bluuebunny/crossref_metadata_2025_split huggingface dataset:
An evaluation of administrative data linkage for measurement of real-world outcomes of large clinical panel sequencing for advanced solid tumors.
Authors: Saleh Ramy , Bedard Philippe L. , Nguyen Paul , Malone Eoghan Ruadh , Yu Celeste , Amir Eitan , Earle Craig , Gyawali Bishal , Hansen Aaron Richard , Mittmann Nicole , Peng Yingwei , Pugh Trevor John , Abdul Razak Albiruni Ryan , Sabatini Peter , Spreafico Anna , Stockley Tracy , Torchia Jonathon , Williams Christine , Siu Lillian L. , Hanna Timothy 
Published: October 2020

283 Background: There is limited real-world evidence of impact of large clinical panel sequencing on treatment-matching for patients with advanced solid tumors. The province of Ontario has a single payer, publicly funded health care system. We linked genomic testing results from a prospective province-wide trial, OCTANE (Ontario-Wide Cancer TArgeted Nucleic Acid Evaluation), to administrative data to determine the feasibility of this approach for evaluating survival and the impact of sequencing on treatment matching. Methods: We linked all Ontario patients from Princess Margaret (PM) with panel testing results (tumor-only 555-gene panel) to province-wide administrative data on treatments and outcomes. Patients were recruited from August 2016 to August 2018. Only clinically actionable variants based upon OncoKB annotation (Level 1 and 2) were assessed for genotype-informed treatment matching. Results: All 888 eligible patients were successfully linked to administrative data. Mean age was 58 (±13) years, 635 (71.5%) were female. Most common disease sites were ovary (26.4%), uterus (14.0%), colorectal (11.8%) and breast (9.5%). Administrative data vital status was more complete than trial collected data with 262 of 476 deaths only recorded in administrative data. Median survival was 1.70 years (95% confidence interval 1.50-1.91). 247 (27.8%) had actionable mutations, most commonly PIK3CA (54.7%), BRCA1 (15.8%), BRCA2 (15.0%) and BRAF (8.9%). 37 (15.0%) and 42 (17.0%) patients with actionable mutations received targeted therapy within 6 and 12 months of test report date, respectively. Conclusions: This is the first known feasibility study of linked administrative data to measure outcomes of large clinical panel sequencing for patients with advanced solid tumors. Vital status was more complete with administrative data compared to trial-collected data, and treatment data was successfully linked. About one in twenty-one enrolled patients received genome-informed treatments within 12 months, or about one in six of all patients with actionable mutations. This may be due to short interval follow up, trial and drug access, successful standard of care treatments, early patient deterioration or limited alterations covered by the panel, among other causes.
Analysis of systemic therapy delivery for gastrointestinal cancer patients during the COVID-19 pandemic.
Authors: Power Robert , O'Donohoe Claire , Enright Cathy , Glennon Louise , McDowell Lisa , Gallagher David James , Lowery Maeve Aine 
Published: October 2020

301 Background: As of June 16, 0.51% of the Irish population has had a confirmed diagnosis of COVID-19, and incidence of new infections peaked on April 10. Cancer patients treated with systemic anticancer therapy (SACT) may have increased risk of contracting COVID-19, and greater incidence of adverse outcomes. We aimed to assess the impact of a COVID-19 SACT clinical pathway on the incidence of SARS-CoV-2 infection in gastrointestinal cancer patients, and alterations to SACT regimens attributed to the COVID-19 pandemic. Methods: A COVID-19 SACT clinical pathway for patients undergoing treatment in a haematology oncology day care (HODC) service was designed and implemented. Interventions included visitor restrictions, telephone clinics, mandatory masks and temperature checks for staff, social distancing at all workspaces, and establishment of a COVID-19 screening pod. A prospective registry of all gastrointestinal cancer patients attending the HODC clinic between February 1 and April 31 2020 was initiated following institutional ethics board approval. Clinical data were retrieved from electronic health records including demographics, performance status, comorbidities, SACT regimen (including changes to treatment), SARS-CoV-2 testing, and radiologic treatment responses. Results: In this period, 175 gastrointestinal (88 gastroesophageal, 8 hepatobiliary, 79 colorectal) cancer patients attended 931 HODC outpatient clinics. Of this, 41 (23%) underwent at least one SARS-CoV-2 test. No patients tested positive. Two gastroesophageal cancer patients undergoing neoadjuvant chemoradiotherapy presented with SARS-CoV-2-negative suspected viral pneumonia and respiratory failure; both required intensive care unit admission and one died. SACT regimen was altered in 48 (27%) patients due to the COVID-19 pandemic. Changes involved prescription of alternative oral therapies (21; 12%), treatment breaks (17; 9%), and stopping treatment (11; 6%). Most (88%) regimen changes took place in a single 3-week period (6-27 March) that coincided with the announcement of government-mandated social distancing measures. Conclusions: Implementing a COVID-19 SACT clinical pathway resulted in a low incidence of SARS-CoV-2 infection in gastrointestinal patients undergoing systemic treatment. SACT regimen changes were common; prospective monitoring of this cohort is ongoing to determine whether these alterations affect patient outcomes.
Status of digitization of medical records in oncology centers in India: A survey of current status.
Authors: Nageswararaj Karthika , Raman Sripriya , Basha Anis 
Published: October 2020

