bluuebunny/crossref_metadata_2025_split huggingface dataset:
Hyponatremia could be an important prognostic factor for oncology patients: Result of a retrospective study.
Authors: Das Prantik , Seneviratne Lalith , Gore Emma , Oo Zin Mar , Hulman Joshua , Sellahewa Luckni 
Published: May 2020

7055 Background: Hyponatraemia is the most common electrolyte disorder encountered in clinical practice. Hyponatraemia in hospitalized people is associated with an increased morbidity, mortality and longer hospital stay compared with people with normal serum sodium concentrations. It is a negative prognostic indicator for survival in oncology patients. Incidence of hyponatremia in malignancy is largely underestimated. Methods: Retrospective analysis of patients admitted to oncology ward in our institution between August to September 2018 was conducted. Patients were identified from admission register and data were analysed from electronic medical records. Primary aim was to evaluate the incidence of hyponatraemia in oncology in-patients and impact on survival. Data were also analysed for patients demography, cancer types, grade of hyponatremia and treatment approach. Results: 119 patients were admitted to oncology ward during study period. Out of them 38% were identified to be Hyponatraemic and 51 % patients were male. Lung cancer was the predominant cancer type followed by breast, upper GI and ovarian respectively. Of hyponatraemic patients, 63% were asymptomatic, among symptomatic patients vomiting, confusion and headaches are common. According to severity, 42% patients had grade 1, 40% grade 2 and 18% grade 3 hyponatraemia respectively. When it comes to status of hydration, 62.2% were noted to be euvolaemic, 6.66% were hypervolaemic and 15.5% were hypovolaemic and the hydration status of the rest of 15.5% were not known. Considering mortality, 53% patients died within 30 days of diagnosis of hyponatremia compared to 17% deaths among non-hyponatraemic patients. Median survival of patients with grade 3, 2 and 1 hyponatremia were 29, 35 and 62 days respectively. Out of 45 patients 14 (31.1%) had acute onset hyponatraemia and they had considerably poorer survival compared to their chronic hyponatraemic counterparts. 80% of acute hyponatraemic patients have died within 30 days of diagnosis, compared to 140 days for chronic hyponatraemics with similar death rate. Out of 48% non-hyponatraemic patients who died within next 6 months, 31% developed hyponatraemia at some point before their death and amongst them, 5.7% had severe, 8.5% had moderate and 17% had mild hyponatraemia respectively. Conclusions: Our study indicated that hyponatremia is poor prognostic factor among oncology patients, with mortality being significantly higher when the grade is higher and when acute in onset. Identifying and early intervention could improve patient outcome.
The association of fitness and body mass index (BMI) on all-cause mortality in cancer survivors: The Henry Ford Exercise Testing Project (The FIT Project).
Authors: Marshall Catherine Handy , McAuley Paul A , Tsai Hua-Ling , Dardari Zeina , Al-Mallah Mouaz H , Brawner Clinton A , Lamerato Lois E. , Keteyian Steven , Ehrman Jonathan , Blaha Michael J 
Published: May 2020

7060 Background: The obesity paradox –i.e. inverse associations between body mass index (BMI) and mortality – has been reported in patients with cancer, heart failure, and diabetes. However, the influence of cardiorespiratory fitness (CRF) on this relationship is not well established. This study assesses the association of BMI and CRF with all-cause mortality among cancer patients. Methods: The Henry Ford (HF) FIT Project is a retrospective cohort study of 69,885 consecutive patients who underwent physician-referred exercise stress testing from 1991 through 2009. Cancer diagnosis was identified through linkage to the HF tumor registry. We included patients 40-70 years old, with BMI recorded, at time of exercise test, with a history of cancer > 6 months prior. BMI was categorized as