bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world comparison of febrile neutropenia rates with same-day versus next-day administration of pegfilgrastim.
Authors: Kitchen Kyle , Mosier Michael C. 
Published: September 2021

299 Background: Febrile neutropenia (FN) is a common side effect of myelosuppressive chemotherapy. Per guidelines, prophylactic pegfilgrastim is to be given 24-72 hours after chemotherapy in each cycle, but administering pegfilgrastim within 24 hours of chemotherapy (same day) is commonly done to reduce the burden on patients (pts) and healthcare systems. The ideal timing is under debate in the supportive oncology care field, but an increasing body of knowledge supports same-day administration as an option. The objective of this study was to compare the incidence of FN after same-day vs next-day administration of pegfilgrastim in pts with cancer receiving cytotoxic chemotherapy. Methods: A real-world, retrospective study of electronic health records of pts treated at Utah Cancer Specialists (Salt Lake City, UT) between February 2018 and December 2020 was conducted. Pts included in the study had a diagnosis of breast cancer, diffuse large B-cell lymphoma, or other cancers (eg. other lymphomas, prostate cancer); received a myelosuppressive chemotherapy regimen; and were administered either same-day or next-day prophylactic pegfilgrastim. FN was physician diagnosed; differences in FN incidence with same-day vs next-day pegfilgrastim were evaluated using a Chi-square test and Wald confidence limits. Results: 297 pts were included in this analysis. Most pts (63.6%) had a diagnosis of breast cancer, 23.6% had lymphoma, and 12.8% had other cancers. Pts received a broad range of chemotherapy regimens, with dose-dense doxorubicin and cyclophosphamide being the most common (43.4%). In cycle 1, pegfilgrastim administration timing was balanced between same-day (39.7% [118/297]) and next-day (60.3% [179/297]). The pegfilgrastim administration day changed in subsequent cycles in 27 pts (9.1%): 4 pts in the cycle 1 same-day group and 23 pts in the cycle 1 next-day group. In cycle 1, 7/117 pts (6.0%) in the same-day pegfilgrastim group and 12/180 (6.7%) pts in the next-day group experienced ≥1 episode of FN. Across all cycles, 11/118 pts (9.3%) in the same-day pegfilgrastim group and 16/179 (8.9%) pts in the next-day group experienced ≥1 episode of FN. The difference in incidence of FN between same-day vs next-day pegfilgrastim was not statistically significant in cycle 1 (0.68% [95% CI –5.0% to 6.3%]; P=.814) and across all cycles (–0.38% [95% CI –7.1% to 6.3%]; P=.910). Conclusions: The overall incidence of FN was low in this pt population receiving prophylactic pegfilgrastim, and no significant differences were detected between same-day and next-day pegfilgrastim administration. These data support the same-day administration of prophylactic pegfilgrastim.
Utilization and patient characteristics for the trastuzumab originator, biosimilars, and other HER2 inhibitors in the United States.
