bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of same day pegfilgrastim (PFG) or PFG-cbqv prophylaxis of chemotherapy induced (Febrile) neutropenia (CIN/FN) in bendamustine plus rituximab (BR) and CHOP+/-R regimens in patients with lymphoma and chronic lymphocytic leukemia (CLL): Real-world, single-center experience.
Authors: McBride Ali , AlRawashdh Neda , Bartels Trace , Moore Logan , Persky Daniel O , Abraham Ivo 
Published: June 2021

e19541 Background: BR and CHOP+/-R regimens are considered an intermediate FN risk (10-20%) per guidelines. Patients (pts) receiving these regimens need to be assessed for FN prophylaxis using specific risk factors. Current guidelines suggest waiting 24 hours post chemotherapy (CTX) to administer PFG due to an increased FN risk. Studies have shown equivocal outcomes between same day (D1) and next day (D2) administration. We evaluated real-world outcomes associated with D1 and D2 PFG administration in pts with lymphoma and CLL treated with these two regimens. Methods: Retrospective chart review of lymphoma or CLL pts treated with CHOP+/-R or BR and PFG or a biosimilar from 11/2013 through 11/2020 at the University of Arizona Cancer Center was conducted. Two pt cohorts were analyzed based on D1 vs D2 PFG administration timing. Outcomes of interest were the incidence of FN across all CTX cycles and after cycle 1, CIN grade 3/4, hospitalizations, antibiotics administration, and CTX dose reduction or delay. A secondary analysis compared the incidence of FN in pts receiving CHOP+/-R in our study with published studies (Burris et al, 2010 and Cheng et al, 2014) of D1 PFG in lymphoma pts. Results: Of the 116 pts meeting inclusion criteria, 103 received PFG on D1 and 13 on D2 of CTX. As shown in the Table, the incidence of 1st cycle FN was 6% vs 8% (P>0.05), FN across all cycles was 4% vs 5% (P>0.05), CIN grade 3/4, hospitalization, anti-biotic administration and dose delays/reductions incidences were 11% vs 16% (P>0.05), 8% vs 11% (P>0.05), 6% vs 32% (P=0.001), 11% vs 5% (P>0.05) for D1 vs D2, respectively. The incidence of 1st cycle FN in D1 cohort was 6% vs 19% (P=0.15) and 11% (P=0.67) in our study vs Burris et al and Cheng et al, respectively. While the incidence of FN across all cycles in D1 group was 5% vs 9% (P=0.03) and 17% (P=0.001) in our study vs Burris et al and Cheng et al, respectively. Conclusions: This data provides evidence that D1 PFG/PFG-cbqv does not increase FN or delayed engraftment risk as compared to previously published studies in lymphoma and may be safe to use after CTX has been administered.[Table: see text]
Clinical outcomes in patients relapsed/refractory after ≥ 2 prior lines of therapy for follicular lymphoma: A systematic literature review and meta-analysis.
Authors: Kanters Steve , Kahl Brad S. , Wiesinger Adriana , Gurung Binu , Limbrick-Oldfield Eve , Sudhindra Akshay , Snider Julia , Patel Anik R. 
Published: June 2021

e19548 Background: Patients with follicular lymphoma (FL) can have high response rates to early lines of treatment. However, among FL patients relapsed/refractory (r/r) after ≥2 prior lines of therapies (LOT), remission tends to be shorter and there is limited treatment guidance. This study sought to evaluate the clinical outcomes for r/r FL after ≥2 prior LOT using currently available treatment options. Methods: Electronic databases were searched on June 2, 2020. Eligible studies were comparative or non-comparative interventional or observational studies of systemic therapies among adults with FL r/r after ≥2 prior LOT. Prior LOT must have included anti-CD20 monoclonal antibodies and alkylating agents, in combination or separately. Overall response rate (ORR) and complete response (CR) were analyzed using inverse-variance weighting with Freeman-Tukey double-arcsine transformations. Kaplan-Meier (KM) analysis for progression-free survival (PFS) and overall survival (OS) were conducted using digitized curves and the Guyot algorithm. Survival analyses were stratified by ≥2 prior LOT and ≥3 prior LOT groups and were restricted to the observational cohorts as a sensitivity analysis. Results: The meta-analysis included 12 studies published from 2014-2020. Sample size for response outcomes was 340, for survival outcomes with ≥2 prior LOT was 1024 and for ≥3 prior LOT was 502. The estimated ORR in the ≥2 prior LOT group was 56.0% (95% confidence interval [CI]: 47.2 – 64.5) and proportion of patients with CR was 12.2% (95% CI: 8.0 – 17.3). The median OS was 54.4 months (95% CI: 45.8 – 76.0) and median PFS was 10.3 months (95% CI: 9.3 – 11.1). The 24-month OS decreased from 66% in the ≥2 prior LOT group to 60% in the ≥3 prior LOT group (Table 1), with a similar trend in PFS at 24-month (28% vs 24%). Conclusions: This study found that few r/r FL patients with ≥2 prior LOT achieve CR, and despite some benefit, approximately 1/3 of patients die within 24 months. The shorter median PFS with increasing prior LOT suggest treatment durability is suboptimal in later LOT. These findings indicate that patients are underserved by current treatments, demonstrating a need for new treatments that can achieve high rates of response that are durable in this disease.[Table: see text]
Healthcare resource use (HRU) by infusion setting of chimeric antigen receptor T-cell (CAR-T) in patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL): A retrospective cohort study using CMS 100% Medicare database.
