bluuebunny/crossref_metadata_2025 huggingface dataset:
Are we ready for biomarker driven, radiation dose–adaptable de-escalation studies for HPV+ oropharyngeal cancer?
Authors: Misiukiewicz Krzysztof , Worona Leslie , Ramos Emily J , Bakst Richard Lorne , Sindhu Kunal K. , Westra Wiliam J , Roof Scott , Posner Marshall R.
Published: June 2023

6084

Background: Plasma circulating tumor modified viral human papillomavirus (HPV) DNA (TTMV) is a sensitive and specific biomarker of HPV+ oropharyngeal squamous cell carcinoma (HPVOPC). Patients with unresectable locally advanced (LA) HPVOPC are currently treated with induction chemotherapy (IC) and standard (sd) or reduced dose (rd) of chemoradiation (CRT). Post IC TTMV can be used in the future to help assign patients to sdCRT or rdCRT. This approach may help to maintain high efficacy and minimize long-term side effects of CRT in HPVOPC. Methods: Patients with LA HPVOPC and High Risk (HR) features (radiographic ECE, T4 primary, >N2c, and isolated lung metastases) were treated with 3 cycles of TPF IC followed by rdCRT to 5600 cGy with weekly carboplatin in responders, sdCRT in clinical non-responders and in M1 patients who also received SBRT to isolated biopsy proven lung metastases. Patients with > 20 pack year smoking history were excluded. Patients were eligible for rdCRT if they had a significant clinical response to IC and were participating in the QB2 trial (NCT02945631). Results: Fourteen subjects had pre and post IC TTMV testing available for analysis. 9/14 subjects after IC received rdCRT to 5600 cGy with weekly Carboplatin. 2 subjects were removed from the QB study for clinically inadequate response, 1 withdrew consent and 2 were M1 and treated for cure. All 5 underwent sdCRT 7000 cGy. 13/14 patients had TTMV testing done prior IC, 1 subject had TTMV done after the start of cycle 1 of IC; all 14 of them had a pretherapy or (1 subject) immediate post infusion positive elevated TTMV test. 11/14 subjects developed negative TTMV after 1 or 2 cycles IC. 3/14 subjects after 1 cycle and additional 6/14 subjects after 2 cycles of IC developed negative TTMV. 3/14 subjects still had abnormal TTMV after 3 cycles of IC; 2/3 subjects underwent 7000 cGy. Remaining 1/3 had a negative repeat TTMV prior to CRT and underwent rdCRT with 5600 cGy. TTMV testing was done for all subjects after completion CRT and all were negative. All subjects in addition to standard surveillance had TTMV testing done during their surveillance visits. 2 subjects developed recurrent HPVOPC after CRT: 1 locoregional and 1 metastatic (elevated TTMV after IC; sdCRT). Conclusions: In contrast to NCCN guidelines, rdCRT in many academic institutions has become a standard for HPVOPC. We have demonstrated a prompt reduction of TTMV to 0 in a subset of patients receiving 1 cycle and in a majority after at least 2 cycles of IC. The small sample size of our study lacks the statistical power to demonstrate that the failing to attain negative TTMV after/during IC is associated with a poor prognosis and warrants more aggressive therapy. TTMV biomarker response may have important prognostic value in delivering primary therapy and warrants further larger and more structured studies.
Tislelizumab plus chemotherapy as induction treatment followed by chemoradiotherapy or surgery in locally advanced hypopharyngeal squamous cell carcinoma: A single-arm, phase II trial.
Authors: Gui Lin , Liu Shaoyan , Wang Xiaolei , Zhang Ye , He Xiaohui
Published: June 2023

