bluuebunny/crossref_metadata_2025_split huggingface dataset:
Preliminary outcomes for non-metastatic breast cancer before and during the coronavirus disease 2019 pandemic at community cancer centers.
Authors: Yuan Fangzheng , Abdelhakeem Ahmed , Blevins Samantha , Peters Chelsey , Whalen Susan E. , Hymel Ernest Clayton 
Published: June 2022

e18634 Background: The Coronavirus Disease 2019 (COVID-19) pandemic has changed the delivery of cancer care and may have impacted the treatment outcomes. This study described the preliminary outcomes in non-metastatic breast cancer (BC) patients before and during the COVID-19 pandemic. Methods: This retrospective study included adult patients newly diagnosed with non-metastatic BC at two community cancer centers in southeast Texas. Patients diagnosed from 1/2018-10/2018 were included in the control group. Patients diagnosed from 4/2020-1/2021 were included in the COVID-19 group. The key outcomes were progression free survival (PFS), overall survival (OS), breast conserving surgery (BCS) rate, pathological complete response (PCR) rate, and time to treatment initiation (TTI). Results: The study included 74 patients (Table). The proportion of patients with self-detected BC was numerically higher in the COVID-19 group (55%) compared to the control group (36%), although this was not statistically significant (P = 0.09). The median follow-up periods were 38 (IQR: 36-43) months in the control group and 15 (IQR: 13-17) months in the COVID-19 group. No significant difference was observed in PFS (P = 0.74), with 1-year PFS of 93% (95%CI: 80%-98%) in the control group and 100% in the COVID-19 group. No significant difference was observed in OS (p = 0.22), with 1-year OS of 98% (95%CI 85%-100%) in the control group and 100% in the COVID-19 group. No significant difference was observed in TTI between control (51 days) and COVID-19 groups (52 days) (95%CI: -14 to 13; P = 0.91). Among patients who received neoadjuvant systemic therapy and surgery, BCS rates were 29% (5/17) in the control group and 50% (5/10) in the COVID-19 group (P = 0.42). Among patients who had triple negative or HER2 positive BC and received neoadjuvant systemic therapy and surgery, PCR rates were 57% (4/7) in the control group and 33% (1/3) in the COVID-19 group. Conclusions: Although total patient volume decreased during the COVID-19 pandemic, no significant difference was observed in clinical outcomes when comparing patients diagnosed with non-metastatic BC during and prior to the pandemic. Ongoing monitoring with a larger study population and longer follow-up period will help to elucidate the long-term impact of COVID-19 on BC treatment.[Table: see text]
The importance of the long Covid-19 in the evolution of patients with neoplasms.
Authors: Popov Viola , Andreescu Mihaela , Pirvu Catalina , Grigorie Andra , Constantin Oana , Calen Andreea , Badoiu Niculae Mihaela Dana , Badea Adriana , Rus Ana , Iliescu Lelia 
Published: June 2022

e18647 Background: Patients with comorbidities especially those with oncological diseases could have severe COVID-19 outcomes. OBJECTIVE: The aim of this study was to evaluate the role of prolonged positivity of SARS-Cov2 in evolution of patients with various neoplasia. Methods: We analysed clinical and laboratory (hematological parameters and inflammatory markers: interleukin-6 and ferritin) data of COVID-19 patients admitted in intensive care unit (ICU) Department of our hospital, during 2020-2021 and presented in medical history solid tumors or haematological neoplasia . The cohort of patients included 78 patients with severe and critical form of COVID-19, 31 patients with solid tumors and 47 patients with hematologic malignancies. We consider long COVID-19 all cases with SARS Cov2 positivity more than 14 days. Results: The frequency of long COVID-19 was quite equal between patients groups with solid tumors and hematologic malignancies, incidence rate 1:2, the incidence rate differences was 1:18, p = 0.75. Long COVID-19 was observed in 60% cases with favourable evolution, Chi-squared 5.35%, p = 0.02, these patients had moderate form and was admitted in hospital in 1 or more days after the onset, median value 3 (min 1, max 55) compared with patients with normal duration of positivity of SARS-Cov2 test- median value 2 (min 1, max 8), p = 0.01. The Kaplan Meyer survival analyses indicated long COVID-19 as predictive factor for unfavourable evolution, Chi-squared 17.97, p < 0.0001. Although we have not obtain significant differences, we observed more severe lymphopenia in patient without long COVID-19, probably because a part of these patients group died in the first 14 days of COVID-19 (0.765 (min 0.04, max 297.64) vs. 1.01 (min 0.09, max 254.35), p = 0.09). The rest of hematological and biochemistry parameters was not significant different between groups. Infectious and thrombotic complication was most frequent in patients with long COVID-19, Chi squared 8.6, p = 0.003. Conclusions: Long Covid-19 is predictable for unfavourable evolution and is associated with sepsis and thrombotic complication. This diagnosis is frequent in patients who was admitted in hospital after the onset of COVID-19 symptoms, early treatment of COVID-19 in oncological patients being very important for favourable evolution.
