bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pathway use and concordance in affiliated academic and community oncology practices.
Authors: Edge Stephen B. , Liu Lu , Stefaniak Nessa , Soucise Allison , Soniwala Saifuddin , George Saby , Kuvshinoff Boris W. , Tear David , Murphy Monica L. , McKinney Mishellene 
Published: June 2021

e18639 Background: Clinical oncology pathways (COP) provide treatment (Rx) decision support and allow detailed quality oversight. There are limited data on use of COP and the proportion of patients receiving COP recommended Rx (concordant / “On Pathway” Rx – OnP) and on the reasons for COP non-concordant “Off Pathway” Rx (OffP). Methods: COP concordance and reasons for OffP Rx were evaluated and compared at an NCI-designated cancer center (Roswell Park Comprehensive Cancer Center – RP) and its 5 affiliated community practice sites (Roswell Park Care Network – RPCN) for COP Rx decisions from 10/1/19 – 9/30/20. Elsevier ClinicalPath Oncology COPs (formerly Via Oncology) were implemented in 2018 at RP and RPCN and are completed at initiation of any systemic Rx. COPs cover about 85% of cancers, excluding most hematologic cancers. COP Rx decisions are classified as OnP (including Rx on a clinical trial) or OffP. All OffP decisions are reviewed retrospectively to identify the reasons for OffP Rx. Differences in OnP rates at RP and RPCN were compared by chi square test or Fisher’s test overall and for 7 cancer type groups and for adjuvant Rx (ADJ) and metastatic disease (MET). ADJ/MET comparison excluded gynecologic cancer (GYN), myeloma and myelodysplastic syndrome (MDS) because COPs do not classify ADJ vs MET for these. Results: At RP there were 4,291 Rx decisions for 3,361 patients and at RPCN 1,349 Rx decisions for 1,198 patients. Breast cancer was the most common cancer type (18% of patients at RP and 36% at RPCN). Proportions of patients with GYN, melanoma, sarcoma, and GU cancers were higher at RP and similar for GI, thoracic and myeloma/MDS. Among 3,153 ADJ and MET Rx decisions at RP, 55% were for METS vs. 36% of 1,096 decisions in the RPCN. Pathway decision concordance (OnP) rates overall were 85% at RP and 89% at RPCN (p < 0.01- Table). OnP rates for ADJ Rx were 89% at RP and 92% at RPCN (p = 0.05), and for MET 84% at RP and 86% at RPCN (p = 0.53). Most OffP Rx was for medically valid reasons including comorbidity, new/targeted therapies, and prior Rx precluding COP recommended Rx. Conclusions: COP concordance was slightly higher in community practice, potentially because newer therapies, patients with greater morbidities and more complex cancers are in the academic practice. RP had a higher proportion of MET cases consistent with the tertiary practice treating more advanced cancer. OffP Rx was higher with MET, likely related to the nuances of Rx of MET cancer and new therapies not yet in pathways. OffP Rx was fully justified in most cases.[Table: see text]
Mental health care utilization among veterans with castration-resistant prostate cancer receiving abiraterone or enzalutamide.
