background Opportunistic infections (OI's) are defined as infections that are more frequent or more severe because of immunosuppression. Conditions like HIV infections, Hematopoietic stem cell transplantation and autoimmune diseases have been established as risk factors for increased mortality in OI. Studies suggest that lymphomas are a risk factor for mortality associated with OI's like Tuberculosis and candida probably due to underlying immunodeficiency and therapeutic exposures inducing prolonged lymphopenia. Data describing association of underlying Non-Hodgkin Lymphoma (NHL) on mortality associated with OI's is limited. Our objective was to study impact of NHL on in‐hospital mortality of patients hospitalized with OI's. Methods We analyzed data from the Healthcare Cost and Utilization Project's (HCUP) National Inpatient Sample, between 2010 and 2014 using the ICD-9 codes for Opportunistic infections (OI). The subset of this cohort with NHL excluding lymphoid leukemias listed as a secondary diagnosis were included for analysis. Baseline characteristics including age, race, gender, Charlson comorbidity index, and infection with HIV etc. were analyzed for patients with admitted with OI's, with and without underlying diagnosis of NHL. Our primary outcome was in-hospital mortality. Characteristics associated with in‐hospital mortality were identified using multivariable logistic regression. Results Between 2010 and 2014, a total of 181,016 admissions were identified with a primary diagnosis of OI. Amongst these, 4442 admissions had an underlying diagnosis of NHL. Mean age of patients hospitalized with OI's with NHL, was higher (65.4 ±0.52 years vs 58.9±0.14years, p Conclusion OI's constitute a major cause of morbidity and mortality in immunocompromised patients. There is limited data from a nationwide analysis which evaluates association of opportunistic infections and lymphoma as risk factor of mortality. Our study suggests that NHL is an independent risk factor for mortality in patients who were admitted in the hospital for OI's. Further studies should be considered to the role of primary prophylaxis for conditions like PCP to avoid morbidity and mortality associated with these conditions. This will help reduce health care cost burden associated with such hospitalizations.

Background As emphasis on optimization healthcare resources and costs is increasing, several studies have suggested higher healthcare costs associated with hematopoietic stem cell transplant (HSCT). Proposed guidelines are present to prevent treatment-related long-term complications. This allows for early intervention with resultant reduction in morbidity and mortality and reduction in healthcare costs. Cardiovascular morbidity and mortality have been associated with increased healthcare cost burden for patients in HSCT. Armenian et al have reported a cumulative incidence of congestive heart failure at 5 years after HSCT of 4.8 %, increasing to 9.1 % at 15 years. The influence of hospital teaching status on average health care costs for patients with history of HSCT developing heart failure (HF) is unknown. Methods NIS is the largest publicly available all-payer inpatient care database in the United States and is sponsored by the Agency for Healthcare Research and Quality as a part of Healthcare Cost and Utilization Project. We queried the Healthcare Cost and Utilization Project's (HCUP) Nationwide Inpatient Sample (NIS) between 2010 and 2014 to identify all adult (>18 years of age) hospitalizations for HF with history of HSCT using ICD-9 CM diagnostic codes and stratified these hospitalizations into two groups based on teaching status of the hospital. STATA version 15.0 (College Station, TX) was used for analysis to accommodate for the complex design of survey sample data. Results We identified 2095980 admissions in teaching hospitals and 2385912 admissions in non-teaching hospitals for HF from 2010 to 2014. Amongst these 1080 total admissions with HF had underlying diagnosis of HSCT, patients admitted to teaching hospitals were younger (average age 55.95 years in teaching vs 61.97 years in non-teaching; p value=0.001). No difference was noted in other baseline characteristics like gender, race, charlson comorbidity index. Patients admitted to teaching hospitals were noted to have a higher average cost per admission ($76555 vs $32440; p value=0.005) and increased length of stay (6.06 days vs 4.23 days; p value=0.0043). Conclusion Our study found increased mean hospital charges and length of stay in heart failure patients with a history of HSCT in teaching hospitals. Previous studies have reported similar results in general population. Opportunities that target cost reduction and length of stay may be leveraged. The use of preventive guidelines, close follow up with targeted services addressing specific conditions such as congestive heart failure in patients with HSCT can help reduce health care cost burden.