Optimizing rural healthcare: A retrospective review of initial diagnostic workup for multiple myeloma or monoclonal gammopathy.
Authors: Schmoyer Jeremy , Sekayan Tro , Rocca Neychelle 
Published: June 2022

e18653 Background: An estimated 65 million people or approximately 20% of the United State residents live in rural areas based on the Census Bureau designation. As of December 31, 2021, 61.5% of the health professional shortage areas were designated in rural primary medicine. The Northern Arizona Healthcare (NAH) system is based in a rural area and experiencing shortages in both primary care and subspecialty physicians. This is making accurate and timely diagnostic studies key to facilitating early treatment. The objective of this study is to review whether complete diagnostic work up was performed for patients with suspected multiple myeloma (MM) or monoclonal gammopathy (MG) disorders prior to the oncology referral. The future goal of this study is to prompt further reviews and creations of order modules to help optimize healthcare for individuals in rural areas. Methods: This retrospective study included patients with the diagnosis of multiple myeloma or monoclonal gammopathy in the NAH system from 2015 to 2020. Data was reviewed to determine if serum protein electrophoresis (SPEP) with immunofixation was requested prior to oncology referral or at first oncology visit. Additionally, we evaluated if the urine protein electrophoresis (UPEP) order was requested on these visits as well. Results: The data consisted of 74 patients. On review, prior to oncology referral or at first oncology visit, only 18 patients (24%) had SPEP with immunofixation and UPEP ordered. 23 patients (31%) had SPEP orders only requesting additional immunofixation for further interpretation of data on future visits, and 47 patients (63%) were missing concurrent UPEP and SPEP orders. Conclusions: This retrospective study demonstrated that for patients with a confirmed final diagnosis of either MM or MG, 31% and 63% of patients had missing immunofixation and concurrent UPEP plus SPEP results respectively. The outpatient cerner system orders were adjusted to remove SPEP and UPEP only orders in the LabCorp and Senora Quest options. These were replaced with SPEP and UPEP with reflux to immunofixation orders. The goal of this adjustment is to prevent re-ordering of labs at initial oncology visit limiting cost burden and delay of diagnosis. In the future, patient care will be further optimized at NAH with the creation of an order set module. This module will include the complete lab workup required for multiple myeloma or monoclonal gammopathy with hematology/oncology referral and allow for further integration of non-oncology clinicians into care delivery.
Factors associated with duration of care in community direct-to-patient (DTP) pharmacies among Chinese cancer patients taking PD-1/PD-L1 inhibitors: Results from a real-world study.