306 Background: Electronic medical or health record (EMR/EHR) system is yet to be universally adopted in India. In 2012 and 2016 Indian Ministry of Health published a detailed roadmap for EHR adoption. We wanted to assess the status of EMR/EHR adoption in oncology centers in India. Methods: Authors developed a short online survey to capture the use of paper charts vs. generic EMR vs. oncology specific EMR by practicing oncologists in India. The survey was shared to oncologists on June 6, 2020 through closed social media groups. Responses to the survey were collected anonymously and data aggregated for analysis. Survey will remain open till July 4, 2020. Results: At the time of abstract submission on June 16, there were 48 unique survey responses. Of those who responded to the survey, 69% were 25-45 years of age, 73% male, 71% were practicing in the state of Tamil Nadu, and 21% were practicing in a rural area or close to a small city. Oncologists from all subspecialties were represented in the survey including radiation oncology (65%), surgical oncology (25%), medical oncology (6%), and pediatric oncology/nuclear medicine (4%). About 46% had completed their training within the last 10 years, and 30% of respondents have done part of their training in foreign countries. Summary of responses to our survey is provided in the table below. Conclusions: Paper chart is still the predominant mode of clinical data capture within oncology. Administrative barriers and cost are perceived as major obstacles despite most oncologists reporting that they would very likely adapt to an onco specific EMR. [Table: see text]
Time to COVID-19 RT-PCR clearance among patients with cancer.
Authors: Xu Wenxin , Piper-Vallillo Andrew , Bindal Poorva , Wischhusen Jonathan W. , Patel Jaymin M. , Costa Daniel Botelho , Peters Mary Linton Bounetheau 
Published: October 2020

49 Background: COVID-19 in oncologic patients presents a clinical dilemma. To reduce the risk of adverse events as well as the risk of exposing others, many institutions have established protocols to define COVID-19 clearance. However, the optimal criteria for discontinuing infection precautions and/or resuming anticancer therapy in COVID-19 patients is unknown. Methods: We identified patients with a positive COVID-19 PCR at a tertiary care hospital between 3/25/2020 and 6/6/2020, and who also had seen an oncologist for a cancer-related diagnosis within the last 3 years. COVID-19 PCR testing was performed using the Abbott Laboratories m2000 platform in conjunction with either the Aldatu Biosciences PANDAA qDxTM SARS-CoV-2 or Abbott RealTime SARS-CoV-2 assays. At our institution, and per current ASCO guidelines, discontinuation of COVID-19 precautions requires two consecutive negative viral PCR tests > 24 hours apart. Results: During the follow-up period, we identified 32 patients with a positive COVID-19 PCR who were receiving active oncology care. Half of this cohort (16/32) had metastatic disease at the time of COVID-19 diagnosis. 17 patients were on active treatment at time of COVID-19 diagnosis (8 receiving cytotoxic chemotherapy). Among patients who met criteria for COVID-19 PCR clearance, median time to clearance was 37 days (range, 10-58 days). When accounting for censoring at the time of last COVID-19 assay, median time to clearance for all patients was estimated at 50 days. 14 patients resumed anti-cancer treatment prior to COVID-19 clearance (5 received cytotoxic chemotherapy), requiring substantial allocation of staff and resources for safe treatment isolated from other oncology patients. Among the 13 patients who met clearance criteria, 2 subsequently had a positive COVID-19 PCR after resumption of treatment. We explored COVID-19 clearance time under an alternative symptom/time based strategy based on CDC criteria (at least 10 days after first positive PCR and 3 days after last day of symptoms). Under this strategy, median time to COVID-19 clearance would be 14 days. Conclusions: In patients with cancer who develop COVID-19 infection, viral shedding can persist for many weeks after disease onset, but the implications of this shedding on likelihood of infection is unknown. Treatment of COVID-19 positive oncology patients requires substantial planning and resources. Test-based versus symptom/time-based strategies for determining discontinuation of precautions and resumption of treatment should be further investigated to provide safe and effective care.
Redesigning care coordination from the patient’s perspective.
Authors: Liu Mark , Bhardwaj Aarti , Kisswany Carol , Smith Cardinale B. 
Published: October 2020

