bluuebunny/crossref_metadata_2025_split huggingface dataset:
Hematologic malignancy patients suffer higher mortality and morbidity from COVID-19 than solid tumor patients.
Authors: Krem Maxwell Masters , Nutalapati Snigdha , Latta Hannah L. , Thomas Chris Z. , El Haddad Hanine , Vilchez Gabriel A. , Hildebrandt Gerhard 
Published: June 2021

e19048 Background: Cancer patients experience morbidity and mortality from infections, including COVID-19. Results are in conflict as to whether hematologic malignancy (heme) patients or solid tumor (solid) patients are at particular risk. We compared COVID-19 infection outcomes in these cohorts at our institution. Methods: Retrospective chart review of COVID-19 patients diagnosed from February 2020 to January 2021 who had a heme or solid diagnosis. We used Chi square analyses and t-tests for statistical correlations. Results: We analyzed outcomes of 146 COVID-19 episodes. Median age was 64 (25-97), 49% were female, and 24% were minorities. 49 (34%) had heme malignancy. Age, race, BMI, Karnofsky, and Charlson index (CCI) were similar for heme and solid cohorts. All-cause mortality (37 vs 15%) and COVID-induced mortality (33 vs 10%) were higher in heme vs solid, Table 1. Need for hospitalization (73 vs 46%, p = 0.009) and ICU care (31 vs 14%, p = 0.02) were worse for heme. Mean length of stay was 14.6 days and did not statistically differ for both groups. Overall risk of thrombosis was 11%. Severity of hypoxemia correlated with mortality. Compared with patients not requiring oxygen, relative risk (RR) of mortality was 3.06 (p = 0.06) for nasal cannula, 3.82 (p = 0.03) for high-flow oxygen, and 11.9 (p = 0.0008) for ventilation. Heme patients trended towards increased need of high-flow oxygen or ventilation vs solid patients, RR = 1.65 (p = 0.06). Additional mortality predictors were chemo within 6 months of COVID-19, age > 65, nursing home residency, CCI > 5, ICU care, max CRP > 100, ferritin > 1000, abs lymph count < 500, platelet count < 100, and bacteremia or C. difficile coinfection (Table). Race, gender, Appalachian status, and BMI did not predict mortality. Among the above factors, recent chemo (p=0.0001) and bacteremia (p = 0.03) were more common in heme vs solid patients. A higher proportion of heme patients received treatment for COVID-19 (51 vs 32%, p = 0.03). The most frequent therapies across the whole group were steroids (n=43), remdesivir (n=29), and azithromycin (n = 17). Conclusions: COVID-19 poses elevated mortality and morbidity risk for hematologic malignancy vs other cancer patients despite similar pre-infection demographics. Not surprisingly, need for ICU care, age, recent chemotherapy, and comorbidities elevate mortality risk in both heme and solid patients. Elevated inflammatory markers and severe lymphopenia appear to identify those patients who have immune dysregulation and greatest mortality risk. Mortality predictors.[Table: see text]
Serious infections and cardiovascular complications among patients with chronic lymphocytic lymphoma treated with first-line ibrutinib or bendamustine/rituximab.