6087

Background: Induction chemotherapy (ICT) followed by chemoradiotherapy (CRT) is the standard of care for locally advanced hypopharyngeal squamous cell carcinoma (LA HPSCC). We aimed to assess whether add immunotherapy to ICT further improving patient outcomes. Methods: In this phase II, single-arm study, eligible pts aged 18-70 yrs diagnosed with stage III-IVB (AJCC 8th) HPSCC received induction therapy with tislelizumab (200 mg), cisplatin (75 mg/m2) and nab-paclitaxel (260 mg/m2) Q3W for 3 cycles. After assessment by multidisciplinary team, pts received surgery or CRT. The primary endpoint was objective response rate (ORR). Secondary endpoints include major pathologic response (MPR) in surgery group, disease control rate (DCR), 2-yr PFS rate in CRT group and 2-yr DFS rate. Results: 29 pts were enrolled (median age, 61 y; 97% male; stage III/IVA/IVB, 7%/90%/3%) from May to Nov 2022. Median follow-up was 7.3 months, no disease progression occurred in all patients. For all pts, the post-induction ORR and DCR were 82% and 100%. In surgery group (n = 10), all pts achieved R0 resection, and 5 (50%) pts reached pathological complete response (pCR). A patient with stable disease underwent a total laryngectomy achieved pCR by postoperative pathologic evaluation. Grade 3 and 4 treatment-related adverse event (TRAE) reached 82.8%, and mainly come from chemotherapy-related neutropenia. There was no TRAE leading to treatment discontinuation. Conclusions: These early data suggested that tislelizumab plus chemotherapy as induction treatment followed by chemoradiotherapy or surgery was safe and had the potential to provide clinical benefits for patients in LA HPSCC. The inconsistency between radiographic and pathological evaluation needs further exploration. Further follow-up is needed to confirm the long-term efficacy. Clinical trial information: ChiCTR2200060094 .
A multicenter, single-arm phase 2 study of surufatinib plus toripalimab for patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.
Authors: Ji Dongmei , Song Lijie , Cheng Ying , Shen Weina , Kuang Muyu , Chen Jiaying , Yang Minjie , Cui Hongxia , Zhou Jinghong , Shi Haiyan , Tan Panfeng , Fan Songhua , Shi Michael , Su Weiguo , Ji Qinghai
Published: June 2023

6089

Background: For patients (pts) with radioactive iodine–refractory differentiated thyroid cancer (RAIR-DTC), there presents a considerable therapeutic challenge with poor long-term outcomes. The open-label, multi-cohort, single-arm phase 2 study was performed to evaluate surufatinib (a small-molecule inhibitor of VEGFR 1-3, FGFR1 and CSF-1R) in combination with toripalimab (an anti-PD-1 antibody) in pts with RAIR-DTC. Methods: Eligible pts were with locally advanced or metastatic RAIR-DTC who were not amenable for surgery or external beam radiotherapy, with a radiologically confirmed disease progression within 12 months before treatment, and with ≥6 months since last radioiodine treatment. Enrolled pts received surufatinib 250 mg orally, QD, plus toripalimab 240 mg IV, Q3W, until disease progression or reaching the maximum treatment duration with toripalimab of 24 months, or other protocol-specified criteria. The primary endpoint was objective response rate (ORR) per RECIST 1.1. Results: From March 2020 to November 2021, 15 pts were enrolled and received a median duration of 11.1 months of the combination treatment, with a median age of 61 years (range: 37-74). 9 (60%) pts were male, and 12 (80%) had papillary thyroid cancer. Of the 13 pts with PD-L1 immunochemical results, 6 pts had PD-L1 CPS ≥1%. As of 28 Dec 2022, the median follow-up duration was 22.11 months. Of the 15 pts with at least one post-baseline tumor assessment, the confirmed ORR was 33.3% (5 PRs) and DCR was 93.3%. mDoR was 8.34 months. mPFS (95%CI) was 10.91 months (4.01, NA). mOS was not reached, and 12-month OS rate was 100%. 14 (93.3%) pts had treatment-emergent adverse events (TEAEs), and 10 (66.7%) pts reported grade ≥3 TEAEs, most commonly (≥10% pts) with hypocalcemia (20%), diarrhea (20%) and hypertension (13%). There was no death due to TEAE in the study. Conclusions: Surufatinib plus toripalimab showed encouraging antitumor activity and tolerable safety profile in pts with locally advanced or metastatic RAIR-DTC. Clinical trial information: NCT04169672 .
Evaluation of potential socioeconomic and racial/ethnic disparities in all-cause mortality in adolescent and young adult patients with cancer.
Authors: Henderson Scott , Duggan Mark , Chao Chun , Cooper Robert Michael
Published: June 2023