6 Background: Cancer patients are frequently admitted to the hospital requiring medical oncologists to take an active role in coordinating with multiple teams. In an effort to redesign care to put patients at the center and address increasing demands on our medical oncologist’s time, we created the Oncology Coordinator (OC) role focused on care setting transitions. We aimed to evaluate whether the OC would improve quality of care and decrease healthcare utilization. Methods: The OCs, are non-clinical and serve as a single point of contact for disease-based teams as patients prepare for elective admissions or discharge from the hospital. The 3 OCs received specialized training in systems and processes in both settings. They coordinate outpatient appointments, prescription delivery, transportation while also providing clinical support. Additionally, they facilitate two interdisciplinary rounds per day across three dedicated oncology units and assist with patients off-unit. We evaluated all patient discharges facilitated by the OCs during 1/1/19-2/29/20 and compared that to non-OC facilitated discharges. Using descriptive statistics, we evaluated the OCs impact on 7- and 30-day readmissions, discharge before noon rate (DBN), average time from admission to chemotherapy start and patient experience as measured by Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS). Results: We had a total of 2,818 discharges between 1/1/19-2/29/20; 1,032 (36.6%) facilitated by the OCs. For those OC facilitated discharges we observed a 5.07% reduction in 7-day readmissions and 30-day readmissions (2.6%). We observed an overall higher average monthly rate of DBN (4.85%) compared to non-OC facilitated discharges. In addition, the average time from admission to chemotherapy administration decreased by 1 hour 31 minutes (6.8%) for the OC facilitated admissions. In the HCAHPS survey, there were improvements in Discharge Information and Care Transitions on the inpatient units where OCs were most active. Conclusions: At our academic medical center, the OCs have contributed to reduction in readmissions, time from admission to chemotherapy administration as well as improvements in discharges before noon and patient experience. This pilot demonstrates that investment in dedicated lay staff to facilitate admissions and discharges for cancer patients across care settings could lead to meaningful improvements in healthcare utilization, quality and the patient experience. Future work will evaluate the sustainability of this program and evaluate association with healthcare costs.
Health care resource utilization (HCRU) and total costs of care (TCOC) among patients (pts) with diffuse large B-cell lymphoma (DLBCL) treated with chimeric antigen receptor (CAR) T-cell therapies in the United States: An analysis of four claims databases.
Authors: Keating Scott J. , Gu Tao , Jun Monika Parisi , Pelletier Corey , McBride Ali 
Published: October 2020

76 Background: Non-Hodgkin lymphoma comprises a heterogenous group of hematologic malignancies, including aggressive lymphomas such as DLBCL. Novel treatment modalities include CAR T cell therapies. Limited real-world data exist on HCRU and costs among pts treated with FDA-approved CAR T cell therapies. Methods: Pts with DLBCL treated with CAR T cell therapies were identified in 4 databases (IBM MarketScan, n = 60; Optum Clinformatics, n = 56; PharMetrics Plus, n = 75; and Humana, n = 14) from September 2017–H2 2019. Mean total, inpatient, outpatient, and pharmacy costs were calculated and adjusted to 2019 US dollars. HCRU and costs were stratified by adverse events (AEs) of interest—cytokine release syndrome (CRS) and neurological events (NEs)—identified through unvalidated “loose” and “strict” criteria. Results: A total of 205 pts were identified. Across databases, mean age ranged from 55.2–68.9 years, 63%−86% were male, and 88%−100% received CAR T cell therapy in the inpatient setting. In the 3 months after CAR+ T cell infusion, mean TCOC for all pts ranged from $353,642−$525,772 across databases (Table); mean TCOC were highest among pts who had CRS ($344,486−$730,224; strict CRS criteria). Mean inpatient length of stay (LOS) ranged from 17−21 days and was longer among pts who had CRS (18−23 days; n = 62) or NEs (20−24 days; n = 89) (strict CRS/NE criteria). Conclusions: HCRU and TCOC among pts with DLBCL treated with CAR T cell therapies were generally higher among pts who experienced CRS or NEs. Payors and health care systems may benefit from considering the total cost of CAR T cell therapy, including HCRU associated with treatment-emergent AEs. [Table: see text]
Biosimilar usage in practices within the ASCO PracticeNET learning network.
Authors: Bourbeau Brian , Garrett-Mayer Elizabeth , Guharoy Mou , Schilsky Richard L. 
Published: October 2020

