bluuebunny/crossref_metadata_2025_split huggingface dataset:
System-level variation in evidence-based multidisciplinary cancer care delivery.
Authors: Montgomery Kelsey B. , Cotler Joseph , Richman Joshua S. , Bhatia Smita , Broman Kristy Kummerow 
Published: June 2024

11064 Background: Widespread health system integration of hospitals continues to reshape the landscape of U.S. healthcare delivery. While complex cancer care has become centralized to high-volume centers, care for common cancers happens across the spectrum of hospital sizes, with known variation in receipt of evidence-based practice (EBP) based on system affiliation. Strategies are needed to evaluate system performance in order to identify system characteristics and processes that contribute to high-quality cancer care. Methods: Using a novel data linkage between the National Cancer Database and AHRQ Compendium of U.S. Health Systems, adult patients treated for breast, colon, melanoma, and thyroid cancers between 2010 and 2020 at Commission on Cancer (CoC) hospitals were identified. Systems were categorized based on number of CoC hospitals (small, 2-3; medium, 4-9; large, 10+). Eight EBP measures were developed using national multidisciplinary guidelines, and measure-specific cohorts were extracted to calculate system-level EBP performance and within-system variation using mixed effects multivariable logistic regression models. Systems were then ranked across all measures for performance and variation, and average rankings were compared by system size. Results: 3,052,453 patients with breast (60.0%), colon (17.0%), melanoma (14.0%), and thyroid (9.0%) cancers were treated at 866 CoC hospitals in 368 health systems. The 8-measure analytic cohort had 104 systems, most of which were small systems (n=74, 71.2%). Large systems (n=9, 8.7%) had worse average performance rankings compared to medium or small systems, though this was not statistically significant (p=0.1) (Table). A significant increase in within-system variation (as measured by average ranking of variability across EBP measures) was seen with increasing system size (p<0.001). Conclusions: Significant variation in EBP performance for common cancers was noted based on health system size in this large, contemporary cohort, with greater within-system variation as system size increased. Future work will identify modifiable system characteristics associated with performance that could aid system leaders and policy makers to design, measure, and incentivize systems that employ effective cancer care delivery strategies. System rankings from 1 to 104 (best to worst), averaged over all measures; data presented as median (IQR). [Table: see text]
Trends in prices of checkpoint inhibitors in the US, 2016-2023.
Authors: Paul Jeddeo , Mitchell Aaron Philip , Kesselheim Aaron S , Rome Benjamin N 
Published: June 2024

11075 Background: Checkpoint inhibitors have revolutionized the treatment of several cancers since the first Food and Drug Administration (FDA) approval in 2014. Yet the cost of these drugs remains high, with implications for patient access and healthcare sustainability. We assessed pricing trends for drugs targeting program death-ligand 1 (PD-L1) or programmed cell death protein 1 (PD-1) from 2016-2023. Methods: This study included 6 PD-L1 or PD-1 inhibitors approved through 2019. Quarterly Medicare Part B spending limits, which are based on the average sales prices of drugs from manufacturers to wholesalers or direct purchasers, were collected from public files. To directly compare drugs, prices were converted to prices per month (28 days), based on the FDA-labeled dosage and frequency for metastatic non-small cell lung cancer (NSCLC), a common cancer for which each drug was approved. Prices were adjusted to 2023 dollars using the consumer price index for all urban consumers. Results: In 2016, monthly prices for pembrolizumab ($15,604) and nivolumab ($15,814) were similar. Prices for these 2 drugs and avelumab, approved in 2017, remained within 5% of each other throughout the study period. Three other drugs (cemiplimab, atezolizumab, and durvalumab) were approved from 2016-2018 and had prices 3%-20% lower than the other 3 drugs (Table). Inflation-adjusted prices for all drugs remained stable from 2016-2019 and decreased from 2020-2023, corresponding with a period of higher inflation. In 2023, monthly prices for the 6 drugs ranged from $11,961 (durvalumab) to $15,043 (pembrolizumab). From 2016-2023, inflation-adjusted prices decreased, by an average of 0.7% (pembrolizumab) to 4.8% (cemiplimab) per year. Conclusions: Although the FDA approved 6 mechanistically similar PD-1 or PD-L1 inhibitors from 2014-2018, prices remained generally unchanged during those years and through 2023, with slight declines in real prices attributable to post-COVID consumer inflation. Competition among these brand-name cancer drugs did not meaningfully affect prices. Regulators should investigate why price competition has not emerged, and policymakers should grant more opportunities to negotiate lower prices for patients and the health care system, as is being rolled out this year in Medicare following passage of the Inflation Reduction Act. [Table: see text]
Use of artificial intelligence (Al) in augmenting prior authorisation process for financial support in hemato-lymphoid malignancies: Joint project of Navya Al and Indian Cancer Society Cancer Cure Fund (ICS-CCF).
Authors: Khanna Nehal Rishi , Gokarn Anant , Sengar Manju , Rawat Ann , Thorat Usha 
Published: June 2024