6501

Background: Adolescent Young Adult (AYA) cancer patients, aged 15-39, have historically been understudied. For older adults, socioeconomic (SES) and racial/ethnic disparities in mortality have been demonstrated, but less is known about survival disparities for AYA patients. Most existing studies do not account for the influence of insurance status and access to care. To address this gap, we evaluated the association of SES and race/ethnicity with overall mortality for AYA cancer patients who were members of an integrated health delivery system with relatively equal access to care. Methods: Patients diagnosed with cancer at age 15-39 years old in Kaiser Permanente Southern California between 2010-2018 were included. The fourteen most common AYA cancer types within our cohort were included (excluding thyroid cancer due to low mortality rate). The Neighborhood Deprivation Index (NDI) was used as a marker of SES. Patients were placed into NDI quartiles (Q1: least deprived-Q4: most deprived). Mortality rate per 1,000 patient years was calculated for each racial/ethnic group and NDI quartile. Multivariable cox model was used to estimate hazard ratios (HRs) for all-cause mortality. Models included race/ethnicity and NDI subgroup simultaneously, adjusting for sex, age and stage at diagnosis, and cancer type. Results: A total of 6,380 patients (59% female, median age: 33) were followed for a maximum of ten years. Racial/ethnic distribution was 45% Hispanic, 36% non-Hispanic White, 10% non-Hispanic Asian/Pacific Islander, 7% non-Hispanic Black, 2% Other/Unknown. Overall mortality was 21.8 deaths per 1,000 person years. Crude mortality rates were higher among Non-White racial/ethnic groups (Asian/Pacific Islander: 26.7, Black: 26.2, Hispanic: 25.6, Other/Unknown: 30.3) compared to White patients (16.4). In the adjusted model, Hispanic (HR=1.32, 95% confidence interval [CI] 1.03-1.50, p=0.004) and Black (HR=1.35, 95% CI 1.00-1.83, p=0.05) patients experienced significantly higher risk of all-cause mortality compared to White patients. No mortality differences were observed between Asian/Pacific Islander and White patients. Patients from more deprived neighborhoods had higher mortality risk (Q1: 19.9, Q2: 19.8, Q3: 24.1, Q4: 27.4). In the adjusted model, there was no significant difference in all-cause mortality between Q1 and Q2-Q4 [Q2 (HR=0.88, 95% CI 0.71-1.10), Q3 (HR=0.94, 95% CI 0.75-1.17), Q4 (HR=0.96, 95% CI 0.76-1.22)]. Conclusions: Our study suggests that for insured AYA cancer patients with similar access to care, Hispanic and Black patients have increased risk of all-cause mortality as compared to White patients, while no significant SES survival disparities were observed. These findings warrant further investigation, awareness, and intervention to address inequities in cancer care among vulnerable populations.
Disparities in outcomes among hospitalized unhoused patients with cancer in the US.
Authors: Shah Kanan , Santos Patricia Mae Garcia , Barnes Justin Michael , Tao Anna , Tsai Chiaojung Jillian , Chino Fumiko
Published: June 2023

6502

Background: Cancer is the 2nd leading cause of death among death among unhoused adults in the US. Use of aggressive medical interventions and costs during hospitalizations remains unstudied in the unhoused population. Methods: All hospitalized adults age ≥18 with a principal cancer diagnosis were identified in the 2016-2020 National Inpatient Sample (NIS). Logistic regression tested associations between unhoused status and: cost of care, mortality, and receipt of invasive procedures/systemic therapy. Adjusted analysis accounted for patient demographics, socioeconomic status, comorbidities, and effect modification of housing status by length of stay (LOS). Results: A total of 9,030 unhoused and 2,758,693 housed adults with cancer were included in the study. There were significant ( p<0.01) differences in age <65 years (77% unhoused vs 41% housed), male sex (75% vs 53%), race (Black, 25% vs 13%; White, 58% vs 71%), and insurance type (Private, 6% vs 27%; Medicaid, 53% vs 11%). There were also differences by primary cancer diagnosis, with higher rates of lung (17% vs 14%) and liver (8% vs 3%) cancers. Unhoused persons received less chemotherapy inpatient (5% vs 7%) and fewer overall procedures (48% vs 58%), while experiencing longer LOS (median 6 vs 4 days). On adjusted analyses, unhoused adults were had lower odds of receiving invasive procedures (aOR [95%CI], 0.34 [0.27-0.42]) or systemic therapy (0.41 [0.20-0.85]); and were less likely to have a higher-than-median cost of stay 0.47 [0.39-0.57]). Additionally, unhoused adults were 35% and 20% less likely to have a higher-than-median cost of stay or die while hospitalized (95% CI 0.59 – 0.71 and 0.67 – 0.96, respectively). When accounting for the possibility of housing status being modified by LOS, unhoused persons remained significantly less likely than housed persons to receive inpatient procedures (aOR 0.38, 0.47, and 0.60 for short, medium, and long LOS, respectively; p<0.001 for each) or have high cost of stay (adjusted OR 0.55, 0.71, 0.70, p<.001 for each), though the differences by housing status were attenuated with longer length of stay. Conclusions: In this first nationwide analysis of hospitalizations among unhoused adults with cancer, unhoused patients remained significantly less likely to receive invasive procedures or systemic therapy. These disparities in inpatient management despite the higher prevalence of more aggressive cancers and comorbidities among the unhoused highlight missed opportunities to improve cancer care.
Clinical value of timely targeted therapy (TT) for patients with advanced non-small cell lung cancer (aNSCLC) with actionable driver oncogenes (ADO).
Authors: Stricker Thomas , Jain Neha , Yu Elaine , Ma Esprit , Schuldt Robert , Wang Rongrong , Sussell Jesse , Ogale Sarika , Szado Tania , Price Richard , Lin Victor T. G. , Slater Dennis , Vaena Daniel A. , Staszewski Harry , Fang Bruno , Seneviratne Lasika , Arrowsmith Edward , Daniel Davey B.
Published: June 2023