Authors: Irwin Debra E. , Thompson Stephen , Ribalov Rinat , Choudhry Azhar 
Published: June 2021

e19503 Background: Clinical trials have shown positive outcomes associated with ibrutinib monotherapy (IM) and bendamustine / rituximab combination (BR) therapy in patients with chronic lymphocytic lymphoma (CLL) compared to other standard treatments, but limited real-world data exist. This study evaluated serious infections and cardiovascular complications in CLL patients treated with first-line IM or BR therapy using US real-world data. Methods: Administrative claims from the MarketScan® Research Databases were used to identify adult patients enrolled in commercial or Medicare supplemental insurance plans based on a first prescription fill of IM or BR therapy (the index date) from 2/1/14 to 9/1/19. Patients were diagnosed with CLL, treatment naïve, and continuously enrolled for ≥12 months prior to and following the index date. Serious infections and cardiovascular complications requiring hospitalization (diagnosis code in any position) were evaluated during a fixed 12-month follow-up period. Statistical differences in outcome distributions between the treatment groups were tested. Multivariate logistic regression models for lower respiratory tract infection (LRTI) and atrial fibrillation (AF) were also conducted to determine the adjusted odds of hospitalization. Results: Of 2,138 CLL patients, 810 had IM and 512 had BR as index therapy with ≥12 months of follow-up data. Patients receiving IM were older and more likely to have had an LRTI during baseline compared to BR patients, otherwise both groups had similar baseline characteristics. Hospitalization for serious infections was more common during follow-up among IM patients than BR patients (17.7% vs. 13.1%; p = 0.027). Specifically, 10.2% of IM patients had a bacterial infection hospitalization compared to 5.7% of BR patients (p = 0.004) and 10.7% of IM patients had a LRTI hospitalization compared to 6.6% of BR patients (p = 0.012). After adjusting for baseline characteristics, IM patients did not have significantly higher odds of a LRTI hospitalization (OR = 1.51; p = 0.069). Hospitalization for cardiovascular complications was more common during follow-up among IM patients than BR patients (18.3% vs. 11.9%; p = 0.002). Specifically, 8.4% of IM patients had an AF-related hospitalization versus 2.7% of BR patients (p < 0.001). After adjusting for baseline characteristics, IM patients were more likely to have a hospitalization for AF versus BR patients (OR = 3.89; p < 0.001). Conclusions: In a real-world setting, serious infections and cardiovascular complications were more common among CLL patients treated with first-line IM compared to BR during 12 months of follow-up. IM patients were more likely than BR patients to have an inpatient admission due to AF after adjusting for other patient characteristics.
Preliminary results of the phase 2 study of zanubrutinib in patients with previously treated B-cell malignancies intolerant to ibrutinib and/or acalabrutinib.
Authors: Shadman Mazyar , Sharman Jeff Porter , Levy Moshe Y. , Porter Ryan , Zafar Syed Farhan , Burke John M. , Chaudhry Arvind , Freeman Benjamin Bruce , Misleh Jamal Ghazi , Yimer Habte Aragaw , Cultrera Jennifer L. , Guthrie Troy H. , Kingsley Ed , Rao Subramanya S. , Chen Dih-Yih , Cohen Aileen , Feng Shibao , Huang Jane , Flinn Ian 
Published: June 2021

e19506 Background: Many patients (pts) with B-cell malignancies require continuous treatment with Bruton tyrosine kinase inhibitors (BTKi). Adverse events (AEs) are a common reason for ibrutinib (ibr) or acalabrutinib (acala) discontinuation. Early data from BGB-3111-215 showed zanubrutinib (zanu) was well tolerated in pts with B-cell malignancies intolerant to ibr or acala. We report preliminary results with a median follow-up of 4.2 mo. Methods: Pts meeting protocol criteria for intolerance to ibr, acala or both (without documented progressive disease) were given zanu monotherapy (160 mg twice daily or 320 mg once daily). Recurrence of AEs that led to intolerance of prior BTKi and additional safety measures were assessed based on the Common Terminology Criteria for AEs v5.0. Investigators determined responses using disease status at study entry as baseline. Results: As of November 1, 2020 (cutoff), 44 pts (n=34 chronic lymphocytic leukemia/small lymphocytic lymphoma, n=6 Waldenström macroglobulinemia, n=2 mantle cell lymphoma, n=2 marginal zone lymphoma) were enrolled, received ≥1 dose of zanu, and analyzed for safety. Median age was 70.5 y (range, 49-91); median duration of treatment was 4.2 mo (range, 0.1-12.6). Median number of prior regimens was 2 (range, 1-12). Regarding prior BTKi, 39 pts received ibr only, 4 received ibr and acala, and 1 received acala only. The median number of ibr- or acala-intolerant AEs per pt was 2 (range, 1-5). 