Authors: Nam Young Hee , Mendelsohn Aaron , Marshall James , Lin Nancy , Brown Jeffrey , McDermott Cara , Pawloski Pamala A. , Lockhart Catherine 
Published: September 2021

308 Background: Biosimilars for trastuzumab, a HER2 inhibitor (HER2I), have been available for use in the US since in 2019, yet information on their utilization and patient characteristics is limited. We assessed utilization and patient characteristics for the trastuzumab originator, biosimilars, and other HER2Is in the US. Methods: We analyzed healthcare claims for 10/1/2016-up to 2/29/2020 (end date varied across health plans) from the Biologics and Biosimilars Collective Intelligence Consortium’s Distributed Research Network ( > 95 million persons) using the FDA’s Sentinel distributed analysis tools. We conducted descriptive analyses on the number of incident users and patients’ characteristics for each HER2I. Adults continuously enrolled in their health plan with medical and drug coverage ≥365 days (baseline period) prior to their incident HER2I use were eligible for analysis. Results: Of the incident users (incident to any HER2Is), we identified 6,631 originator trastuzumab users, 122 trastuzumab-anns, 116 ado-trastuzumab emtansine, 54 neratinib, and 54 lapatinib users. Trastuzumab-dkst and trastuzumab/hyaluronidase-oysk had < 11 users each. Mean age was the highest for trastuzumab/hyaluronidase-oysk (73.7 years; SD, 18.6) and similar between the trastuzumab originator and biosimilars (52.5-59.0). The number of incident users/100,000 person-years decreased for the trastuzumab originator from 13.5 in 2016 to 9.4 in 2020 and increased for trastuzumab-anns from 0.4 in 2019 to 4.9 in 2020. Of the baseline clinical characteristics examined, Charlson/Elixhauser comorbidity score was the highest for lapatinib (2.0), lowest for trastuzumab-dkst and neratinib (0.5), and similar between the trastuzumab originator (1.1) and trastuzumab-anns (1.3). The proportion of patients who received any chemotherapy during the baseline period was 38.9% for lapatinib, 18.5% for the trastuzumab originator, and 14.8% for trastuzumab-anns. The proportion of endocrine therapy users was the highest for neratinib (63.0%) and similar between the trastuzumab originator (11.1%) and trastuzumab-anns (10.7%). Among incident users with metastatic breast cancer, endocrine therapy receivers during the baseline period accounted for 19.3% for the trastuzumab originator and 69.6% for lapatinib. Conclusions: Though full data were not available for 2019-2020 for all health plans, these preliminary findings suggest that utilization of biosimilar trastuzumab-anns increased whereas the trastuzumab originator use decreased over time and that there is a variation in patient characteristics between HER2Is and by metastatic status while the characteristics were generally similar between the trastuzumab originator and trastuzumab-anns. We plan to conduct ongoing assessment of HER2I utilization as more data become available to help inform clinical practices and health policies.
Hospitalization burden and end-of-life (EOL) care in elderly patients with glioblastoma (GBM).
Authors: Donovan Laura , Buono Donna , Accordino Melissa Kate , Wright Jason Dennis , Lassman Andrew B. , Hershman Dawn L. 
Published: September 2021

31 Background: GBM is associated with a poor prognosis and early death in elderly patients. Prior studies have demonstrated a high burden of hospitalization in this population. We sought to evaluate and examine trends in hospitalizations and EOL care in GBM survivors. Methods: Using SEER-Medicare linked data, we performed a retrospective observational cohort study of patients aged ≥ 65 years diagnosed with GBM from 2005-2017 who lived at least 6 months from the time of diagnosis. Aggressive EOL care was defined as: chemotherapy or radiotherapy within 14 days of death (DOD), surgery within 30 DOD, > 1 emergency department visit, ≥ 1 hospitalization or intensive care unit admission within 30 DOD; in-hospital death; or hospice enrollment ≤ 3 DOD. We evaluated age, race, ethnicity, marital status, gender, socioeconomic status, comorbidities, prior treatment and percentage of time hospitalized. Multivariable logistic regression was performed to determine factors associated with aggressive end of life care. Results: Of 5827 patients, 2269 (38.9%) survived at least 6 months. Among these, 1106 (48.7%) survived 6-12 months, 558 (24.6%) survived 12-18 months, and 605 (26.7%) survived > 18 months. Patients who survived 6-12 months had the highest burden of hospitalization and spent a median of 10.6% of their remaining life in the hospital compared to those surviving 12-18 months (5.4%) and > 18 months (3%) (P < 0.001). 10.1% of the cohort had claims for palliative care services; 49.8% of initial palliative care consults occurred in the last 30 days of life. Hospice claims existed in 83% with a median length of stay 33 days (IQR 12, 79 days). 30.1% of subjects received aggressive EOL care. Receiving chemo at any time (OR 1.510, 95% CI 1.221-1.867) and spending ≥ 20% of life in the hospital after diagnosis (OR 3.331, 95% CI 2.567-4.324) were associated with aggressive EOL care. Women (OR 0.759, 95% CI 0.624-0.922), patients with higher socioeconomic status (OR 0.533, 95% CI 0.342-0.829), and those diagnosed ≥ age 80 (OR 0.723, 95% CI 0.528-0.991) were less likely to receive aggressive EOL care. Race, ethnicity, marital status, and extent of initial resection were not associated with aggressive EOL care. Conclusions: A minority of elderly patients with GBM in the SEER-Medicare database survived ≥ 6 months; hospitalizations were common and patients spent a significant proportion of their remaining life hospitalized. Although hospice utilization was high in this cohort, 30% of patients received aggressive EOL care. Despite the aggressive nature of GBM, few patients had palliative care consults during their illness. Increased utilization of palliative care services may help reduce hospitalization burden and aggressive EOL care in this population.