Background Sepsis with multiple organ failure is one of the frequent causes of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). Patients with HSCT are at particular risk of developing sepsis due to their immunocompromised state. Studies have suggested that anywhere from 3.3% and 55% of such patients require Intensive Care admissions. Reports on outcomes of patients with sepsis with HSCT are limited. With our study we aim to study the demographics and outcomes of sepsis in adult patients with HSCT. Methods We analyzed hospitalizations for sepsis among adults in the Nationwide Inpatient Sample (NIS) available through Agency for Healthcare Research and Quality as a part of Healthcare Cost and Utilization Project. Patients were stratified into two groups based on the status of HSCT; using ICD-9 CM diagnostic codes. Descriptive statistics were represented as means/medians for continuous and as frequencies and percentages for categorical variables. A survey weighted multivariate regression analysis was used to adjust for confounders when calculating mortality. Results A total of 4501621 admissions with sepsis were identified from 2010-2014 and amongst these 4396 admissions also had underlying HSCT. Patients with history of HSCT admitted with sepsis was younger in age (55.96 years vs 67.06 years; p value=0.00), mostly males (60.56% vs 48.23%; p value=0.00) and increased comorbidities. They were more likely to be admitted to an urban teaching hospital. Patients with history of HSCT had increased mortality (17.82% patients vs 14.22% patients; p value=0.002) and increased costs per hospitalization ($ 83241 vs $65590; p value=0.0003). There was no significant difference in length of stay. When adjusted for confounders, patients admitted with sepsis with history of HSCT were found to have a 56% increased risk of mortality compared to general population. (Odds Ratio=1.565; 95% CI 1.283-1.911; p value=0.00). Conclusion Patients admitted with sepsis with history of HSCT are more likely to have poor outcome from sepsis than nontransplant patients. Clinicians should be vigilant about the screening and managing infections timely in patients with history of HSCT, to prevent poor outcomes from sepsis in patients with HSCT. Implementationof strategies that are known to improve outcomes in sepsis such as early administration of antibiotics and fluid resuscitation may be of particular importance in this high-risk population.

Background According to the 2013 HCUP statistical brief, sepsis accounted for $23.7 billion or 6.2 percent of the aggregate costs for all hospitalizations. Sepsis is the second most common cause for hospitalizations, accounting for 3.6 percent of stays. Considering such a high cost burden of sepsis in the healthcare, it is of paramount to delineate the factors responsible for it. The objective of the study was to study the impact of non-Hodgkin lymphoma (NHL) on hospital cost and outcomes of patients hospitalized with sepsis. Studies have suggested increased risk of infections and mortality from bacteremia in patients with NHL in the past, but data describing health care cost burden associated with sepsis in NHL is limited. Methods We analyzed admissions for sepsis among adult patients using the Healthcare Cost and Utilization Project's (HCUP) National Inpatient Sample, between 2010 and 2014. Patients were stratified into two groups based on status of NHL; using the ICD-9 CM diagnostic codes. Baseline characteristics including age, race, gender, Charlson comorbidity index, were described using descriptive statistics. A survey weighted multivariate regression analysis was used to adjust for confounders. STATA version 15 (College Station, TX) was used to perform statistical analysis. Results Between 2010 and 2014, around 4.5 million admissions were identified with a primary diagnosis of sepsis. A total of 45,943 admissions had an underlying diagnosis of NHL. Mean age of patients hospitalized with sepsis with NHL, was higher (69.04 ±0.167 years; p Conclusion Sepsis is a major cause of healthcare cost burden in the US. Recognition of early sepsis, along with recognition of high-risk population could help us decide early therapeutic strategies which could decrease the mortality along with decrease in overall cost burden. This study highlights NHL as an independent factor for mortality and healthcare costs for sepsis. With our study, we are trying to fill the gap in literature. It may guide us to implement preventive strategies to avoid complications from infections and reduce cost burden associated with sepsis and NHL. Future studies are needed to focus on strategies like improved vaccination coverage, early recognition and prompt treatment of infections to prevent progression to sepsis in patients with non-Hodgkin lymphoma.

