bluuebunny/crossref_metadata_2025_split huggingface dataset:
Project facilitate: A review of the FDA oncology center of excellence expanded access pilot program.
Authors: Kormanik Natasha L , Chan Mitchell , Boehmer Jessica , Kim Tamy , Blumenthal Gideon Michael , Pazdur Richard 
Published: May 2020

7023 Background: Expanded Access (EA), also known as “compassionate use,” is a regulatory pathway in which a patient with an immediate life-threatening condition or disease can gain access to an investigational product for treatment when no satisfactory therapy is available. Oncology practices may lack the regulatory experience or administrative support to use EA. In response, FDA OCE launched Project Facilitate (PF), a call center to assist oncology healthcare providers requesting EA. An analysis of single-patient investigational new drugs (IND) was performed to assess the first 10 months of PF compared to the period prior to its launch. Methods: Preliminary data was extracted from the FDA’s central database that yielded 719 single-patient INDs between May 31-November 30, 2018 & 2019 in the Office of Oncologic Diseases (OOD). Data collected included IND receipt date, acknowledgment date, application status, drug name, underlying malignancy of patient, address of requesting physician, withdrawal date, and patient demographics. A manual review of INDs was performed to assess for actual processing dates and to capture demographics not captured by the database. A total of 28 INDs were excluded due to duplications, cancellation by Sponsor prior to issuance of FDA decision, or coding errors in the database. Industry denial explanations were reported by the provider by emails. Results: Data from 692 INDs were analyzed and 692 (100%) were granted safe to proceed. The median processing time was 1 day (mean=2) in 2018 and 1 day (mean= 1.5) in 2019. Our findings indicate that the volume of oncology EA requests increased by 76 (19%) in 2019 vs 2018. A total of 207 unique drugs were requested. Malignancies most frequently involved included: Acute myeloid leukemia (n = 84, 8.3%), soft tissue sarcoma (n = 77, 7.6%), and non-small cell lung cancer (n = 60, 5.9%). States with the highest requests included: California (n = 82, 11.8%), New York (n = 81, 11.7%), and Massachusetts (n = 42, 6.1%). A majority of requests were from major academic centers (77%). All denied requests (N = 9) by industry were due to company’s decision to not provide products outside of a clinical trial. Conclusions: The positive trends in decreased processing times and increased number of requests are consistent with OCE’s mission to improve efficiency of the EA program and ensure equitable access to all oncology patients. [Table: see text]
Breast and cervical cancer screening disparities among transgender patients.
Authors: Oladeru Oluwadamilola Temilade , Ma Sung Jun , Miccio Joseph , Wang Katy , Attwood Kristopher , Singh Anurag K , Haas-Kogan Daphne A. , Neira Paula M 
Published: May 2020

7024 Background: Over a million Americans identify themselves as transgender and this population is growing. Transgender status was a pre-existing condition prior to the Affordable Care Act (ACA), and transgender individuals faced unique disparities in gender-specific cancer screening in part due to discrimination in health insurance coverage. Modern literature for transgender adults’ adherence to cancer screening is limited. To fill this knowledge gap, we conducted a cross sectional study to investigate transgender individuals’ self-reported adherence to cancer screening and access to primary care compared to cisgender individuals. Methods: The Behavioral Risk Factor Surveillance System database was queried for transgender (either male-to-female [MTF] or female-to-male [FTM]) and cisgender adults from 2014-2016 and 2018. Primary endpoints were adherence to breast and cervical cancer screening guidelines and access to primary health care. Those with prior hysterectomy, breast and cervical cancer were excluded. Multivariable logistic regression was performed to evaluate the association of transgender status with cancer screening and healthcare access, after adjusting for demographic characteristics and survey weights. Results: A total of 219,665 and 206,446 participants were eligible for breast and cervical cancer screening, respectively. Of those, 614 (0.28%) and 587 (0.29%) transgender participants were eligible for each cancer screening type, respectively, representing a weighted estimate of nearly 200,000 transgender participants total. When compared to cisgender counterparts, transgender participants were less likely to adhere to breast cancer screening (FTM: OR 0.47, p < 0.001; MTF: OR 0.04, p < 0.001) and to have received any breast cancer screening (FTM: OR 0.32, p < 0.001; MTF: OR 0.02, p < 0.001). Similarly, FTM participants were less likely to adhere to cervical cancer screening (OR 0.42, p < 0.001) and to have received any cervical cancer screening (OR 0.26, p < 0.001). In addition, transgender participants were more likely to have no primary care physician (FTM: OR 0.79, p < 0.001; MTF: OR 0.58, p < 0.001) and to be unable to see a physician when needed within the past year due to medical cost (FTM: OR 1.44, p < 0.001; MTF: OR 1.36, p < 0.001). Conclusions: Despite the implementation of the ACA, limited primary care access and poor adherence to breast and cervical cancer screening are evident for transgender populations. Further research efforts to improve the utilization of preventive cancer services are needed for this underserved population.
Global oncology authorship and access patterns.
Authors: Bourlon Maria Teresa , Jimenez Brenda , Matar Charbel Fadi , Gunn Emilie M. , Ginsburg Ophira M. , Lopes Gilberto , Segelov Eva 
Published: May 2020