normal (18.5-24.9kg/m2), overweight (25-29.9kg/m2), or obese ( > = 30kg/m2). All-cause mortality was obtained from the National Death Index. Because of a significant interaction between BMI and cancer type, patients with breast or prostate cancer were excluded. Multivariable adjusted Cox proportional hazard models were used to evaluate the association of CRF andBMI with all-cause mortality; adjusted for age at exercise test, sex, diabetes, smoking, cancer stage, and time from cancer diagnosis to exercise test. Results: Included were 676 patients with a mean age of 58 years (SD 7.5), 51% female, 70% White, 25% Black, with a median of 4.8 years from diagnosis to exercise test and median follow up time of 10.3 years. Among patients achieving < 10 METs, those who are overweight and obese had a lower risk of mortality HR 0.47 (95% CI 0.25,0.86) and HR 0.44 (95% CI 0.26, 0.74, respectively), compared to those with normal BMI. Among patients with METs > = 10, those who were overweight had the lowest risk of all-cause mortality (HR 0.23, 95% CI 0.09-0.62) compared to normal weight, while no statistically significant different risk of mortality was observed when comparing those who are obese to normal weight (HR 0.37, 95% CI 0.13-1.06). In an analysis combining BMI and fitness groups (four categories), those with BMI > = 25 and METs > = 10 had the lowest risk of all-cause mortality (Table). Conclusions: In non-breast/non-prostate cancer patients, increased BMI is associated with improved overall survival in those with METs < 10, while a U-shaped relationship between BMI and all-cause mortality exists among those with METs > = 10. [Table: see text]
Perioperative chemotherapy versus adjuvant chemoradiation in resectable gastric cancer: A national cancer database analysis.
Authors: Malapati Sindhu Janarthanam , Singh Sunny R K , Kumar Rohit , Abdalla Ahmed , Hadid Tarik H. 
Published: May 2020

7066 Background: In patients with resectable gastric cancer, the use of either perioperative chemotherapy (POC) or adjuvant chemoradiotherapy (CRT) are acceptable treatment options in addition to surgical resection. Both approaches improved overall survival (OS) compared to surgery alone. Randomized controlled trials comparing these two modalities are lacking. This study uses real-world data to compare the clinical outcomes of these two approaches. Methods: We identified gastric cancer patients in the NCDB who had definitive surgery between years 2004 and 2015. They were divided into two cohorts: POC and adjuvant CRT. We compared the OS and surgical outcomes in both groups. Kaplan-Meier method and multivariable Cox regression model were used to estimate survival. Results: Of 75,654 patients who underwent definitive surgical resection, 1,920 had POC and 9,161 had adjuvant CRT. Median OS was 56 months with POC and 38.5 months with CRT. After adjusting for age, gender, race, insurance status, comorbidity index, and treatment facility, patients who received POC had an 18% reduction in all-cause mortality compared to those who received adjuvant CRT (p <0.0001, 95% confidence interval 0.74- 0.88). Although, 30- and 90-day mortality was slightly higher with POC compared to CRT (0.047 vs. 0.03%, p<0.0001 and 1.46 vs. 0.45%, p<0.0001 for 30 and 90 day mortality, respectively). Length of hospital stay for primary tumor resection was similar between the two groups; but the 30 day readmission rate after surgery was higher with CRT compared to POC (12.74 vs. 8.33%, p<0.0001). Conclusions: Among patients undergoing definitive surgical resection for gastric cancer, our study shows an association between the use of POC (vs. adjuvant CRT) and improvement in OS. In the POC cohort, while there was a slight increase in postoperative mortality, this was surpassed by the benefit derived from use of POC, resulting in net improvement of survival. These interesting observations warrant confirmation in randomized clinical trials. [Table: see text]
The correlation between clinical benefit and financial cost of cancer drugs.