77 Background: In recent years, several antineoplastic biosimilar products have been approved and marketed for use. We analyzed data from the ASCO PracticeNET learning network to gain insights on the adoption of biosimilar products for bevacizumab, rituximab, and trastuzumab. Methods: Our analysis included the following products: bevacizumab, bevacizumab-awwb, bevacizumab-bvzr, rituximab (excluding rituximab and hyaluronidase), rituximab-abbs, trastuzumab, trastuzumab-anns, and trastuzumab-dkst, administered from July 2019 to March 2020. 19 practices submitted their billing data; practices ranged in size from 2 to 29 hematologists/oncologists. Products were identified through use of healthcare common procedure coding system codes. The proportion of biosimilar product doses administered, as a percent of total doses for all related products, was calculated per participating practice. Results: Use of biosimilar products for bevacizumab (first biosimilar approval in September 2017) was first detected in August 2019, averaging 1.4% of administered doses (confidence intervals included in Table) with a range from 0% to 27% among participating practices; by March 2020, average use increased to 31% with a range from 0% to 100%. Use of biosimilar products for rituximab (first biosimilar approval in November 2018), was first detected in January 2020, averaging 2.6% of administered doses, with range of 0% to 30%; by March 2020, average use increased to 18%, with a range of 0% to 61%. Use of biosimilar products for trastuzumab (first biosimilar approval in December 2017) was first detected in September 2019, averaging 0.9% of administered doses with a range of 0% to 17%; by March 2020, average use increased to 35%, with a range of 0% to 98%. Conclusions: The release of biosimilar products has been identified as a potential opportunity to lower the cost of drug therapy for cancer patients. Our analysis identified an approximate 2-year lag from product approval to initial utilization followed by a steady increase in the use of biosimilar products, along with a wide range of use among practices. [Table: see text]
Racial disparities in cancer clinical trials.
Authors: Khandwala Pushti , Desai Devashish , Das Devika Govind , Desai Aakash 
Published: October 2020

97 Background: Cancer-related mortality has been found to be disproportionately higher in racial minorities and medically underserved populations.[1] This necessitates adequate representation of these subgroups in clinical trials for these practices to become an acceptable benchmark for all.However, this has been historically challenging and various studies have failed to show the equitable representation of various ethnic groups in these trials that ultimately guide clinical practice. Methods: We reviewed all abstracts presented at the 2020 ASCO Virtual meeting, from which we selected abstracts discussing results from phase III trials. Of these, we included phase III studies that provided explicit information on the demographic distribution of the clinical trial participants with respect to their race/ethnicity. We then extracted information on the demographic data of participants in the clinical trial using the slides or posters available on the ASCO website. Further, we utilized descriptive statistics to analyze and compare the clinical trial population with the general cancer population using the 2020 ACS Cancer statistics. However, our analysis was potentially limited by the absence of full demographic distribution when previously described elsewhere and the lack of uniform reporting of different ethnicities among these abstracts. Results: Of the total 476 abstracts studied, 120 described phase III studies. Among these, 23 did provide detailed demographic (race/ethnicity) distribution. However, 98 studies did not include standardized subgroups (White, African American, and Others) and 6 studies provided data only on Whites. A total of 9 studies were included in the final analysis. Overall, the following was found: White 7083 (76.8%), African Americans 675 (7.3%), and “Others” 1466 (15.9%). Meanwhile, a comparison of cancer demographic data from the American Cancer Society (ACS) demonstrates the overall cancer incidence rates from 2012-2017 was found to be 464.6/100,000 in non-Hispanic whites and a comparable 460/100,000 in Non-Hispanic Blacks. However, our analysis shows that these ethnic minorities continue to be severely underrepresented in these phase III clinical trials. Conclusions: Despite several efforts, health care disparities persist and racial minorities continue to be underrepresented in cancer clinical trials. Further measures are needed to ensure adequate representation, healthcare equity and the generalizable nature of these “practice-changing” trials. References: 1. https://seer.cancer.gov/csr/1975_2017/results_merged/topic_race_ethnicity.pdf .
Rate of Whole-Breast Hypofractionated Radiation Therapy Before Versus After Virtual Tumor Board Implementation
Authors: Powell Adam C. , Ceylan Mitchell , Long James W. , Deshmukh Uday U. , Loy Bryan , Mirhadi Amin J. 
Published: October 2020

