bluuebunny/crossref_metadata_2025_split huggingface dataset:
Graphical representations of patient tolerability data: Recommendations from the National Cancer Institute (NCI) Cancer Moonshot Standardization Working Group.
Authors: Gresham Gillian , Mazza Gina L. , Langlais Blake , King-Kallimanis Bellinda , Rogak Lauren J. ,   Patient Tolerability Consortia Standardization Working Group
Published: June 2021

e18612 Background: Effective communication of treatment tolerability data is essential for clinical decision making and improved patient outcomes, yet standardized approaches to the analysis and visualization of tolerability data in cancer clinical trials are currently limited. To address this need, the Standardization Working Group (SWG) was established within the NCI Cancer Moonshot Tolerability Consortium. This abstract describes the SWG’s initiative to develop a publicly accessible online toolkit with a comprehensive set of guidelines, references, and resources for graphical displays of tolerability data. Methods: A multidisciplinary group of PRO researchers including biostatisticians, clinicians, epidemiologists, and representatives from the NCI and FDA convened monthly to discuss toolkit development and content. Considerations for standardization of graphical displays of tolerability data included (1) types of graphical displays, (2) incorporation of missing data, (3) labeling and color schemes, and (4) software to produce graphical displays. For consistency, considerations of tolerability relied on the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE), which includes 124 items assessing the frequency, severity, interference, and/or presence of 78 symptomatic adverse events. Graphical displays were generated using simulated PRO-CTCAE data and summarized by composite score (range 0-3).Color schemes that were Section 508 compliant and color blindness accessible were created. Surveys were distributed to 68 consortium members to assess preferences and interpretability of the graphical displays. Results: The SWG created graphical displays for PRO-CTCAE data, including bar charts, butterfly plots, and Sankey diagrams and compiled SAS macros and R functions to do so. Graphical displays made available in the toolkit maximize the use of PRO-CTCAE data, incorporate missingness, support between-arm comparisons, and present data longitudinally over treatment cycles or study timepoints. Survey results for labeling and color schemes were summarized and informed a list of short labels for PRO-CTCAE items (e.g., “radiation burns” for “skin burns from radiation”) and standardized color schemes for use in graphical displays. Survey results were also summarized to provide insight into PRO researchers’ ability to accurately interpret the graphical displays. Conclusions: Standardizinggraphical displays is important for improving the communication and interpretation of tolerability data. The type of graphical display used depends on the purpose of the analysis and should be tailored to the intended audience, including patients. This toolkit will provide a comprehensive resource with best practice recommendations.
Reducing hospitalizations: Implementation of CADD pumps in infusion clinic at a Los Angeles safety net hospital.
Authors: Do Tiffanie Thy , Yeh James Jen-Chi 
Published: June 2021

e18648 Background: Computerized ambulatory drug delivery (CADD) pumps introduced in the 1980s made it possible to move infusion delivery from the hospital to the home. At Harbor-UCLA Medical Center, hundreds of scheduled chemotherapy admissions occur annually. The procurement and implementation of CADD pumps was a collaborative effort with members of pharmacy, nursing, physicians and administration. The implementation of CADD pumps for home chemotherapy demonstrated a cost-savings by decreasing the number of inpatient hospital days required for scheduled chemotherapy admissions. Methods: The first outpatient chemotherapy infusion by CADD pump began on 12/5/2017. Records from 12/5/2017 through 12/4/2018 (365 days) were reviewed to assess the benefit of CADD pumps, defined by inpatient hospital days avoided. Eight chemotherapy regimens were administered through outpatient CADD pumps; the equivalent number of inpatient hospital days were estimated based on inpatient hospital records between 2015 and 2017. The average number of hospital days that would have occurred inpatient per chemotherapy regimen was multiplied by the number of outpatient CADD pump chemotherapy infusions to estimate the number of inpatient hospital days avoided. Based on information provided by our hospital’s finance department, including reimbursement for inpatient and similar outpatient care, each hospital day avoided was estimated to provide $1,695 in cost-savings. On average, a typical hospitalization for infusional 5-FU chemotherapy was three days in length. Results: Over one year, 35 patients received a total of 178 outpatient CADD infusions. The average number of CADD infusions per patient was five. We estimated that 642 hospital bed days were saved over a 1-year period following the implementation of outpatient CADD pumps. With the estimate that each hospital bed day saved was valued at $1,695, we concluded a savings of $1.1 million dollars at our hospital through the implementation of CADD pumps within the first year. Conclusions: The implementation of CADD pumps for home chemotherapy demonstrated cost-savings by decreasing the number of inpatient hospital days required for scheduled chemotherapy admissions. This shift provides a superior value for the patient with equivalent treatment outpatient, spending less time in the healthcare setting, and reduced health care costs. [Table: see text]
Transition of dose-adjusted EPOCH therapy into the outpatient healthcare setting, quality and cost considerations under an alternate payment model.