7061 Background: Global Oncology is a movement to improve equitable access to cancer control and care, recognizing challenges due to economic and social factors between high, middle, and low-income countries (HIC, MIC, LIC). Access to local, regional, and global cancer data and analysis is a major driver for building a global oncology community. The JCO Global Oncology (JCO GO) online open access journal was established in 2015 with the mission to be the voice of research relevant to populations with limited resources. To assess its goals of encouraging global interaction and increasing MIC and LIC engagement, we analyzed authorship and accessing data. Methods: Logged views of articles published in 2018 were identified by DOI, using Google Analytics during the period 01/01/2018 to 06/30/2019. The country of origin of all authors and the location of downloads were classified according to the 218 economies listed in The World Bank Data (WBC) of 2019. Results: 132 articles were published in JCO GO in 2018 with 88152 views, from which the accessing nation was identified for 99%. Views originated from 180 countries: 35% HIC, 51% MIC, and 14% LIC. The most common accessing countries were: USA (37%), India (14%), United Kingdom (3%), Brazil (3%), and Ethiopia (3%). Corresponding authors came from 34 nations: 60% HIC, 32% MIC, and 8% LIC. The most common economies involved in any authorship were: USA (47%), India (10%), Brazil (5%), Mexico (4%), and Nigeria (3%). Reader origin did not differ according to corresponding author WBC. Article authorship was exclusively from one economic category in 49%: 23% HIC 16% MIC, 2% LIC. For 59% of articles, authorship came from mixed economies: 42% HIC + MIC, 11% HIC + LIC, 0% MIC + LIC, 6% HIC + MIC + LIC. Conclusions: JCO GO ’s reach extends to over 80% of the world´s economies. The majority of articles have authors from mixed WBC countries. Areas identified to address are: low level of LIC corresponding authorship; few papers from authors across all economies; no papers from only LMICs authors; low percentage of views by LIC. This information provides focus for global oncology authorities to target interventions to reduce the academic segregation of LICs, such as global oncology funding opportunities, mentorship and policies to encourage interactions and develop MIC and LIC leaders.
Vital status ascertainment in cancerlinq discovery (CLQD): Improvement in mortality capture with a supplemental data source.
Authors: Potter Danielle , Kaltenbaugh Melinda , Kabadi Shaum , Taylor Aliki , Pascual Esther , Koskimaki Jacob , Brothers Raven , Stoeber Philip , Mena Jose , Garrett-Mayer Elizabeth 
Published: May 2020

