bluuebunny/crossref_metadata_2025_split huggingface dataset:
Results of NC-6300 (nanoparticle epirubicin) in an expansion cohort of patients with angiosarcoma.
Authors: Riedel Richard F. , Chua Victoria S. , Kim Ted , Dang Jonathan , Zheng Kitty , Moradkhani Ania , Osada Atsushi , Chawla Sant P. 
Published: June 2021

11543 Background: NC-6300 is a polymeric micelle exhibiting increased tumor accumulation compared to small-molecule epirubicin through enhanced pharmacokinetics and controlled release within the tumor through a pH-sensitive linker conjugated to epirubicin. In a phase 1b trial, which accrued twenty-nine patients with various types of sarcoma as well as solid tumors, observed dose-limiting toxicities included thrombocytopenia, stomatitis, lung infection, and febrile neutropenia. The maximum tolerated dose and the recommended phase 2 dose were determined to be 185 mg/m2 and 150 mg/m2, respectively. The objective response rate (ORR) in soft tissue sarcoma subset (n = 17) was 18% with both angiosarcoma patients achieving partial response. To further evaluate the anti-tumor activity of NC-6300 in angiosarcoma, we conducted an expansion cohort of 10 additional angiosarcoma patients. Methods: Eligible patients, at least age 18 years old, with histologically confirmed angiosarcoma, including cutaneous and non-cutaneous variants, not amenable to curative treatment with surgery or radiotherapy were included. No more than two lines of prior systemic therapy were allowed. NC-6300 was administered at the dose of 150 mg/m2 intravenously on Day 1 of a 21-day cycle. Treatment was continued until disease progression or unacceptable toxicity. Disease assessment was performed every 6 weeks using RECIST v1.1. The primary endpoint was median progression-free survival (mPFS). Results: Ten patients (cutaneous: 2 pts; non-cutaneous: 8 pts) were enrolled and deemed evaluable. Median line of prior systemic treatment in the advanced disease setting was 1.0 and seven patients (70%) received prior anthracycline therapy. Objective response rate (ORR) was 30% (cutaneous: 1 pt, non-cutaneous: 2 pts) and mPFS was 5.4 months (95% CI: 1.2-NA). Across all angiosarcoma patients included in the phase 1 portion and expansion cohort (phase 1b portion: 2 pts, expansion cohort: 10 pts), ORR and mPFS was 42% and 7.3 months (95%CI: 3.3-NA), respectively. All patients enrolled in the expansion cohort experienced grade 3/4 AEs and no treatment related death was observed. Most frequent grade 3/4 AEs were neutropenia without fever (80%), thrombocytopenia (40%), anemia (20%) and leukopenia (20%). AEs led to NC-6300 dose reduction and medication withdrawal were seen in 70% and 10% of patients, respectively. Conclusions: Promising anti-tumor activity was observed in this cohort of patients with cutaneous and non-cutaneous angiosarcoma. The safety profile of this expansion cohort was consistent with previous clinical study results of NC-6300. Our study results warrant further development of NC-6300 for angoisarcoma. Clinical trial information: NCT03168061.
Treatment patterns, and survival of patients with metastatic undifferentiated pleomorphic sarcoma: A National Cancer Database (NCDB) study.
Authors: Rangoonwala Hussain I , Dahl Mary Elizabeth , Gootee Jonathan , Gundepalli Sai Giridhar , Aurit Sarah J , Silberstein Peter T. 