Introduction Heparin-induced thrombocytopenia (HIT) is an uncommon and a serious complication of heparin therapy. Currently, only two intravenous Direct Thrombin Inhibitors (DTI) are approved for its therapy. However, their cost and frequent monitoring make the Direct-Acting Oral Anticoagulants (DOACs) an attractive option for its treatment. Several case series and systematic reviews have been published with positive results for use of NOACs in HIT. No head to head trials comparing NOACs and DTI have been published as infrequency of cases make such a study prohibitive. The landmark multicenter trials establishing the role of Argatroban in the treatment of HIT used historical controls to establish it's efficacy. In this study, we aim to compare a cohort of patients treated with Rivaroxaban as recruited from prior case series with a historical cohort treated with Argatroban to establish it's safety and efficacy compared to Argatroban. Methods: A literature review was done using Embase and Pubmed to find HIT patients treated with Rivaroxaban. A total of 14 publications were found including case studies, case series, and systematic reviews. A database was created of a total of 51 HIT patients treated with Rivaroxaban alone or argatroban followed by Rivaroxaban using all the publications. All the cases were confirmed HIT cases based on Serotonin release assay and/or HIT antibody. Platelet nadir and Platelet count at the start of therapy as noted wherever possible. Patients with known bleeding diathesis and bleeding sites were excluded from both the cohorts. Outcomes were thrombosis after initiation of therapy and bleeding after initiation of therapy. The cohort was compared with a historical cohort of patients treated with Argatroban alone in the paper published by Lewis et al. Chi-square test was done to compare new thrombosis and bleeding during hospitalization. Results: No significant difference was found in the rates of new thrombosis (OR: 0.18, CI: 0.02-1.36, p: 0.06). 5% of patients had major bleeding in the argatroban cohort while none of the patients had major bleeding in Rivaroxaban cohort. Conclusion: The study indicates that Argatroban is not significantly better in the treatment of HIT in preventing new thrombosis. However, the bleeding complications might be lower with Rivaroxaban therapy compared to Argatroban therapy. The study is limited by less than ideal comparability of cohorts and low power. However, it provides only such evidence of it's kind. Table. Table. Disclosures No relevant conflicts of interest to declare.

Background: According to the 2013 HCUP (Health Care Utilization Project) statistical brief, sepsis accounted for US$23.7 billion, or 6.2% of the aggregate costs for all hospitalizations. Sepsis is the second most common cause for hospitalizations, accounting for 3.6% of hospital stays. When considering the sepsis high cost burden, it is of paramount importance to identify the responsible factors. The main objective of this study is to evaluate impact of Non-Hodgkin Lymphoma (NHL) as a comorbidity either a history or as a present diagnosis of NHL, in patients admitted in the hospital with sepsis. Studies suggested increased risk of infections and mortality from bacteremia in patients with NHL in the past, (Shaikh et al, Cancer, 1987; Williams et al, Critical Care 2004 ) but recent data on health care cost burden associated with sepsis in NHL is limited. Methods: We analyzed the admissions for sepsis among adult patients using the Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample, between 2010 and 2014. Patients were stratified into two groups based on the status of NHL (sepsis with NHL and sepsis without NHL) using the ICD-9 CM diagnostic codes. Baseline characteristics including age, race, gender, Charlson comorbidity index, were described in the two groups, using descriptive statistics. A survey weighted multivariate regression analysis was used to adjust for confounders. STATA version 15 (College Station, TX) was used to perform statistical analysis. Results Between 2010 and 2014, a total of 4,501,621 admissions were identified with a primary diagnosis of sepsis. A total of 45,943 admissions had an underlying diagnosis of NHL. Mean age of patients hospitalized with sepsis and with NHL, was higher than patients without NHL (69.04 ±0.167 years; p Conclusion Sepsis is responsible for a major healthcare cost burden in the US. Identification of signs of early sepsis and high-risk patients could support the design of early therapeutic strategies with the goal of decreasing negative outcomes and also decrease overall costs This study highlights NHL as an independent factor for mortality and healthcare costs for sepsis. It may help implement preventive strategies to avoid complications from infections and reduce cost burden associated with sepsis and NHL. Future studies are needed to focus on improving preventive strategies e.g vaccinations, early diagnosis and prompt treatment of infections to prevent progression to sepsis in patients with NHL. Table. Table. Disclosures No relevant conflicts of interest to declare.