Authors: Savaya Sandra , Villanueva Joselyn , Sharif Atefeh , AlRawashdh Neda , Garcia Andrew , Abraham Ivo , Persky Daniel O , McBride Ali 
Published: June 2021

e18655 Background: Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin DA-(EPOCH)-containing regimens are frequently utilized in lymphoma, however, outpatient EPOCH or modified inpatient/outpatient EPOCH has not been described extensively. We transitioned inpatient EPOCH to the outpatient setting and modified EPOCH to be given in the inpatient setting with rituximab outpatient to improve quality of care and access to patient assistance programs. Methods: A single-center, institutional review board-approved retrospective study was conducted for adults receiving EPOCH-based regimens. Data were collected by chart review for each patient between January 2013 and September 2020. The primary outcomes were to determine the incidence of chemotherapy delays due to disease-related reasons as febrile neutropenia (FN), adverse events or abnormal labs and the incidence of FN between patients receiving inpatient (IP), outpatient (OP), or combination inpatient/outpatient DA-EPOCH +/- R (hybrid). Secondary cost analysis including hospital stay cost, chemotherapy and laboratory monitoring costs was performed for the three settings. Results: A total of 43 patients received 175 cycles of an EPOCH regimen (18 [10.3%] IP), 90 [51.4%] OP, and 67 [38.3%] hybrid). The mean maximum dose level achieved with DA-EPOCH+/-R was dose level 2 with the average number of cycles at 4.1 cycles/patient. A total of 15 cycles were delayed due to disease related reasons: 1 (6%) in IP, 12 (18%) in hybrid (P = 0.196, when compared with IP) and 2 (2%) in OP (P = 0.432 when compared with IP). A total of 166 cycles received granulocyte-colony stimulating factor (G-CSF); 16 cycles (9.6%) administered IP with a FN incidence of two (12.5%), 62 cycles (37.4%) administered in the hybrid setting with a FN incidence of seven (11.3%) (P = 0.893 when compared with IP) and 88 cycles (53%) administered OP with a FN incidence of ten (11.3%) (P = 0.896 when compared with IP). The incidence of FN was 9.3% and 12.7% in patients received pegfilgrastim same day versus next day, respectively, P = 0.558. The incidence of FN in patients received reference pegfilgrastim was 9.5% vs 7.7% for patients received pegfilgrastim-cbqv in OP setting (P = 1.00). Transitioning EPOCH to a hybrid IP/OP or OP setting yielded a total cost savings to the health-system of $3,523,174 with 607 hospital bed days saved. Conclusions: EPOCH-containing regimens can be safely transitioned into the outpatient setting or utilized as a hybrid of EPCOH and outpatient Rituximab after chemotherapy side effects can be monitored and outcomes optimized, to better adapt treatment strategies for individualized patient therapies. As new healthcare payment models are developed, outpatient treatments allow for adaptive financial options both for the payor and the patient.
Improving pneumococcal vaccination rates in pediatric acute lymphoblastic leukemia/lymphoblastic lymphoma.
