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Autologous stem cell transplant (ASCT) is the standard of care for eligible patients with multiple myeloma (MM) [1]. Eligibility is dependent on medical comorbidities and functional status, amongst...

Background Despite advances in treatment, multiple myeloma (MM) remains incurable and results in significant morbidity and mortality. Further research investigating where MM patients die and characterization of end-of-life hospitalizations is needed. Methods We utilized the National Inpatient Sample (NIS) to explore the hospitalization burden of MM patients at the end of their lives. Results The percent of patients dying in the hospital as a percent of overall MM deaths ranged from 54% in 2002 to 41.4% in 2017 (p p Conclusion Our study demonstrates that patients with MM dying in the hospital have a significant requirement for blood transfusions and have a high infection burden. We also show that palliative care and hospice involvement at the end of life has increased over time but remains low, and that ultimately, inpatient mortality has decreased over time, but MM patients die in the hospital at a higher rate than the general population.

Several targeted agents including multi-tyrosine kinase inhibitors (mTKIs) and immunotherapy (IO) agents have been approved for use beyond the frontline setting in patients with advanced hepatocellular carcinoma (HCC). Due to lack of prospective head-to-head comparative trials, there is no standardized way for alternating those agents beyond frontline. Therefore, we performed a retrospective review of the Kansas University (KU) cancer registry to determine whether IO may be superior to non-IO therapy. Patients with advanced HCC were divided into two groups based on the second-line systemic regimen received (IO vs. non-IO). Progression-free survival (PFS) and overall survival (OS) were calculated under the Kaplan&ndash, Meier and Cox proportional hazards models. No statistically significant differences in PFS and OS were found, although a non-significant delayed separation in the survival curve favoring IO was identified (median PFS 3.9 months vs. 3 months, median OS 10 months vs. 10 months respectively for IO vs. non-IO). This retrospective analysis is one of the earliest and largest studies comparing second-line IO and non-IO therapies thus far reported. Future studies should aim to define specific biomarkers for response prediction and treatment optimization based on individual patient and tumor characteristics. Furthermore, combinatorial therapeutic strategies is an evolving approach showing early promising signal.

The estimated prevalence of leukemia (including all sub-types) in the United States for 2019 was 414,773 based on data from the Surveillance, Epidemiology and End Results (SEER) database [1]. The h...

Introduction Gastrointestinal bleeding (GIB) complicating septic shock (SS) presents a therapeutic challenge in intensive care units. Large-scale data regarding utilization, length of stay, and cost outcomes of this association are lacking. Methods We queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample from 2003 to 2012, and identified all adult patients aged ≥18 years hospitalized for SS by the International Classification of Diseases, Ninth Revision (ICD-9) diagnostic code for SS and GIB. We compared the baseline characteristics and outcomes among patients with SS plus GIB to patients with SS without GIB. Results The weighted sample size from 2003 to 2012 was 119,684 admissions for SS. Among them, 6,571 (5.4%) patients were found to have a GIB. The mean age of the SS population with and without GIB was (mean/standard error of mean) [70.85 (0.43) vs. 67.43 (0.13) P < 0.001, respectively]. The incidence of GIB over the course of 10 years has remained stable; however, the mortality associated with GIB among SS patients is found to be declining especially from 2008 (59.2%) to 2012 (45.1%) (P < 0.01). Patients with SS and GIB compared to patients with SS and no GIB were found to have a longer length of stay [20.56 (0.61) vs. 15.76 (0.13) P < 0.001], higher mortality [54% vs. 45% P < 0.001], and higher admission costs in United States dollar ($) (mean/SEM) [$192,524.89 (7,378.20) vs. $142,688.55 (1,336.65) P < 0.001]. Univariate analysis demonstrated that comorbid conditions like peptic ulcer disease and cirrhosis had significant odds ratios {1.56 and 1.709, P = 0.016 and 0.046 respectively} for the occurrence of GIB with SS. Gastroesophageal reflux disease was found to be associated with a lower incidence of GIB [odds ratio: 0.57, P = 0.0008]. The cause of sepsis (pneumonia, urinary tract infection, or abdominal infections) was not a significant distinguishing factor for the incidence of GIB in SS. Conclusion GIB continues to affect the patients with SS admitted in intensive care units in the United States. We found an incidence of 5.4% of GIB in patients with SS, and it was associated with worse outcomes.

Background: The goal of our study was to determine the impact of gastrointestinal bleeding (GIB) on in-hospital outcomes among acute respiratory distress syndrome (ARDS) patients, and subsequently determine the potential risk factors for the development of GIB. Methods: ARDS patients with and without GIB were identified using the National Inpatient Sample (2002 - 2012). Linear regression analysis was used to assess impact of GIB on in-hospital mortality, length of stay and total charges. Univariate logistic regression was used to determine associated odds ratios (OR) for causes of ARDS and common comorbid conditions. Results: We identified 149,190 ARDS patients. The incidence of GIB was the highest among patients > 60 years (P < 0.001). GIB was associated with longer hospitalization days (7.3 days versus 11.9 days, P < 0.001), higher mortality (11% versus 27%, P < 0.001) and greater economic burden ($82,812 versus $45,951, P < 0.001). GIB was common in cirrhosis (OR: 8.3), peptic ulcer disease (OR: 3.7), coagulopathy disorders (OR: 3.003), thrombocytopenia (OR: 2.6), anemia (OR: 2.5) and atrial fibrillation (OR: 1.5). ARDS secondary to aspiration pneumonia (OR: 2.0), pancreatitis (OR: 2.0), sepsis (OR: 1.6) and community acquired pneumonia (OR: 0.8) was more likely to have GIB. Conclusion: Our study demonstrates that GIB in ARDS patients is associated with significant increased mortality, hospitalization and health care cost. J Clin Med Res. 2019;11(1):42-48 doi: https://doi.org/10.14740/jocmr3660

