bluuebunny/crossref_metadata_2025_split huggingface dataset:
Physician burnout: An innovative way to find “sanity out of madness” in the infusion center of a cancer institute.
Authors: Sewaralthahab Sarah , Thorne Shaunika , King Linda , Goswami Debolina , Gallagher Christopher , Kaufman Laura , Veytsman Irina 
Published: May 2020

e19246 Background: Physician burnout is affecting over 50% of physicians in the US alone and is related to the high workload, loss of anonymity and a sense of powerlessness in the face of multiple bureaucratic hurdles. The result is physical exhaustion, moral distress, high turnover and increased rates of suicide. Methods: The faculty and staff at Washington Cancer Institute (WCI) were surveyed using AMA/ASCO burnout questionnaire to identify burnout rates. A brainstorming session with staff captured the perceived causes of burnout in a fishbone diagram, and the most prominent cause was noted to be pertaining to delays in the infusion center (IC) related to chemotherapy orders. We tracked causes of delay in starting chemotherapy from 7/23/19 to 8/7/19, and utilizing a Pareto Chart identified that over 80% of the delays were due to missing chemotherapy orders on the day of IC appointment. Process flow charts were developed for all provider teams at WCI noting variations that may be leading to delays. The aim was to decrease the number of missing chemotherapy orders for patients coming to the IC by 50%, decreasing the resultant stress on providers and IC nurses. Results: By retrospective chart review, 6/21/2019 to 8/30/ 2019, an average of 13.18% of patients scheduled to receive chemotherapy at WCI IC had missing orders on the day of the infusion, which resulted in up to a 111-minute delay in starting chemotherapy. This, in turn, resulted in stress/burnout among 42.1% of providers and 55.6% of supportive staff. To remedy the problem, we implemented 4 interventions over two plan-do-study-act (PDSA) cycles. In the first PDSA cycle the process was standardized to obtain necessary labs 48 hours prior to IC appointment and review and sign orders by 2 pm the day prior to IC appointment. Email notifications were also sent to all providers and nurse navigators regarding missing orders 48 hours prior to IC appointment. In the second PDSA cycle we continued with the previous interventions in addition to addressing pharmacy related delays in releasing premedication if dose adjustments of chemotherapy are needed. In the time period of 10/2/2019 to 11/11/2019, two PDSA cycles were implemented and resulted in a decrease in the average number of missing orders on the day of IC appointment to 7% achieving our aim. Conclusions: Using a systems approach to standardize the process promotes a more effective environment in the work place and decreases burnout on physicians and staff.
Incorporating molecular markers in standard prognostic models for DLBCL patients using real-world data.
Authors: Mathura Shivam , Fung Vicki Kay , Dilwali Keshava , Lakshmanan Ashwin Subramanian 
Published: May 2020

e19251 Background: NCCN-IPI is a prognostic scoring system that outperforms other risk classification mechanisms in diffuse large B-cell lymphoma (DLBCL) but does not consider the molecular profile of patients. We evaluated the predictive value of NCCN-IPI and clinically relevant molecular markers on the overall survival (OS) of patients with diagnosed DLBCL in real-world data (RWD). Methods: Patients diagnosed with DLBCL were identified in the COTA RWD population, and then subset to those with sufficient attributes to calculate NCCN-IPI at diagnosis (age, stage, LDH ratio, performance status, extranodal disease) and those who received a monoclonal antibody targeting CD20 (n = 383). This population was further filtered to patients tested for BCL-2, BCL-6, and C-MYC (n = 176). Disease characteristics were summarized using descriptive statistics and chi-square tests of independence were performed to assess the relationship between NCCN-IPI Risk-Group and molecular marker results. A Cox proportional hazard model was used to identify prognostic features of OS. Results: There were statistically significant relationships between NCCN-IPI Risk-Group and both BCL-2 (p = 0.007) and C-MYC (p < 0.001) after Bonferroni correction for the number of molecular markers tested. A Cox proportional hazard model with the three molecular markers as covariates revealed a statistically significant correlation between the presence of C-MYC alteration and decreased OS (HR = 2.02, CI: 1.24-3.32, p = 0.005). However, when NCCN-IPI Risk-Group was added as a covariate, the relationship between C-MYC and OS was no longer significant. The hazard ratios associated with high-intermediate and high risk groups were larger than that of the low-intermediate group. All three of these risk groups were statistically significant in the model (p < 0.038). Conclusions: The inclusion of molecular markers to the NCCN-IPI prognostic model did not increase predictive power in this RWD cohort. We validated the NCCN-IPI model and found it to be a robust tool for classifying risk and estimating OS in patients who have received a CD20 monoclonal antibody. A larger sample size would increase power to further explore the impact of molecular markers on overall survival. [Table: see text]
The role of non-oncology specialties in the real world longitudinal journey of prostate cancer patients.
Authors: Carnegie Daniel , Argentinis Elenee , Mazumder Dibyajyoti , Dhangar Indu 
Published: May 2020