6507

Background: Recent real-world studies observed that some aNSCLC pts with ADO initiated non-targeted therapy (non-TT) before biomarker test results became available. This study assesses the clinical impact of the timing of first line (1L) TT in aNSCLC pts with ADO. Methods: In a retrospective analysis of the nationwide Flatiron Health electronic health record-derived de-identified database, pts aged ≥18 years, diagnosed (Dx) with aNSCLC between 1/1/2015-10/18/2022, had ADO (ALK, BRAF, EGFR, RET, MET, ROS-1, or NTRK) based on biomarker testing ≤ 90 days of advanced Dx, and received 1L treatment (tx) were included. Cohorts were defined by tx patterns after test result: Cohort 1 received 1L TT ≤ 42 days; Cohort 2 initiated 1L non-TT before or after testing but switched to TT ≤ 42 days; Cohort 3 initiated non-TT before or after testing and did not switch to TT ≤ 42 days. Pts were followed from test results + 42 days until 11/30/2022 or death, whichever earliest. Multivariate Cox regression evaluated real-world progression-free survival (rwPFS) and overall survival (OS) between cohorts. Results: A total of 5156 aNSCLC pts with ADO were included: 79% were treated in the community setting and 56% received NGS testing. Most common ADO were EGFR and ALK for both Cohort 1 (78% and 13%) and Cohort 2 (67% and 24%); EGFR (39%) and BRAF (35%) for Cohort 3. Cohort 3 included more rare mutations (MET, NTRK, RET). Statistically significant differences were observed in gender, race/ethnicity, practice type, and area-level socioeconomic status across all cohorts. There was no significant difference in outcomes observed between Cohort 2 and 1, but significantly inferior outcomes in Cohort 3 vs 1. Conclusions: Our findings demonstrated better outcomes with upfront 1L TT vs non-TT in aNSCLC pts with ADO. The comparable outcomes between pts who received 1L TT after test result and pts who switched to TT ≤ 42 days of test result available underscore the importance of timely tx decisions based on ADO detection in lieu of tx-switch at progression. Opportunities remain to improve utilization of NGS to identify all ADO upfront to inform the appropriate 1L TT when indicated. [Table: see text]
Strategies to increase accrual of underrepresented populations in Alliance NCTN trials.
Authors: Paskett Electra D. , Subbiah Niveditha , Wood Marie , Steffens Craig , Kaur Judith Salmon , Adams-Campbell Lucile L. , George Suzanne
Published: June 2023