Authors: Zhao Jing , Bollu Vamsi , Yang Hongbo , Dalal Anand , Tesfaye Mimi , Ma Qiufei , Lax Angela , Lim Stephen 
Published: June 2021

e19550 Background: Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CAR-T therapies that were approved for r/r DLBCL in 2017 and 2018, respectively. While majority of the CAR-T infusions occur at inpatient (IP) setting in clinical trials, CAR-T infusions can also occur in the outpatient (OP) setting. This study aimed to compare the real-world HRU between IP vs. OP infusion of CAR-T among patients with r/r DLBCL. Methods: Adult patients with r/r DLBCL receiving tisa-cel or axi-cel were selected from the CMS 100% Medicare data from 2017 to 2019 and classified into IP and OP cohorts based on CAR-T infusion setting. Number of IP, OP, intensive care unit (ICU) visits, IP days, and ICU days by month post-CAR-T infusion were compared between cohorts using generalized linear models, adjusting for age, sex, race, and National Cancer Institute comorbidity index. Average length of stay (LOS) per IP episode during the first month was also described. Results: A total of 430 patients receiving CAR-T (380 IP and 50 OP) were identified. Among those with CAR-T regimen identifiable in the OP cohort, 90.2% received tisa-cel and 9.8% received axi-cel. Mean age at CAR-T infusion in IP and OP cohorts was 70.8 and 68.4 years, respectively. Most of the CAR-T infusions occurred in 2019 (66.6% in IP cohort and 74.0% in OP cohort). During the first month post-CAR-T infusion, OP cohort had significantly lower number of IP visits, IP days, ICU stays, and ICU days compared to the IP cohort. Average LOS per IP episode was 14.2 days in the IP cohort and 7.1 days in the OP cohort. Number of IP visits, IP days, and ICU days were nominally lower while number of OP visits were nominally higher in the OP cohort compared to the IP cohort in subsequent months (Table). Conclusions: Over 90% of the patients treated with CAR-T in the OP setting received tisa-cel. Patients receiving CAR-T in the OP setting had lower resource use of IP and ICU compared to patients receiving CAR-T in the IP setting.[Table: see text]
Health care utilization and outcomes of sepsis in HIV versus non-HIV patients with Burkitt Lymphoma: A nationwide analysis.