BackgroundAs most of the patients previously enrolled in trials had nephrectomy before starting systemic treatment (syst-Rx), the response of the intact-Rmass to novel ICI and tyrosine kinase inhibitor (TKI) combination regimens is not well described.MethodsA retrospective review of 227 patients with mRCC who were treated with ICI (single agent or combinations) in the 1st- or 2nd-line was conducted. Following the appropriate regulatory process, collaborators from 6 US sites collected clinical, pathological, and outcome data via chart review. Overall response was investigator-assessed for all patients with at least one post-treatment scan or evidence of clinical progression after treatment initiation. Overall radiographic response (ORR) represents any radiographic response in the metastatic disease per investigator’s assessment. To accurately assess response in intact-Rmass, 3-dimensional measurement of the intact-Rmass was performed and Rmass volume was calculated at baseline and at the time of best overall response for 1st- and 2nd-line therapy. Radiographic response in intact-Rmass is defined as >30% decrease in the Rmass volume.ResultsMedian age at diagnosis was 62 years, 69% were male, 82% had clear cell histology. 15% and 12% had sarcomatoid and rhabdoid features, respectively. Overall, 82 patients (36%) had a measurable intact-Rmass while receiving syst-Rx. 63 (28%) patients never had a nephrectomy, and 10 (4%) patients had delayed nephrectomy after a good overall response to syst-Rx. 108 (48%) received ICI in 1st-line (88/108 received ipilimumab/nivolumab combination). 91 (40%), and 18 (8%) patients received TKI, or ICI+TKI in 1st-line. 161 (71%) and 86 (38%) of the patients received 2nd-line and 3rd-line therapy, respectively. 104 (46%) received ICI in 2nd-line (75/104 treated with single-agent ICI). 48 (21%), and 4 (2%) patients received TKI, or ICI+TKI in 2nd-line. Radiographic response in intact-Rmass for evaluable patients is summarized in table 1. The highest response rates in intact-Rmass were seen with ICI+TKI combinations. Higher rates of radiographic response in intact-Rmass were seen in patients treated with ICI in 1st-line compared to 2nd-line, possibly related to higher usage of ICI combinations (ipilimumab/nivolumab) in 1st-line. Overall metastatic disease response to different regimens in the 1st-line or 2nd-line was not different based on the history of nephrectomy prior to syst-Rx (table 2).Abstract 294 Table 1Radiographic response (≥30% decrease in volume) in the intact renal massAbstract 294 Table 2Overall radiographic response (ORR) per investigator assessmentConclusionsHigher radiographic response rates in the intact-Rmass were seen in patients treated with ICI+TKI and ICI in the 1st-line. There was no significant difference in overall metastatic disease response to 1st- or 2nd-line treatment based on the history of nephrectomy prior to syst-Rx.Ethics ApprovalEach of the 6 participating centers had their IRB approved protocol for retrospective study and data collection. Data Use Agreements were obtained for each center to share limited data set data with University of Wisconsin - Madison (IRB protocol UW17148 # 2018–0213). Final analysis was performed at University of Wisconsin.Consent not applicable to retrospective studies.

INTRODUCTION: With the advent of newer treatment options for patients with acute leukemia and myeloma, therapies are increasingly safely administered on an outpatient basis. We hypothesized increasing utilization of outpatient options would result in decreased hospitalizations for chemotherapy, albeit with increased hospitalization charges. We interrogated chemotherapy utilization amongst adult inpatients with these malignancies using the National Inpatient Sample (NIS). METHODS: The NIS is a database providing information on all inpatient hospitalizations in the United States (US), including primary and secondary diagnoses, procedures, length of stay, and disposition. Approximately 20% of admissions are tracked, and weighted estimates are provided regarding the total number of hospitalizations in the US. Using the NIS, we tracked chemotherapy admissions for patients with the following hematological malignancies: acute myeloid leukemia (AML), acute lymphoid leukemia (ALL) and multiple myeloma (MM). Admissions for hematopoietic stem cell transplants were excluded from our analysis, and only patients aged 18 or greater were included in our analysis. Procedural International Classification of Disease (ICD) 9 and 10 codes were used to gain insight into trends of hospitalizations, elective versus urgent status, costs and length of stay for each indication. Time frame 2002-2017 was chosen as this was the most recent year for which NIS data is available. Inflation adjustments for charges were calculated based on US Department of Labor statistics. RESULTS: For MM, there were a total of 54,357 admissions for chemotherapy from 2002-2017. Amongst these admissions, 37,517 were elective, and 16,670 were non-elective, with the remainder lacking data on elective status. Figure 1 highlights trends in admissions for MM, with a significant decrease noted in the overall volume (7,547 in 2002 to 2,710 in 2014 (p=0.003)). Mortality rates for MM chemotherapy admissions, also highlighted in Figure 1, did not change significantly from 2002 to 2017 (p=0.15). Mean length of stay for chemotherapy hospitalizations increased from 4.67 days in 2002 to 6.47 days in 2017 (p For AML, we noted 198,288 admissions for chemotherapy from 2002-2017 of which 127,277 were considered elective, and 70,566 non-elective, with the remainder lacking data on elective status. Figure 2 highlights trends in AML admissions with a decreased volume of admissions noted from 2011 onwards after an initial increase from 2005-2008. There was a total of 14,214 admissions in 2011 compared to 10,515 in 2017 (p=0.004) There was a decrease in inpatient mortality rates from 5.5% in 2002 to 2.4% in 2017 (p There was a total of 82,730 admissions for chemotherapy from 2002-2017 for ALL. Amongst these admissions, 54,565 were elective and 27,963 were non-elective, with the remainder lacking data on elective status. Figure 3 highlights trends in admissions, with an increase in number of admissions from 4,092 in 2002 to 5,960 in 2017 (p=0.86). There was a decrease in the inpatient mortality rate from 0.8% in 2002 to 0.4% in 2017 (p=0.0007). Mean length of stay stayed consistent at 7.70 days in 2002 to 7.62 days in 2017 (p=0.06). Mean inflation-adjusted hospitalization charges increased from $49,283 in 2002 to $94,787 in 2017 (p CONCLUSIONS: There has been a steady decline in the number of admissions for inpatient chemotherapy for patients with multiple myeloma and acute myeloid leukemia over time, owing to advances in therapies delivered safely and efficaciously as an outpatient. There has also been a steady decline in inpatient mortality for chemotherapy for acute myeloid and acute lymphoid leukemia, in part due to advances in supportive care. However, the inpatient mortality rate for myeloma has not decreased, likely due to sicker patients preferentially needing admission for inpatient chemotherapy. Inflation-adjusted hospitalization charges have gone up dramatically and further work is needed to elucidate factors driving these costs, and how to mitigate them. Disclosures Ganguly: Kadmon: Other: Ad Board; Settle Genetics: Speakers Bureau; KITE Pharma: Speakers Bureau. McGuirk:Astellas: Research Funding; Novartis: Research Funding; Allo Vir: Consultancy, Honoraria, Research Funding; Juno Therapeutics: Consultancy, Honoraria, Research Funding; Kite Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pluristem Ltd: Research Funding; Gamida Cell: Research Funding; Bellicum Pharmaceutical: Research Funding; Fresenius Biotech: Research Funding.