11086 Background: Hemato-lymphoid malignancies have a special urgency on time to initiate treatment and prior authorisation has relied on rapid review by domain experts. Since 2011, ICS-CCF has contributed over $32 million to cover the treatment costs of 14,600 underprivileged patients, including hematolymphoid malignancies. A mandate of ICS-CCF for this philanthropic funding is to choose beneficiaries who have a high chance of cure with standard of care. For this, a Due Diligence Team (DDT) of expert oncologists and the Governing Advisory Council (GAC) of ICS-CCF sequentially adjudicate every application. To augment and scale up this process, in Feb 2021, ICS-CCF evaluated and implemented the use of Al for prior-authorizations. Navya Al is a clinically validated Al model that matches clinical data of applicants with available evidence and registry data to predict survival, and generates payor/national guidelines based optimal treatment plans. Since Feb 2021, 80% of applications are adjudicated by Navya Al with a 99% concordance with GAC. Methods: This study was planned to assess the impact of Navya Al on the process of prior authorisation in a cohort of adult and pediatric hemato-lymphoid malignancies. All patients evaluated by Navya AI alone or with DDT from February 2021 to July 2023 were analyzed. Adjudication rates reflecting effort and time savings were calculated as the % of patients for whom Navya Al could make a decision on its own without referring to the DDT for review. Results: Of the 5775 applications reviewed by Navya Al, 2255(39.04%) were hematolymphoid malignancies. 37.16%(838/2255) of patients were pediatric (Age<=15years) and 62.8%(1417/2255) were adults (Age>15 years). Of these 2255, Navya AI alone adjudicated 73.61%(1660/2255) cases and 25.36%(572/2255) were referred to DDT for adjudication. Analysis was done on 2232 cases excluding the 1.01%(23/2255) reapplication cases. Details in table. Conclusions: With Al, only one fourth of beneficiary applications with hematolymphoid malignancies need expert review for prior authorisation. Implementation of AI has potential to save time in the authorization process for philanthropic funding for governmental and non governmental health care schemes. [Table: see text]
Multilevel factors associated with delays to neoadjuvant chemotherapy among young adults with operable breast cancer.
Authors: Beauchemin Melissa , Wooster Margaux , DeStephano David , Harkins Sarah , Wang Shikun , Wright Jason Dennis , Kahn Justine , Accordino Melissa Kate , Hershman Dawn L. 
Published: June 2024

11091 Background: Breast cancer (BC) rates are increasing in young adults (YAs: age 18-39) and this population may experience unique barriers to treatment initiation. We identified factors associated with treatment initiation delays in a cohort of YAs with operable BC who received neoadjuvant chemotherapy (NACT). Methods: Using the National Cancer Database, we identified YAs diagnosed with non-metastatic BC from 2010-2020 who received NACT. We grouped patients by receptor status and clinical stage: 1) Hormone Receptor positive/HER-2 negative (HR+/HER2-) and were lymph node (LN) LN+; 2) HER-2 positive (HER2+) cT2+ or LN+; and 3) triple negative BC (TNBC) cT2+ or LN+. Primary outcome was delayed treatment initiation, defined as > 60 days from diagnosis date to NACT. Multivariable (MV) logistic regression was used to model factors associated with delay and adjusted for sociodemographic, clinical, and facility-level factors. We also examined factors associated with delays by tumor type. Results: Of 23,078 included patients, 62% were non-Hispanic White (NHW) and 74% had private insurance. By tumor type, 28% (n=6,350) were ER/PR+, 39% (n=8,921) were HER2+, and 34% (n=7,807) had TNBC. Most patients were treated at academic comprehensive cancer programs (ACCP) or comprehensive community cancer programs (CCCP) (40% and 34%). Treatment delays were observed among 7% of patients (n=1,638) across all tumor types. In MV analysis, non-Hispanic Black (NHB) and Hispanic YAs had 2-fold higher odds of delays compared with NHW YAs. YAs with low-income had higher odds of delays compared with higher income (OR=1.41), and YAs with private insurance had lower odds of delays compared with Medicaid (OR=0.54). YAs treated at any non-ACCP facility were less likely to experience delays. The results were similar for each tumor type. Conclusions: While the overall incidence of delays was low, significant racial, ethnic, and institutional-level treatment initiation disparities were observed among YAs receiving NACT for BC. [Table: see text]
Feasibility and utilization of electronic patient-reported outcome measures for lung cancer in routine clinical care.
Authors: Basch Ethan , Lin Huamao Mark , Cala Mary Lynn , Styliadou Melpomeni , Galaznik Aaron , Wujcik Debra , Rusli Emelly , Coombs Nicholas C , Beamon Emily R 
Published: June 2024