Authors: Tsao Phoebe A. , Burns Jennifer A. , Entenman Shami , Kumbier Kyle , Sparks Jordan , Bohnert Amy S. B. , Skolarus Ted A. , Caram Megan Veresh 
Published: June 2021

e18680 Background: Abiraterone and enzalutamide are oral therapies widely used to treat men with castration-resistant prostate cancer (CRPC). Recent data have suggested potentially worsened quality of life and depression with use of enzalutamide compared to abiraterone. Because Veterans are at a higher risk for mental health conditions, we sought to compare mental health service utilization in Veterans with CRPC receiving enzalutamide to those receiving abiraterone. Methods: The Veterans Health Administration Corporate Data Warehouse was used to identify men with CRPC who received abiraterone or enzalutamide for ≥ 30 days as first-line treatment between 2010-2017. We compared the rate of mental health visits per 100 patient-months for men on abiraterone versus enzalutamide using an exact rate ratio test, assuming Poisson counts. Results: Among 2902 male Veterans, 68.6% (n=1992) received abiraterone and 31.4% (n=910) enzalutamide as first-line therapy. Men who received enzalutamide were older (76 vs 74, p<0.01) and had a higher comorbidity burden (Charlson Comorbidity Index [CCI] ≥ 2 in 28.7% vs 21.6%, p<0.01); no differences were noted in race or prevalence of preexisting documented mental health diagnoses. Median time on drug was 8 months for both medications. There was no difference in the rate of mental health visits per 100 patients-months on enzalutamide versus abiraterone (6.6 v. 6.7, p=0.66). However, within patient sub-groups, men who were age 75 or older, not married, or without notable comorbidities had lower rates of mental health visits with enzalutamide compared to abiraterone; whereas those who were younger than 75, married, had higher comorbidities, or a preexisting mental health diagnosis had higher rates of mental health visits with enzalutamide (Table). Conclusions: Among Veterans with CRPC who received a novel antiandrogen therapy first-line, there was no difference in engagement in mental health care between those who received abiraterone versus enzalutamide. Sub-group analysis revealed significant differences between patients on the two medications in demographic and diagnostic characteristics associated with number of visits, suggesting that vulnerability for mental health symptoms may vary by medication type. Further work in understanding the long-term impact of novel antiandrogens on mental health is needed.[Table: see text]
Real-world overall response rate and other outcomes related to originator and biosimilar rituximabin patients with chronic lymphocytic leukemia or non-Hodgkin’s lymphoma in the United Kingdom.
Authors: McBride Ali , Daniel Shoshana , Driessen Maurice T. , Szende Agota , Choudhry Azhar , Tian Marc , Ariely Rinat , Thompson Stephen 
Published: June 2021

e18696 Background: Rituximab is a chimeric anti-CD20 monoclonal antibody therapy, used primarily for treating chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL). Rituximab-abbs, the first rituximab biosimilar, was approved in the UK in 2017 and was expected to significantly reduce drug acquisition costs, but there is a lack of real-world evidence regarding patient outcomes with rituximab-abbs. This non-interventional study assessed the real-world effectiveness and tolerability of rituximab-abbs and rituximab in treatment-naive patients with CLL or NHL. Methods: Anonymized data on patient characteristics, response to treatment, healthcare resource utilization and costs were abstracted retrospectively via an online physician survey. UK-registered hematologists and oncologists reported on randomly selected patients aged ³18 years from four cohorts with documented CLL or NHL, who had received rituximab-abbs or rituximab as first-line immunotherapy (between January 1, 2018 and June 30, 2019). Patient outcomes data were provided from first treatment to the last date of follow-up available in the medical records. Results: In total, 46 physicians abstracted data from 201 patient charts. Demographic profiles of the cohorts were similar. For both treatments, the overall response rate (ORR) was very high for patients with CLL or NHL (Table) along with rates for six-month progression-free survival (96–98% across cohorts) and one-year survival (98–100% across cohorts). Most patients did not experience a grade ≥3 adverse event during treatment (54–66% across cohorts); the most common grade ≥3 adverse events were neutropenia, fatigue, anemia and infusion reactions. Healthcare resource utilization was similarly high across cohorts, driven by drug costs, diagnostic testing, oncologist office visits, and day case hospital admissions. Mean annual savings of approximately £1,000 per patient were seen with rituximab-abbs, attributable to first-line treatment costs. Conclusions: The originator (rituximab) and biosimilar (rituximab-abbs) products yielded comparable efficacy and tolerability in treating CLL and NHL in routine UK clinical practice, with rituximab-abbs demonstrating cost-savings. These findings should inform decision-makers on the potential for cost reductions where the biosimilar rituximab-abbs is available as a treatment alternative.[Table: see text]
Evaluation of cardiotoxicity related to cancer treatment in an urban safety-net hospital.