e19255 Background: Electronic health records (EHRs) are increasingly being recognized by regulators and researchers as reliable sources of evidence. It is therefore critical that real world evidence databases accurately reflect all diagnostics and interventions that could affect patient outcomes. Some of the commercially available datasets source data solely from oncology clinics, which may not reflect patients’ full care journey. This analysis assessed the contribution of non-oncology specialties to prostate cancer care. Methods: Newly diagnosed prostate cancer patients with encounters between Jan 2014 to Dec 2017 were analyzed from the deidentified Optum Electronic Health Record Data Repository. Diagnostic procedures 6 months prior to the index date (first diagnosis date within the study period) and 1 year post index date were identified. Attending physician specialties were identified. All treatment related encounters up to 1 year post the index dates were mapped by specialty. Codes were verified by certified medical professional. Results: A total of 186,299 prostate cancer patients were identified between Jan 2014 to Dec 2017. In the 6 months prior to index date, biopsy was most commonly ordered by urologists (70%), followed by surgical specialists (14%). Biomarker tests were ordered mostly by general practitioners (40%) followed by urologists (18%). The trend was similar for 1 year post biopsy and other histology procedures. Interestingly, a large portion of treatment encounters was observed outside oncology: 48% of surgical management by urologists (48%), chemotherapy was prescribed by both oncologists (27%) and urologists (31%) in a similar ratio, while radiotherapy was performed predominantly by radiation oncologists (81%). Conclusions: In prostate cancer, a large proportion of care encounters occur outside oncology specialties, with urology conducting a significant proportion of diagnostic testing and early treatment. Restricting source data to oncology specialties may omit key factors affecting patients’ outcomes, therefore data for such studies should reflect the entire care continuum.
Hepatic failure in malignancy: A nationwide analysis.
Authors: Baral Binav , Vohra Ishaan , Attar Bashar , Katiyar Vatsala , Lingamaneni Prasanth , Moturi Krishna Rekha , Banskota Shristi Upadhyay , Malapati Sindhu Janarthanam , Singh Sunny R K , Farooq Muhammad Zain , Ba Aqeel Sheeba Habeeb , Gupta Shweta 
Published: May 2020

e19257 Background: Hepatic failure (HeF) accounts for 6% of all liver-related mortality and 7% liver transplants (LT) in the US. Epidemiologically, while viral hepatitis, acetaminophen and drug injuries are common; malignancy-related HeF remains relatively unexplored. Methods: We performed a retrospective study using nationwide inpatient database (NIS) 2016, which is the largest US inpatient database. HeF admissions were identified as primary diagnosis (through ICD-10 codes) and stratified into two major groups with and without cancer. The cancer group was subdivided into solid (excluding hepato-cellular cancer (HCC)) and non-solid malignancies. Primary outcome was inpatient mortality while secondary outcomes included Length of stay (LOS), Total charge (TCHG), LT and respiratory failure requiring ventilation (MV). Results: 71,000 inpatients met inclusion criteria for HeF, of which 7,715(10.87%) had an underlying malignancy. 39.4%( n = 3,045) had solid malignancies (excluding HCC), 8.4%( n = 650) had non-solid malignancies and 56%( n = 4,020) had HCC. Mean LOS was 5.4 days (95% CI 5.4-5.6, p = 0.23) and mean TCHG was 63,240$(95% CI 57,258$-69,222$, p = 0.03). African Americans (61.2 % vs 53.6%, p = 0.001) and males (12.05% vs 8.71%, p = 0.001) were preponderant in the cancer group. Inpatient mortality was higher in the cancer group (15.3% vs 5.5% p = 0.000), among which solid cancer (20.39%) predominated over non-solids (13.85%) and HCC (11.71%). LT was higher in cancer group (3.7 % vs 2%), whereas no difference in MV was found. Multivariable analysis results are summarized in the table below. Conclusions: HeF patients with underlying malignancy have higher mortality, LOS, TCHG and LT rates. Furthermore, high median income, large center admissions, HCC and Charlson index < = 3 among others were associated with higher odds of undergoing LT in HeF. This study sheds light on the epidemiology and impact of HeF in cancers, as well as disparities in LT among GI cancer patients with HeF. [Table: see text]
Safety of immunotherapy in Peruvian patients with diverse type of malignancies: Experience at a private center.
Authors: Aguilar Alfredo , Mariñas Michelle , Bravo Leny , Zavaleta Jenny , Pinto Joseph , Ruiz Rossana , Schwarz Luis 
Published: May 2020