11107 Background: Prior studies have shown the value of Patient-Reported Outcomes (PRO) in cost burden, quality of life (QoL), and survival in cancer care. To facilitate focus on patient-centricity and value-based care, the International Consortium for Health Outcomes Measurements (ICHOM) and European Health Outcomes Observatory (H2O) developed a Core Outcomes Set (COS) in lung cancer. We explored the feasibility of deploying standardized PRO measures among patients with lung cancer in US clinical practice. Methods: A retrospective database study was conducted, with IRB waiver, using Carevive PROmPT, an electronic PRO (ePRO) remote symptom monitoring platform with weekly surveys comparable in scope to ICHOM/H2O COS, of symptomatic adverse events (PRO-CTCAE), physical function (PROMIS 4A Physical Function), and QoL items (EORTC QLQ-C30 items #29,30). Severe PRO-CTCAE symptom scores triggered care team alerts. From 9/2020 to 5/2023, 207 patients enrolled across 9 US cancer centers. Patients were ≥18 years, with lung cancer, and in current treatment. Patient engagement was measured by survey compliance, follow-up time, and completeness; clinician engagement was measured by platform utilization time, time to alert response, and clinical action taken. Results: Participants were 50% female, 86% White, 12% African American, median age 68, 81% NSCLC, and 26% with metastatic disease. Median survey persistence: 8 weeks, with 85% compliance over that time. Of domains assessed, 37 (58%) from Carevive data overlapped with ICHOM/H2O COS, with 19 measured over time. Overlapping domains included 15 clinical outcomes with 60% median completion rate and 22 PRO domains with 98% median completion. Of 19 domains assessed longitudinally, median compliance was 76%. Of patients triggering ≥1 ePRO symptom alert, 87% were within 4 weeks, with 46% requesting call-backs. Median clinician follow-up to alerts was 20 hours, with 69.3% addressed within 48 hours. Clinicians accessed the platform 2-3 times weekly, for median 2 minutes (range: 1-14 minutes) per login for nurses and Advanced Practitioners (AP). 89% of alerts were addressed by nurses and AP. Of alert responses, 66% indicated continuation of treatment, 12% were escalated to the clinical team, and 1% were escalated to hospitalization or ER visit. Conclusions: Results support the feasibility of integrating a standard set of multi-domain ePRO measures, comparable to the ICHOM/H2O COS, into routine cancer care, across multiple sites, with consistent patient engagement and provider utilization. One limitation is that clinical and financial impact were not directly assessed. Future research should explore direct clinician feedback, systematic implementation of PRO measures, and impacts on patient outcomes, resource utilization, and health systems.
If you build it, they will come: Success of the EROS (Engendering Reproductive Health Within Oncologic Survivorship)—ECOG-ACRIN E1Q11 in recruitment of minority patients.
Authors: Patel Ashlesha , Lee Ju-Whei , Zaren Howard A. , Radeke Erika K , Lerner Rachel E. , Fukui Jami Aya , Makower Della F. , Tamkus Deimante , Rowland Kendrith M. , Adler William M. , Throckmorton Alyssa , ghamande sharad A. , Croley Jessica Jones , Hackney Mary Helen Helen , Pippas Andrew William , Qamar Rubina , Cella David , Fisch Michael Jordan , Wagner Lynne I. 
Published: June 2024