INTRODUCTION: Multiple myeloma (MM) remains a largely incurable disease, and despite the variety of treatment options available, duration of response decreases with each subsequent line of therapy resulting in refractory disease . In this setting, studies have shown most patients prefer to die in the comfort of home, yet hospitalizations remain frequent at the end of life. We explored the hospitalization burden of MM patients at the end of their life using the National Inpatient Sample (NIS). METHODS: The NIS is a database that provides information on all inpatient hospitalizations in the United States (US), including primary and secondary diagnoses, procedures, length of stay, and disposition. Approximately 20% of admissions are tracked and weighted estimates are provided regarding the total number of hospitalizations. Using the NIS, we tracked hospital admissions for MM patients and inpatient mortality from 2002 to 2014 via procedural International Classification of Disease (ICD) 9 codes to gain insight into trends in transfusions, infectious complications, and cost of admission. Linear regression modeling was used for analysis. Overall annual number of deaths for MM in the United States was obtained from publicly available reports from the Centers for Disease Control (CDC) and Prevention and the National Cancer Institute (NCI). RESULTS: During the time period 2002-2014, the CDC and NCI reported a total of 144,105 deaths from MM, ranging from 10,913 in 2002 to 12,112 in 2014. The NIS identified a total of 233,932 (non-weighted) hospitalizations for MM during this time period. Amongst these, a total of 14,770 (non-weighted) hospitalizations resulted in death, thus 6.3% of all hospitalizations for myeloma patients resulted in death. A weighted sample of 69,825 hospitalizations resulting in deaths were identified. During our study time period, 48.4% of all deaths related to myeloma in the United States occurred in the hospital, ranging from 5,893 (54%) in 2002 to 5,035 (41.6%) in 2014, p We analyzed blood transfusion dependency in the hospitalization leading to death. There was a receipt of blood transfusions (35.8%) in 5,285 of the 14,770 (non-weighted) admissions leading to death. Infection frequency was identified using the Clinical Classification Software. The Clinical Classifications Software (CCS) is a tool that allows for clustering patient diagnoses and procedures into clinically meaningful categories. A total of 6,644 infections were identified amongst the 14,770 (non-weighted) hospitalizations leading to death (45.0%). We then analyzed palliative care/hospice involvement during the hospitalization leading to death over time. Palliative care/hospice was consulted in 67 of the 1260 (non-weighted) hospitalizations in 2002 (5.3%), and 338 out of the 1007 (non-weighted) hospitalizations in 2014 (33.57%), p Median cost of the hospitalization leading to death increased over time from $48,709 in 2002 to $104,115 in 2014, p CONCLUSIONS: Despite a decrease in the percentage of inpatient deaths over time, greater than 40% of patients with myeloma continue to die in the hospital, with significant transfusion requirements and infections at the end of life. This comes with an increased cost to the health care system. Our analysis suggests that while palliative care involvement at the end of life has also increased over time, earlier involvement of palliative care and incorporation of transfusion support within hospice services may decrease the number of myeloma patients dying in the hospital and, therefore, the overall burden and cost of care. Disclosures No relevant conflicts of interest to declare.

Introduction Renal impairment is a common problem in patients with multiple myeloma (MM), and approximately 2-3% of patients develop renal impairment requiring dialysis. Autologous stem cell transplantation (ASCT) is a mainstay of treatment for eligible patients. Although dialysis is not a contraindication to ASCT, further data on the safety of ASCT for these patients is needed, especially for patients on peritoneal dialysis (PD) for which there is limited data available. Methods The National Inpatient Sample (NIS) is a database that provides information on all inpatient hospitalizations in the United States (US), including primary and secondary diagnoses, procedures, length of stay, and disposition. Approximately 20% of admissions are tracked, and weighted estimates are provided regarding the total number of hospitalizations in the US. Using this database, we were able to track hospital admissions for MM patients who underwent ASCT. We reviewed data from 2002 to 2014, using ICD 9 coding. Results During the years 2002-2014, the total weighted estimate of inpatient admissions for ASCT among MM patients was 47,253 (unweighted N=10,231). However, a weighted total of only 45 patients with MM received PD during their hospital stay for ASCT in theUS, as opposed to 1709 patients with MM who received HD during their hospital stay for ASCT. The inpatient mortality rate was numerically higher for patients receiving hemodialysis (HD) compared to PD during their hospital stay for ASCT (20.5% for patients receiving peritoneal dialysis versus 13.8% for patients receiving HD), but this difference was not statistically significant (p=0.58). However, inpatient mortality overall for patients with MM undergoing ASCT not on dialysis was only 1.1%, indicating a markedly increased risk of inpatient mortality for patients with MM on dialysis undergoing ASCT (p The length of stay was comparable between patients receiving HD vs PD (28.7 days for HD vs 26.7 for PD, p=0.69). The length of stay for patients not on dialysis was 17.9 days (p Conclusion Patients with MM requiring either PD or HD undergoing inpatient ASCT are at a significantly increased risk of inpatient mortality. Collaborative efforts are needed to help determine best practices for these patient populations, especially as pertains to patients on PD.