PURPOSE: The virtual tumor board (VTB) is a multidisciplinary group of specialist physicians who remotely educate the treating physician on the development of an evidence-based cancer treatment plan that will enhance patient outcomes according to the available literature. The use of hypofractionated (HF) radiation therapy (RT) is a preferred approach according to National Comprehensive Cancer Network guidelines and is encouraged by the VTB, when appropriate. MATERIALS AND METHODS: An observational, cohort study using prior authorization and claims data were conducted to show how the relative use of HF and conventional fractionated (CF) RT changed after the implementation of the VTB. Orders and claims for qualifying patients from 1 year before launch (August 2016) to 1 year after launch (August 2018) of the VTB were extracted. Claims were examined to observe which patients received CF (28-35 fractions) versus HF (15-21 fractions) RT. χ2 tests were used to assess the association between time period and the ordering and use of HF RT. Logistic regressions were used to test the association, after adjusting for the patient’s age, urbanicity, local average income, and the RT modality used. RESULTS: After implementation, we observed a significantly higher percentage of orders for HF RT (60.3% [n = 1,254 of 2,079] v 53.2% [n = 1,010 of 1,899]; P < .001) and claims for HF RT (71.5% [n = 1,143 of 1,598] v 59.0% [n = 941 of 1,595]; P < .001). Relative to before implementation, the adjusted odds of an order for HF RT was 1.35 (CI, 1.19 to 1.54), and the adjusted odds of a claim for HF RT was 1.76 (CI, 1.52 to 2.04). CONCLUSION: After the VTB was implemented, there was a significant increase in HF RT orders and claims.
Comprehensive Genetic Analysis of 128 Candidate Genes in a Cohort With Idiopathic, Severe, or Familial Osteoporosis
Authors: Rocha-Braz Manuela G M , França Monica M , Fernandes Adriana M , Lerario Antonio M , Zanardo Evelin A , de Santana Lucas S , Kulikowski Leslie D , Martin Regina M , Mendonca Berenice B , Ferraz-de-Souza Bruno 
Published: October 2020

AbstractContextThe genetic bases of osteoporosis (OP), a disorder with high heritability, are poorly understood at an individual level. Cases of idiopathic or familial OP have long puzzled clinicians as to whether an actionable genetic cause could be identified.ObjectiveWe performed a genetic analysis of 28 cases of idiopathic, severe, or familial osteoporosis using targeted massively parallel sequencing.DesignTargeted sequencing of 128 candidate genes was performed using Illumina NextSeq. Variants of interest were confirmed by Sanger sequencing or SNP array.Patients and SettingThirty-seven patients in an academic tertiary hospital participated (54% male; median age, 44 years; 86% with fractures), corresponding to 28 sporadic or familial cases.Main Outcome MeasureThe identification of rare stop-gain, indel, splice site, copy-number, or nonsynonymous variants altering protein function.ResultsAltogether, we identified 28 variants of interest, but only 3 were classified as pathogenic or likely pathogenic variants: COL1A2 p.(Arg708Gln), WNT1 p.(Gly169Asp), and IDUA p.(His82Gln). An association of variants in different genes was found in 21% of cases, including a young woman with severe OP bearing WNT1, PLS3, and NOTCH2 variants. Among genes of uncertain significance analyzed, a potential additional line of evidence has arisen for GWAS candidates GPR68 and NBR1, warranting further studies.ConclusionsWhile we hope that continuing efforts to identify genetic predisposition to OP will lead to improved and personalized care in the future, the likelihood of identifying actionable pathogenic variants in intriguing cases of idiopathic or familial osteoporosis is seemingly low.