e19258 Background: Immunotherapy has changed the landscape of cancer treatment. The aim of this work was to describe the adverse events related to immunotherapy treatment in diverse type of malignant tumors using real-world data. Methods: This is a retrospective review of patients with diverse type of advanced malignancies treated with immunotherapy at Oncosalud-AUNA (Lima-Peru) during the period 2016-2018. We present a descriptive analysis of the clinicopathological and treatment features of the patients, as well as data of safety of immunotherapeutic agents. Results: In total, 37 patients were included in the study. The median age was 67 years (38 to 84 years); 64.9% of patients were male; 54.1% were smoker/former smoker and 45.9% non-smokers. Regarding to the primary tumor, 75.7% were lung cancers (82.1%, adenocarcinomas and 17.9%, squamous cell carcinomas), 16.2% were melanomas, 5.4, head and neck cancers and 2.7%, were bladder cancers. Central nervous system metastases were present in 29.7% of patients. Immunotherapy was given after a first line in 43.2% of cases, 40.5% after the second line and 16.2%, after the third line of treatment. The types of immunotherapy were prembrolizumab in 54.1%, nivolumab in 40.5%, atezolizumab in 2.7% and avelumab in 2.7%. 27% of cases had combination of immuno with chemotherapy. Finally, regarding to adverse events, 94.6% had any adverse event; 48.6% fatigue and asthenia; 35.1%, nausea; 32.4, pruritus/rash; 27.7%, decreased appetite; 18.9%, hypo/hyperthyroidism; 13.5%, diarrhea/colitis; 10.8%, pneumonitis and 5.4%, infusion-related reactions. Conclusions: During the study period we had a slightly higher incidence of adverse events than reported by other works. It could be probably due to the age of patients and several prior lines of treatment.
Clinical outcomes of pancreas cancer patients with peritoneal spread: Results from the chord consortium.
Authors: Pauls Mehrnoosh , AlJassim AlShareef Abdulaziz , Cheung Winson Y. , Goodwin Rachel Anne , Meyers Brandon M. , Kim Christina , Vickers Michael M. 
Published: May 2020

e19268 Background: Prior studies have demonstrated that clonal cells that give rise to pancreatic peritoneal metastases (PM) are geographically and genetically distinct from clonal cells, giving rise to lung and liver metastases. The objective of this study was to assess if there is a distinct difference in prognosis and therapeutic response among patients with pancreatic cancer with (PM compared to the lung/liver. Methods: Using a retrospective cohort design, medical records from adult patients diagnosed with metastatic adenocarcinoma of the pancreas at five Canadian academic cancer centers (2014 - 2019) were reviewed. Prognostic variables including age, Charlson comorbidity index, ECOG, cigarette smoking, nodal status, sites of metastases, and first line chemotherapy were collected. Cox proportional hazards model (MVA) was used to examine the association between peritoneal involvement and survival, adjusted for measured confounders. Analyses were completed using SAS, where alpha of 0.05 was defined as the level of significance. Results: A total of 1161 patients were included. Metastatic sites included peritoneum (n = 170, 14.6%), lung (n = 145, 12.5%) and liver (n = 563, 48.5%). Patients with PM received first-line FOLFIRINOX (FFX, n = 31), Gemcitabine + nab-paclitaxel (G/N, n = 20), Gemcitabine (G, n = 18), and no treatment (n = 97). In univariate analyses, worse ECOG PS was associated with PM (p = 0.002). The majority of patients died (89%), with a median overall survival (OS) of 3 vs 7 months for patients with PM and those without PM (p < 0.001), respectively. The median OS in patient whom receive first-line chemotherapy was 7 months in FFX group (95% CI 1.66-12.33), 6 months in G/N (95% CI 4.54-7.45) and 2 months in G group (95% CI 1.42-2.57). Patients had significantly better OS when treated with FFX or G/N compared to G alone (p = 0.002). Time to treatment failure was significantly shorter among patient treated with G alone compare to patients treated with FFX and G/N (P < 0.005). Conclusions: In the setting of combination chemotherapy for advanced pancreatic cancer, patients with PM continue to have a poor prognosis. This may be due to the impact of PM on PS and the inability to administer palliative chemotherapy. For eligible patients, FFX or G/N results in a higher OS than G monotherapy.
Overall survival (OS) in advanced non-small cell lung cancer (aNSCLC) patients treated with frontline chemotherapy or immunotherapy by comorbidity: A real-world data (RWD) collaboration.
Authors: Rivera Donna R. R , Lasiter Laura , Christian Jennifer , Enewold Lindsey , Espirito Janet L. , Hansen Eric , Henk Henry J. , Kushi Lawrence H. , Lane Daniel , Natanzon Yanina , Pe Benito Ruth , Rasmussen Erik , Robert Nicholas J. , Stewart Mark , Sweetnam Connor , Tymejczyk Olga , Valice Emily , Wagner Joseph , Zander Alia , Allen Jeff 
Published: May 2020