6509

Background: Accrual of underrepresented populations (URPs-racial and ethnic minorities, women, rural populations, and younger and older populations) to clinical trials has been historically low, hampering progress in cancer treatment, symptom intervention and prevention for all. In 2018, the Alliance for Clinical Trials in Oncology (Alliance), as a part of the NCI's National Clinical Trials Network (NCTN) and a Research Base for the NCI Community Oncology Research Program (NCORP) began a multi-pronged strategy to increase accrual of underrepresented minorities by race and ethnicity (URMs) to both treatment and cancer control trials conducted by the Alliance. Methods: Alliance leadership set a goal of 20% accrual for racial and ethnic minorities to all trials in 2018. The Health Disparities Committee (HDC) implemented several strategies over time including leadership promotion/expectation of goals; funding junior investigators and special projects focusing on URPs; working groups for specific populations in HDC; HDC co-chairs to selected protocols; translation services of patient facing materials; opening studies at NCORP Minority Underserved Sites; real time monitoring of accrual demographics, by Alliance and by site; protocols addressing aims for specific populations; closing protocol enrollment to majority populations; and increasing the study sample size to enroll additional minority participants to allow for analyzing intervention effects by subgroups. Results: Accrual data from 117 NCTN and NCORP trials led by Alliance was included from 2014-2022. Over time, accrual of racial and ethnic minorities increased from 13.6% to 25.3% for treatment and 13% to 21.5% for cancer control trials. This results in overall increase from 13.5 % to 23.6% of URMs for all trials, a 74.8% improvement. Conclusions: Intentional approaches to increase URMs has led to an increase in URM accruals to Alliance trials. Future strategies include implementation of the Alliance Patient Questionnaire to prospectively measure the prevalence of specific social determinants of health among patients enrolled to further expand the understanding and address the needs of unique population accrued to Alliance trials. In addition, accrual of women, rural populations, and younger and older adults (65+ years) are now being monitored over time to increase all URP accruals.
Big data in oncology: Challenges and solutions.
Authors: Shah Neil J. , Bahadur Nadia , Niederhausern Andrew , Insinga Alysha , Shah Ibrahim , West Gianna , Ahmad Hamza , Martin Sene , Watson Adam , Nichols Chelsea , Lee Jasme , Brown Samantha , Rosenberg Jonathan E. , Moran Michael , Riely Gregory J. , Panageas Katherine , Stetson Peter D. , Bakker Theodora , Philip John
Published: June 2023

6513

Background: Oncology care is complex and often multimodal. With recent technological advances, only a fraction of data is structured feasibly for research. Here we present a step-by-step method of building a novel comprehensive pan-cancer oncology data model using standard data definitions and industry-standard benchmarks. Methods: A team of 133 members was assembled including a project manager, bioinformatic engineers, business analysts, biostatisticians, data stewardship experts, clinical curators, and quality assurance (QA) managers. We first identified data domains that capture a comprehensive patient journey, leveraging existing oncology data models as a starting point, including NAACCR, PRISSMM (Deb Schrag & Eva Lepisto), and mCODE (ASCO). A common data model was developed using standard terms plus 5-10 disease specific elements (DSE). REDCap was used as the database platform, as it is HIPAA compliant and allows customizations. The data was stored in AuroraDB using an architecture and products that provide scalability from both an integration and consumption perspective. Results: We identified 10 data domains, including 186 distinct elements: demographics (20), comorbidities (2); cancer diagnosis & staging (27), pathology (45), imaging (18), medications (11), oncology responses (11), radiation treatments (14), cancer surgeries (11), cancer genomic (19), tumor markers (8), and vitals (8). Standard ontologies were used, including ICD-0-3 histology codes, ICD-10 comorbidities codes, CPT cancer surgeries codes, and CTCAE 5.0 for toxicities. We identified a data steward for each tumor type across medical oncology, surgery, pathology, radiology, and radiation oncology domains who aided curator training and the identification of DSE. QA managers and analysts performed 20% source data verification. In addition, we built REDCap rules (applicable across a form), and complex queries (applicable across multiple forms). To support QA and clinical engagement, interactive Tableau dashboards were constructed. In addition, timing and quality errors were monitored via Tableau dashboards at the individual curator level to provide timely feedback, leading to improved data quality and curation efficiency in real time. The Medical oncology and radiology domains were the most time-consuming, whereas Cancer diagnosis was the most difficult to curate. Conclusions: We collected genomic and phenomic data for 15,579 patients across six tumor types to date. Collecting comprehensive oncology data across tumor types is possible but requires institutional support, collaboration between clinical & informatics teams, and a dedicated QA team. [Table: see text]
End-of-life spending analysis of randomized trial of machine learning nudges to prompt serious illness communication among patients with cancer.
Authors: Parikh Ravi Bharat , Chen Jinbo , Heintz Jonathan , LaPergola Marc , Bilker Warren , Patel Mitesh S , Bekelman Justin E. , Manz Christopher
Published: June 2023