Authors: Mitchell Aaron Philip , Tabatabai Sara , Dey Pranammya , Ohn Jennifer , Curry Michael A. , Bach Peter 
Published: May 2020

7071 Background: The cost of many cancer drugs is very high, but it is unclear if these costs are associated with commensurate improvement in outcomes. We aimed to assess the association between the cost of cancer treatments and their clinical benefit, using the NCCN Evidence Blocks value assessment framework. Methods: The NCCN Evidence Blocks include 4 measures of clinical benefit: Efficacy, Safety, Quality of Evidence, and Consistency of Evidence. The NCCN assigns scores on each measure ranging from 1 (least favorable) to 5 (most favorable). We obtained the NCCN Evidence Blocks scores as of December 31, 2018 for all recommended cancer treatments for the 30 most prevalent cancers in the US. For each treatment, we calculated total treatment costs (including drugs, administration fees, and supportive care medications) using Medicare reimbursement rates. We categorized treatments as either “time-limited” or “time-unlimited” according to whether their costs are best reflected as per full treatment course (often, adjuvant/neoadjuvant treatments) (time-limited) or per month of therapy (often, treatments for advanced disease) (time-unlimited). We used generalized estimating equations, with clustering within treatment indications, to estimate the association between Evidence Blocks scores and treatment costs, modeling the expected change in cost associated with a one-unit increase in the score on an Evidence Blocks measure. Results: There were 541 time-unlimited and 845 time-limited treatments. Among time-unlimited treatments, monthly treatment cost ranged from $4 to $64,630. Monthly treatment cost was positively associated with Efficacy ($3,036, 95%CI: $1,782, $4,289) and Quality of Evidence ($1,509, 95%CI: $171, $2,847) but negatively associated with Safety (-$1,470, 95%CI: -$2,790, -$151) and Consistency of Evidence (-$2,003, 95%CI -$3,420, -$586). Among time-limited treatments, cost per course of therapy ranged from $0 to $775,559, and no measure was significantly associated with cost. Evidence Blocks scores accounted for little of the variation in treatment cost (linear model R-squared = 0.10 for time-unlimited, and < 0.01 for time-unlimited). Conclusions: The association between NCCN Evidence Blocks measures and treatment cost was inconsistent, and accounted for little of the cost variation among treatments for the same indication. The clinical benefit of cancer treatments does not appear to be a primary determinant of treatment cost, suggesting that current pricing models may be inadequate to incentivize the development and utilization of high-value treatments.
Breast density notification with adjunctive digital breast tomosynthesis (DBT): A cost-effectiveness analysis.
Authors: Semprini Jason , Vaughan-Sarrazin Mary 
Published: May 2020

7072 Background: Dense breasts increase a woman's risk of developing cancer while also raising the likelihood of a missed diagnosis from traditional mammography screening. Digital Breast Tomosynthesis (DBT) has been shown to identify positive breast cancer more accurately in women with dense breasts, but no study has estimated the cost-effectiveness of this screening mode under a notification requirement. Methods: Taking the perspective of a healthcare system, we estimated the incremental cost-effectiveness ratio (ICER) of providing DBT as an alternative to mammography for 40-year old women. Model parameters reflecting risk of breast cancer, detection rates, and costs were estimated from recent meta analyses, Tufts’ CEA registry, and Medicare Fee Schedules. We used probabilistic Markov Models to estimate the ICER under uncertainty, and a time-variant model in which breast density and cancer risk change over time. Additionally, a heterogeneity analysis included all women between the ages of 40-65, while also using 1st and 2nd degree family history to calculate cancer risk. Results: In the probabilistic model, adjunctive DBT has a cost differential of $12,203, with an increase of 0.0382 quality-adjusted life years (ICER = $319,491/QALY) compared to mammography. This result was most sensitive to the probability of a missed diagnosis for women with dense breasts. At a willing-ness to pay of $50,000, adjunctive DBT had a 57% chance of being more costly and less effective than standard mammography. Conversely, DBT only had a 20% chance of being cost-effective and a 9.9% chance of being less costly and more effective. The time-variant model reported an ICER of $174,218, but adjunctive DBT became even more cost-effective after expanding the population and including family history of cancer (ICER_All Ages = $157,146; ICER_FamHist = $153,388). Conclusions: Breast density notification laws which provide additional screening via DBT are not cost-effective at a willingness to pay of $50,000. Policymakers, however, should note that many modern cancer therapeutics also exceed this threshold. As an adjunctive screening technique, DBT would result in fewer deaths and increase quality of life, but the effect is minimal and carries a high cost. Including breast density within greater risk stratification protocols, however, may prove highly cost-effective, especially for older women with a family history of cancer.
