bluuebunny/crossref_metadata_2025_split huggingface dataset:
Predicting major bleeding events in anticoagulated cancer patients with venous thromboembolism using real-world data and machine learning.
Authors: Muñoz Martín Andrés J. , Palacios María Luisa , Souto Juan Carlos , Obispo Berta , Aparicio Jorge , Garcia-Palomo Andres , Sanchez Antonio , Aguayo Cristina , Gutierrez Abad David , Viñuela-Benéitez Maria Carmen , Benavent Diego , Taberna Miren , Arumi Daniel , Hernández-Presa Miguel Ángel 
Published: June 2022

e18744 Background: Evidence regarding the clinical predictors of bleeding risk in patients with cancer and venous thromboembolism (VTE) is lacking. Our aim was to develop a predictive model to assess the risk of major bleeding (MB) in anticoagulant-treated patients with active cancer during the first 6 months following VTE diagnosis. Methods: Observational, retrospective, and multicenter study based on the secondary analysis of unstructured clinical data in electronic health records (EHRs). Using the EHRead technology, based on Natural Language Processing (NLP) and machine learning (ML), data were collected from EHRs from 9 Spanish hospitals between 2014 and 2018. The study population comprised all adult cancer patients with a diagnosis of VTE under anticoagulant treatment and no history of MB. This population was downsampled to prevent bias and class imbalance. A total of 94 patient characteristics were explored, and Random Forest (RF) feature selection was performed to identify the most relevant predictors. Multiple algorithms were used to train different prediction models, which were subsequently validated in a hold-out dataset. The model with the best performance metrics (i.e., ROC-AUC) was selected as the final model. Results: Among a source population of 2,893,208 patients, 21,227 anticoagulant-treated patients with VTE and active cancer were identified from EHRs. Of these, 53.9% men, with a median age (Q1, Q3) of 70 (59,80) years. The median duration of follow up across all patients was 0.7 (0.11, 2.03) years. During the study period, estimated in-hospital prevalence of cancer-related VTE was 5.8 %. The most common type of VTE at baseline was deep vein thrombosis (68.2 % of patients), followed by pulmonary embolism (28.4%). The most frequent primary cancers were colorectal (10.1%) and lung cancer (8.5 %). Of all trained and validated models, the RF approach yielded the best performance, with a ROC-AUC = 0.7. The following predictors of MB were identified: hemoglobin levels, presence of metastasis, patient’s age, platelet count, leukocyte count, and serum creatinine levels. Conclusions: This is the first multicenter study to use NLP to extract the unstructured information from EHRs to develop a predictive model for MB in anticoagulated cancer patients with VTE. These results may improve the prevention and management of bleeding in these patients.
Post-acute sequelae of SARS-CoV-2 infection in patients with cancer.
Authors: Warner Jeremy Lyle , Pinato David J. James , Mishra Sanjay , Saliby Renee Maria , Hwang Clara , Gulati Shuchi , McKay Rana R. , Labaki Chris , Griffiths Elizabeth A. , Jani Chinmay , Yu Peter Paul , Portuguese Andrew Jay , Puc Matthew , Egan Pamela , Shah Sumit , Kasi Anup , Berg Stephanie A. , Flora Daniel Blake , Accordino Melissa Kate , Shah Dimpy P ,   COVID-19 and Cancer Consortium
Published: June 2022