Authors: Baral Binav , Tariq Muhammad Junaid , Lingamaneni Prasanth , Baranwal Anmol , Shrivastava Trilok , Almani Muhammad Usman , Gupta Shweta 
Published: June 2021

e19561 Background: Burkitt lymphoma (BL) is an aggressive AIDS-defining malignancy, the incidence of which has not declined over the last 2 decades despite use of antiretroviral therapy. HIV-BL is more advanced at diagnosis compared to non-HIV-BL with increased risks of immunosuppressive chemotherapy (Lancet Hematology 2020;7(8):e594-e600). We attempted to explore and quantify the prevalence, outcomes and healthcare utilization of HIV-BL vs non-HIV-BL patients admitted with sepsis. Methods: Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample (NIS) database was queried to identify all adult HIV and non-HIV admissions with BL between 2016–2018 with a primary diagnosis of sepsis. The groups were compared for demographic differences, inpatient mortality, length of stay (LOS) and hospital charges. Secondary outcomes studied included rates of septic shock (SS), acidosis, acute kidney injury (AKI), tumor lysis syndrome (TLS), pancytopenia, anemia, neutropenia, protein energy malnutrition (PEM) and history of bone-marrow/stem-cell transplant. Statistics were performed using the t-test, z-test and chi-square test. Results: A total of 2310 HIV-BL admissions comprising 205 (8.9%) with sepsis and 11,950 non-HIV-BL admissions with 865 (7.2%) with sepsis (p = 0.006) were identified. Compared to non-HIV cohort, HIV-BL patients were significantly younger (mean age 43.6 versus 55.3 years, p = 0.001) with few over 65 years old (2.4% vs 36%, p = 0.001). Both groups had similar gender ratio, but a higher number of HIV-BL admissions were African American (AA) (51.4% vs 4.9%, p = 0.001), on Medicaid (31.7% vs 15.6%, p < 0.0001), from lowest quartile income zip codes (p < 0.0001) and more likely to be treated at teaching hospitals (73.2% vs 54.9%, p < 0.0001). The overall inpatient mortality was 21.9% in HIV-BL vs 15.6% in non-HIV-BL (p = 0.02). HIV-BL reported increased mean LOS (9 vs 8 days, p = NS) and average $39,599 more in hospital charges for each HIV-BL admission compared to non-HIV-BL with sepsis (amounting to over $8 million over 3 years). The rates of anemia, neutropenia, TLS, AKI, SS, TLS and PEM were similar (p = NS) between the groups. Conclusions: Nationwide, HIV-BL patients had significantly higher rates of sepsis despite being significantly younger. They were also more likely to be AA from lower socioeconomic zip codes and more likely to be on Medicaid. The mean inpatient LOS and hospital charges, although not statistically significant, were higher in HIV-BL compared to their non-HIV counterparts. Also, the difference in total charges for all HIV-BL admissions amounted to over $8 million extra compared to non-HIV-BL in 3 years. These trends need to be evaluated in prospective studies to help identify interventions to improve clinical outcomes and healthcare utilization.
Clinical utility of interim CT scans in patients receiving bendamustine and rituximab for first line treatment of follicular lymphoma.
Authors: Manji Farheen , Bhella Sita , Prica Anca A. , Kridel Robert , Kukreti Vishal , Kuruvilla John , Crump Michael 
Published: June 2021

e19565 Background: Interim imaging with computed tomography scanning (CT) has been performed during most clinical trials of chemoimmunotherapy in patients with follicular lymphoma (FL) receiving first line systemic therapy. Based on this, interim imaging is commonly performed, but there is little evidence of its utility in clinical practice. Methods: The objective of this study was to retrospectively review outcomes of interim CTs (iCT) in adult patients with biopsy proven FL (grade 1-3a, 3b excluded) who received first line therapy with bendamustine and rituximab (BR) at Princess Margaret Cancer Centre from January 1 2013- December 31 2018. Baseline patient characteristics at diagnosis and treatment were retrieved from a prospectively populated database, and results of interim, end of treatment and end of maintenance therapy (if applicable) imaging were assessed. Disease response was assessed using Lugano response criteria as partial response (PR), complete response (CR), stable disease (SD) or progressive disease (PD). Descriptive statistics and Kaplan Meier Survival functions with a log rank test were used to analyze the data. The study was approved by the Princess Margaret Research Ethics Board. Results: A total of 108 patients were identified: mean age at diagnosis 61 years (IQR 52.4-69.5), 83% with stage III/IV disease, 27.8% bulky ( > 10cm) and median FLIPI score 2. Median follow up was 55.9 months (6.6-100.1 months). Of them, 101 patients (93.5%) had interim imaging done between cycle 2 and cycle 5 , most commonly CT scan (n = 98, 97.0%). The majority of iCTs showed a PR (n = 81, 80.1%), with a minority showing a CR (n = 11, 10.9%) and SD (n = 2, 1.9%). Seven patients had PD noted on iCT. Four patients had a second malignancy identified on biopsy of lesions found on iCT (thymoma, poorly differentiated carcinoma, lung adenocarcinoma and spindle cell tumour), 2 of whom were symptomatic at the time of iCT. Three patients had biopsy proven transformation to diffuse large B cell lymphoma (DLBCL); 2 were symptomatic at the time of iCT and only 1 had asymptomatic PD. The 3 year progression free survival (PFS) for all patients was 87.55%. Patients with a PR on iCT had similar 3 year PFS compared to those with CR (87.25% vs 90.00%, p = .52) as well as overall survival (94.80% vs 88.89%, p = .88). Conclusions: In this cohort, iCT was not useful for identifying patients with asymptomatic early progression of FL during treatment with BR. The majority of patients receiving systemic treatment for FL have at least a PR to BR on iCT, which is not associated with inferior PFS or OS compared to those with CR. Patients with symptomatic or asymptomatic PD during treatment warrant biopsy to identify histologic transformation or other malignancies. The rate of second cancers identified on iCT will be further explored in a cohort of FL patients treated with R-CVP and R-CHOP.