11124 Background: The average recruitment of minority subjects in oncology trials is 4%. The ECOG-ACRIN EROS trial was designed to be inclusive of minority subjects by inviting Minority/Underserved NCI Community Oncology Research Program (MU-NCORP) sites first, with remaining sites fulfilled by inviting NCORP sites. Our objective is to examine if the EROS study recruited more than 4% minority patients, and if MU-NCORP sites provided higher rates of minority recruitment than NCORP sites. Methods: The EROS trial is a clustered randomized trial performed at 17 NCI Community Oncology Research Program (NCORP) sites (including 8 NCORP sites and 9 Minority/Underserved NCORP sites) from 2016-2023. Eligible subjects included reproductively capable women aged 15-55 with new cancer diagnosis. Intervention included RH didactics and decision aids. With respect to self-reported minority status, patients were classified into one of two categories, White and non-Hispanic/Latino or minority (non-White or Hispanic/Latino). Chi-square tests were used to evaluate distribution difference between groups and binomial tests were used for testing proportions against reference points. Results: Of the 434 patients enrolled to the trial, MU-NCORP sites recruited 266/434 (61.3%) and NCORP sites 168/434 (38.7%) patients. Among all enrolled patients, 422 patients’ race/ethnicity status could be classified. 202/422 (47.9%) self-reported as Hispanic/Latino or non-White (p<.0001 0.48 against 0.04). In MU-NCORP (174/258) 67.4% and NCORP sites (28/164) 17.1% were of minority status. (p < .0001). Conclusions: The EROS trial was designed with minority inclusion for generalizability of results. Prioritization to include MU-NCORP sites in the EROS trial did result in substantially increased minority recruitment, with the overall minority recruitment rate above usual cancer trials. Such strategy may be followed to increase minority recruitment to oncology trials.
Comprehensive molecular pathology review service to reduce barriers to precision oncology in rural eastern North Carolina.
Authors: Badami Sunil , Pun Insha , Garcia Daniela Chala , Tumin Dmitry , Zhou Yaolin 
Published: June 2024

11129 Background: ECU Health system serves a rural 29-county region where cancer mortality rates exceed those of the state’s remaining 71 counties combined. Insufficient tissue and lack of local infrastructure contribute to suboptimal precision oncology care. We aimed to enhance the clinical utility of send-out molecular tests for patients with solid cancers through a quality improvement (QI) initiative. Methods: We used the EPIDEM model of QI to explore, promote, and implement a molecular review service, which includes intervening on send-out molecular orders that would otherwise have been insufficient for the requested molecular pathology test. The interventions include combining blocks, sending alternative specimens, and/or modifying testing strategy. We documented cases in a molecular send-out database and electronic health records, evaluated the service's impact, and modified it to include an orderable molecular consultation. Results: In 2023, We reviewed 699 send-out comprehensive genomic tests on solid tumors (173 cytology, 192 resections, 332 biopsies), including 582 (83.3%) advanced cancers. In total, there were 576 sufficient reports. Actions taken on 185 orders (26.5% of reviewed cases) led to 156 reported results. Of these, 70 showed clinically significant findings, and 31 patients received targeted therapy because of those interventions. In March 2023, we initiated a formal consultation service with in-depth review. From 3/3/2023-1/29/2024, we performed 50 pre-test (e.g., specimen to use, testing strategy, tumor origin testing) and 60 post-test (e.g., result interpretation, treatment based on molecular data) consultations; 10 patients received both pre and post-test support. The molecular pathologist tended to initiate post-test, while clinicians preferentially initiated pre-test consultations (p<.01). Clinician-initiated consultations were more frequent in community practices (p <.01). Conclusions: Even without the resources for in-house testing, our molecular review service provides essential pre- and post-analytic support by successfully rescuing cases that would have otherwise been insufficient molecular tests and by providing comprehensive consultative support. The positive impact and reception among community oncologists suggest that our strategy holds potential to alleviate barriers to precision oncology in underserved areas. [Table: see text]
Demographics and survival outcomes of stage IV male breast cancer: A retrospective analysis of SEER database.
Authors: Thalambedu Nishanth , Fugere Bradley , Malapati Sindhu 
Published: June 2024