e18746 Background: Most patients with cancer and COVID-19 will survive the acute illness. The longer-term impacts of COVID-19 on patients with cancer remain incompletely described. Methods: Using COVID-19 and Cancer Consortium registry data thru 12/31/2021, we examined outcomes of long-term COVID-19 survivors with post-acute sequelae of SARS-CoV-2 infection (PASC aka “long COVID”). PASC was defined as having recovered w/ complications or having died w/ ongoing infection 90+ days from original diagnosis; absence of PASC was defined as having fully recovered by 90 days, with 90+ days of follow-up. Patients with SARS-CoV-2 re-infection and records with low quality data were excluded. Results: 858 of 3710 of included patients (23%) met PASC criteria. Median follow-up (IQR) for PASC and recovered patients was 180 (98-217) and 180 (90-180) days, respectively. The PASC group had a higher rate of baseline comorbidities and poor performance status (Table). Cancer types, status, and recent anticancer treatment were similar between the groups. The PASC group experienced a higher illness burden, with more hospitalized (83% vs 48%); requiring ICU (29% vs 6%); requiring mechanical ventilation (17% vs 2%); and experiencing co-infections (19% vs 8%). There were more deaths in the PASC vs recovered group (8% vs 3%), with median (IQR) days to death of 158 (120-272) and 180 (130-228), respectively. Of these, 9% were attributed to COVID-19; 15% to both COVID-19 and cancer; 15% to cancer; and 23% to other causes. Conversely, no deaths in the recovered group were attributed to COVID-19; 57% were attributed to cancer; and 24% to other causes (proximal cause of death unknown/missing in 38% and 19%, respectively). Cancer treatment modification was more common in the recovered group (23% vs 18%). Conclusions: Patients with underlying comorbidities, worse ECOG PS, and more severe acute SARS-CoV-2 infection had higher rates of PASC. These patients suffered more severe complications and incurred worse outcomes. There was an appreciable rate of death in both PASC and non-PASC, with cancer the dominant but not only cause in fully recovered patients. Further study is needed to understand what factors drive PASC, and whether longer-term cancer-specific outcomes will be affected.[Table: see text]
The impact of COVID-19 on patients with cancer in the Oncology Care Model in the U.S. Oncology Network during performance period 8.
Authors: Wilfong Lalan S. , Ives Hope , Indurlal Puneeth , Staggs Stuart , Payne-De Bock Judi , Neubauer Marcus A. 
Published: June 2022

e18747 Background: The COVID-19 pandemic had a profound impact on cancer care delivery throughout the nation. Data regarding the outcomes of patients on cancer therapy who had COVID-19 is lacking. The US Oncology Network had 14 practices participating in the Oncology Care Model (OCM) during performance period 8 (PP8) which enrolled patients from 1/2/2020 to 7/1/2020. OCM enrolls patients with Medicare undergoing treatment for a cancer diagnosis. Utilizing OCM claims files, we evaluated the impact of COVID-19 on outcomes and costs for patients enrolled in the OCM during the first stages of the pandemic. Methods: Utilizing claims and episode data from the OCM, we were able to identify episodes with patients who had a positive COVID-19 diagnosis. Episodes were flagged with COVID-19 based on the ICD-10 code U07.1 on claims files. We were then able to compare the total cost of care (TCOC), inpatient costs and death rate to those patients in the OCM that did not have a COVID-19 ICD-10 claim. Results: 2.5% of patient episodes in PP8 had a positive COVID-19 ICD-10 claim. TCOC per episode increased 36% per patient from $34,340 for those without COVID-19 to $53,605 for those with COVID-19, a difference of $19,265 per patient. Inpatient costs increased from $3,276 for those without COVID-19 to $12,226 for those with a COVID-19 diagnosis. 8.9% of patients without a COVID-19 diagnosis died during the episode vs 20.0% of those with a COVID-19 diagnosis. Other costs including the cost of drugs did not significantly differ between the two groups. Conclusions: A diagnosis of COVID-19 for patients in the OCM receiving cancer treatment during PP8 led to a significant increase in costs, especially the costs of hospitalization. The death rate more than doubled for patients with COVID-19 during an OCM episode. Patients with Medicare and cancer undergoing treatment were at high-risk for complications and death from COVID-19 during OCM performance period 8.
Clinical impact of SARS-CoV-2 delta variant infection in tumor patients and the impact of vaccination on different cancer treatment regimens.
Authors: Hempel Louisa , Piehler Armin , Gandorfer Beate , Veloso de Oliveira Julia , Philipp Patrick , Robert Sebastian , Axel Kleespies , Schick Cordula , Fleischmann Bastian , Schweneker Katrin , Milani Valeria , Schenk Kristina , Ebner Florian , Donhauser Lara , Zehn Dietmar , Hempel Dirk 
Published: June 2022