7064 Background: Overall survival (OS) is the gold standard outcome in clinical cancer research but many clinical trials cannot assess long-term OS. Real-world data sources can be used to calculate long-term OS, but only if vital status is accurately captured. Methods: The primary goal was to assess concordance of death dates from CLQD and an external source, and the effect of incorporation of external death data on estimates of OS. CLQD obtains electronic medical record (EMR) data from participating US oncology sites. Under-reporting of vital status is a common problem with EMR data; we investigated the value of including death data from a commercially available database, obituarydata.com (OBD) into CLQD. OBD pulls death data from published obituaries across the US. A matching algorithm is used to match patients in CLQD and OBD. OBD death data from breast, lung, ovarian, and pancreatic cancer patients diagnosed between 2010–2018 supplemented the CLQD in this study. OS was calculated using Kaplan-Meier estimation; Pearson correlation was used for comparing time to death. Results: The addition of OBD modestly changes OS estimates (see Table). Among a subset of patients with death dates in both CQLD and OBD, dates were highly correlated for breast (r = 0.98), lung (r = 0.93), ovarian (r = 0.99), and pancreatic (r = 0.88) cancers. When date differences existed, they were ≤10 days for > 95% of the patients. These results suggest death dates are reliable in CLQD EMRs. OS curves were as expected, with OS decreasing by stage and age at diagnosis. Conclusions: Incorporating OBD modestly improves OS estimates and shows that when death data is present in CLQD, it is reliable. Future enhancements will focus on improving sensitivity of mortality ascertainment with external data linkages, without compromising specificity. [Table: see text]
Three versus six months of adjuvant chemotherapy for colorectal cancer: A multi-country cost-effectiveness and budget impact analysis.
Authors: Hanna Catherine , Robles-Zurita Jose Antonio , Jones Robert J. , Boyd Kathleen 
Published: May 2020

7076 Background: The international Short Course Oncology Treatment (SCOT) trial demonstrated non-inferiority and significantly less toxicity of 3 versus 6 months of adjuvant chemotherapy for patients with colorectal cancer (CRC). This study assesses the value of shorter treatment and the economic implications of implementing the findings from the perspective of the countries that participated in the SCOT trial. Methods: Individual patient level data (n=6055) from the SCOT trial was used in a fully-pooled, cost utility analysis for the six participating countries. The incremental net monetary benefit (INMB) per patient was calculated using a willingness to pay threshold of one Gross Domestic Product per capita for each country. Responses to a clinician questionnaire (n=265 across 21 countries collected in April 2019) were used to estimate extent of practice change. The budget impact over 5 years of using shorter treatment was calculated, using 2019 and US dollars (USD) as the base year and currency, respectively. Results: Cost drivers for differences between the SCOT trial arms were reduced chemotherapy costs and fewer hospitalisations in the first treatment year. The INMB per patient of using shorter treatment and subsequent monetary impact on healthcare provider budgets resulting from implementation are shown in Table. This is a cost saving treatment strategy in all countries. The budget impact over 5 years amounts to savings of nearly half a billion USD. Conclusions: The economic burden of CRC treatment globally exceeds $39 billion per annum. Understanding the costs and consequences of widespread clinical practice change is important for optimal budget planning. This study has widened the transferability of results from a phase III cancer trial, showing shorter treatment is cost-effective from a multi-country perspective. The vast savings could provide benefit elsewhere within a limited healthcare budget, and justify the investment in conducting the SCOT trial. [Table: see text]
Total cost of lung cancer care associated with broad panel versus narrow panel sequencing.
Authors: Brito Rogelio Alberto , Cullum Bob , Hastings Kevin , Avalos-Reyes Elisea , Karos Rebecca , Johnson Kjel Andrew 
Published: May 2020