Authors: Chang Simone , Cheerva Alexandra , Huang Michael Angelo , McGowan Kerry , Knapp Esther E , Raj Ashok , Slone Natalie , Zhao Jun , Tse William T , Barbour Mustafa 
Published: June 2021

e18666 Background: Pediatric Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (ALL/LLy) is the most common pediatric cancer. Invasive pneumococcal disease (IPD) is prevalent in this population and the Centers for Disease Control and Prevention recommends pneumococcal vaccination to decrease morbidity and mortality. Despite these recommendations, vaccination rates remain low and the incidence of IPD among children with hematologic malignancy is significantly higher compared to the average pediatric population. An interventional study was designed to improve the vaccination rate and reduce the incidence of IPD in our institution. Methods: A plan-do-study-act (PDSA) model of quality improvement (QI) was used. Chart review at our institute was done for the 6-month period of January 2020 - June 2020 and baseline rates for pneumococcal polysaccharide (PPSV23) vaccination were calculated. Patients were included if they were ≥ 2 years old, diagnosed with ALL/LLy, and undergoing maintenance. A multidisciplinary team performed the root cause analysis. Immunization records were obtained and reviewed and targeted interventions were implemented. The interventions used are outlined in Table. The percentage of pediatric ALL/LLy patients per month in maintenance who received age-appropriate pneumococcal vaccinations was monitored before and after the interventions. Results: Analysis of the 6-month retrospective cohort (n=36) showed a baseline vaccination rate of 5.5%. During the subsequent 6-month phase with interventions, 40 patients were prospectively enrolled. Demographics showed a mean age of 10.2 years (range, 2-21) and a predominantly male (66.7%) cohort. B-cell ALL/LLy comprised the majority (78.9%); the rest included T-cell ALL/LLy and mixed phenotype acute leukemia. As seen in Table, the percentage receiving at least 1 pneumococcal vaccine increased from 5.5% to 84.8% over the first 3 months, this plateaued around 81%. Completion of the series mirrored this and increased to 74.2%. Pre-visit planning and cues proved to be the most helpful interventions. Conclusions: Use of a PDSA model successfully improved pneumococcal vaccination rates in the pediatric ALL/LLy population. We suggest these results can be achieved with planning and implementation of the outlined interventions. [Table: see text]
The efficacy and safety of oral levofloxacin therapy for overall infection prophylaxis in cancer patients with neutropenia in outpatient settings.
Authors: Davenport Lilia , Chin Jamie , Blum Sharon , Akerman Meredith 
Published: June 2021

e18681 Background: Patients undergoing chemotherapy treatment are at risk for bacterial infection during their period of neutropenia. However, not all neutropenic patients are at high risk for developing infection. The purpose of this study was to evaluate the efficacy and safety of prophylactic oral levofloxacin in high, intermediate, and low infection risk patients with cancer in the ambulatory care setting. Methods: This was a retrospective chart review of 100 cancer patients with high, intermediate, and low overall infection risk who were prescribed outpatient oral levofloxacin prophylaxis between October 2019 and July 2020. This quality improvement project included adults with a history of malignancy and presence of neutropenia who have received chemotherapy treatment and oral levofloxacin therapy for overall infection prophylaxis. The primary efficacy outcome was the rate of hospital admission due to febrile neutropenia. The primary safety outcome was the occurrence of side effects of levofloxacin therapy. Secondary outcomes evaluated the duration of levofloxacin therapy, the rate of fluoroquinolone resistance in positive bacterial cultures, progression to sepsis in hospitalized patients and the rate of death due to mult-idrug resistance including fluoroquinolones. Results: Hospital admission due to febrile neutropenia after a chemotherapy cycle occurred in 18% of patients prescribed levofloxacin. Among hospitalized patients due to febrile neutropenia, 2% had low to intermediate overall infection risk and 16% had high overall infection risk. The primary safety outcome occurred in 25% of patients. The incidence of QTc prolongation occurred in 8% of patients; dermatologic side effects occurred in 9% of patients; the rate of Clostridioides difficile infection was 6%, and the rate of tendon rupture was 2%. Median duration of levofloxacin prophylaxis in the low overall infection risk group was 7 days, compared to the intermediate overall infection risk group (8.5 days) and the high overall infection risk group (14 days) with Kruskal-Wallis test p-value of 0.0009. The rate of fluoroquinolone resistance in positive bacterial cultures was 10%. Progression to sepsis in hospitalized patients occurred in 17% of patients. The rate of death due to multi-drug resistance including fluoroquinolone was 2%. Conclusions: Our findings signify preserved efficacy of levofloxacin prophylaxis in the ambulatory setting. Our findings should be considered to develop rational strategies to reduce fluoroquinolone overprescribing or limit duration of levofloxacin prophylaxis. If patients present with solid tumors and experience neutropenia, the use of antibacterial prophylaxis is not recommended because in general, patients recover from neutropenia quickly.