e18750 Background: Data on SARS-CoV-2 infections in oncological patients in the outpatient settings are scarce. Methods: During the spread of the delta variant between April 2021 and September 2021, a total of 10.677 patients were tested for SARS-CoV-2 infection by RT-qPCR in seven outpatient clinics in Bavaria, Germany. Results: Within the tested patient cohort, 4.960 patients (46.5%) suffered from a malignant disease (74% solid tumors and 26% malignant hematological diseases). This group was compared with 5.717 patients (53.5%) without a malignant disease (33.1% with other hematological diseases and 66.9% patients without a hematological or oncological disease). During the observation period, 119 (2.4%) patients with malignancies were tested positive (88 patients with solid tumors; 31 patients with malignant hematological diseases) compared to 115 positive patients (2.0%) in the control group. 32 of 119 positively tested patients (26.9%) suffering from malignant disease required hospitalization and 9/32 patients (28.1%) died during the clinical course. Conclusions: These observations are in clear contrast to data from patients we evaluated during the pre-delta variants period between 15 and 26 April 2020 in the same seven outpatient clinics. In this period, a total of 1.227 patients were tested for SARS-CoV-2 by RT-qPCR. 78/1227 patients (6.3%) were tested positive in RT-qPCR and most showed mild symptoms of infection. None of the SARS-CoV-2 infected patients died. These data were analyzed when no vaccination was available. These data were evaluated during a period where no vaccine was available. Vaccination of patients with malignancies with BiontechPfizer's mRNA vaccines was started in April 2021. The response to the vaccine was tested by an antibody assay (Elecsys Anti-SARS-CoV-2 S-immunoassay, Roche) at the earliest four weeks after the second vaccination. To assess the response, we compared five patient cohorts: Patients who received (i) B cell depleting antibodies, (ii) checkpoint inhibitors (ICI), (iii) chemotherapy, or (iv) tyrosin kinase inhibitors (TKIs), and (v) healthy controls. The patients treated with ICI or TKI showed a comparable vaccination response to the healthy patients, while patients receiving Rituximab/Obinutuzumab showed no significant humoral vaccination response at all. The more severe disease course of patients infected by the SARS-CoV-2 delta variant compared to the initial waves of infections strongly underline the importance of vaccination in cancer patients.
Consequences of the COVID-19 pandemic on new cancer visits to a comprehensive cancer center in New York.
Authors: Garcia Katherine , Rohatgi Abhinav , Okpara Chinyere , Winner Megan , Weber Jeffrey S. , Braunstein Marc Justin 
Published: June 2022

e18752 Background: Studies on cancer patients during the COVID-19 pandemic have shown a decrease in new diagnoses, delays in care, and a shift to later stage disease presentations. Considering that NY has been an epicenter for COVID-19 in the U.S., we investigated its impact on new cancer diagnoses at the two campuses of NYU’s Perlmutter Cancer Center and hypothesized that there would be a decrease in presentations during the peak outbreaks in NY. Methods: We conducted a single center, retrospective analysis of new cancer diagnoses before, during, and after the peak of the pandemic between Dec 1, 2019, and Aug 31, 2020. Following IRB approval, subjects were identified using our cancer center database, which includes both inpatient and outpatient visits. Subjects were included regardless of their treatment plan. New diagnoses before COVID-19 (Dec to Feb), at first peak (March to May), and during the initial recovery phase (June-Aug) were assessed. No COVID-19 vaccines were available during this time. Results: As summarized in Table, during the initial COVID-19 peak, there was a substantial decrease in new patient visits with statistically significant differences seen by age and certain cancer types including breast, skin, and hematologic malignancies. In all cancers, there was a decrease in the proportion of new patient visits among those over age 75 during the peak. When confining analyses to breast, skin, and hematologic cancers, we saw a significant increase in the proportion of younger new patients at the peak period. We also observed an association between age and stage, with an increase in new stage I diagnoses in the younger (age 18-54) population at peak. Telemedicine was most utilized by the younger population during both peak and recovery periods. Conclusions: In this retrospective analysis, we found that during the initial COVID-19 peak, prior to vaccine availability, outpatient visits for hematologic and solid malignancies decreased at our cancer center in NY. The decrease in the proportion of all cancer types in elderly patients during the peak was likely related to hesitancy among this vulnerable population to seek care. The widespread use of telemedicine also likely contributed to the increased incidence in new patient visits in younger patients. Lessons learned from this experience can help guide outreach to vulnerable populations during future outbreaks, particularly by fostering telemedicine use among the elderly.[Table: see text]
Real-world (RW) treatment patterns and clinical outcomes for chemotherapy-based regimens in first line (1L) MSI-H/dMMR metastatic colorectal cancer (mCRC).
Authors: Chase Monica , Amonkar Mayur , Myer Nicole , Wang Tongtong , Turzhitsky Vladimir , Spira Alexander I. 
Published: June 2022