Prevalence and outcomes of sepsis in HIV versus non-HIV patients with diffuse large B-cell lymphoma: A nationwide analysis.
Authors: Tariq Muhammad Junaid , Baral Binav , Lingamaneni Prasanth , Gannamani Vedavyas , Almani Muhammad Usman , Gupta Shweta , Rubinstein Paul G. 
Published: June 2021

e19567 Background: With the advent combined anti-retroviral therapy (ART), the survival of people living with HIV has improved, thereby increasing their prevalence, while concurrently decreasing the incidence AIDS defining malignancies. Despite its decrease, AIDS-related Diffuse Large B-Cell Lymphoma (DLBCL) remains the 3rd most common malignancy in the HIV population and an important cause of cancer related morbidity and a leading cause cancer attributed mortality. Currently the treatment modalities between HIV and non-HIV DLBCL are similar, however a comparison of the infectious complications has never been assessed. We aim to explore the prevalence and outcomes of sepsis in persons living with HIV and DLBCL versus the non-HIV DLBCL patient population. Methods: We identified all adult DLBCL patients admitted between 2016–2018 from The Nationwide Inpatient Sample (NIS) with a primary diagnosis of sepsis. Patients with and without HIV were identified and compared for demographic differences and primary outcomes of inpatient mortality, length of stay (LOS) and hospital charges. Secondary outcomes studied included rates of septic shock, acidosis, Acute Kidney Injury (AKI), Tumor Lysis Syndrome (TLS) pancytopenia, anemia, neutropenia, protein energy malnutrition (PEM) and history of bone-marrow/stem-cell transplant. Statistics were performed using t-Test, chi-square test and multivariable logistic regression. Results: There was a total of 5740 HIV-DLBCL and 158,445 non-HIV-DLBCL inpatient admissions of which 480 (8.4%) and 16085 (10.1%) respectively had sepsis (p < 0.0001). Compared to non-HIV cohort, HIV-DLBCL patients were significantly younger (47.5 versus 67 years, p < 0.001), more likely to be male (66.7% vs 55.3%, p = 0.02), Black (43% vs 7.7%) or Hispanic (18% vs 11%) (p < 0.001), more likely to be on Medicaid (44.9% vs 8.2%, p < 0.001) and lived-in low-income zip-codes (p < 0.0001). Overall adjusted inpatient mortality was not significantly different between HIV and non-HIV groups (14.6% vs 16.9%, p = NS). But HIV-DLBCL patients had significantly high Chalrson co-morbidity index (p < .0001), longer inpatient LOS (8.75 vs 8.65 days, p < 0.0001) and higher total hospital charges (average $5338 higher for each admission, p < 0.0001). HIV-DLBCL cohort also reported significantly higher TLS (7.3% vs 2.6%, p = 0.005) and PEM (42.7% vs 28.9%, p = 0.004). Other secondary outcomes were not significantly different between the groups. Conclusions: Demographic differences between the two cohorts are reflective of known racial & socio-economic disparities associated with HIV. Lower rates of sepsis in HIV cohort were not translated into improved inpatient mortality. Longer LOS and hospitalization charges in HIV patients likely due to high comorbidity burden.
Real-world evidence (RWE) study of CAR-T agents in leukemia and lymphoma patients.