83% of ibr and 78% of acala intolerant events did not reccur on zanu; Table. At data cutoff, 43 pts remained on treatment; 1 withdrew consent due to zanu-unrelated grade 3 syncope. Overall, 34 pts (77.3%) reported any AE; most commonly reported AEs were myalgia (n=9; 20.5%), contusion (n=8; 18.2%), dizziness (n=7; 15.9%), fatigue (n=7; 15.9%), and cough (n=5; 11.4%). Grade ≥3 AEs were reported in 6 pts (13.6%), serious AEs in 1 pt (2.3%, febrile neutropenia and salmonella infection), AEs requiring dose interruptions in 6 pts (13.6%), and AEs leading to dose reduction in 2 pts (4.5%). No AEs led to zanu discontinuation. No deaths were reported. All efficacy evaluable pts (26/26 [100%]) maintained (10 [38.5%]) or achieved deepening (16 [61.5%]) of their response. Conclusions: Zanu provides an additional treatment option after intolerance to other BTKi, demonstrating tolerability and sustained or improved efficacy. Updated results will be presented. Recurrence and Severity Change of AEs Leading to Ibr or Acala Intolerance. Clinical trial information: NCT04116437. [Table: see text]
The impact of atrial fibrillation on hospitalization outcomes for patients with chronic lymphocytic leukemia: A large database analysis.
Authors: Ammad Ud Din Mohammad , Thakkar Samarthkumar , Patel Harsh P. , Hussain Syed Ather , Zafar Aneeqa , Liaqat Hania , Shah Zunairah , Ganatra Sarju , Mushtaq Muhammad Umair , Anwer Faiz 
Published: June 2021

e19508 Background: With the increased use of novel agents like Bruton tyrosine kinase inhibitors (BTKi) for the treatment of chronic lymphocytic leukemia (CLL), the incidence of atrial fibrillation (AF) is on the rise in these patients. However, the excess burden added by AF to the morbidity and mortality of CLL patients is unclear. Methods: Using the appropriate ICD-9 and ICD-10 codes, the National Inpatient Sample (NIS) database was accessed to gather data of hospitalized CLL patients with AF from 2008 to 2019. Propensity-score matching (PSM) and logistic regression model were performed to control for baseline patient factors like age, sex, income, and the relevant co-morbidities to match 7265 CLL patient admissions with AF and 7265 CLL patient admissions without AF. The primary outcome was all-cause mortality (ACM), while secondary outcomes included stroke, acute heart failure (AHF), and total cost of hospital stay. Results: The mean age of the cohorts was 82 years. Females made up 44% of both groups. The AF group had similar prevalence of systemic hypertension (62.38% vs 62.10%; p= 0.73), diabetes mellitus (5.09% vs 5.43%; p= 0.35), congestive heart failure (5.57% vs 5.36%; p= 0.58), valvular heart disease (1.17% vs 1.44%; p= 0.14), and pulmonary hypertension (0.21% vs 0.14%; p= 0.31) compared to the group without AF. PSM revealed CLL patients with AF had a higher rate of ACM (6.06% vs 4.47%; p= <0.0001), AHF (7.50% vs 3.85%; p= <0.001), and stroke (3.09% vs 1.65%; p= <0.0001). Admission in the AF group also had a higher median total cost of hospital stay ($9097 vs $7646). A logistic regression model was done to adjust for confounders which revealed similar results for the AF group with increased adjusted odd’s ratio (aOR) of ACM (aOR:1.39, 95% confidence interval (CI): 1.19-1.61; p= <0.001), AHF (aOR: 2.16, 95% CI: 1.85-2.52; p= <0.001), and stroke (aOR:1.94, 95% CI: 1.54-2.44; P= <0.001) (Table). Conclusions: Our data suggest that hospitalized CLL patients with AF are at a significantly increased risk of all-cause mortality, AHF, and stroke. Several limitations like the inability to establish the temporal relationship between CLL and AF and the lack of data regarding medications of individual patients are important to keep in mind while interpreting the results.[Table: see text]
Outreach: Preliminary safety and efficacy results from a phase 2 study of lisocabtagene maraleucel (liso-cel) in the nonuniversity setting.