Authors: Han Sheng , Wen Yi , Zheng Xin , Wang Ning Ruo , Hua Jin , Zhu He 
Published: June 2022

e18654 Background: Several PD-1/PD-L1 inhibitors have been approved in China for multiple cancers. Community DTP pharmacies play an important role in both drug distribution and patient management. Using real-world patient management data, we explored the factors associated with duration of care in community DTP pharmacies among cancer patients using PD-1/PD-L1 in the country. Methods: This is a retrospective cohort study using real-world sales and follow-up data routinely collected from 79 Medbanks community DTP pharmacies between Jan 1, 2019 and Mar 31, 2021. Duration of follow-up (DoFU) was defined as the time interval between first PD-1/PD-L1 purchase and last follow-up contact. Duration of drug purchase (DoDP) was defined as the time interval between the first and the last PD-1/PD-L1 purchase date plus a buffer period which was determined based on the amount of last purchase. Covariates included: gender, age, enrollment in a patient access program (PAP), experience of adverse events (AE) during treatment, patient’s awareness of the disease, and follow-up response rate (FRR; < 30%, 30-70%, > 70%). Uni- and multivariate Cox regression models were conducted to assess the association of DoFU/DoDP with predicting variables among both total population and cancer specific sub-populations. Results: A total of 23,559 patients were evaluated (median age: 61 yrs; male: 73%). The three most common cancer types were lung cancer (51.90%), hepatobiliary cancer (19.69%) and esophageal cancer (9.98%). The median DoFU and DoDP were 6.3 month (95% CI: 6.23̃6.50) and 2.3 months (95% CI: 2.27̃2.33). In multivariate Cox regression model, factors associated with longer DoFU included enrollment in PAP (HR = 0.52, p < 0.001), experience of AE during treatment (HR = 0.71, p < 0.001), FRR 30-70% (HR = 0.66, p < 0.001; ref: < 30%) and FRR > 70% (HR = 0.56, p < 0.001; ref: < 30%); factors associated with longer DoDP included enrollment in PAP (HR = 0.90, p < 0.001), experience of AE during treatment (HR = 0.84, p < 0.001) and FRR > 70% (HR = 0.80, p < 0.001; ref: < 30%). The protective effects of PAP, AE and higher FRR on DoFU and DoDP were also observed in the three main cancer specific sub-populations. Conclusions: High quality patient management service provided in community DTP pharmacies is significantly associated with longer duration of care, which implies the important role of DTP pharmacies in the longitudinal care of cancer patients. A comprehensive service package should be developed and applied in community DTP pharmacies for cancer patients in order to better address their medical needs and financial strain.
Impact of establishing a precision oncology program at a rural academic cancer center on cancer care delivery.
Authors: Brewer Idona , Kettle Jacob , Johnson Alexander James , Vosuri Venkata , Tuncer Tolga , Papageorgiou Christos N. 
Published: June 2022

e18660 Background: The use of molecular profiling, biomarkers, and other targetable tumor alterations is becoming a central component of modern cancer care. Many oncologists use Next Generation Sequencing to guide treatment decisions. There are many challenges of implementing precision oncology through traditional clinical operations. The purpose of this project is to enhance patient care by establishing a new clinical program with the specific focus of advancing and expanding the utilization of precision oncology. Methods: The precision oncology program (POP) was designed as a consult service and functions to assist oncologists in appropriate testing, interpreting results, and identifying additional treatment options. After referral, the POP committee discusses each patient case and offers testing and/or therapeutic recommendations to the referring provider. POP predominantly focused on patients with unresectable or metastatic solid tumors that had relapsed after at least one line of standard of care therapy. The effect of the program will be measured by the volume of patient consults, the number and nature of recommendations from the consulting program, and the direct impact of recommendations on patient care. Results: There were approximately 323 new diagnoses of advanced stage solid tumors in 2021 at the Ellis Fischel Cancer Center (EFCC) at the University of Missouri-Columbia. There were 205 FoundationOne liquid and tissue Next Generation Sequencing (NGS) of solid tumors ordered since initiation of this service. Utilization of NGS testing has increased by 100% year-over-year from 2020 to 2021 since the implementation of this program. The impact of this program is reflected in the increased NGS testing for multiple malignancy types. Specifically, 34% more NGS tests in advanced lung cancers, 733% in breast, 60% in head and neck cancers, 166% colorectal and 500% in prostate cancer. Since the launch of POP in late 2020, we obtained consults on 46 patients. Additional biomarker testing was recommended for 39% of all consults, with a new actionable target being identified in 33% of patients. The amount of biomarker testing increased from averaging 6-7 tests per month to averaging 21 tests per month with an average number of 5 mutations per sample. Conclusions: The POP consult service has improved the testing and the identification of actionable mutations of patients at EFCC. The program has led to new treatment options in 33% of patients reviewed.