Background Acute myeloid leukemia (AML) remains a disease of high mortality and allogeneic hematopoietic stem cell transplant (HCT) is frequently indicated for its curative potential. However, access can be limited by availability of HLA-matched donors, comorbidities, and performance status. Recently, half-match (haploidentical) donors and reduced-intensity conditioning (RIC) have increasingly been used to alleviate limitations. The objective of this study is to compare outcomes between different types of donors (matched-sibling (MSD) vs matched-unrelated (MUD) vs haploidentical (HI) and to investigate the role of conditioning for patients with AML. Methods In this single-center retrospective study, 253 AML patients receiving first allo-HCT between 2013-2018 were included. Baseline characteristics were collected and the primary outcome of overall survival was evaluated with Kaplan Meier survival analysis and hazard ratios using cox regression models. Baseline difference between these groups were significant for mean age of donor [53.0 years (MSD), 34.8 (HI), 27.8 (MUD); p Results Two-year survival amongst groups stratified by type of donor was not significantly different with 44.0% for MSD (95% CI: 30.4 to 57.6), 53.8% for MUD (95% CI: 44.4 to 63.2), and 53.5% for HI (95% CI: 38.6 to 70.0). When patients were stratified by conditioning type, differences in overall survival were also not statistically significant. Conclusion In this cohort of adult patients with AML, receiving an allo-HCT. Overall survival outcomes were not different between different donor types. This data is consistent with other recent reports demonstrating similar outcomes with haploidentical transplants when compared to matched-donor transplant.

e17012 Background: Salvage therapy for advanced Testicular Carcinoma involves patients receiving ifosfamide are treated in hospital for risk of neuro-toxicities. We evaluated annual trends to assess the health care burden of testicular patients admitted for chemotherapy, as well as co-morbidities and complications associated with mortality. Methods: The National Inpatient Sample is a nationwide sample of all US hospital discharges. We collected data from the years of 2002 to 2017 on patients with Testicular Carcinoma who were receiving chemotherapy, to capture patients recieving ifosfamide and cisplatin in an in-patient setting. Patients undergoing an autologous stem cell transplant were excluded. Annual trends for inpatient mortality, length of stay, and total costs of admission were assessed. A univariate logistic regression analysis was used to calculate odds ratios (OR) for the effect of comorbid conditions and acute inpatient complications on in-patient mortality. Results: Hospitalizations for ifosfamide and cisplatin based treatment among patients with Testicular Carcinoma remained stable from a weighted national estimate of 2,261 in 2002 to 2,160 in 2017. Length of stay increased from 4.6 days to 5.5 days (p=0.01). Cost of stay increased from $26,140 to $53,193 (p

e16194 Background: Hepatocholangiocarcinoma (HCC-CC) is a rare form of cancer with a poor prognosis. Of all primary liver cancers, the incidence of HCC-CC ranges from 0.4 to 14.2%. HCC-CC is a mixed carcinoma with findings of both hepatocellular carcinoma and cholangiocarcinoma. Immune checkpoint inhibitors are a potent first line treatment in hepatocellular carcinoma with multiple clinical trial showing effectiveness in cholangiocarcinoma. HCC-CC has limited proven treatment options as patients are generally excluded from clinical trials. In this study we reviewed outcomes of patients with HCC-CC who received immune checkpoint inhibitor in a single center. Methods: Records of patients who had a pathological confirmed HCC-CC by a subspecialized hepatic pathologist at the University of Kansas medical center were reviewed. We identified 6 patients with locally advanced unresectable or metastatic HCC-CC that received immune checkpoint inhibitor between February 2017 and January 2021. Baseline characteristics were obtained, as well as best response, line of therapy, and duration of response. Results: Of the six patients 4 (66%) received PD-1 inhibitor alone and 2 (34%) received combination therapy with CTLA-4 inhibitor for the treatment of HCC-CC. There were 3 (50%) females and 6 (100%) with prior hepatitis C infection. four (66%) patients had metastatic disease and 2 had locally unresectable advanced disease. Objective response rate was 83.3%. One patient achieved complete response and had a treatment holiday after receiving treatment for 2 years, and restarted immunotherapy upon relapse. Four patients had a partial response, of which two passed away after disease progression. One patient had stable disease on 2 different lines of immunotherapy then progressed. Of those who responded, one patient received immunotherapy, 3 (50%) received liver directed therapy and two received chemotherapy or Lenvatinib as first line treatment (Table). Conclusions: Immune checkpoint inhibitors demonstrate potential activity in patients with HCC-CC without unexpected side effect in this unmet need high-risk population. Larger studies are needed to confirm activity and efficacy in this setting.[Table: see text]

Importance Standard therapy for locally advanced rectal cancer includes concurrent chemoradiotherapy followed by surgery and adjuvant chemotherapy (CRT plus A). An alternative strategy known as total neoadjuvant therapy (TNT) involves administration of CRT plus neoadjuvant chemotherapy before surgery with the goal of delivering uninterrupted systemic therapy to eradicate micrometastases. A comparison of these 2 approaches has not been systematically reviewed previously. Objective To determine the differences in rates of pathologic complete response (PCR), disease-free and overall survival, sphincter-preserving surgery, and ileostomy between patients receiving TNT vs standard CRT plus A. Data sources MEDLINE (via PubMed) and Embase (via OVID) were searched from inception through July 1, 2020, for the following terms: anal/anorectal neoplasms OR anal/anorectal cancer AND total neoadjuvant treatment OR total neoadjuvant therapy. Only studies in English were included. Study selection Randomized clinical trials or prospective/retrospective cohort studies comparing outcomes in patients with locally advanced rectal cancer who received TNT vs CRT plus A. Data extraction and synthesis Data regarding the first author, publication year, location, sample size, and rates of PCR, sphincter-preserving surgery, ileostomy, and disease-free and overall survival were extracted using Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines and pooled using a random-effects model. Main outcomes and measures Rates of PCR, sphincter-preserving surgery, ileostomy, and disease-free and overall survival. Results After reviewing 2165 reports, 7 unique studies including a total of 2416 unique patients, of whom 1206 received TNT, were selected. The median age for the patients receiving TNT ranged from 57 to 69 years, with 58% to 73% being male. The pooled prevalence of PCR was 29.9% (range, 17.2%-38.5%) in the TNT group and 14.9% (range, 4.2%-21.3%) in the CRT plus A group. Total neoadjuvant therapy was associated with a higher chance of achieving a PCR (odds ratio [OR], 2.44; 95% CI, 1.99-2.98). No statistically significant difference in the proportion of sphincter-preserving surgery (OR, 1.06; 95% CI, 0.73-1.54) or ileostomy (OR, 1.05; 95% CI, 0.76-1.46) between recipients of TNT and CRT plus A was observed. Only 3 studies presented data on disease-free survival, and pooled analysis showed significantly higher odds of improved disease-free survival in patients who received TNT (OR, 2.07; 95% CI, 1.20-3.56; I2 = 49%). Data on overall survival were not consistently reported. Conclusions and relevance The findings of this systematic review and meta-analysis suggest that TNT is a promising strategy in locally advanced rectal cancer, with superior rates of PCR compared with standard therapy. However, the long-term effect on disease recurrence and overall survival needs to be explored in future studies.