Real-world data analysis of the utilization of second-line maintenance therapy for patients with advanced ovarian cancer.
Authors: Reid Robert Lawrence , Xie Yiqiong , Shi Junxin , Wallace Katrine L 
Published: June 2021

e18702 Background: Although ovarian cancer (OC) represents about 1% of all new cancer cases in the US, it is the 5th leading cause of cancer death among women. Several maintenance therapies have been introduced (ie, bevacizumab and poly[ADP-ribose] polymerase inhibitors [PARPi]) to extend the time between chemotherapy and relapse (ie, progression-free survival) in this population. Both bevacizumab and PARPi have been recommended as second-line (2L) maintenance treatment by the National Comprehensive Cancer Network for OC patients (pts) with and without BRCA alterations since 2013 and 2017, respectively. We present recent estimates of 2L maintenance utilization. Methods: From the iKnowMed electronic health record database of the US Oncology Network, which includes 1,200 physicians operating in over 470 sites of care in the US, adult females were included if diagnosed with advanced OC, received a 2L platinum-containing regimen for advanced OC, and had ≥2 visits within the database between 1 Jan 2016 and 31 July 2020. Pts were followed longitudinally until 31 Oct 2020, the last pt record, or date of death, whichever occurred earliest. Rates of 2L maintenance therapy (ie, bevacizumab monotherapy or PARPi following discontinuation of 2L platinum-based chemotherapy) were determined for 1) all pts, 2) pts with a BRCA1 or BRCA2 gene alteration (BRCA+), and 3) pts without a BRCA alteration (BRCA-). Results: 11,494 pts were identified with a diagnosis of advanced OC; of those, 1,051 met the study inclusion criteria. Median age at advanced OC diagnosis was 64.2 years. Median follow-up time from discontinuation of 2L platinum chemotherapy until the end of observation was 24.6 mo. Of 1,051 pts who received 2L platinum-based chemotherapy, 513 (49%) subsequently received maintenance therapy (271 [26%] PARPi, 294 [28%] bevacizumab, 32 [3%] a non-platinum chemotherapy) and 538 (51%) did not receive maintenance (ie, underwent “active surveillance”). The proportion of eligible pts receiving 2L maintenance did not increase over the study period, with 53%, 58%, and 56% of pts receiving 2L maintenance versus 47%, 42%, and 44% of pts undergoing active surveillance in the years 2017, 2018, and 2019, respectively. Among the 1,051 pts who received 2L platinum chemotherapy, 662 pts had a documented BRCA test result (94 [14%] BRCA+, 568 [86%] BRCA-). Among BRCA+ pts, 67% received 2L maintenance, while BRCA- pts received significantly less maintenance treatment (53%, p = 0.0104). Conclusions: Despite having several treatment options available for 2L advanced OC maintenance, fewer than half of eligible pts receive maintenance treatment. Although the utilization rate was higher among pts with BRCA alterations versus those without, our data suggest that there is a significant proportion of eligible pts who are not receiving maintenance therapy despite treatment guideline recommendations.
Incidence of tozinameran adverse events among the employees of National Cancer Institute.