e19270 Background: Friends of Cancer Research convened 9 data partners to identify data elements and common definitions for real world (rw) endpoints to evaluate populations typically excluded from clinical trials. Here we report on rwOS by frontline treatment and comorbidities. Methods: A retrospective observational analysis of patients with aNSCLC initiating frontline platinum doublet chemotherapy (chemo) or PD-(L)1-based immuno-oncologic (IO) therapy (monotherapy or chemo combination) between 1 Jan 2011 to 31 Mar 2018 was conducted using administrative claims, EHR, and cancer registry RWD. We evaluated rwOS from frontline therapy initiation using Kaplan-Meier methods, stratified by ECOG status, brain metastases (ICD), history of chronic kidney or liver disease (CKD/ CLD, ICD), and evidence of kidney or liver dysfunction (KD/ LD, lab-based). Results: A total of 33,649 patients were included (N 972-17,454) with 10 to 26% of patients receiving IO as frontline therapy. There was a broad range of comorbidity prevalence across datasets and patients with evidence of comorbidity had comparatively shorter 12-month OS (Table). Conclusions: RWD analyses can generate expanded evidence on patient outcomes for populations routinely excluded from clinical trials and may help inform decision making where sparse data exist on appropriate treatment approaches. Additional understanding of data missingness, sensitivity of definitions, and covariate adjustment are needed to make direct comparisons across regimens and data sources. [Table: see text]
Udenyca has equivalent efficacy to the pegfilgrastim originator in breast cancer patients receiving highly myelosuppressive chemotherapy.
Authors: Webster Jennifer , Scott Jeffrey A. , Smith Helen , Wieland Danielle , Donaldson Joseph , Catasus Casey , Smith Robert E. 
Published: May 2020

e19273 Background: In late 2019, the Center for Medicare and Medicaid Innovation (CMMI) issued a request for information (RFI) for the Oncology Care First (OCF) program, which will extend the evaluation of value-based care in the community oncology setting for an additional five years, through 2026. We have learned through the Oncology Care Model (OCM) that there are savings to be found by reducing inpatient admissions and emergency department visits and controlling for things such as duplicate labs. However, it has become increasingly clear that further savings will require practices to evaluate their use of both cancer-directed therapy and supportive therapy. To this end, Integra Connect has developed a tool, the Value Monitor, that allows for statistically rigorous comparative effectiveness research at scale, using real world data. As an initial proof of concept, we used the Value Based Care Monitor to compare the efficacy for febrile neutropenia prophylaxis between two pegfilgrastims: Udenyca, a biosimilar, and Neulasta, the originator. Methods: The Integra Connect Value Monitor was used to perform a matched cohort analysis of breast cancer patients receiving Udenyca vs patients receiving Neulasta from 1/1/2017 – 8/31/2019. Patients were matched on age (within 5 years), gender, OCM participation status and date of treatment (within 90 days). Each Udenyca patient (n = 496) was matched to 5 Neulasta patients. The efficacy endpoint was neutropenia rate, where neutropenia was defined as the presence of a neutropenia ICD-10 code (D70*), and/or an Absolute Neutrophil count less than 1,500. We are in the process of adding grade IV neutropenia (ANC < 500) to the tool. Results: Udenyca and Neulasta showed similar rates of neutropenia at 28.6% and 29.1% respectively (McNemar’s p-value 0.82). These rates are likely higher than those reported in the literature due to the very broad definition of neutropenia used in this study. Follow up will include neutropenia rates by grade. Conclusions: This proof of concept study established two key findings. First, that it is possible to do comparative effectiveness research at scale in order to drive value-based decisions in oncology care. Secondly, it confirms that we are seeing equivalent pegfilgrastim efficacy for neutropenia prophylaxis when comparing Udenyca, a biosimilar, to the originator agent.
Rates of primary prophylaxis for venous thromboembolism in high-risk patients with pancreatic and gastric cancer: A single tertiary care academic center experience.
Authors: Martin Karlyn , Molsberry Rebecca , Khan Sadiya S , Benson Al Bowen 
Published: May 2020