Published: June 2021

11561 Background: Undifferentiated Pleomorphic Sarcoma (UPS) is regarded as one of the most common types of soft tissue sarcoma. Although prior studies have highlighted its metastatic potential, there have been no database studies that delineate the clinical/social characteristics and outcomes in UPS patients with metastatic disease. Utilizing the National Cancer Database (NCDB), we want to observe the complex interplay between treatment approaches and non-biologic modifiers. Methods: 737 patients diagnosed with metastatic UPS above the age of 17 years between 2004 and 2015 were identified utilizing the NCDB. Patients were identified with ICD-O-3 morphologic code 8830/3. Demographic factors (Race/ethnicity, biological sex, Median household income/education at zip code level, facility type, insurance) were studied in relation to the type of treatment they received: No treatment; chemotherapy only; chemotherapy and radiation therapy; chemotherapy and surgery; chemotherapy, surgery, and radiation; radiation therapy and/or surgery; and other treatments. Survival tables were utilized to generate 1-year and 3-year survival rates, and Kaplan-Meier method with associated log-rank list was used to examine the differences in unadjusted survival. Results: Approximately 17% of our cohort were left untreated, whereas 83% received treatment. Patients who were untreated were likely to be older, on Medicare, and had a Charlson-Deyo (CD) score of 2 or above. Patients who were more likely to receive treatment were younger educated males with private insurance, residing in areas of higher income, and receiving care at an academic program. Patients who only received chemotherapy were more likely to belong to areas with lower income and had a CD score of 0. Patients who received a combination of chemotherapy, surgery, and radiation therapy were more likely to belong to areas of high income, private insurance owners, and received care at an academic facility. Patients who received chemotherapy with surgery and without radiation therapy were more likely to be younger males from areas of highest income, and received care at an academic facility. Patients who had better unadjusted survival were younger educated patients on private insurance or Medicaid, with distant lymph nodes metastases at diagnosis, who received a combination of chemotherapy, radiation therapy and surgery at an academic program. Patients who had poorer unadjusted survival were untreated older patients on Medicare, and with bone metastases. Conclusions: This is one of the most comprehensive studies involving patients with metastatic UPS that analyzes demographic variables in relation to the treatment approach. Some of the major determinants that influence outcomes in these patients included age, insurance status, treatment at academic facility, CD score, and type of metastases at diagnoses.
The comparative effectiveness of direct oral anti-coagulants and low molecular weight heparins for prevention of recurrent venous thromboembolism in cancer: The CANVAS pragmatic randomized trial.
Authors: Schrag Deborah , Uno Hajime , Rosovsky Rachel Pam Greenerger , Rutherford Cynthia , Sanfilippo Kristen Marie , Villano John L. , Drescher Monic R , Jayaram Nagesh H. , Holmes Chris E. , Feldman Lawrence Eric , Zattra Ottavia , Cronin Christine , Basch Ethan M. , Weiss Anna , Connors Jean M. ,   CANVAS Investigators
Published: June 2021

12020 Background: Previous randomized trials in cancer patients suggest that DOACs are non-inferior to LMWH for preventing recurrent VTE but have higher risk of bleeding. However, the balance of benefits and burdens remains uncertain. Objective: The CANVAS pragmatic trial compared recurrent VTE, bleeding and death in cancer patients following an initial VTE treated with either DOAC or LMWH therapy. Methods: CANVAS was an unblinded hybrid comparative effectiveness non-inferiority trial, with randomized and preference cohorts. Between 12/16 and 4/20, 671 participants were randomized and followed for 6-months. Between 12/16 and 12/17, 140 participants declined randomization, chose their preferred anticoagulant and were followed for 6-months. The preference cohort was closed when predetermined stopping criteria were met. Final follow-up was 11/30/20. Randomized patients were assigned 1:1 to receive either a DOAC or a LMWH. If assigned to LMWH, transitions to warfarin were allowed. Physicians and patients could choose among any DOAC or LMWH. Doses were suggested based on FDA-approved labeling but not mandated. Patients from 67 practices in the US with any invasive solid tumor, lymphoma, multiple myeloma or CLL and a diagnosis of symptomatic or radiographically detected VTE within 30 days of enrollment were eligible. The 1° analysis was conducted in the randomized modified-into to treat popululation, (all subjects who received study drug). The 1° outcome was recurrent VTE. The aim was to establish noninferiority of anticoagulation with a DOAC as defined by the upper limit of the 2-sided 90% CI for the difference in the event rate at 6 months of < 3%. Secondary outcomes included death and bleeding. Hypothesis testing included only the randomized cohort but propensity score adjusted results for the preference and combined cohorts are also shown. Results: The non-inferiority criteria for recurrent VTE was met. Conclusions: Among adult cancer patients with VTE, the use of a DOAC compared with a LMWH resulted in a noninferior risk of recurrent VTE with no differences in rates of bleeding or death in randomized patients. Clinical trial information: NCT02744092. [Table: see text]
Real-world outcomes in older adults treated with immunotherapy: A United Kingdom multicenter series of 2,049 patients.