6515

Background: Early serious illness conversations (SICs) between oncology clinicians and patients in the outpatient setting may improve mood and quality-of-life among patients with cancer. However, the impact of early SIC “nudges” on end-of-life spending is unknown. Methods: This was a secondary analysis of a stepped-wedge randomized trial (NCT03984773) that randomized 9 medical oncology practices and their high-risk patients at a large academic institution to a behavioral intervention to increase SICs (performance reports and peer comparisons; precommitments for high-risk patients; weekly opt-out text prompts before high-risk encounters) vs. standard of care, between June 2019 and April 2020. We identified high-risk patients using a machine learning (ML) algorithm predicting 180-day mortality. This secondary analysis included 1187 (957 intervention, 230 control) patients with complete data who died by December 2020. We abstracted spending (defined as inflation-adjusted reimbursements for acute care [inpatient + ED], office/outpatient care, intravenous chemotherapy, other therapy [e.g. radiation], long-term care, and hospice) from the institution’s accounting system; we captured spending at University of Pennsylvania inpatient, outpatient, and pharmacy settings. To evaluate intervention impacts on spending, we used a two-part model: first, logistic regression to model zero versus nonzero spending, and second, generalized linear models with gamma distribution and log-link function to model daily mean spending in the last 180 days of life. Models were adjusted for clinic and wedge fixed effects and clustered at the oncologist level. Results: Median age at death was 68 years (IQR 15.5), 317 (27%) patients were non-White, and 448 (38%) patients had a SIC prior to death. The intervention was associated with lower mean spending in the last 180 days of life (mean daily spending $377.96 [intervention] vs. $449.92 [control]; adjusted mean difference -$75.33, 95% CI -$136.42, -$14.23 , p = 0.016) (Table), translating to $13,559 total adjusted savings. Intervention patients incurred lower mean daily spending for chemotherapy (adjusted difference -$51.35, p < 0.001), office/outpatient care (-$14.59, p < 0.001), and other therapy (-$10.35, p = 0.043). The intervention was not associated with differences in end-of-life spending for acute care utilization, long-term care, and hospice. Results were consistent for spending in the last 30 and 90 days of life and after adjusting for age, race, and ethnicity. Conclusions: A ML intervention to prompt SICs led to end-of-life savings, driven by decreased chemotherapy and outpatient spending. Clinical trial information: NCT03984773 . [Table: see text]
Biosimilar uptake and cost savings analysis before and after implementation of a pharmacist-driven substitution program within a National Community Oncology Network: One-year follow-up.
Authors: Chang Melody , Li Jenny , Peters Brooke , Winegar Bradley , Carr Robert , Rodriguez Camilo , Kohler-Gerber Ashley , Connor Darell , Freeman Taqyra , Brown Kyle
Published: June 2023

6516

Background: As of December 2022, 22 of the 40 biosimilar approvals in the United States, are used for the treatment of cancer or for the supportive care of patients with cancer. Our organization is a network of community oncology practices, representing 107 oncologists at 76 locations across 17 states. Because our network faces formulary selection and reimbursement challenges related to a diverse payor mix across multiple states, we sought to see the impact of utilizing regional clinical pharmacists (RCPs) to assist with selection of the most cost-effective biosimilar products. Methods: In October 2021, our network initiated an RCP-driven biosimilar substitution program, whereby the RCP acts as a liaison between providers and financial teams to evaluate existing drug orders and their financial impact. We previously presented data on the financial impact to payors and providers before and after implementation of the program from 4/1/2021 to 4/1/2022. This study evaluates the one-year results following program implementation. Additionally, outcomes related to biosimilar utilization as well as financial impacts to payors, patients, and providers were assessed. Payor savings is defined as the difference of the calculated 80% Medicare ASP+6 for the administered biosimilar compared to the originator; patient savings is defined as the difference of the calculated 20% Medicare ASP+6 co-insurance for the administered biosimilar compared to the originator; provider savings is defined as the difference between the invoiced cost of the biosimilar compared to the originator. Results: By the end of 2022, preferred product utilization was achieved for >90% of bevacizumab, trastuzumab, and rituximab orders. Use of the preferred pegfilgrastim product increased from <20% in 4/2021 to >60% by 12/2022. Use of filgrastim biosimilar product increased from <75% in 4/2021 to >90% by 4/2022, then decreased to 55% by 12/2022 due to trending ASP. Payor preference prevented biosimilar switching in approximately 34% of cases. Conclusions: Use of institution-preferred biosimilar products increased across all agents in this study after implementation of the RCP-driven biosimilar substitution program, except for filgrastim. Significant cost savings were noted for payors, patients, and providers. Barriers to switching to institution-preferred products included non-medical switching requirements by payors, patient assistance and compassionate use programs, and patient and/or provider preferences. [Table: see text]
The impact of adverse financial events on healthcare utilization and treatment costs at the end of life.
Authors: Kwendakwema Chipo Natasha , Li Li , Yu Kaiyue , Khan Hiba , Kestner Shannon , Fedorenko Catherine R. , Kreizenbeck Karma L. , Ramsey Scott David , Shankaran Veena
Published: June 2023