Authors: Lee Michelle Jeung-Eun , Chang Eric , Onwuanyi Anekwe , Jain Sanjay R. 
Published: June 2021

e18804 Background: Improvements in survival of cancer patients has led to an increased awareness of the long-term cardiac effects of chemotherapy. American Society of Clinical Oncology (ASCO) Clinical Practice Guideline emphasizes the needs of identifying patients with higher risk for cardiovascular toxicity prior to treatment initiation. African American (AA) race has been associated with higher incidence of cardiotoxicity and resultant incomplete adjuvant therapy compared to white patients. Here, we investigate the utilization of various imaging modalities to monitor chemotherapy-induced cardiotoxicity in a predominantly AA breast cancer population at the safety-net hospital. Methods: This study was a retrospective analysis of breast cancer patients (n = 33) who received trastuzumab, doxorubicin, and/or paclitaxel between year 2018 and 2020 at the safety-net hospital in Atlanta, Georgia. Patient demographics, clinical characteristics, pathologic variables as well as utilization of echocardiography, echocardiography with global longitudinal strain (GLS), and multigated acquisition scans (MUGA). Results: The majority of patients were AA female (27/33, 81.8%) and the mean age at diagnosis was 52 ± 13.2 years. 11/33 (33%), 24/33 (72.7%), and 20/33 (33.3%) were treated with trastuzumab, paclitaxel, and doxorubicin respectively. Baseline left ventricular ejection fraction (LVEF) was assessed in 32/33 (96.7%) of patients: MUGA 21/32 (65.6%), echocardiography 10/33 (31.3%), and echocardiography with GLS 1/32 (3.1%). 13/32 (40.6%) patients underwent repeated imaging, with the average time between repeat MUGA and echocardiography being 254.3 and 147 days respectively. LVEF decrease of > 10% was noted in 4 patients with repeat MUGA but in none of the repeat echocardiography group. Only 5 patients had echocardiography with GLS over the study period, of which 2/5 (40%) had a drop in GLS in the setting of normal ejection fraction, consistent with occult LV systolic dysfunction. Conclusions: Our study suggests that African American patients at a safety net hospital receive the equivalent level of cardiac surveillance during cancer treatment. However, GLS imaging is underutilized in the detection of subclinical cardiac dysfunction in breast cancer patients receiving chemotherapy. Larger, long terms prospective studies are needed to assess the implications of abnormal GLS and progression to clinical left ventricular systolic dysfunction in the AA breast cancer population.
Impact of COVID-19 in the screening and treatment of breast cancer in the Brazilian public health system: Data from a healthcare data warehouse.
Authors: Morelle Alessandra Menezes , Venero Fernando Castilho , Dal Ponte Ferreira Rafael , Santanna Pedro Tofani , da Silva Rommel Fabricio Pereira , Zieguelmann Patrícia 
Published: June 2021

e18807 Background:Since December 2019, the world is facing a pandemic caused by a novel coronavirus (SARS-CoV-2). We sought to analyze the behavior of cancer treatments and procedures in breast cancer in Brazil after the beginning of the COVID-19 pandemic through an artificial intelligence platform with real life data. Methods:Data evaluation was performed using the TechTrials platform. This platform created a unique healthcare data warehouse containing hundreds of different publicly available data sources about Brazilian Public Health System and with proprietary technology, developed several analytics products that explore and release real-world data (RWD) insights. For this analysis data were extracted from DATASUS – SIA (outpatients information system). For each outcome, data from January 2011 to February 2020 were used to