e18755 Background: Until the global approval of pembrolizumab for the treatment of first line (1L) MSI-H/dMMR metastatic CRC (mCRC), newly diagnosed patients were managed with standard of care (SOC) treatments like chemotherapy with or without an EGFR/VEGF inhibitor, independent of biomarker testing or status. This study assessed the RW SOC treatment patterns and outcomes among 1L MSI-H/dMMR mCRC patients. Methods: A retrospective observational study was conducted among patients ≥18 years diagnosed with stage IV MSI-H/dMMR mCRC (index event) who received care in the US community-based Oncology Network. Eligible patients were identified between 01-Jun-2017 to 29-Feb-2020 and followed longitudinally until 31-Aug-2020, last patient record, or date of death: whichever occurred first. Baseline demographics, clinical characteristics, treatment patterns and clinical outcomes were reported descriptively. Key clinical outcomes of interest were time to treatment discontinuation (TTD), rw-progression free survival (rwPFS) and overall survival (OS). Kaplan-Meier survival analysis was conducted for all time-to-event variables. Results: 150 MSI-H/dMMR CRC patients treated in the 1L setting were included, of which 38.7% were treated with chemotherapy and 61.3% with chemotherapy + an EGFR/VEGF inhibitor. Nearly 75% of patients had an ECOG PS of 0-1, and the time from diagnosis of metastatic disease to initiation of 1L treatment was 5.2 (0.1, 1157.4) weeks. The median duration of follow-up was 12.9 (0.1, 37.1) and 16.2 (0.8, 36.2) months among patients treated with chemotherapy and chemotherapy + EGFR/VEGF inhibitors, respectively. Within the chemotherapy group, 86% received FOLFOX while 14% received FOLFIRI. Within the chemotherapy + EGFR/VEGF group, the most common regimen was FOLFOX+bevacizumab (67%). Conclusions: The totality of RW clinical outcomes in 1L MSI-h/dMMR mCRC suggest that despite the availability of chemotherapy and EGFR/VEGF inhibitors, an unmet need still exists that may be addressed with the recent availability of pembrolizumab for select patients. This data further supports the rationale for biomarker testing and personalized treatment of 1L CRC. Patient characteristics and clinical outcomes are summarized in the table.[Table: see text]
Evaluation of flibanserin's benefits and tolerability in women with low libido and a history of breast cancer.
Authors: Javaid Somi , Brown Louise 
Published: June 2022

e18761 Background: After cancer treatment, women with sexual problems are more likely to have a poor quality of life and lack self-esteem. The 2018 American Society of Clinical Oncology guidelines on interventions to address sexual problems in people with cancer lists flibanserin as a treatment option for premenopausal women with low libido and a history of cancer. However, flibanserin's clinical trials excluded women with a history of breast cancer; as a result, there is limited information on benefits and tolerability in this subset of women. This retrospective chart review study was conducted to address this knowledge gap. Methods: Structured data (partner and menopausal status, medications, medical history, and weight) were extracted from predefined fields in the clinic's electronic health record (EHR) system using on-demand reports. Free-text encounter notes served as the data source for unstructured data (benefits and tolerability). Patients with low libido (R68.82 or F52.0) plus a history of breast cancer and ≥1 flibanserin prescription submitted through the clinic’s EHR system (“Flibanserin Plus History of Breast Cancer” [FPHBC] patient), seen at the clinic between September 1, 2015, and August 31, 2021, are included in this analysis. Encounter notes were reviewed to ensure patients had a personal history of breast cancer and terms related to their benefits and tolerability coincided with their actual flibanserin usage. Patients were categorized as either FPHBC-User or FPHBC-Non- Users based on verified flibanserin usage. Results: Findings from the 20 FPHBC-Users are presented in the table below. Conclusions: Flibanserin was generally well-tolerated among FPHBC-Users and most women reported benefits in libido. Unexpected benefits included improved orgasm and other non-sexual benefits. The clinic consulted with all patients’ oncologists before initiating flibanserin which likely contributed to its safe use. It is important to acknowledge that flibanserin is just one component of care, and the benefits and tolerability reported here may or may not be related to treatment alone. Our findings may not generalize to all clinical practices, and more extensive studies are needed to verify these findings.[Table: see text]
Prognostic value of the SEER-Medicare myelodysplastic syndromes risk score for a contemporary cohort of patients with MDS.
Authors: Afzal Amber , Fiala Mark A. , Jacoby Meagan , Walter Matthew 
Published: June 2022