Authors: Olsson-Brown Anna Claire , Baxter Mark , Dobeson Caroline , Feeney Laura , Lee Rebecca , Maynard Alec , Mirza Shagufta , Parikh Shefali , Rodgers Lisa Jane , Salawu Abdulazeez , Shotton Rohan , Tinsley Nadina , Heseltine Jonathan , Cotton Jenny , Hughes Daniel , Zhao Steven , Parry James , Jones Christopher , Rowe Michael , Tivey Ann ,   The U.K. National Oncology Trainee Collaboration for Healthcare Research (NOTCH)
Published: June 2021

12026 Background: Immune checkpoint inhibitor (ICI) therapy is now commonly used in a range of tumours and settings. Most data relating to outcomes and rates of immune-related adverse events (irAE) is derived from clinical trial or registry populations and small case series. Limited data exist for patients aged > 75 years. Here we present a multi-centre, real-world analysis of the outcomes and incidence of irAEs in older adults managed within a single comprehensive public health service. We also compare these outcomes to younger patients in the same cohort. Methods: A retrospective analysis of 2049 patients treated with ICIs was undertaken across 12 centres. All patients were managed within the UK National Health Service outside of a trial setting between June 2016 and September 2018. Patients received either ICI monotherapy (MT) or duel combination ICI therapy (CT) for malignant melanoma (MM), non-small cell lung cancer (NSCLC) or renal cell cancer (RCC). Data were collected using a standardised, collection tool. IrAEs ≥ grade 2 or all-grade endocrinopathies were recorded as per the Common Terminology Criteria for Adverse Events (V5) (CTCAE). Statistical analyses were performed using T-tests, Mann-Whitney and Chi-squared. Kaplan-Meier analysis and log-rank test were used for overall survival (OS) analysis. Results: 409 (20%) of patients were aged > 75 years(a), 1413 (69%) aged 50-75(b) and 227 (11.1%) aged < 50(c). There was no difference in sex, ethnicity or PD-L1 status (in the NSCLC cohort) between groups. Older patients were less likely to receive combination therapy (3%(a) v 13%(b) v 34%(c), p < 0.001). There was no difference in median OS across age groups in the cohort as a whole (p = 0.822) or for the individual tumour groups when treated with single agent ICI. Across the total cohort patients aged > 75 had no increased risk of any irAE (35%(a) v 33%(b) v 41%(c),p = 0.074). However there was an increase in irAEs in older patients treated with MT (36%(a) v 26(b) v 25%(c), p = 0.011) However there was no difference in the > 75s with regard to severe (G3/4) toxicity, toxicity type, admission or discontinuation due to toxicity in the aPD-1 group. In the overall cohort younger patients were more likely to develop irAEs and be admitted. Conclusions: Patients aged > 75 years treated with anti-PD1 therapy in the standard of care setting derive similar survival benefit to younger patients. There was no increase in ≥G3 toxicity. Our data support the safety of single agent aPD-1 ICI therapy in older adults and provide reassurance relating to the impact of toxicity.[Table: see text]
Investigating the prevalence and risk of chemotherapy-induced neuropathy among cancer patients.
Authors: Jordache Philip , Danahey Keith , Reizine Natalie Marie , O'Donnell Peter H. 