adjust a time series to predict values for March to November 2020. Those values were compared with the observed ones. Results: Biopsies, mammograms and procedures showed a sharp decrease (41.9%, 73.7% and 31.1%, respectively), in April 2020 (following month of the first COVID-19 case in Brazil) with some recovering in the following months. All observed values of biopsies, the number of mammograms from March to October and the number of procedures in April and May were significantly smaller than the predicted ones. Number of women undergoing chemotherapy began to decline in August and remained falling until the last month of available data.(Table). Conclusions: This study is the first one that analyzes RWD of breast cancer screening, diagnosis and treatment in Brazil as a result of the COVID-19 pandemic. The impact of the decrease observed in screening and diagnosis is already evident in the number of women undergoing chemotherapy. These data will continue to be monitored in the coming months when only then will data be available for staging at diagnosis.[Table: see text]
U.S. budget impact analysis of an intravenousrituximab biosimilar versus subcutaneous rituximab for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
Authors: James Elizabeth , Trautman Holly , McBride Ali , Choudhry Azhar , Thompson Stephen 
Published: June 2021

e18821 Background: Rituximab-abbs is a CD20-directed monoclonal antibody and the first rituximab biosimilar approved in the US, expected to significantly reduce drug acquisition costs. This budget impact model (BIM) estimated budgetary impact of replacing a proportion of rituximab/hyaluronidase human subcutaneous injection (SC-R) utilization for NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL with rituximab-abbs (IV-R-BIOSIM). The objective was to project incremental cost differences between IV-R-BIOSIM and SC-R over one year for a hypothetical 5-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM was developed to estimate 1-year drug and administration costs for a one-quarter shift in SC-R market utilization to IV-R-BIOSIM, with equal efficacy and safety assumed. Values for epidemiology, market share, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Infused rituximab (IV-R) dosing assumed a mean body surface area (BSA) of 1.8m2. Annual dose counts of IV-R-BIOSIM or SC-R per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL. IV-R infusion duration was 3 hours. Drug acquisition and infusion/subcutaneous administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. SC-R costs included an initial IV-R originator dose. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drugs. Univariate sensitivity analyses were conducted. A scenario analysis used 2-year dosing to estimate costs for further FL maintenance treatment. Results: For a 5-million-member insured population, an estimated 972 patients would receive rituximab for NHL or CLL; 49 would receive SC-R. Estimated total incremental savings for one year for a 13-patient shift from SC-R to IV-R-BIOSIM were $57,864, equating to $0.02 per enrolled member per year (PMPY). Per-patient incremental annual savings with IV-R-BIOSIM for one year ranged between $2,359–$8,186 (Table). The model was most sensitive to low or high BSA dosing and proportion of patients with CLL. Conclusions: This BIM estimated annual savings of over $57,000 ($0.02 PMPY) for a 5-million-member US payer following a 25% shift of current SC-R use to IV-R-BIOSIM. These findings demonstrate the potential economic benefits of IV-R-BIOSIM vs SC-R that may result in expanded access to rituximab therapy.[Table: see text]
Health care cost impact associated with adverse events (AEs) among treatments in third-line+ (3L+) relapsed/refractory follicular lymphoma (R/R FL).