e17046 Background: Patients receiving neoadjuvant chemotherapy (NAC) for muscle invasive bladder cancer (MIBC) often are not able to complete three or four cycles of therapy which is standard of care. Pathological completed response (pCR) is a surrogate marker for long term survival. We set out to determine if pCR differed based on total tolerated cycles prior to surgery in those receiving cisplatin based NAC. Methods: Data was gathered at our institution on patients receiving neoadjuvant gemcitabine with cisplatin (GC), or dose dense methotrexate, vinblastin, adriamycin, cisplatin (ddMVAC)). The primary outcome was pCR, and secondary outcome was downstaging. pCR was compared between those who received 1-2, 3, and 4 cycles. Results: A total of 92 patients receiving NAC during the years of 2014 to 2019. 12 received 2 or less cycles, 22 received 3, and 57 completed 4. Age was not significantly different between groups (69.7, ≤ 2), (69.0, 3), (67.4, 4). Gender differences were noted: (41.7% female, ≤ 2), (22.7% female, 3), (12.3% female, 4), p = 0.05. The rates of pCr among the three groups were: (16.7%, ≤ 2), (22.7%, 3), (40.4%, 4), p = 0.14. Downstaging was seen in: (33.3%, ≤ 2), (59.1%, 3), (52.6%, 4), p = 0.35. Conclusions: While not statistically significant our study suggests a trend on pCR rates related to the total of cycles of neoadjuvant chemotherapy prior to surgery. Limitations include retrospective design and small sample size.

e16803 Background: Pancreatic cancer has a dismal 5 year survival of 5-10%. Deaths commonly occur in-hospital as they present with acute complications. The purpose of this study is characterize this population compared to all pancreatic deaths, identify causes for admission, trends in palliative care utilization and its effect on costs and patient stay. Methods: From the years of 2002 to 2014, admissions for patients with a diagnosis of pancreatic cancer were identified using the National Inpatient Sample. Annual trends in death were compared to overalls deaths using SEER data. Trends in hospital length of stay (LOS) and total charges (TC) were assessed, as well as utilization of palliative care. The effect of palliative care utilization on hospital LOS and TC were also identified. Results: 97,389 (weighted) patient deaths occurred from 2002 to 2014, with 7,634 in 2002, compared to 7,200 in 2014. Compared to total overall deaths of 38,026 and 42,047 respectively. Signifying 25% (2002) to 21% (2014) total patients expiring in an in-patient setting. The most common billed primary diagnosis was sepsis at 15.5%, followed by acute renal failure and fluid disorder (12.5%) and liver failure (5.3%). Overall length of stay trended down from 9.0 days to 7.5 days (p < 0.001). And total charges for admission increased from $36,704 to $88,063 (p < 0.001). Palliative care consults increased from 12% in 2002 to 45% in 2014. In 2014, the TC for deaths among those who received palliative care consults was $52,612 (p < 0.001 when compared to all deaths). LOS among these patients also decreased from 7.5 days to 6.2 days. When looking at patients with sepsis who did not die, a palliative care consult decreased costs from $86,738 to $74,544 (p < 0.001). LOS was not significantly different at 8.8 days compared to 8.5 days (p = 0.15). Conclusions: A quarter of patients with pancreatic cancer die in an in-hospital setting. Palliative involvement decreased health care resource utilization. In reviewing patients who developed sepsis without in-hospital mortality, a palliative care consult decreased total charges of admission.

e16673 Background: Liver cancer and bile duct cancer remain among of the most deadly cancers with a dismal 5 year survival of 2-15%. Patients often end up dying in an in-hospital setting as a result of acute complication of cancer progression. The purpose of this study is to identify annual trends in this sub-population, including cause of admission, palliative care utilization and economic impact on healthcare. Methods: From the years of 2002 to 2014, admissions for patients with a diagnosis of liver and bile duct cancer were identified using the National Inpatient Sample. Annual trends in incidence were compared to overall deaths via the SEER database. Trends were identified in hospital length of stay (LOS), total charges (TC), as well as utilization of palliative care. The effect of palliative care utilization on hospital length of stay and costs were also studied. Results: 73,833 (weighted) patient deaths were recorded from 2002 to 2014, 4,577 in 2002, compared to 6,595 in 2014. Signifying 33% (2002) to 32% (2014) of total deaths related to these cancers. The most common billed primary diagnosis was liver failure at 16.9%, sepsis (15.3%) and renal failure (6.7%). Overall LOS trended down from 5.9 days to 4.8 days (p < 0.001). Palliative consults increased from 8.2% in 2002 to 39.4% in 2014. In 2014, the mean TC for those who received palliative consults versus those who did not was $52,612 and $64,388 respectively (p < 0.001). LOS among these patients did not significantly change at 5.9 and 5.6 days (p = 0.13). When looking at patients with sepsis who did not die, a palliative care consult decreased costs from $87,564 to $75,223 (p < 0.001). LOS was not significantly different at 8.8 days to 8.5 days (p = 0.15). Conclusions: A third of patients with liver and bile duct cancers die in an in-hospital setting. More effort needs to be undertaken to identify these patients and establish appropriate goals of care prior to such an event. Nonetheless, palliative involvement decreased health care resource utilization. Even among patients with sepsis who did not die, a palliative care consult decreased total charges of admission.