Authors: Lal Lincy S. , Blauer-Peterson Cori , DaCosta Byfield Stacey , Malin Jennifer 
Published: June 2021

e19573 Background: Chimeric antigen receptor T (CAR T) cell products are considered gene treatments, producing long term results, with just one infusion. Real world evidence on the two available CAR T cell products, tisagenlecleucel (T) and axicabtagene ciloleucel (AC) are limited in leukemia and lymphoma patients, specifically at the individual product level. This study presents treatment outcomes and resource utilization of these products from a payer perspective. Methods: Patients with evidence of CAR T administration per claims algorithm and from documentation from a prior authorization program from January 1, 2017 to May 30, 2020 were included; the CAR T administration was the index event. Baseline demographics and clinical characteristics, healthcare resource utilization (HCRU) for the CART T administration and pre and post CAR T administration for a fixed 6-month period, and previous treatments were captured and presented by product, using descriptive analytics. Results: The study population included 148 patients, mean age (SD): 57.4 (16.9), with 34% female, and 64% Commercial patients versus 36% Medicare patients, with a mean follow-up of 319 days (SD: 210). There were 15 leukemia patients, 119 lymphoma patients, and 14 patients with other indication in the study population; 71(48%) had evidence of being on a clinical trial during the study. The mean Charleson Comorbidity score at baseline was 3.9. Major comorbidities included anemia (71%), diseases of the heart (72%). 29(20%) patients were treated with T of which 24% were for leukemia and 76% for lymphoma and 67 (46%) were treated with AC of which 100% were for lymphoma, and 52 (35%) patients did not differentiate between products. Majority of the CAR T administration took place inpatient (84%). Baseline 6-month HCRU was 52% ER visits and 59% hospitalizations, compared to post 6-month utilization at 45% ER visits and 49% hospitalizations for the total population. 118 (80%) patients had evidence of prior treatment indicating that the CAR T was at least in the second line setting or higher. The most common priming chemotherapy was cyclophosphamide-fludarabine in 69 (47%) patients. Of the total population, 72% did not have any evidence of further treatment in the available follow-up time, specifically, 47% in the leukemia and 76% in the lymphoma populations, respectively. Conclusions: Majority of patients have evidence of prior treatments before the CAR T index date, indicating relapse. There is evidence of decrease in the HCRU subsequent to treatment, compared to pre period and 72% do not have subsequent treatment in the available follow-up time, indicating a high level of efficacy.
Effect of acute kidney injury on hospital-based outcomes in patients with multiple myeloma.
Authors: Zafar Muhammad Usman , Tarar Zahid , Ghous Ghulam , Farooq Umer , Lash Bradley Walter 
Published: June 2021

e20006 Background: Multiple Myeloma, a cancer of plasma cells, is treatable, but incurable. 5-year survival rate is about 54% depending upon the stage. Studies have suggested that up to 50% of the patients experience acute kidney injury or chronic kidney disease at some point in their disease course. Approximately 3% of the patients will end up on hemodialysis. In this study we utilize the National Inpatient Sample (NIS) to understand the effect of acute kidney injury (AKI) on inpatient mortality in multiple myeloma patients. Methods: This is a retrospective study utilizing the data obtained from the NIS for the year 2018. We queried this NIS database for ICD-10 codes for multiple myeloma or plasmacytoma that had not achieved remission or was in relapse. We also looked at codes for acute kidney injury as secondary diagnosis. Primary outcome was inpatient mortality. Secondary outcomes were hospital length of stay and cost utilization. We then ran multivariate logistic regression analysis in STATA MP 16.1. Various comorbidities were accounted for by adding them into the analysis. These included previous history of coronary artery disease, congestive heart failure, stroke, smoking, hyperlipidemia, stem cell transplant, neutropenia and chemotherapy. Results: The population of multiple myeloma patients under investigation were all adults more than 18 years of age and numbered in 3944 patients. The mean age was 65.71 years. Among these 45% were females. While examining inpatient mortality we see that for patients that had AKI the odds of inpatient mortality are higher (Odds Ratio (OR) 1.75, p = 0.003, 95% Confidence Interval (CI) 1.21 – 2.56). History of Heart Failure (OR 2.28, 95% CI 1.59 – 3.28), and increasing age (OR 1.02, 95% CI 1.01 – 1.04) also appear to contribute towards higher odds of mortality. The effect of other comorbidities was not statistically significant. Among demographical characteristics being of Native American heritage or not belonging to any descriptive race predicted higher odds of mortality. Mean LOS was 11 days. Patients with AKI stayed in the hospital longer by ̃1.4 days (Coef. 1.39, 95% CI 0.41 – 2.37). LOS was higher in patients with a history of heart failure (2.61, 95% CI 0.89 – 4.34 and in those with a history of neutropenia (5.52, 95% CI 4.42 – 6.62). LOS was lower in patients with a history of smoking by 1 day. Age lowered the LOS by a clinically insignificant amount. Teaching hospitals had higher LOS by ̃4 days. The total charge for hospitalizations from AKI is higher by $31019 (95% CI 14444.23 – 47594.37). Other factors incurring higher cost include history of neutropenia, and teaching hospitals. Hospitals in the Midwest had lower cost compared to hospitals in the Northeast. Conclusions: Among patients that present with a principal diagnosis of multiple myeloma, having acute kidney injury, adversely affects inpatient outcomes that include, mortality, hospital length of stay and total hospitalization cost.