Hospital admissions and place of death prior and during COVID-19: Real-world data from a Brazilian cancer center.
Authors: Nascimento Karla Lúcia Lucia , Philip Errol James , Sacchi Luana , Pereira Juliana , Nazario Jose , Matos Neto Joao Nunes , Bergerot Cristiane Decat , Lee David , Bergerot Paulo Gustavo 
Published: September 2021

313 Background: Treatment decisions for patients with cancer have changed during the COVID-19 pandemic due to the increased risk of infection among this population. In recognition of the impact of COVID-19 in Brazil, this study sought to explore the potential consequences of this disruption to oncology care by comparing the prevalence and place of death one year prior to the pandemic (January 2019 to February 2020) and during the pandemic (March 2020 to March 2021). Methods: Consecutive patients with cancer receiving treatment at a single institution located in the capital of Brazil were included in this analysis. Patients’ characteristics were collected via chart review: age, sex, histology, COVID-19, hospital admission and place of death. Chi-square analysis was used to determine differences among this sample of patients (pre-COVID-19 and during COVID-19). Results: We reviewed data from 3,833 patients (53% of patients during the pandemic). Patients’ characteristics were well balanced between both groups of patients. The proportion of patients with breast and prostate cancers increased (P < 0.01). Rates of hospital admission were similar between both timepoint, with reasons for hospital admission also similar: surgery (22% vs 19%, respectively) and pulmonary dysfunction (14% vs 19%, respectively); 9% were diagnosed with COVID-19 during the pandemic. Similarly, no differences were found among rates of deaths between samples (7%); 42% of patients pre-COVID were receiving supportive care, while 40% were during pandemic. The proportion of patients dying at home was the same among both groups (12%). A slight increase was observed for those dying in the ICU (45% vs 46%, respectively) or hospital (35% vs 36%, respectively). Pre-COVID-19, no patient has died in the emergency room, and during pandemic, 3% has died). Conclusions: A similar proportion of hospital admission and place of death were found between patients prior and during the COVID-19 pandemic. Most patients died in institutional settings. Future studies are needed to better understand patient’s wishes and preferences and to develop strategies to improve communication surrounding death and dying.
A virtual tumor board platform: A way to enhance decision-making for complex malignancies.
Authors: Hopkins Steven , Vidri Roberto J , Hill Maureen , Vijayvergia Namrata , Farma Jeffrey M. 
Published: September 2021

316 Background: Multidisciplinary tumor boards (TBs) are crucial for optimal decision making and management of patients diagnosed with complex malignancies. The social distancing conditions imposed by COVID-19 presented an opportunity to assess the value of conducting virtual TBs compared to traditional in-person TBs. Methods: A retrospective analysis of multi-specialty attendance data from a NCI designated cancer center’s Gastrointestinal TB participants from September 2019 to October 2020 was performed. An online survey, containing 21 questions, assessing the virtual TB experience was sent to participants of all TBs across multiple specialties. Interrupted time series analysis was performed to evaluate the transition from in-person to virtual TBs. Results: The overall mean attendance for Gastrointestinal TB was 30 participants; this value increased from 23 to 34 attendees after instituting virtual TBs (p < 0.001). Increased attendance was observed among all participant categories: attending physicians (11 to 15 attendees, p < 0.001), fellows and residents (8 to 11, p < 0.001), supporting staff (3 to 6, p < 0.001). There was no significant difference in the mean number of cases discussed between TB formats. The majority of the 141 survey respondents were attending physicians with > 20-year experience. Of all respondents, most supported a permanent virtual or hybrid TB format, 72.5% found this format to be more time efficient and just as productive, 85.8% found it easier to attend, and 56.7% believe it does not lead to greater distractions; most would not support a “cameras on” policy (65.2%). The majority (89.9%) also stated that confidence in the decision-making process was not affected by virtual interactions. Conclusions: A virtual platform for multi-specialty TBs allows for greater attendance without sacrificing the decision-making process. This survey supports continuing this virtual format, which may subsequently improve care and facilitate access to multidisciplinary discussions for patients.