Background Allogeneic hematopoietic stem cell transplant (HCT) is a potentially curative treatment modality for patients with AML. However, the success of transplant is limited by transplant-related mortality. Post-transplant complications have been linked to endothelial damage through derangements in vascular and blood cell homeostasis. The EASIX (Endothelial Activation and Stress Index) score has been studied as a marker for endothelial dysfunction in the setting of allo-HCT using routine laboratory tests (LDH) x serum creatinine (mg/dL)/ Platelets (109 cells/L). The aim of this study is to investigate the prognostic value of a post-transplant day-100 EASIX score in patients with AML. Methods In this single-center retrospective study, 237 patients with AML who underwent a first allo-HCT between 2013-2018 were included. Those alive at 100 days post-transplant were stratified by scores of less than 1, 1-1.99, 2-2.99, and 3 and above. Kaplan Meier survival analysis and hazard ratios using cox regression models were employed to assess overall survival. Results There were no significant baseline differences between groups except for recipient sex [p=0.02]. Survival analysis demonstrated a decreased overall survival with incremental increases in 100-day EASIX scores (p=0.001) with a 2-year overall survival of 67.3% ( Conclusion Endothelial dysfunction contributes significantly to the pathophysiology of complications after transplant. Our data suggests that in patients with AML undergoing HCT, a 100-day EASIX score can be used as a predictor to identify those who are at increased risk of poor outcomes after transplant. This is especially important in settings where patients are discharged from the transplant program after 100 day work-up.

533 Background: Sorafenib or lenvatinib are the current frontline options for advanced HCC. Multiple biologic agents including multi-Tyrosine Kinase Inhibitors (TKI) cabozantinib & regorafenib have been recently approved for the previously treated population. Immunotherapy (IO) agent Nivolumab have also been approved in the same setting. Due to lack of prospective head to head comparison, there is no standardized way for alternating those agents beyond frontline. Methods: We performed a retrospective review of KU cancer registry. Patients with advanced HCC were divided into 2 groups based on the 2nd line systemic regimen (IO vs non-IO). Kaplan–Meier and Cox proportional hazards models were utilized to evaluate progression free survival (PFS) and overall survival (OS). Results: Between 2016-2019, 98 patients were identified, 41 received IO, while 57 received biologics. All patients had sorafinib as 1st line therapy. Most patients have ECOG 0-1 and Child-Pugh class A or B. 55% had hepatitis C, 6% hepatitis B and 27 % have history of alcohol misuse. Almost 50% of patients have received prior liver directed therapy. Comparing IO vs non-IO groups, median PFS was 3.9 months vs 3 months and median OS was 10 months vs 10 months. There was no statistically significant difference in PFS & OS but there was a delay separation in the survival curve favoring IO. Similar outcome was seen in a sub-group analysis of the hepatitis C patients. Conclusions: This retrospective comparative review of current 2nd line regimens is one of the first & largest studies reported. In this study population, IO was not superior to multi-TKI as a 2nd line regimen. The late survival curve separation favoring IO might suggest a delay IO effect in a subgroup of patients. Future studies should define specific biomarkers that could predict response and allow treatment to be optimized depending on patient and tumor characteristics. Furthermore, combining IO plus multi-TKI might be a promising next step in development. A number of ongoing trials are testing this strategy including our CAMILLA trial of Cabozantinib plus Durvalumab, currently enrolling patients at the University of Kansas Cancer Center NCT03539822 .

Background: Volume overload in patients on hemodialysis (HD) is an independent risk factor for cardiovascular mortality. B-lines detected on lung ultrasound (BLUS) assess extravascular lung water. This raises interest in its utility for assessing volume status and cardiovascular outcomes. Methods: End-stage renal disease patients on HD at the Island Rehab Center being older than 18 years were screened. Patients achieving their dry weight (DW) had a lung ultrasound in a supine position. Scores were classified as mild (0-14), moderate (15-30), and severe (>30) for pulmonary congestion. Patients with more than 60 were further classified as very severe. Patients were followed for cardiac events and death. Results: 81 patients were recruited. 58 were males, with a mean age of 59.7 years. 44 had New York Heart Association (NYHA) class 1, 24 had class 2, and 13 had class 3. In univariate analysis, NYHA class was associated with B-line classes (p = 0.0049). Multivariate Cox regression analysis showed the independent predictive value of BLUS class for mortality and cardiac events with a heart rate of 2.98 and 7.98 in severe and very severe classes, respectively, compared to patients in the mild class (p = 0.025 and 0.013). Conclusion: At DW, BLUS is an independent risk factor for death and cardiovascular events in patients on HD.

Leptomeningeal carcinomatosis (LC) is an uncommon sequelae of non-small cell lung cancer. The treatment modalities for LC have historically been limited with an overall poor prognosis. This case report outlines a 76-year-old female who presented with recurrence of non-small cell lung cancer as LC. LC is difficult to treat, and options include radiation, chemotherapy (systemic and intrathecal), as well as targeted therapies. This case outlines a unique approach and reviews the current literature on the effectiveness of these options in non-small cell lung cancer.

Introduction: Autologous stem cell transplant (ASCT) is the standard of care for eligible patients with multiple myeloma (MM). With the considerable advances in supportive care for patients receiving ASCT, many institutions now perform ASCT for MM on a completely outpatient basis. The National Inpatient Sample (NIS) tracks all inpatient hospitalizations in the United States. Hence, using the NIS, hospital admissions for MM patients undergoing ASCT and their mortality over a period of time can be tracked. We interrogated the NIS to analyze characteristics of these patients. Methods: From the years of 2002 to 2014, admissions for ASCT for MM patients were identified using the NIS via procedural ICD 9 codes for autologous bone marrow transplantation and MM. Annual trends in mortality, hospital length of stay, and costs of admission were assessed with a linear regression analysis. Chronic co-morbid conditions were investigated for associations with in-hospital mortality in the years of 2013 and 2014 using univariate logistic regression analysis. Results: A total weighted estimate of inpatient admissions for ASCT among MM patients totaled 47,253 (unweighted N=10,231) between the years of 2002 and 2014. Annual inpatient transplants increased from 1,601 in 2002 to 5,170 in 2014. Publicly available data from the Center for International Blood and Marrow Transplant research indicates that the number of ASCT for MM in the US were approximately 2100 in 2002, compared to 7500 patients in 2014, hence the number of inpatient transplants as a ratio of overall transplants decreased significantly from 76.2% in 2002 to 68.9% in 2014 (p The in-hospital mortality decreased non-significantly from 0.018% in 2002 to 0.007% in 2014 (p=0.077). The mean length of stay decreased only slightly from 18.8 days in 2002 to 17.3 days in 2014 (p=0.005), Costs of admission increased from $97,391 in 2002 to $184,002 in 2014 (p Amongst common co-morbidities, significant associations with in-hospital mortality were seen in congestive heart failure (odds ratio (OR) = 4.60), weight loss (OR=4.15), chronic renal disease (OR=4.99) and valvular heart disease (OR=6.16) (Table 1). Conclusion: The proportion of patients receiving ASCT for MM as an outpatient has increased significantly from 2002 to 2014. Among those patients admitted for ASCT, the average length of stay has changed minimally, but the average cost of hospitalization has almost doubled. The presence of co-morbid conditions including congestive heart failure, previous weight loss, chronic renal disease, and valvular disease are significantly associated with a higher incidence of in-hospital mortality for patients with MM undergoing ASCT and likely drive up the cost for inpatient stays. As institutions continue to shift ASCT for MM from an inpatient to outpatient setting, further analysis of the inpatient drivers of cost is needed, as well as a cautious understanding of risk factors for mortality in this setting. Disclosures No relevant conflicts of interest to declare.