Authors: Godwin John E. , Mattar Bassam Ibrahim , Maris Michael B. , Bachier Carlos R. , Stevens Don A. , Hoda Daanish , Varela Juan Carlos , Cherry Mohamad , Fanning Suzanne R. , Essell James H. , Yimer Habte Aragaw , Courtright Jay G. , Sharman Jeff Porter , Trede Nikolaus S. , Youssef Marina , Lymp James , Shaughnessy Paul 
Published: June 2021

e19513 Background: Concerns about adverse events (AEs) related to CAR T cell therapy have resulted in administration of this therapy largely in an inpatient setting. OUTREACH (NCT03744676) evaluates safety and efficacy of liso-cel in patients (pts) with R/R large B-cell lymphoma (LBCL) across inpatient and outpatient settings at nonuniversity medical centers (NMCs). Methods: NMCs, including centers naïve to CAR T cell therapy, enrolled adults with R/R LBCL in this open-label, multicenter study. Eligible pts had R/R PET-positive disease after ≥2 lines of prior systemic therapy, ECOG PS ≤1, and adequate organ function. Prior autologous HSCT was allowed. Pts received sequential infusions of equal target doses of CD8+ and CD4+ cells at a total target dose of 100 × 106 CAR+ T cells. Primary endpoint was incidence of grade (G) ≥3 cytokine release syndrome (CRS) graded per 2014 Lee criteria, neurological events (NEs), prolonged cytopenias (Day 29 G ≥3 lab values), and infections. Secondary endpoints were safety and overall response rate (ORR). Outpatient AE monitoring/management was managed by a multidisciplinary CAR T cell therapy team following standard operating procedures (SOPs). Results: At data cutoff, 46 pts (inpatients n = 16, outpatients n = 30) were treated with liso-cel. Inpatients and outpatients had similar demographics and baseline disease characteristics; median age was 63 y (range, 34–83), 63% had diffuse LBCL not otherwise specified, and 91% were refractory to last therapy. Safety data were similar across inpatients and outpatients (Table). Early (study Day ≤4) and overall hospitalization in outpatients was reported in 27% and 63%, respectively; median time to hospitalization was 5 (2–61) days and median length of stay was 6 (1–28) days. For efficacy-evaluable pts (n = 44), ORR was 75% for inpatients and 79% for outpatients; CR rates were 50% and 61%, respectively. Conclusions: Liso-cel was successfully administered to pts with R/R LBCL in the outpatient setting and pts were monitored for CAR T cell therapy–related toxicities by multidisciplinary teams using SOPs. The incidences of severe CRS and NEs and use of tocilizumab and/or corticosteroids were similar in inpatients and outpatients, and consistent with the pivotal study observations (Abramson, The Lancet 2020). Updated data with longer follow-up will be presented. Clinical trial information: NCT03744676. [Table: see text]
A nationwide analysis of healthcare utilization and outcomes of sepsis in HIV versus non-HIV patients with Hodgkin lymphoma.