U.S. health utility in advanced non-small cell lung cancer (NSCLC) patients harboring MET exon 14 (METex14) skipping mutations treated with tepotinib.
Authors: Paik Paul K. , Yang Mo , Knowles Emma , Hatswell Anthony , Vioix Helene , Liu Frank Xiaoqing 
Published: September 2021

319 Background: To complement the clinical findings, utilities were analyzed based on patient-reported outcomes (PROs) from VISION trial (Cohort A; data cut: July 1, 2020), a Phase II trial showed durable clinical activity of tepotinib in advanced NSCLC METex14+. Methods: The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaires were completed at Day 1, every 6 weeks for 9 months, then every 12 weeks, for up to 30 days after the last tepotinib dose. The Quality of Life Utility Measure-Core 10 dimensions (QLE-C10D) and EQ-5D-5L utilities were derived using the utility algorithm from published literature and the US crosswalk, respectively. Utilities are preference-based, health-related quality of life (HRQoL) metrics expressed on a scale including 0 (dead) and 1 (full health). Linear mixed regression models were used to analyze utilities at baseline, pre-progression, and post-progression, and to understand the relationship between EQ-5D and QLE-C10D. Utilities were assessed by both independent review committee (IRC) and investigators. Results: Utilities were estimated for 150 of 152 pts, with 983 observations for EORTC and 907 for EQ-5D. Mean EORTC utilities increased after tepotinib initiation, from 0.691 at baseline to 0.722 in the IRC-assessed progression-free period, and decreased after progression (0.671). Consistent trends were identified when progression was based on investigator's assessment. Analyses of EQ-5D utilities yielded similar findings and utilities. The two questionnaires were generally highly correlated (Table). Prior treatment (yes/no; p=0.554), adenocarcinoma (p=0.881), or squamous histology (p=0.841) were not statistically significant predictors of EQ-5D utility, while progression status significantly predicted utility in all progression-based models (p≤0.002). Conclusions: VISION is the first trial of a MET inhibitor to provide data on PROs and utilities in NSCLC harboring METex14 skipping mutation. EORTC and EQ-5D (minimally important difference: 0.08) utilities show an increase in HRQoL from baseline during tepotinib treatment until progression. Utility with tepotinib did not vary by prior treatment status or histology. Clinical trial information: NCT02864992. [Table: see text]
COVID-19 and advance care planning: A unique opportunity.