e18762 Background: Prognostication of patients with myelodysplastic syndromes (MDS) using IPSS-R is not possible in administrative database analysis. In 2014, a claims-based prognostic scoring system, the SEER-Medicare MDS Risk Score (SMMRS) was developed to risk-stratify MDS patients for overall survival using ICD9 codes {Uno, 2014}. In 2015, ICD9 codes were replaced by ICD10 codes. In this study, we updated SMMRS with inclusion of both ICD-9 and -10 codes, and studied its predictive value for overall survival, leukemia-free survival and initiation of treatment among MDS patients. Methods: Patients with MDS were identified through ICD-O-03 codes in the SEER-Medicare database between 2007 and 2017. SMMRS was calculated using MDS subtype, age, comorbidities, cytopenias, transfusion-dependence, and recent hospital admissions. We analyzed the association of SMMRS with overall survival, leukemia-free survival (time from MDS diagnosis to leukemia), and initiation of treatment (hypomethylating agents /stem cell transplant) in Cox proportional hazards models while adjusting for potential confounders. Results: Patients with MDS (N = 12,710) had a median age of 80 years, half were males, and most were Caucasians. SMMRS stratified patients into low-risk (n = 3155), intermediate-1 risk (n = 3255), intermediate-2 risk (n = 3121), and-high risk (n = 3209) categories at diagnosis. The overall survival, leukemia-free survival and treatment initiation for patients in each SMMRS category is summarized in Table. The 5-year overall survival for the entire cohort was 20%. At 5 years, 10% of the MDS patients had transformed to leukemia, and 1/3rd had started MDS treatment. Conclusions: SMMRS based on ICD-9 and -10 codes predicts overall survival, leukemia-free survival and MDS treatment initiation by stratifying MDS patients into 4 risk-categories. It can be utilized to design/analyze future observational studies.[Table: see text]
Retrospective single system analysis of side effects experienced with mRNA (Pfizer-BioNTech and Moderna) vaccinations in immunocompromised cancer patients compared with CDC VAERS database between December 15th, 2020, through July 31st, 2021.
Authors: Danak Shivang , Fadel Celine , Rynarzewska Ania , Dalton Drew , Jones Louise , Johnson Andrew Thomas 
Published: June 2022

e18782 Background: Immunotherapy is becoming a common therapy in cancer patients. Cancer patients on systemic therapy are a vulnerable population, making them highly susceptible to illness from any infection. The purpose of this study was to collect and analyze data reported by patients regarding the side effects of COVID-19 vaccines (Pfizer-BioNTech and Moderna) in cancer patients with solid tumors receiving immunotherapy. Due to the lack of studies and inclusion of cancer patients in the clinical trials for the vaccine, it is pivotal to investigate of the effects of the SARS-2-CoV vaccine on patients receiving immunotherapy to begin to bridge the current gap in knowledge. Methods: We performed a two-phased retrospective analysis of adult patients (age ≥18 years) who received either Moderna or Pfizer-BioNTech COVID-19 vaccinations and were currently on immunotherapy (December 15th, 2020, through July 31st, 2021). Phase 1 included a tertiary health system (n = 15,910) in Northeast Georgia. Phase 2 involved cross-tabulation with the VAERS CDC database to compare results at a national level (n = 374,667). The primary endpoints were severity of side effects, timing of side effects and the relationship between the vaccines. The method to evaluate outcome was the Pearson-Chi-Squared test. Results: Results showed that patients on immunotherapy were more likely to have at least one side effect in the tertiary health system (OR 6.727 [95% CI, 2.748 - 16.465] compared to least two side effects in the national dataset (X² = 7.032, p < 0.05). This difference was driven by the Moderna vaccine recipients, demonstrating a higher likelihood of experiencing two or more side effects (X² = 6.159, p < 0.05). Those receiving the Pfizer-BioNTech vaccine did not demonstrate statistically significant side effects. The most common reaction noted was weakness in both datasets, which was more likely to occur after the Moderna vaccine. Gender analysis showed no difference in side effects in those receiving immunotherapy. In terms of timing of side effects, patients on immunotherapy (M = 10.66, SD = 25.1) had a delayed side effect onset of 10 days vs. four days. (M = 4.72, SD = 15.5, p < 0.05). Conclusions: Both local and national datasets demonstrate cancer patients receiving immunotherapy compared to those that were on immunotherapy, were more likely to experience mild vaccine side effects, specifically weakness being the most common. There was no statistically significant increase in more serious adverse reactions. Additionally, side effect onset was delayed in patients on immunotherapy. These findings provide a foundation for understanding mRNA vaccines in patients on immunotherapy, with future research needs involving larger sample sizes.