Prevention of venous thromboembolism in ambulatory patients with active cancer: Results from ACT4CAT study.
Authors: Tsoukalas Nikolaos , Christopoulou Athina , Koumarianou Anna , Timotheadou Eleni , Athanasiadis Ilias , Samelis Georgios , Peroukidis Stavros , Psyrri Amanda , Kapodistrias Nikolaos , Nikolakopoulos Achilleas , Demiri Stamatina G , Andreadis Charalampos , Bokas Alexandros , Ardavanis Alexandros , Samantas Epaminondas , Mavroudis Dimitrios , Barbounis Vasileios , Athanasiadis Athanasios , Papakotoulas Pavlos , Boukovinas Ioannis 
Published: June 2022

e18677 Background: Venous ThromboEmbolism (VTE), might be a challenge with a lot of negative consequences for patients with active cancer. VTE affects ongoing anticancer treatment, worsening morbidity and mortality, increases economic burden and escalates psychological distress. Incidence of VTE in patients with cancer reported 20%. Current guidelines recommend pharmacologic prophylaxis in ambulatory cancer patients with Khorana score ≥2. Methods: ACT4CAT is a prospective observational phase IV study conducted by HeSMO Greece, aiming to record the clinical practice of VTE prophylaxis in active cancer patients. Ambulatory patients who received thromboprophylaxis enrolled after signing informed consent. Study was approved by bioethics committee. Results: 691 patients from 19 oncology departments received thromboprophylaxis in 1st line 57.6%, 2nd line 14.8%, adjuvant 9.0% and neoadjuvant 7.5%. Age ≥65 found 55%, BMI≥30 17.5% and males 63%. Tumor types: gastrointestinal 45.4%, lung 25.8%, urological 11.6%, gynecological 6.0%, breast 4.2% and others 7.0%. High-Risk for Thrombosis Agents (HRTAs) received 87.2%, specifically: platinum agents (56.3%), antimetabolites (54.2%) and immunotherapy (12.1%). 54,5% of the anticancer agents had potential drug-drug interaction (DDI) with anticoagulation treatment. Thromboprophylaxis duration lasted 5.3±3.5 months. Main agents were: tinzaparin 89.6%, fondaparinux 6.0%, bemiparin 2.2%, enoxaparin 1.6%, apixaban 0.3% and rivaroxaban 0.3%. Intermediate thromboprophylaxis dose received 68% of patients, lower in adjuvant setting (45.2%), with a preference in metastatic cases (OR: 1.5 95% CI: 1.02-2.3, p = 0.026). 14 thrombotic events reported (efficacy: 98.0%, 95%CI: 96.6-98.8%) and 12 grade 1 bleeding (1.7%, 95%CI: 1.0-3.0%). Conclusions: Prevention of VTE in ambulatory patients with active cancer found effective and safe. Apart from the Khorana score, specific patient characteristics, metastasis, HRTAs and DDIs seemed that affect clinical decision for thromboprophylaxis mainly with LMWHs and often on intermediate dose regardless the clinical setting. Oncologists appeared informed that CAT is not negligible risk. Clinical trial information: NCT03909399. [Table: see text]
Towards a more systematic evaluation of cancer endpoints: A method for synthesis and analysis of NSCLC regulatory filings and clinical evidence.
Authors: Hinkel Jennifer M. 