7077 Background: Many lung cancer patients are diagnosed late with advanced or metastatic disease. Targeted therapies can improve quality of life and increase the chances of progression-free survival versus conventional treatments. An understanding that there may be more than one driver mutation associated with a specific lung tumor is crucial for the timing and delivery of the most effective line of therapy. Broad panel sequencing (BPS) minimizes tissue use and enables personalized treatment that decreases the use of ineffective agents and unwarranted side effects, in addition to opening pathways to early clinical trials. However, many payors do not reimburse for BPS. The objective of this study was to determine if BPS leads to lower total cost of care versus narrow panel sequencing (NPS). Methods: We identified new lung cancer patients who completed BPS (Current Procedural Terminology (CPT) code 81455, 51+ genomic test) or NPS (CPT code 81445, 5-50 genomic test) using medical claims from January 1, 2018, to March 31, 2019. We defined total cost of care as allowed costs paid for medical and pharmacy claims across a six-month time period from the first gene sequencing panel. We also compared the allowed costs of BPS and NPS. A Student’s t-test was used to compare differences and results are presented as mean +/- standard deviation. Results: From January 2018 to March 2019, we identified 45 patients who underwent BPS sequencing and 399 patients who underwent NPS. The average BPS cost was $1,977 +/- $2,713 versus the average NPS lab cost $719 +/- $1,087, p < 0.0001. The average 6-month per member per month (PMPM) total cost was $11,535 +/- $9,168 among those who underwent BPS compared to $20,039 +/-19,642 in those who underwent NPS. This difference of $8,504 was statistically significant, p = 0.0022. Conclusions: BPS has been shown to optimize treatments in patients with lung cancer. These initial results of claims suggest that while lung cancer patients undergoing BPS have higher total sequencing costs than those undergoing NPS, BPS significantly reduces overall total cost of lung cancer care. Identifying the broader genomic landscape of a patient’s tumor earlier will empower oncology providers and lung cancer patients with information to make timely, precise treatment decisions that are ultimately more cost effective.
Patient-reported benefit from proposed interventions to reduce financial hardship during cancer treatment.
Authors: Aviki Emeline , Chino Fumiko , Ramirez Julia , Blinder Victoria Susana , Mueller Jennifer Jean , Leitao Mario M. , Abu-Rustum Nadeem , Gany Francesca 
Published: May 2020

7080 Background: Awareness of cancer patients’ financial toxicity (FT) has increased substantially over the past decade; however, interventions to minimize financial burden remain underdeveloped and understudied. This survey-based study explores patient beliefs on which potential mitigating strategies could improve their financial hardship during cancer treatment. Methods: Interviewer-administered surveys were conducted with consecutive patients in an outpatient, urban, private academic Gynecologic Cancer clinic waiting room for 2 weeks in August 2019. The survey items included patient demographics, disease characteristics, the Comprehensive Score for Financial Toxicity (COST) tool (validated measure of FT with score 0-44; lower scores indicate worse FT), assessment of cost-coping strategies, and patient-reported anticipated benefit from described potential interventions (items that were feasible and relevant to implement in clinic). Results: Of 101 patients who initiated the survey, 87 (86%) completed it and were included in this analysis. The median age was 66 (range, 32-87). Thirty-eight patients (44%) had ovarian, 29 (33%) uterine, 5 (6%) cervical, and 15 (17%) an “other” gynecologic cancer. The median COST score was 32 (range, 6-44). Twenty-nine patients (33%) had COST scores ≤25 and 16 (18%) had COST scores ≤18. The most frequent cost-coping strategy reported was reducing leisure activities (n = 36, 41%) and using savings to pay for medical bills (n = 34, 39%). Six patients (7%) reported not taking a prescribed medication in the past 12 months due to the inability to pay and 0 reported skipping a recommended imaging study. When it came to interventions patients anticipated would improve their current financial hardships, 34 (39%) indicated access to transportation assistance to and from appointments, 31 (36%) said “knowing up front how much I’m going to have to pay for my healthcare”, 29 (33%) indicated “minimizing wait time associated with appointments, which keeps me away from work”, and 22 (25%) indicated “access to free food during/around appointments and treatments”. Only 26 (30%) noted they were not experiencing financial hardship. Conclusions: For an outpatient population of gynecologic cancer patients, several focused, feasible interventions could be implemented to potentially decrease patient FT. Our study can help health care providers in the design of interventions to create meaningful improvements in patient financial burden. Next steps should assess the impact of targeted interventions on patient outcomes.
Financial burden of discarded weight-based cancer drugs to payers and patients in private insurance market.
Authors: Shih Ya-Chen T. , Xu Ying , Zhao Hui , Yao James C. 
Published: May 2020