Authors: Lingamaneni Prasanth , Tariq Muhammad Junaid , Baral Binav , Shrivastava Trilok , Almani Muhammad Usman , Gupta Shweta 
Published: June 2021

e19520 Background: Hodgkin lymphoma (HL) is a non-AIDS defining malignancy with a high relative risk in people with HIV compared to general population. The incidence is also higher with those with higher CD4 counts. In the US, reported mortality in HIV-HL is similar to non-HIV-HL per clinical trials, but higher in studies outside clinical trials. Sepsis is a common complication during the course of HL treatment. We attempted to explore outcomes and healthcare utilization of HIV vs Non-HIV-HL patients admitted with sepsis. Methods: We identified all adult patients with HL admitted between 2016 – 2018 from Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database, 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 (SS), acidosis, Acute Kidney Injury (AKI), Tumor Lysis Syndrome (TLS) pancytopenia, anemia, neutropenia and protein energy malnutrition (PEM). Statistics were performed using the t-test, z-test and chi-square test. Results: We identified a total of 1140 HIV-HL and 43,120 non-HIV-HL admissions of which sepsis was a principal diagnosis in 235 (20.6%) and 5390 (12.5%) admissions respectively (p < 0.0001). Compared to non-HIV-HL, HIV-HL patients were significantly younger (47.1 vs 56.8 years, p < 0.001), more likely to be men (79% vs 57%, p < 0.001), African American (47% vs 13%) and Hispanic (23% vs 14%) (p < 0.001), more likely to be on Medicaid (34% vs 18%, p < 0.001) and from low-income zip-codes (p < 0.0001). The overall inpatient mortality was lower in HIV-HL (10.6%) vs non-HIV-HL (15.8%) (p < 0.05). However, HIV-HL was associated with increased mean LOS (12.5 vs 9.1 days, p < 0.05) and higher mean hospital charges, a $39,082 difference, for each admission of HIV-HL compared to non-HIV-HL (amounting to over $9 million over 3 years). HIV-HL also had significantly high Charlson Comorbidity index of > 10 (p < 0.05) and significantly higher rates of TLS, acidosis, AKI and PEM (all p < 0.05). All other outcomes were non-significant. Conclusions: Nationwide, HIV-HL inpatients were younger minorities from lower socio-economic status zip codes and more likely to be on Medicaid compared to non-HIV-HL cohort. HIV-HL had significantly higher rates of sepsis compared to non-HIV-HL. However, despite high rates of sepsis in HIV-HL, these patients had significantly lower mortality than non-HIV-HL group but significantly higher inpatient LOS and higher hospital charges, likely related to higher comorbidity and complication burden. Prospective studies are needed to clarify these findings and identify interventions to improve secondary outcomes and healthcare utilization in HIV-HL patients.
Real-world incidence and costs of serious infections and cardiovascular complications among patients with indolent non-Hodgkin lymphoma treated with first-line ibrutinib or bendamustine/rituximab.
Authors: Irwin Debra E. , Thompson Stephen , Ribalov Rinat , Choudhry Azhar 
Published: June 2021

e19528 Background: Patients with Indolent non-Hodgkin lymphoma (iNHL) have shown positive outcomes with ibrutinib monotherapy (IM) as well as bendamustine/rituximab combination (BR) therapy, but no studies have reported on patient outcomes using real-world data. The current analysis evaluated serious infections and cardiovascular complications in iNHL patients treated with first-line IM or BR therapy using US real-world data. Methods: Administrative claims from the MarketScan® Research Databases were used to identify adult patients enrolled in commercial or Medicare supplemental insurance plans based on a first prescription fill of IM or BR therapy (the index date) from 2/1/14 to 9/1/19. Patients included in the study were diagnosed with iNHL, were treatment naïve, and were continuously enrolled for ≥12 months both prior to and following the index date. Serious infections and cardiovascular complications requiring hospitalization (diagnosis code in any position) and associated inpatient costs were evaluated during a fixed 12-month follow-up period. Statistical differences in outcome distributions and costs (reported per patient per month [PPPM]) between the groups were tested. Results: Of 1,948 iNHL patients, 147 had IM and 1,058 had BR as index therapy with ≥12 months of follow-up data. Patients receiving IM were older, more often male, and more likely to have had a lower respiratory tract infection (LRTI) or atrial fibrillation (AF) during baseline compared to BR patients, otherwise the groups had similar baseline characteristics. Hospitalization for serious infections was similar for IM and BR patients during the follow-up period (17.0% vs. 14.4%; p = 0.397); among hospitalized patients, the IM and BR groups incurred similar PPPM inpatient costs ($2,839 vs. $3,954; p = 0.188). Specifically, 7.5% of IM patients had a bacterial infection hospitalization and incurred $2,561 PPPM vs 7.6% of BR patients who incurred $3,975 PPPM (both p > 0.05); 8.8% of IM patients had a LRTI hospitalization and incurred $3,629 PPPM vs 6.1% of BR patients who incurred $4,980 PPPM (both p > 0.05). Hospitalization for cardiovascular complications was similar during follow-up for IM and BR patients (15.6% vs. 12.2%; p = 0.237); among hospitalized patients, the IM and BR groups incurred similar PPPM costs ($3,777 vs. $3,862; p = 0.948). Specifically, 7.5% of IM patients had a hospitalization for AF and incurred $4,481 PPPM vs 3.6% of BR patients who incurred $4,860 PPPM (p = 0.025 and p = 0.875, respectively). Conclusions: In a real-world setting, serious infections and cardiovascular complications requiring hospitalization, including associated costs, were similar among iNHL patients treated with first-line IM or BR over 12 months, although IM patients were more likely to have an AF-related complication.