Authors: Gaballa Sameh , Levy Moshe Y. , Keith Michael , Wong Alex , Proudman David , Nellesen Dave , Mamlouk Khalid 
Published: June 2021

e18836 Background: Tazemetostat, a first-in-class oral, selective methyltransferase inhibitor of enhancer of zeste homolog 2 (EZH2) activity, was approved by the US Food and Drug Administration for treatment of patients with R/R FL after demonstrating single-agent antitumor activity in patients with wild-type or mutant EZH2. Phosphoinositide 3-kinase inhibitors (PI3Kis; idelalisib, duvelisib, and copanlisib) are also indicated for 3L+ R/R FL, but these drugs are associated with serious toxicities, such as neutropenia, infection, and immune-mediated toxicities. A matching-adjusted indirect comparison (MAIC) of tazemetostat with these 3 PI3Kis was previously presented in 3L+ R/R FL, showing that tazemetostat is associated with more favorable safety, and similar efficacy compared to each of the PI3Kis. The objective of this study was to estimate the difference in AE-related health care costs for each treatment. Methods: AE-related costs were sourced from a study of costs in patients hospitalized with AEs, using oncology-specific data when available. Matching-adjusted AE incidence was multiplied by costs related to each AE. Grade ≥3 AEs with incidence ≥5% for any of the evaluated treatments were included. Cost differences were estimated per treatment episode, based on duration of exposure in the tazemetostat clinical trial (9.3 months for tazemetostat, <7 months for the 3 comparators). Incidence rates were then converted to a monthly basis using an exponential curve. Results: The PI3Kis are estimated to incur $13,534 to $18,737 higher AE-related management costs per episode compared with tazemetostat. Adjusting for duration of exposure, each of the PI3Kis is project to cost $2,563 to $3,820 more per month than tazemetostat in AE-related costs. These estimates indicate that the AE-related cost impact of PI3Kis compared with tazemetostat is 3.4- to 6.1-fold higher on a per-episode basis, and 5.0- to 10.4-fold higher on a monthly basis. Conclusions: Quantifying the AE cost impact of tazemetostat based on AE incidence rates estimated by MAIC analysis adjusts for population differences and allows for more direct cost savings comparisons when accounting for duration of exposure to different treatments. Patients with 3L+ R/R FL who are treated with tazemetostat are estimated to incur substantially lower AE-related costs compared with PI3Kis (idelalisib, duvelisib, and copanlisib). [Table: see text]
Outcomes with preemptive donor lymphocyte infusions after allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndromes: A systematic review and meta-analysis.
Authors: Hussain Syed Ather , khan Atif N , THAMMINENI VENKATA S , Riaz Muhammad Nauman , Shahzad Moazzam , Pulipati Priyanjali , Khalid Fatima , Ahmed Zahoor , Anwar Iqra , Chaudhary Sibgha Gull , Balusu Ramesh , Ahmed Nausheen , Khurana Sharad , Anwer Faiz , Mushtaq Muhammad Umair 
Published: June 2021

e19014 Background: Allogeneic hematopoietic stem cell transplantation (HSCT) is the only curative therapy for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) but relapse and graft versus host disease (GVHD) remain the most common challenges. Donor lymphocyte infusion (DLI) is the infusion in which lymphocytes from the original stem cell donor are infused, after the transplant, to augment an anti-tumor response or to ensure that the donor stem cells remain engrafted. In this systematic review and meta-analysis, we focused at outcomes of preemptive DLI in AML and MDS. Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA) PubMed, CINAHL, Cochrane, and Clinical trials.gov were searched. We included 8 out of 214 articles, excluding duplicates and non-relevant articles. The quality of the included studies was evaluated using NIH quality assessment tool. Proportions along with 95% Confidence Interval (CI) were extracted to compute pooled analysis using the ‘meta’ package by Schwarzer et al. in the R programming language (version 4.16-2) to report the efficacy of preemptive DLI. We pooled the experimental arms results of the included trials using the inverse variance method and logit transformation. Between studies, the variance was calculated using Der Simonian-Laird Estimator. Results: We identified 222 patients who received preemptive DLI. Median age, time since transplant and DLI dose were 48 (32-58) years, 82 (7-160) days and 1.4 million cells/kg respectively. CR and PR were 43% (95%CI 0.14-0.78, I293%, n= 127) and 61% (95%CI 0.40-0.78, I262%, n= 81) respectively. After median follow up of 46 months, non-relapsed mortality (NRM) was 52% (95%CI 0.38-0.65, I249%, n = 121). OS was reported 72% (95%CI 0.62-0.80, I20%, n= 100). Acute and chronic GVHD incidence after DLI was 20% (95% CI 0.13-0.29, I24%, n= 105) and 25% (95% CI 0.08-0.56, I2=79%, n=101) respectively (Table). Conclusions: Preemptive DLI significantly improves OS with a low incidence of acute and chronic GVHD. However, NRM was seen in more than half of all the patients and prospective studies are needed to evaluate safety of preemptive DLI. Outcomes with preemptive DLI (n= 222).[Table: see text]