Introduction: Acute myeloid leukemia (AML) is a disease with poor overall prognosis, about 4.3 per 100,000 men and women per year are diagnosed with AML with a deaths rate of 2.8 per 100,000. The incidence of AML increases with age which leads to an older population with multiple comorbidities and inferior prognosis. Hematopoietic stem cell transplant (HCT) remains the standard of care in most intermediate and high-risk AML patients. However, HCT puts these patients at risk of severe cytopenia, opportunistic infections, acute graft versus host disease and financial stress, especially in the early phases of transplant. The purpose of this study is to identify the annual trends in in-hospital mortality and morbidity associated with patients with AML admitted for HCT and impact of comorbid conditions on the likelihood of death during admission. Method Data was collected from the National Inpatient Sample from the years of 2002 to 2014. Admissions for HCT for acute myeloid leukemia patients were identified using a procedural clinical classification software code for bone marrow transplants in combination with ICD 9 codes for acute myeloid leukemia. Annual trends in mortality, hospital length of stay, and costs of admission were assessed with a linear regression analysis. Univariate logistic regression analysis was used to test for associations between chronic medical conditions and mortality among these patients. Co-morbid conditions were identified using the Agency for Healthcare Research and Quality comorbidity measures for underlying chronic conditions in patients in 2013 to 2014. Results: Between and including the years of 2002 to 2014, a total weighted estimate of transplants for acute myeloid leukemias in the United States totaled 31,811 (N=6,102). Annual transplants increased from 1,761 in 2002 to 3,030 in 2014. In-hospital mortality decreased from 8.4% in 2002 to 4.8% in 2014 (p=0.02). The mean length of stay remained unchanged from 32.8 days in 2002 to 32.7 days in 2014. Costs of admission increased from $226,280 to $474,106. In-hospital mortality in the years 2013 and 2014 were most strongly associated with comorbid conditions of congestive heart failure (Odds ratio (OR)=5.93), weight loss (OR=4.32), coagulopathy (OR=3.84), liver cirrhosis (OR=3.41). Any two of these conditions increased the OR to 8.34. Conclusions: HCTs have traditionally been associated with high upfront including in-hospital mortality. Our data demonstrates that in the last two decades mortality has been reduced by almost 50% while the length of hospital stay has not changed. This could be related to improvements in supportive care and better selection of conditioning regimens for the patients. It also shows that the costs of hospitalization has doubled. Congestive heart failure, weight loss, underlying coagulopathy and liver cirrhosis are most strongly associated with worse outcomes with any combination of these further potentiating risk of death. Careful selection of patients with special attention to the pre-existing comorbidities is the key to improving early outcomes in HCT. Consideration should also be given to expanding infrastructure to perform outpatient transplants to bend the cost curve. Disclosures No relevant conflicts of interest to declare.

165 Background: Neoadjuvant chemoradiation followed by esophagectomy is the standard of care in advanced EC. While 5FU based chemoradiation has been a common regimen in the past, its utilization has declined in recent years as the CROSS trial study regimen of carboplatin/paclitaxel has become widely adopted. A prospective evaluation of the CROSS regimen compared to the 5FU based regimen was never performed. The aim of this study is to report our institutional experience with these two chemotherapy regimens. To the best of our knowledge, this is the largest retrospective study comparing the two types of chemotherapy regimens. Methods: We performed an IRB-approved retrospective review of a prospectively maintained institutional cancer registry. EC patients who completed trimodality therapy with either carboplatin/paclitaxel or 5FU/platinum were identified and divided into groups based on their chemotherapy regimens. Multivariable logistic regression was used to analyze pathologic complete response (pCR) rates, while the Kaplan–Meier and Cox proportional hazards models were utilized to evaluate DFS and OS. Analytical models were adjusted for age, stage, radiation dose, histology sub-type, and time interval from completion of neoadjuvant therapy to surgery. Results: 224 patients treated between January of 2007 and July of 2017 were identified . Of this group, 139(62%) had received Carbo/Taxol, while 85 (37%) had received 5FU/platinum. There was no increase in the odds of pCR with 5FU based chemo compared to CROSS regimen (OR = 2.68, P = 0.671). Furthermore, the OS and DFS of 159 patients(80 5FU/platinum, 77 carbo/taxol) with median follow up of ~ 5 yrs were not statistically different with HR 1.08 (0.6-1.7) and P value 0.71. Conclusions: Neoadjuvant chemoradiation with 5FU/platinum in resectable EC is not associated with higher rates of pCR, DFS and OS compared to the CROSS regimen of carbo/taxol. Those findings will need to be validated in a larger cohort.