Authors: Palacka Patrik , Slopovsky Jan , Zanchetta Katarina , Drgona Lubos , Badurikova Eva , Bernadicova Beata , Baranova Vladimira , Pechan Juraj , Mego Michal 
Published: June 2021

e18724 Background: Active immunization seems to be the most effective protection against COVID-19. The objective of this prospective study was to explore the side effects of mRNA vaccine Tozinameran and possible differences in their incidence between different categories of employees at the National Cancer Institute in Bratislava, Slovakia (NCI). Methods: Four hundred and thirteen subjects (89 men) were enrolled into this ongoing prospective study in January, 2021. Median age was 47 years (range 19-79 years). Majority were healthcare professionals (N=306), including nurses (N=125), medical-technical workers (N=89), and physicians (N=42). Presence of side effects was entered by the physicians into electronic data files and their accuracy validated for each subject by an independent investigator. Number of adverse events in the subgroups were compared with log-rank test. Results: At median follow up of 4 weeks, injection site pain (63.0%), pain in the extremity (45.5%), and fatigue (28,6%) belonged among the most common adverse events of Tozinameran. Median number of side effects was 2 (range 0-13). Adverse event incidence was significantly higher in females compare to males (median number 2 vs. 1, P < 0.00001). In a subgroup of healthcare professionals, we found a significantly higher incidence of side effects compared to non-healthcare workers (median number 2 vs. 1, P = 0.00017). Conclusions: In this study, incidence of Tozinameran adverse events was significantly higher in females vs. males and healthcare professionals vs. non-healthcare workers. All side effects were mild and no new safety signals were recognized during follow-up. Key Words: Tozinameran, Active Immunization. COVID-19. Healthcare Professionals. Adverse Events. This study was supported by National Cancer Institute in Bratislava (SK) and OncoReSearch (SK).
Prospective cohort of real-world, curative-intent breast cancer treatment patterns in Malawi.
Authors: Morgan Jennifer , Zuze Takondwa , Elmore Shekinah Nefreteri Cluff , Painschab Matthew , Gondwe Yolanda , Nyasosela Richard , Kajombo Chifundo , Manda Agness , Reeder-Hayes Katherine Elizabeth , Tomoka Tamiwe 
Published: June 2021

e18736 Background: Despite increasing availability of curative-intent breast cancer treatment in concordance with the National Comprehensive Cancer Network (NCCN) Harmonized Guidelines for Sub-Saharan Africa (SSA), few descriptions of their application in SSA are available. Our aim was to describe patterns of curative-intent treatment including neoadjuvant (NAC) and/or adjuvant chemotherapy (AdC) and surgery (S) by stage and HIV status, and the association between guideline-concordant treatment completion and overall survival (OS). Methods: We enrolled newly diagnosed breast cancer patients in a prospective cohort study at Kamuzu Central Hospital in Malawi from Dec 2016 – Oct 2018. Unadjusted odds ratios (OR) with 95% CI were calculated to identify factors associated with completion of guideline-concordant treatment, defined as S and at least 4 cycles of NAC or AdC. A logistic regression model was performed using variables with p<0.1. Survival analysis was performed with Kaplan Meier methods and log-rank test. Results: 67 non-metastatic patients were included. 12 (18%) were HIV+; 13 (19%) were Stage II and 54 (81%) Stage III. 46 (69%) began treatment with NAC, of which 39 (85%) were Stage III and 7 (15%) Stage II. 12 (18%) began treatment with S+AdC, of which 5 (42%) were Stage II and 7 (58%) were Stage III. 2 (3%) Stage III patients were treated with palliative chemotherapy (PC). 7 (10%) never received treatment. Overall, 41 (61%) underwent S. In bivariate analysis, factors associated with failure to complete treatment were HIV+ (OR 0.25 CI (0.06-0.99), Stage III (OR 0.10 CI (0.01-0.89) and ER/PR-/HER2+ (OR 0.07 CI (0.01-0.49). In adjusted analysis, ER/PR-/HER2+ (OR 0.12 (0.01-0.97) was associated with failure to complete treatment. HIV+ patients received less NAC than HIV- (2.5 vs 4 cycles; p=0.07) and similar AdC as HIV- (6 vs 6 cycles; p=0.7). Median OS for those who began treatment with NAC was shorter than with S+AdC (28.5 vs 40 months; p=0.01). Median OS for HIV+ vs HIV- who received NAC was 19.7 vs 32.7 months (p=0.10) and received S+AdC was unreached vs 37.1 months (p=0.27). Conclusions: When applying NCCN Harmonized Guidelines for SSA to Malawi, most patients received NAC for curative breast cancer treatment and had significantly shorter OS compared to those receiving upfront S+AdC. Stage III, HIV+, and ER/PR-/HER2+ patients were less likely to complete guideline-concordant treatment which may reflect advanced disease or poor treatment tolerability. Further study is needed to identify barriers to guideline-concordant treatment and inform interventions to improve breast cancer treatment outcomes in Malawi and SSA.[Table: see text]