e19274 Background: Venous thromboembolism (VTE) causes significant morbidity and mortality in patients with cancer. The International Society of Thrombosis and Hemostasis published guidelines in 2014 recommending a risk-based approach to VTE prophylaxis in ambulatory cancer patients, but uptake in real-world clinical practice is unknown. This study's objective was to describe rates of primary VTE prophylaxis in ambulatory patients with gastric and pancreatic cancer receiving chemotherapy and at increased risk of VTE. Methods: We identified patients at a single academic tertiary care center who received chemotherapy from 1/1/2015 to 10/1/2018 for a diagnosis of pancreatic or gastric cancer through retrospective query of electronic health records. Data abstracted included the Khorana score components (body mass index, leukocyte, hemoglobin, and platelet counts) on day of chemotherapy initiation, anticoagulation prescription, and VTE diagnosis within 6 months of chemotherapy initiation. Patients were excluded if they had contraindications to anticoagulation or alternate indications for anticoagulation. Results: We identified 437 patients, of which 72% had pancreatic cancer and 29% had gastric cancer. Mean (standard deviation) age was 64.2 (11.7) years, and patients were predominately male (54%) and white (75%). Overall, only 13% of patients received a prescription for anticoagulation with similar rates in patients with pancreatic cancer (14%) compared to gastric cancer (9%). Anticoagulation prescription rates by Khorana score (2 or ≥3) are shown in Table. Approximately 10% of patients had a VTE within 6 months of chemotherapy initiation. Conclusions: Our results show that in a cohort of patients with gastric and pancreatic cancer at intermediate to high-risk of VTE by Khorana score (≥2), only 1 in 10 received a prescription for prophylactic anticoagulation. In addition, we observed high rates of incident VTE in 6-month follow-up confirming the high-risk nature of this group. Opportunity remains to enhance implementation of primary VTE prevention in clinical practice to reduce VTE morbidity and mortality in patients with cancer. [Table: see text]
Real-world sustained minimal residual disease (MRD) negativity using NGS in multiple myeloma.
Authors: Demaree Audrey , Hewitt Anthony , Lee Lik Wee , Eckert Benjamin 
Published: May 2020

e19280 Background: MRD assessment has been increasingly incorporated into guidelines and routine care for patients (pts) with multiple myeloma (MM). It has been widely shown that pts who achieve deep MRD negativity (MRD-) have longer PFS/OS. Clinical guidelines now include sustained MRD- (two consecutive MRD- results; (10−5, 12 mo. apart) as a response criterion. . NGS MRD (clonoSEQ; Adaptive Biotechnologies; Seattle, WA) is the only FDA authorized method for bone-marrow MRD assessment in MM. A large longitudinal database of quantitative NGS MRD values from routine patient care now enables real-world analysis. We used our data to provide insight into testing patterns and sustained MRD-. Methods: The population included internal data of NGS MRD clinical samples from Jan 2018 to Jan 2020. We examined MRD- achievement overall and sustained MRD- as defined by guidelines. For pts who achieved sustained MRD- and had subsequent MRD testing, we examined if they remained in an MRD- state. Results: We identified 1,675 pts with MM who had ≥1 MRD tests after baseline Clonality (ID) assessment. The age/sex distribution (med. age = 65; 58% male) was consistent with epidemiologic data. 837 (49.9%) and 541 (32.2%) achieved MRD- at 10−5 or 10−6 thresholds, respectively. Of the 190 pts with ≥2 MRD tests at least 12 mos. apart, 82 (43.2%) and 45 (23.7%) had sustained MRD- at 10−5 and 10−6 thresholds, respectively. Of 82 pts who achieved 12 mo. sustained MRD- at 10−5, 15 had a subsequent MRD test, of which all remained MRD-. Of 45 pts who achieved 12 mo. sustained negativity at 10−6, 4 had a subsequent MRD test, of which all remained MRD-. Conclusions: We believe this represents one of the earliest real-world study examining NGS MRD attainment of sustained MRD- defined by guidelines. It is notable that many pts reached deep MRD negativity, with a significant percentage having sustained MRD negativity meet guideline-defined criteria. Long-term follow-up and incorporation of clinical parameters & outcomes data will enable further insights from this real-world dataset. [Table: see text]