11142 Background: Male Breast Cancer (MBC) is a rare malignancy accounting for <1% of all breast cancer cases in the United States. It is often lately diagnosed due to lack of awareness leading to substantial morbidity and mortality. Previous studies revealed higher risk of death among males compared to females across all stages, but little known about the impact of Hormone Receptor (HR) and Human Epidermal growth factor Receptor 2(HER 2) statuses on prognosis and survival among MBC patients. So, we aim to study the survival outcomes of stage IV MBC patients using SEER (Surveillance, Epidemiology, and End Results) data. Methods: A retrospective analysis was conducted using a SEER database and identified stage IV MBC cases (Any T, Any N, M1) diagnosed between 2010-2015. The selection of these years is based on the reporting of HER2 status on SEER database starting from 2010 and to ensure a current period and a minimum of 5 years of follow-up. Patient demographics, tumor HR/HER 2 status and survival data were extracted and analyzed. Subgroup analyses were performed to show the correlation between HR/HER 2 status and survival. Results: The study included 144 patients. 59.7%(86/144) were above 60 years of age. Majority were Caucasians up to 68.1%(98/144) followed by African Americans 18.7% (27/144), Hispanics 6.9%(10/144) and Asians/Pacific Islanders 6.2%(9/144). Among the subtypes, the most common was HR+/HER2- consisting of 69.4%(100/144) followed by HR+/HER2+ 19.4%(28/144), HR-/HER2- 9.7%(14/144), HR-/HER2+ 1.4%(2/144). The median overall survival varied among different subtypes of breast cancer and was noted to be 31.5 months, 25 months, 4.5 months and 10 months among HR+/HER2-, HR+/HER2+, HR-/HER2- and HR-/HER2+ respectively (Table). In the comparison between HR+/HER2+ and HR-/HER2-, the risk of death differed significantly, as indicated by a hazard ratio of 0.26 (95% CI 0.12-0.56, p = 0.001), highlighting a poor survival of HR-/HER2-. Conclusions: This retrospective analysis provides valuable insights into the demographics and survival outcomes of stage IV MBC patients. Triple negative (HR-/HER2-) subtype continues to have poor outcomes in males as well, emphasizing the need to explore novel treatment strategies to improve outcomes for this unique patient population. Although, treatment regimens for MBC are extrapolated from women, the disparity in survival across all subtypes requires the need to get more men on breast cancer clinical trials when feasible. [Table: see text]
Retrospective analysis: Does 5-FU dose adjustment per DPYD mutation status affect toxicity?
Authors: Parekh Deevyashali , Noronha Vanita , Patil Vijay Maruti , Menon Nandini Sharrel , Shah Minit Jalan , Chougule Anuradha , Prabhash Kumar 
Published: June 2024

11172 Background: 5-Fluorouracil (5-FU) forms a cornerstone in neoadjuvant chemotherapy (NACT) regimens for solid tumors including head and neck cancers. The DPYD gene encodes for enzyme dihydropyrimidine dehydrogenase (DPD) which catalyses an essential, rate-limiting step in the metabolism of 5-FU. Heterozygous genomic alteration of DPYD (30-35% of population) result in reduced potency of DPD enzyme, while homozygous DPYD alteration (0.1-0.2% of population) results in no functional DPD. Reduced functioning of DPD leads to slower metabolism of 5-FU causing toxicity such as bone marrow suppression, cytopenias etc. The Clinical Pharmacogenetics Implementation Consortium (CPIC) have released guidelines recommending reducing the dose of 5-FU in patients with these genomic alterations of DPYD from 25% to avoiding its use based on a calculated activity score (DPYD-AS). Methods: A phase III randomized study compared a DC vs DCF regimen as NACT in technically unresectable oral cancer was published in March 2024. We utilised data from the ‘DCF’ arm of this study. Patients underwent DPYD testing and we stratified these patients based on DPYD status. In the study, patients underwent the appropriate dose reductions per the CPIC guidelines based on DPYD-AS scores. We evaluate the frequency and degree of adverse events in these groups to determine whether this dose reduction effectively reduces toxicity from 5-FU in these patients. Adverse events were graded per CTCAE. Analysis by Fishers exact test. Results: 247 patients in the DCF arm were included. 85 (34.4%) did not undergo DPYD testing. 118 (47.8%) did not have any DPYD mutation, 44 (17.8%) had heterozygous mutation while 0 had homozygous mutation. The adverse events by DPYD genotypic subgroup are shown in the table. Conclusions: There was no statistically significant difference in adverse events between the group with no DPYD mutation who received the full dose of 5-FU and the heterozygous DPYD mutation group receiving a lower 5-FU dose based on DPYD-AS score. Thus, the dose reduction as set out by the CPIC appears to appropriate. [Table: see text]