Background: Opportunistic infections (OI's) are defined as infections that are more frequent or more severe because of immunosuppression. Conditions like HIV infections, Hematopoietic stem cell transplantation, autoimmune diseases like SLE and RA have been established as risk factors for increased mortality in OI. Studies suggest that lymphomas are a risk factor for mortality associated with OI's like Tuberculosis and candida (Silva et al, 2005; Chen et al, 2014) probably due to underlying immunodeficiency and therapeutic exposures inducing prolonged lymphopenia. Data describing association of underlying Non-Hodgkin Lymphoma (NHL) on mortality associated with OI's is limited. Our objective was to study impact of NHL on in‐hospital mortality of patients hospitalized with OI's. Methods: We analyzed data from the Healthcare Cost and Utilization Project's (HCUP) National Inpatient Sample, between 2010 and 2014 using the ICD-9 codes for Opportunistic infections (OI) which included tuberculosis (010-018), non-tubercular mycobacteria (031), cytomegalovirus (078.5), Herpes Zoster( 053), Candidiasis(112.4), Toxoplasmosis (130), Pneumocystis (136.3), Cryptococcosis(117.5), Listerosis (027.0), Nocardiosis (039), Aspergillosis (117.3) coccidiomycosis (114), histoplasmosis (115), blastomycosis (116.0) . The subset of this cohort with NHL excluding lymphoid leukemias listed as a secondary diagnosis were collected for analysis. Baseline characteristics including age, race, gender, Charlson comorbidity index, and infection with HIV etc. were analyzed for patients with admitted with OI's, with and without underlying diagnosis of NHL. Our primary outcome was in-hospital mortality. Characteristics associated with in‐hospital mortality were identified using multivariable logistic regression. Results Between 2010 and 2014, a total of 1,81,016 admissions were identified with a primary diagnosis of OI. A total of 4442 admissions had an underlying diagnosis of NHL. Mean age of patients hospitalized with OI's with NHL, was higher (65.4 ±0.52 years vs 58.9±0.14years, p Conclusion OI's constitute a major cause of morbidity and mortality in immunocompromised patients. There is limited data from a nationwide analysis which evaluates association of opportunistic infections and lymphoma as an independent marker of mortality. Our study suggests that NHL is an independent risk factor for mortality in patients who were admitted in the hospital for OI's. Further studies should be considered to the role of primary prophylaxis for conditions like PCP to avoid morbidity and mortality associated with these conditions. This will help reduce health care cost burden associated with such hospitalizations. Table. Table. Disclosures No relevant conflicts of interest to declare.

Bronchiolitis obliterans organising pneumonia as an initial manifestation of systemic lupus erythematosus (SLE) is a rare and uncommon presentation. We describe a case of SLE presenting with shortness of breath, found to have pneumothorax, bilateral nodular infiltrates along with pleural effusions and pericardial effusion. Work-up suggested a diagnosis of active SLE with anaemia, thrombocytopenia, positive antinuclear antibodies (ANAs) and positive anti-double-stranded DNA. On retrospective review of patient records, from 8 years prior to presentation, lung biopsy histology consistent with bronchiolitis obliterans organising pneumonia with positive ANA serology was found, without any further autoimmune work-up. In our opinion, bronchiolitis obliterans organising pneumonia was the index presentation of SLE. Treatment with steroids and subsequent management with immunosuppressive therapy could have prevented subsequent hospitalisations. Prompt work-up for autoimmune diseases should be considered in patients with positive ANA and histological evidence of bronchiolitis obliterans organising pneumonia.

e18735Background: Clostridium Difficile Infection (CDI) resulted in almost half a million cases, 83,000 re-infections and 29,000 deaths in 2011. Limited studies have shown increased incidence of CD...

e18754Background: Skeletal-related events (SRE) are frequent consequences of bone metastases from solid tumours like breast, prostate and lung. In 2010, US FDA approved Denosumab, a monoclonal anti...

Background Collapsing Glomerulopathy (CG), also known as the collapsing variant of Focal Segmental Glomerulosclerosis (FSGS), is distinct in both its clinical severity and its pathophysiologic characteristics from other forms of FSGS. This lesion occurs disproportionally in patients carrying two APOL1 risk alleles, and is the classic histologic lesion resulting from Human Immunodeficiency Virus (HIV) infection of podocytes. Other viral infections, including parvovirus B19, and drugs such as interferon that perturb the immune system, have also been associated with CG. Despite significant advances, explaining such genetic and immune/infectious associations with causative mechanisms and supporting evidence has proven challenging. Case presentation We report the case of a healthy (HIV-negative) pregnant 36 year-old Caribbean-American woman who presented with nephrotic syndrome and fetal demise in the setting of acute parvovirus B19 infection. A series of three renal biopsies and rapid clinical course showed progression from significant podocyte injury with mild light microscopy findings to classic viral-associated CG to ESRD in less than 3 months. Genetic analysis revealed two APOL1 G1 risk alleles. Conclusions This is the first published case report of CG in the setting of acute parvovirus infection in a patient with two APOL1 risk allelles, and parvoviral proteins identified in renal epithelium on kidney biopsy. These findings support the causative role of parvovirus B19 infection in the development of CG on the background of APOL1 genetic risk. Electronic supplementary material The online version of this article (doi:10.1186/s12882-016-0330-7) contains supplementary material, which is available to authorized users.