Venous thromboembolism prophylaxis in ambulatory cancer patients initiating chemotherapy: A cost-effectiveness analysis.
Authors: Ryan Emma , Salinaro Julia , Havrilesky Laura J , Davidson Brittany Anne 
Published: May 2020

7074 Background: Venous thromboembolism (VTE) is a major cause of morbidity and mortality among cancer patients. The Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients (AVERT) randomized controlled trial concluded that apixaban is a safe and effective option for VTE prophylaxis in high-risk ambulatory cancer patients initiating a new chemotherapy regimen. We performed a cost-effectiveness analysis from a health system perspective to determine if apixaban is a feasible prophylactic strategy for this population. Methods: A decision model was created from a third party payer perspective with a time horizon of 6 months, based on the treatment arms of the AVERT trial: (1) apixaban 2.5 mg twice daily for 6 months during active chemotherapy versus (2) placebo. Rates of VTE (4.2% apixaban vs 10.2% placebo), major bleeding (3.5% vs 1.8%) and clinically relevant nonmajor bleeding (CRNMB) (7.3% vs 5.5%) were modeled from the results of the AVERT trial. Cost estimates for treatments and events were obtained from wholesale drug costs, previously published studies and Medicare reimbursement data, and adjusted for inflation to 2018 dollars. Quality adjusted life years were calculated based on previously published utility values for the health states of advanced cancer, DVT, PE, and major bleeding events. An exploratory analysis was performed comparing prophylactic aspirin to no prophylaxis assuming a VTE rate of 7.2%, major bleeding rate of 3.5%, and CRNMB rate of 7.3%, based on the conservative assumptions that while aspirin may not be as effective at preventing VTE, the rate of clinically significant bleeding events would be similar or greater than that of apixaban. Results: In the base case model, apixaban is more costly and more effective than placebo (ICER = $5,013,190/QALY), and the cost per VTE prevented in the apixaban arm is $33,000. In one-way sensitivity analysis, if the cost of apixaban were reduced by 40% from $3,197 to $1,250 for a 6 month course, this could potentially be a cost-effective prophylaxis strategy with an ICER less than $100,000/QALY. In the alternative analysis, aspirin dominates placebo as it is both more effective and less expensive, and remains cost-effective even when the rate of clinically recognized bleeding with aspirin exceeds 15%. Conclusions: Further investigation into less costly prophylactic options such as generic direct oral anticoagulants (once available) and aspirin is warranted prior to broader implementation of a VTE prophylaxis strategy in this population.
Cost-effectiveness of genomic profiling in veterans with metastatic lung adenocarcinoma.
Authors: Poonnen Pradeep , Dong Olivia , Winski David , Reed Shelby D. , Vashistha Vishal , Bates Jill S. , Kelley Michael J. , Voora Deepak 
Published: May 2020

7075 Background: Tumor profiling identifies patients who are eligible for targeted anticancer therapies. Common tumor profiling approaches include targeted gene panel testing (TGPT), which tests for common mutations in select genes, and multigene panel sequencing (MGPS), which tests for a broad range of mutations in a comprehensive set of genes. Our objective was to determine the lifetime cost-effectiveness of MGPS and TGPT compared to no tumor profiling for Veterans with metastatic lung adenocarcinoma from the Veterans Health Administration’s (VHA) perspective. Methods: A decision analytic model was developed to simulate outcomes for a closed cohort of hypothetical Veterans with metastatic lung adenocarcinoma considering anticancer therapy. OncoKB genes with levels of evidence 1 and 2 for guiding therapy were included. Three profiling strategies were studied: TGPT ( ALK, EGFR, ROS1), MGPS ( ALK, BRAF, EGFR, HER2, MET, NTRK1, NTRK2, NTRK3, RET, ROS1), and no tumor profiling. We assumed 95% of patients with actionable mutations received targeted therapies. Non-targeted therapy options included chemotherapy and/or immunotherapy, and no anticancer therapy. Model inputs were derived from randomized trials (progression-free survival), VHA and Medicare (drug costs), published studies (non-drug cancer-related management costs, health care utilities), and VHA National Precision Oncology Program and cBioPortal for Cancer Genomics databases (mutation prevalence). Costs (2019 US$) and quality-adjusted life years (QALYs) were discounted at 3%/year. Base-case scenario, one-way sensitivity analyses, and probabilistic sensitivity analyses (PSA) using 1,000 Monte Carlo simulations were completed. Results: Base-case results and corresponding 95% credible intervals from the PSA indicated the cost/QALY gained was $309,399 ($280,371-$343,161) for TGPT and $324,707 ($296,086-$359,778) for MGPS compared to no tumor profiling. Of the 3 strategies, MGPS resulted in the highest number of QALYs. One-way sensitivity analyses revealed the cost/QALY estimates were most impacted by changes in health state utility on a targeted therapy (quality of life), costs of alectinib, and non-drug cancer-related costs in patients receiving targeted therapy. Compared to no tumor profiling, cost-effectiveness ratios for both profiling approaches surpassed the $150,000/QALY threshold in 100% of PSA simulations. Conclusions: Tumor profiling (TGPT or MGPS) can optimize anticancer therapy selection in patients with metastatic lung adenocarcinoma and improve quality-adjusted survival, but compared to no tumor profiling, is not cost-effective.
Patient-reported out-of-pocket costs and financial toxicity during early-phase oncology clinical trials.
Authors: Huey Ryan , George Goldy , Phillips Penny , White Revenda , Fu Siqing , Janku Filip , Karp Daniel D. , Naing Aung , Piha-Paul Sarina Anne , Subbiah Vivek , Tsimberidou Apostolia Maria , Pant Shubham , Yap Timothy A , Rodon Ahnert Jordi , Meric-Bernstam Funda , Shih Ya-Chen T. , Hong David S. 
Published: May 2020

7082 Background: Clinical trials are an important therapeutic option for cancer patients (pts). Although financial burden in cancer treatment is well-documented, the financial burden associated with clinical trials is not well understood, especially for pts with lower income. Methods: We conducted a survey regarding economic burden and financial toxicity in cancer pts who had been on Phase I clinical trials for ≥1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicate worse toxicity). Pts also reported monthly out-of-pocket (OOP) medical and non-medical expenses. We applied multivariable logistic regression to analyze risk of financial toxicity, and unanticipated expenses. Results: Early-phase clinical trial pts (N = 213, median age = 59y; 59% female; 74% White, 45% w/ annual income ≤$60K; 50% lived > 300 miles from the clinic; 40% required air travel; 37% had Medicare, 54% had employer sponsored insurance) had a median FTS of 20, with interquartile range of 12. Median monthly OOP costs for non-medical expenses was $1075, and for medical expenses was $475. Median total monthly OOP costs was $1750. 55% and 64% of pts reported that actual medical and non-medical expenses were higher than expected, respectively. Worse financial toxicity (≤ median FTS) in pts was associated with yearly household income < $60K (OR: 2.7, P = 0.008), having medical costs higher than expected (OR: 3.2, P = 0.024), participation on ≥1 Phase I clinical trial prior to their current trial (OR: 2.2, P = 0.028), and living > 100 miles away from the clinical trials hospital (OR: 2.3, P = 0.043). However, 34% of pts who lived > 100 miles away received partial/full reimbursement of clinical trial-related travel costs from study sponsor/other/insurance. Racial/ethnic minority (OR: 2.6, P = 0.008) and pts who were unemployed or not working outside the home (OR: 2.4, P = 0.023) were more likely to report that actual medical costs were much higher than expected. 53% of pts used savings and 18% retirement accounts to pay for treatment. Conclusions: Among cancer pts participating on clinical trials, economic burden is high, and most of pts’ OOP costs were on non-medical expenses. Financial toxicity is disproportionally higher in pts with lower income. OOP costs can be substantial and are often unexpected for pts. Furthermore, prior participation in ≥1 Phase I clinical trial and living far away from the clinical trials hospital seem to increase risk of financial toxicity.