Published: June 2022

e18681 Background: Ongoing debate surrounds the use of surrogate and proxy endpoints in oncology such as Progression Free Survival (PFS) and Overall Response Rate (ORR); the oncology community has debated the utility, meaningfulness, validity, and evidentiary definitions of such outcomes. Literature across disease states points to potential inconsistencies in the reporting of, and definition of, clinical trial endpoints more broadly. No data source currently exists to robustly analyze how endpoints are defined, deployed, and applied across a number of trials within a particular tumor type, let alone across oncologic diseases more broadly. This study presents a systematic method to build such a dataset using regulatory filings and clinical evidence publications. Methods: This study developed a five-step method to synthesize and analyze data in a systematic manner. Given the number of new therapeutic approvals in NSCLC, it was selected as a disease area of focus to test the method. For each step of the method, data was extracted and recorded in a Google Sheets database. Step 1 identified therapy FDA approvals from 2016-2020 via systematic search of the FDA website. Step 2 searched the Drugs@FDA database to identify approval packages. Step 3 synthesized the clinical evidence supporting approvals through systematic analysis of FDA Review Documents. Step 4 identified the published protocol for each study from Step 3 using ClinicalTrials.gov. Step 5 identified publications reporting results from Step 4 using the National Clinical Trial identifier numbers and keywords. Results: A systematic search and synthesis of FDA and clinical trial documentation in this manner yielded a dataset of six first approvals for NSCLC and 27 line extensions for NSCLC indications between 2016 and 2020. Conclusions: Informed debate around the use of proxy and surrogate endpoints is difficult to achieve without an evidentiary basis for the discussion. At present, no data source exists for researchers to answer questions such as: “How frequently was PFS used as the primary endpoint in registrational trials for lung cancer over the past ten years?” By developing and deploying a systematic method as described above, researchers can build such a dataset, and then apply the same method across additional disease states and tumor types to understand a more comprehensive picture of how endpoints are defined, measured, and applied in clinical trials. Not only can such a dataset enable research that informs clinical trial design, but it can also enable research and policy development regarding endpoint fidelity, utility, and meaningfulness.
Reporting consistency in radiation therapy after breast conservative surgery between Arkansas Cancer Registry and all payers claims database.
Authors: Li Chenghui , Malapati Sindhu Janarthanam , Hutchins Laura Fulper 
Published: June 2022

e18685 Background: Cancer registries linked to insurance claims databases are an important source for real-world evidence cancer research. However, most studies used SEER-Medicare linked data, which limits studies by location and age. Arkansas has developed an all-payers claims databases (APCD) that includes insurance claims from both public and private payers, enabling tracking patients of all ages throughout the continuum of care and across payers. However, APCD lacks tumor-specific characteristics. Arkansas is one of only four known states that have linked APCD to the state cancer registry. Using Arkansas APCD linked to Arkansas cancer registry (ACR), we evaluated the reporting consistency of radiation therapy (RT) in the two sources. Methods: We identified women > = 18 years who were diagnosed in 2013-2017 with stage 0-3 hormone receptor positive breast cancer who received breast-conserving surgery. Patients must have continuous insurance coverage (any private plans, Medicaid, Medicare Part A and B without any Part C coverage) in the 13 months (month of diagnosis and 12 months after). Receipt of RT was identified independently from ACR and APCD. ACR collects information on RT if it is part of the first course of therapy. In APCD, RT claims within one year of breast cancer diagnosis were identified using procedure codes. We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for receipt of RT coded by the registry compared with APCD billing claims as the gold standard. We assessed the degree of concordance between the data sources by Cohen’s kappa statistic. Results: Of the 2348 patients, 1477 (62.9%) were documented in the ACR as received RT and had RT claims in the APCD, 498 (21%) were documented in the ACR as not received RT and had no RT claims in the APCD, 183 (7.8%) were documented as received RT in ACR but had no RT claims in the APCD, and 190 (8.1%) were documented as not received RT but had RT claims in the APCD. Using APCD claims as the gold standard, the sensitivity, specificity, PPV and NPV were 88.8%, 72.8%, 88.6%, and 73.1%. Findings were very similar using ACR as the gold standard, the sensitivity, specificity, PPV and NPV were 88.6%, 73.1%, 89.0% and 72.4%. The kappa statistic for agreement between the two sources was 0.62 (95% CI: 0.58-0.65, p = 0.7170). Conclusions: In patients who received BCS, recording of RT receipt was moderately consistent between Arkansas APCD and ACR. Future studies are needed to identify factors affecting reporting consistency to better utilize this unique resource in addressing population health problems.[Table: see text]