7083 Background: Studies assessing wastage of discarded weight (WT)-based cancer drugs (can-RX) derived their estimates from Medicare Average Sales Prices + 6% mark-up. With higher mark-ups, financial impact of discarded can-RX can be much higher in private insurance market. In addition, no study has examined the financial burden for patients(pts) even though they are subject to out-of-pocket payment (OOP) of the discarded RX. This study fills in these important knowledge gaps. Methods: We obtained the list of WT-based can-RX from the 2017 Centers for Medicare and Medicaid Services Part B Discarded Drug Units Report and gathered information on package size and recommended dose from IBM Micromedex. We identified pts who received WT-based can-RX from 2017 MarketScan data and linked to MarketScan Health Risk Assessment to obtain WT and height for a subset of pts. For each claim, we derived the recommended dose based on pt’s RX and his/her WT or body surface area (calculated from WT and height) and estimated the % of discarded dose. We quantified OOP as the sum of deductible, copayment, and coinsurance, and classified pts’ insurance by their enrollment to high-deductible (HD) plans. For claim-level analysis, we applied beta regression (for fractional outcomes) to determine factors associated with % discarded while accounting for within pts correlations. Covariates were age group (grp) ( < 50, 50-59, > = 60), WT grp ( < 150, 150-199, > = 200lb), HD plan (yes/no), region, cancer type, and can-RX. For pt-level analysis, we calculated the amount payers and pts spent on all and discarded can-RX in 2017 and compared OOP b/t pts in HD and non-HD plans. Results: Of 27,883 claims of WT-based can-RX, the median discarded % was 0.10 (mean 0.19, SD = 0.21). In addition to can-RX and cancer type, significantly higher discarded % was found in the lowest WT grp (0.03, P < 0.001, vs. WT > = 200lb) and significantly lower % was found in the middle age grp (-0.01, P = 0.02 vs. age < 50). Of 1963 pts, 778 (40%) had HD plans. Payments by payers (NETPAY) and pts (OOP) for total and discarded can-RX and the comparison b/t HD and non-HD plans are shown in Table. Conclusions: Payers incurred substantial financial burden from discarded can-RX. While OOP costs were modest for most privately insured pts, 5.3% of pts (~8% in HD plans) paid > $400 for discarded RX. [Table: see text]
Cost implications of clinical trial (CT) participation in metastatic non-small cell lung cancer (NSCLC).
Authors: Merkhofer Cristina , Chennupati Shasank , Sun Qin , Eaton Keith D. , Martins Renato G. , Ramsey Scott David , Goulart Bernardo H. L. 
Published: May 2020

7084 Background: To assess the value of CTs in advanced NSCLC from the payer perspective, we compared insurance-related total direct medical costs for NSCLC patients who enrolled in CTs vs. those who did not. Methods: After linking electronic health records with tumor registry and claims data, we identified 101 patients with metastatic NSCLC diagnosed between 1/1/2007 and 12/31/2015 and treated at the Seattle Cancer Care Alliance. Eligibility criteria included 60-day minimum survival, claims for ≥ 1 anti-cancer drug within 180 days of diagnosis and insurance enrollment for the first 12 months after diagnosis. We abstracted patient sociodemographic, disease and treatment data, and obtained death dates from the Washington State Cancer Registry, censoring patients alive on 3/7/2019.We used the Kaplan-Meier sample-average (KMSA) estimator with bootstrapped 95% confidence intervals to describe direct medical costs and compared costs in CT enrollees vs. non-enrollees by applying a generalized linear model (Gamma distribution, log link) adjusted for confounding covariates. Results: Of 101 patients, 39 (39%) enrolled in CTs. Compared with non-enrollees, CT enrollees were younger (mean age 61.6 vs. 66.5 years), female (67% vs. 47%), Asian (18% vs. 11%), never smokers (41% vs.32%), had commercial insurance (44% vs. 35%), resided in metropolitan areas (90% vs. 79%) and had a higher median income ($81,149 vs. $76,844). Table shows KMSA estimates of total direct medical costs and adjusted mean lifetime total direct medical costs by CT participation. After adjusting for sex, smoking status, residence, income, insurance payer, ECOG and mutation status, CT enrollment was associated with an increase in lifetime total direct medical costs compared with no enrollment (adjusted cost ratio=1.39; 95% CI: 1.01, 1.90; p=0.043). Conclusions: CT participation is associated with increased total direct medical costs in patients with metastatic NSCLC. Our results may inform partnerships between trial sponsors, oncology centers and payers to sustain treatment innovation through CTs. [Table: see text]