Published: June 2021

12078 Background: Neuropathy is a common side effect of some chemotherapies. Clinical and other factors may confer neuropathy risk, but rates and risk factors across neuropathy-causing chemotherapies are incompletely understood. Methods: We examined 15 chemotherapy drugs known to confer neuropathy. Within a broad population of cancer patients who underwent treatment with these agents at the University of Chicago Medicine between 2012-2018, we determined prevalence of chemotherapy-induced neuropathy, defined as patients with initiation of a neuropathy treatment medication (amitriptyline, carbamazepine, duloxetine, gabapentin, or pregabalin) after starting chemotherapy. We then analyzed chemotherapy-induced neuropathy risk for different drugs and based on clinical demographic factors. Results: We analyzed 7,866 patients (65.3% White, 53.7% Female, 27.6% Black/African-American, 5.6% Hispanic or Latino, 3.1% Asian/Mideast Indian, 2.4% More than one Race, 0.2% American Indian or Alaska Native, 0.2% Native Hawaiian/Other Pacific Islander). The overall prevalence of chemotherapy-induced neuropathy was 24.3% across our patient population. Black/African-American patients had an increased risk of chemotherapy-induced neuropathy compared to the rest of the patient cohort (OR 1.4, 95% CI 1.3-1.6, P = 1.6e-10). Females also exhibited an increased risk of chemotherapy-induced neuropathy compared to males (OR 1.2, 95% CI 1.1-1.3, P = 1.5e-3). Conclusions: Certain chemotherapy agents confer substantial risk of chemotherapy-induced neuropathy, and risk is increased in Blacks and females. Future work will investigate additional risk-modifying factors including the potential role of germline polymorphisms on chemotherapy neuropathy risk.[Table: see text]
Receipt of palliative care (PC) in acute myeloid leukemia (AML) using data from the National Cancer Database (NCDB).
Authors: Chan Bryan Lee , Taylor Allison O. , Doucette Kimberley , Ahn Jaeil , Ma Xioyang , Lai Catherine 
Published: June 2021

12087 Background: AML is an aggressive disease with high mortality and significant impact on quality of life. Palliative care (PC) services have become integral in managing patient’s symptoms during treatment as well as at the end of life. We hypothesize that socioeconomic factors such as achieving higher levels of education, and higher incomes, increases the odds of receiving PC. Methods: This is a retrospective analysis using NCDB data of 124,988 newly diagnosed non-M3 AML patients over 18 yrs from 2004-2016. Unadjusted and multivariate adjusted logistic regression analysis (MVA) evaluated the impact of socioeconomic variables on the receipt of PC. In the MVA, we adjusted for demographic variables and facility characteristics including facility type, facility volume, age, sex, race, Hispanic origin, income, education, urban/rural residence, Charlson-Deyo score, great circle distance, Medicaid expansion status state group, and insurance status. Patients with Medicaid expansion < 39yrs were excluded due to low patient numbers. Results: For the 124,988 patients, median age was 63 years (range 18-90) with 54% males and 86% White. 25% of patients lived in regions with the highest education level defined as < 6.3% of adults over 25 without a high school diploma. 35% of patients had a household income bracket of ≥ $63,333. A total of 3% of patients received PC. MVA showed that patients within the highest income bracket of ≥ $63,333 were less likely to have used PC services (OR 0.82, p < 0.01). More educated patients residing in regions with < 6.3% of adults without a high school diploma had higher odds of receiving PC treatment compared with patients with less education (OR 1.23, p < 0.01). Residence in states with Medicaid expansion in January 2014 or later was associated with greater utilization of PC services (Jan 2014 expansion states: OR 1.33 and late expansion states/after Jan 2014: OR 1.43, p < 0.01) compared to residence in non-expansion states. No difference was seen across races; except Hispanics with decreased use of PC services(OR 0.8, p = 0.022). Conclusions: In this large cohort, a small percentage of patients received PC. Higher education was associated with higher likelihood of using PC, while, surprisingly, higher income was associated with a lower likelihood of PC. Additionally, the higher use of PC services with Medicaid expansion suggests a broad impact of public health insurance in providing increased access to PC services.
Implementation of electronic patient-reported outcomes for symptom monitoring in a large multi-site community oncology practice.
Authors: Patt Debra A. , Wilfong Lalan S. , Hudson Kathryn Elizabeth , Patel Amila , Books Holly , Ortega Lance , Pearson Ben , Boren Rhonda , Patil Shrutika , Olson-Celli Kristin , Basch Ethan M. 