Authors: Gessling Aliya , Rank Mary , Larson Deborah , Soloway Ann , Langston Jessica , Tran Quy 
Published: September 2021

32 Background: Advance Care Planning (ACP) is a process to document patient preferences for future health care. Conversations between healthcare providers, patients, and loved-ones are required to reflect a patient’s values, goals, and ultimately their choices for life-sustaining treatments (LST). The COVID-19 pandemic has highlighted the critical importance of these discussions and the need for improved patient engagement. Methods: As COVID-19 infections surged, the VA Northern California Health Care System (VA NCHCS) Hospice and Palliative Care Section (HPCS) partnered with Patient Aligned Care Teams to expand urgent outreach to high-risk patients needing LST documentation. High risk was defined as age > 80, COPD or asthma diagnosis, or Care Assessment Need Score > 80 (CAN Score models risk of hospitalization or death within 1 year). An experienced HPCS Nurse Practitioner (NP) contacted these identified patients to 1.) provide COVID-19 education, 2.) conduct a high-quality goals of care conversation, and 3.) complete LST documentation and other ACP needs. A representative cohort was then followed up to evaluate concordance of treatment with their documented preferences. Results: Between March 2020 and September 2020, 910 patients were identified as high risk. Of these patients, 294 agreed to participate in the telehealth visit and complete LST documentation. Importantly, 108 (37%) patients chose DNR and other LST limitations. In addition, 142 (48%) patients created POLST documentation and 128 (43%) completed Advance Directives. Over 70% of patients who were hospitalized in the VA received care concordant with the newly documented LST preferences. A follow up survey of 29 participants found the outreach impactful and their preferences documented correctly. Conclusions: Prior studies have demonstrated success at educating primary providers to conduct ACP discussions, but given the limitations imposed by COVID-19 restrictions, this novel and highly cost-effective process of coupling a highly trained HPCS NP with a primary care team to perform ACP was piloted with success. After only a single ACP discussion, patients were able to formalize their limits to treatment and subsequent care aligned with these preferences. Patients also found this focused ACP discussion meaningful. This pathway will be integrated within the VA NCHCS as a long-term approach to continued ACP outreach.
Clinical treatment pathways utilization in an outpatient academic cancer center.
Authors: Chen Anna , Park Seojin , Csik Valerie Pracilio , Maio Vittorio , Walsh Karen , Binder Adam F 
Published: September 2021

323 Background: Clinical treatment pathway (CTP) tools have been incorporated into oncology practices to help standardize treatment, reduce care variation in cancer patients, and move towards value-based care. CTP tools incorporate the latest guidelines and are developed through multidisciplinary committees. Treatment decisions are prioritized by efficacy, toxicity, and cost to improve quality and value. This is especially important in cancer care which is associated with high drug costs. However, use and implementation of CTP tools has been met with mixed reviews and published data from academic medical centers are limited. Methods: Outpatient treatment decisions for patients across different cancer types, including colorectal, gastroesophageal, and breast cancers from July 2018 to March 2020 at an urban NCI-designated cancer center were evaluated. Every treatment decision was evaluated in relation to physician utilization of CTP tools. Treatment decisions were categorized as choosing a CTP recommended option ( pathways dependent), not choosing a CTP recommended option ( pathways independent), or not using the CTP tool at all ( non-pathways). Descriptive statistics and significance testing were used to explore CTP utilization over time, physician years in practice, cancer type, and cancer stage. Multinomial and binary logistic regression models were used to evaluate associated factors with CTP utilization. Results: During the study period, 1,007 treatment decisions were identified. Of these, 76% were pathways dependent, 13% were pathways independent, and 11% were non-pathways. CTP utilization was statistically significant in association with cancer type, cancer stage, physician years in practice, and year of encounter. In multinomial logistic regression models, physicians with more years in practice were more likely to be pathways independent and non-pathways than pathways dependent. Physicians treating colorectal or gastroesophageal cancer were more likely to be pathways independent [OR 3.27; 95% CI: 1.98-5.42 and OR 2.25; 95% CI: 1.12-4.49, respectively] or non-pathways [OR 2.98; 95% CI: 1.65-5.37 and OR 3.21; 95% CI: 1.58-6.54, respectively] than pathways dependent compared to physicians treating breast cancer. Treatment decisions for patients with either stage 2 and stage 4 cancers were more likely to be pathways independent than stage 1 cancers [OR 4.13; 95% CI: 1.44-11.84 and OR 4.37; 95% CI: 1.27-15.04, respectively]. Conclusions: This study found that a large proportion of treatment decisions for patients across different cancer types were made utilizing CTP tools, but utilization varies according to cancer type, stage, and physician years in practice. Further research is needed to better understand the physician decision making process and implementation of CTP tools to drive improvement in design, education, and training.