Real-world treatment patterns and outcomes in patients with follicular lymphoma in the United States.
Authors: Ta Jamie T. , Itani Taha , Shapouri Sheila , Arndorfer Stella , Julian Cristina , d’Ario Giovanni , Sud Cheryl 
Published: June 2021

e19534 Background: Despite the availability of new therapies for follicular lymphoma (FL), there are limited data on the real-world treatment (tx) of FL in a contemporary cohort of patients (pts). We examined tx patterns and outcomes in pts who received FL therapy in the US. Methods: This retrospective cohort study used the nationwide Flatiron Health electronic health record-derived de-identified database. During the study, the de-identified data originated from ̃280 cancer clinics (̃800 sites of care) in the US. We selected pts aged ≥18 years, with an initial FL diagnosis (ICD-9-CM: 202.0x; ICD-10-CM: C82.0x) between January 2011 and July 2020, who had received ≥1 line of therapy (LOT) for FL (follow-up ended September 2020). The initiation date of a LOT was considered the index date for analyses by LOT. Pts with evidence of clinical trial participation during the study period, high-grade (3b) FL at diagnosis, transformed aggressive lymphoma at any time before first-line (1L) FL tx, or chemotherapy/immunotherapy or stem cell transplant 12 months before 1L FL tx, were excluded. Pt characteristics at diagnosis were assessed using descriptive statistics. Tx patterns and clinical outcomes (time to next tx [TTNT] and overall survival [OS]) were reported by LOT. Median TTNT and OS were estimated using Kaplan–Meier methods. Results: Overall, 2383 pts met all eligibility criteria. Median age at FL diagnosis was 66 years; 49.2% were male, 77.5% had low-grade (1–2) FL, and 75.2% had advanced stage (III/IV) FL at diagnosis. Median follow-up was 43.1 months, and median time from diagnosis to 1L FL tx was 38 days. Most pts received up to 2 LOTs (n=2258 [94.8%]). The most common regimens across all LOTs were rituximab-bendamustine (R-benda; n=1256 [52.7%]), R monotherapy (n=812 [34.1%]), R-CHOP (n=483 [20.3%]), R-CVP (n=172 [7.2%]), and obinutuzumab (G)-benda (n=77 [3.2%]). The use of newer FL therapies was limited across all LOTs, but more common in the third-line onwards (3L+): chemotherapy-free combinations (R-/G-lenalidomide): 2.3% (all LOTs) and 19.2% (3L+); and phosphoinositide 3-kinase inhibitors: 1.6% (all LOTs) and 21.6% (3L+). In total, 111 (4.7%) pts received G-based regimens. Median TTNT after 1L and second-line onwards (2L+) was 79.4 months and 38.3 months, respectively. Median OS was not reached (NR) and 82.9 months after 1L and 2L+, respectively (Table). Conclusions: We provide a comprehensive update on real-world tx patterns and clinical outcomes in pts with FL in the US. Chemoimmunotherapy remains the standard of care across all LOTs, though the shorter durations of TTNT and OS in 2L+ may support the role of novel therapies in this setting. Tx outcomes by LOT.[Table: see text]