Published: June 2021

12103 Background: Among patients receiving chemotherapy, symptomatic adverse event monitoring with electronic patient-reported outcomes (ePRO) is associated with improved clinical outcomes, satisfaction, and compliance with therapy. Standard approaches for ePRO implementation are not established warranting evaluation in community cancer practices. Objective: Evaluate implementation of ePRO symptom monitoring across a large multi-site community oncology practice network. Methods: Patients initiating a new systemic therapy at one of 210 practice sites in the Texas Oncology Practice were invited to use in the Navigating Cancer ePRO platform, with rolling implementation from July-December 2020. Participating patients received a weekly prompt by text message or email (patient choice) to self-report common symptoms and well-being via web or smartphone. Severe self-reported symptoms triggered a real-time notification alert to nursing triage to address the symptom. Enrollment and compliance were systematically tracked weekly with evaluation of barriers and facilitators to adoption and sustainability. Results: 4375 patients planning systemic treatment enrolled and participated, with baseline characteristics are shown in Table 1. 73% (1841/2522) of enrolled patients with follow up completed at least one ePRO assessment, and among these individuals, 65% (8762/25061) of all available weekly ePRO assessments were completed. Over a 10-week period, compliance with weekly symptom reporting declined from 72% to 52%. Patients on oral therapy had higher compliance rates overall. Barriers currently being addressed include lack of a second reminder text/email prompt, inconsistent discussion of reported ePROs by clinicians at visits, and COVID-related changes in workflow. Facilitators included patient and staff engagement on the importance of PROs for symptom management. Conclusions: ePROs can be effectively implemented in community oncology practice. Utilization of ePROs is high, but diminishes over time without attention to barriers. Ongoing work to address barriers and optimize compliance are underway.[Table: see text]
Evaluating a high-dimensional machine-learning model to predict hospital mortality among elderly cancer patients.
Authors: Qiao Edmund , Qian Alexander , Nalawade Vinit , Lee Terrence C. , Kotha Nikhil V. , Voora Rohith S. , Dameff Christian , Coyne Christopher John , Murphy James Don 
Published: June 2021

1512 Background: Elderly hospitalized cancer patients face high risks of inpatient hospital mortality. Identifying patients at high risk of hospital mortality could help with risk stratification, and potentially help inform future interventions aimed at improving outcomes. We evaluated the predictive capacity of a high-dimensional machine-learning prediction tool to predict inpatient mortality, and compared the performance of this new tool to existing prediction indices. Methods: We identified cancer patients 75 and over who presented to an emergency department (ED) and were subsequently hospitalized from the National Emergency Department Sample (NEDS) between 2016 and 2018. We used an extreme gradient boosting approach to predict the risk of death during hospitalization. Model covariates included patient demographics, hospital characteristics, and International Classification of Diseases, version 10 (ICD-10) diagnosis codes recorded during the ED visit. The data were split 75%/25% into training/testing datasets. We constructed the model with training data and evaluated performance within the test data using area under the curve (AUC), with an AUC of 1.0 indicating perfect prediction. We compared the performance of this risk prediction model to standard prediction indices including the Hospital Frailty Risk Score, modified 5-item frailty index, and Charlson comorbidity index. Results: We identified 1,892,690 weighted-hospitalizations among elderly cancer patients, of which 133,379 (7.0%) who died in the inpatient setting. Our final predictive model included 238 features, which contained 5 demographic variables, 3 hospital characteristics, and 230 ICD-10 diagnosis codes. The predictive model achieved an AUC of 0.92. Our comparator models including the Hospital Frailty Risk Score, modified 5-item frailty index, and Charlson comorbidity index achieved AUCs of 0.67, 0.56, and 0.60, respectively. Conclusions: Using a high-dimensional machine-learning model enabled a high level of precision in predicting hospital mortality among elderly cancer patients, substantially out-performing existing prediction indices. High-dimensional prediction models show promise in helping to identify patients at risk of severe adverse outcomes, though additional validation is needed as well as research studying how to implement these tools into practice.