Background There is a debate among cancer researchers about the use of single-arm or randomized phase II clinical trial designs; however, there is limited published objective evaluation of this issue. Purpose To objectively quantify the impact on phase III clinical trials of a policy of all single-arm versus all randomized phase II trials. Methods A simulation study was performed comparing optimal single-arm and randomized phase II trial designs with a variety of commonly used α and β error rates. Parameters modeled included: between-institution variability in the standard of care response rate, between-institution variability in the treatment effect, between-institution variability in the estimate of historical control rate (for selecting H0), presence of historical bias, and proportion of phase II trials conducted using active agents. Results Using single-arm phase II trials resulted in a higher percentage of phase III trials conducted using active agents when there was minimal standard of care activity, or in the presence of a positive historical bias (H0 estimated to be greater than truth). Randomized phase II trials performed better in the presence of a negative historical bias, in the presence of high variability, and were more consistent across variation of historical bias. The proportion of phase III trials conducted using active agents was increased by reducing the α error. Presence of historical bias and the proportion of active agents studied in phase II had the greatest influence on results. Limitations It was estimated that between 5% and 20% of agents studied in phase II trials are active; however, the conclusions could change if this estimate is incorrect. This study did not account for the possibility of a new drug application submission immediately following phase II. The primary outcome looked at was response rate, although some investigators have suggested that time-to-event outcomes should be used in phase II, particularly for randomized phase II trials. Conclusions Both single-arm and randomized phase II trials appear warranted in certain situations. Investigators should increase consideration of the potential impact on phase III trials to optimally select the proper trial design prior to phase II study implementation.

e20517Background: Hypercalcemia is a common electrolyte abnormality and is known to occur in 20-30% of patients with underlying malignancy. The presence of hypercalcemia in malignancy indicates a p...

It has been speculated that the number of NSTEMI cases are growing however the exact incidence and use of PCI in the management of these cases is uncertain. Using Nationwide Inpatient Sample database, NSTEMI cases hospitalized between years of 2002-2014 were identified by 9th International

e18103 Background: Febrile Neutropenia (FN) is associated with significant in-patient morbidity and mortality. The goal of this study is to describe the in-patient outcomes of febrile neutropenia as well as the impact of comorbid conditions through a large national dataset. Methods: Using the Nationwide Inpatient Sample (NIS) for years 2007-2012, FN was defined as ICD-9 codes 288.0x for a primary discharge diagnosis of neutropenia in conjunction with 780.61 and 780.6 for fever in cancer patients. Linear regression analysis assessed for annual trends in in-hospital mortality, length of stay (LOS), and cost of stay (COS). Seasonal variations in admission rates were evaluated using ANOVA. We employed univariate and multivariate logistic regression analysis to elucidate the relationship between common comorbid conditions and mortality. Results: Among 55,253 cancer patients (weighted N = 264,384) admitted with FN between 2007 and 2012, there is a mean decrease in LOS from 5.78 to 5.47 days (p < 0.0001), an increase in COS from $33,939 to $41,395 (p < 0.0001), and a 12-15% drop in hospital admissions in winter months. Mortality rate is unchanged annually (1.06-1.28%). Univariate analysis identified an increased risk of mortality associated with atrial fibrillation (OR = 4.06), coronary artery disease (OR = 2.09), congestive heart failure (OR 4.39), hypertension (1.20), COPD (OR 2.33) pancytopenia (OR 1.81), and adrenal insufficiency (OR 5.32). All remained significant on multivariate analysis, except hypertension and diabetes mellitus. Conclusions: Between 2007-2012, FN had a slight decrease in length of stay, unchanged in-patient mortality and a 22% increase in hospitalization costs. Our results are in line with recently presented analyses of the same database (Blood 2016 128:4762, Blood 2016 128:5904). Comorbid conditions are associated with higher in-patient mortality, with up to 5-fold increase for those with atrial fibrillation, congestive heart failure and adrenal insufficiency. Clinicians should consider the significant impact of such comorbidities. Additional vigilance and potentially prophylactic antibiotics following treatment should be considered in affected patients.

e12022 Background: The ODX RS predicts the risk of distant recurrence and the benefit of adjuvant chemotherapy (CT) in patients with ER+/Her2- breast cancer. High RS predicts a large benefit whereas low RS predicts minimal benefit from CT. A prospective trial showed that patients with low RS of 0-10 may be safely spared adjuvant CT. Recommendations in patients with intermediate RS are less clear. We performed a retrospective study of adjuvant therapy decision in patients with RS 11-30. Methods: We identified patients with ER+/Her2-, node-negative breast cancer with ODX RS 11-30 treated at our center from 2010-2016. Data on patient age, type of surgery, tumor size, grade, lymphovascular invasion (LVI), RS and treatment were collected. Statistical associations were tested using Chi square/Fisher's exact test and t test. Logistic regression analysis was used to determine odds ratios (OR). Results: 76 patients were identified. 86% (65/76) of them received adjuvant endocrine therapy alone and 14% (11/76) received adjuvant CT plus endocrine therapy. Patient characteristics are shown in the table. Using univariate analysis, significant predictors of receiving CT included RS, LVI, and ER positivity. In the patients who received CT, RSs were all ≥ 18 whereas in the group who did not receive CT, 42% (27/65) patients had RS 11-17. Increase in RS was associated with increase in the likelihood of receiving CT (OR 1.40, 95% CI 1.14-1.74, p=0.00017). Decrease in ER positivity was correlated with increased likelihood of receiving CT (OR 0.922, 95% CI 0.856-0.992, p=0.03). The presence of LVI increased the likelihood of receiving CT (OR 26.24, 95% CI 4.16-165.43, p=0.0005). Conclusions: In patients with ER+/Her2-, node-negative breast cancer with RS 11-30, the majority received endocrine therapy alone. RS and some clinicopathologic features (LVI, ER) impacted the decision to receive CT. [Table: see text]

Meeting the supportive care needs of cancer patients remains a challenge to cancer care systems around the world. Despite significant improvements in the organization of medical care of patients with cancer, numerous surveys of cancer populations demonstrate that significant proportions of patients fail to have their supportive care needs met. One possible solution is the introduction of a care coordinator role using oncology nursing to help ensure that patients' physical, psychological, and social support needs are addressed. Although having face validity, there is little empirical evidence on the effects of nurse-led supportive care coordinator roles on patient reported supportive care outcomes. In this article the authors present the results of a prospective longitudinal cohort study of 113 patients referred to a community-based specialist oncology nursing program. Using validated instruments they found significant improvements in patient-reported outcomes in key supportive care domains: unmet needs, quality of life, and continuity of care, as well as a shift in patterns of health resource utilization from acute care settings to the community over the course of the intervention. The results of this study are important in supporting the design and development of controlled trials to examine provider roles in the coordination of supportive cancer care.