6517

Background: Patients with cancer are at higher risk of bankruptcy and other adverse financial events (AFEs) compared to similar individuals without cancer. However, little is known about how AFEs affect cancer care, particularly at the end of life (EOL). We investigated the association between AFEs, healthcare utilization, and healthcare costs at the EOL among patients with cancer. Methods: Western Washington Surveillance Epidemiology and End Results (SEER) cancer registry cases were linked to credit records from TransUnion and to claims from commercial payers and Medicare. Patients with AJCC Stage I-IV solid tumors who died between January 2013 and December 2019 and who had continuous enrollment in commercial or Medicare insurance for the 6 months prior to death were included. Emergency department (ED) and inpatient (IP) visits in the last 3 months of life, place of death, and mean healthcare costs per patient (paid by insurer) were compared between patients with versus without AFEs (charge-offs, third-party collections, tax liens, delinquent mortgage payments, foreclosures, or repossessions). A multivariate logistic regression analysis was used to evaluate the association between AFEs, ED or IP visits (>1 of either), and inpatient death, adjusting for sociodemographic factors, comorbidities, payer type, and cancer stage. Two-sample t tests were used to compare mean per-patient costs in the last 6 and 3 months of life among patients with versus without an AFE. Results: A total of 13,545 patients (median age 75, 54% male) were included, of which 15.6% experienced an AFE. Patients with AFEs were more likely to have multiple ED or IP visits (OR 1.19, CI 1.07-1.34) and die in a hospital (OR 1.37, CI 1.22-1.55) (Table). Younger age, higher Carlson Comorbidity Index (CCI), and being partnered were also associated with greater EOL healthcare utilization while race, sex, payer type, and cancer stage were not. Mean total healthcare costs were higher in patients with AFEs than those without in the last 6 months ($66,232, vs. $55,831, p<0.0001) and 3 months ($39,664 vs. $33,638, p<0.0001) of life. Conclusions: We demonstrated an independent association between AFEs as measured in credit records, increased EOL healthcare utilization, and greater per-patient costs in the months before death. These findings suggest that addressing patient financial hardship could improve their EOL experience and decrease healthcare costs. [Table: see text]
Guideline-concordant use of olanzapine as part of a 4-drug antiemetic regimen for high emetic risk chemotherapy across the state of Michigan.
Authors: Bowen Ashley , Mackler Emily R. , DeVries Kelly , Liu Manlan , Griggs Jennifer J.
Published: June 2023

6519

Background: Chemotherapy-induced nausea and vomiting (CINV) is a feared side effect of cancer treatment. If not adequately controlled, CINV can negatively affect both quality of life and increase the costs of care. Clinical practice guidelines from both ASCO and NCCN recommend inclusion of olanzapine as part of a 4-drug antiemetic regimen in patients receiving high emetic risk chemotherapy (HEC). Uptake of olanzapine has been low, however, in part due to oncologists’ lack of familiarity with the medication, lack of awareness or agreement with the guidelines, and lack of olanzapine inclusion on prepopulated order sets. Current labeling of olanzapine as an antipsychotic poses an additional barrier. The purpose of this project was to increase guideline-concordant prescribing of olanzapine as part of a 4-drug antiemetic regimen in patients receiving HEC in practices that are part of the Michigan Oncology Quality Consortium (MOQC), a physician-led consortium of nearly 90% of oncologists in Michigan. Methods: In 2019, MOQC began measuring guideline-concordant HEC prophylaxis with a 4-drug regimen of olanzapine added to corticosteroids, a 5HT3RA, and an NK1RA as part of its measure set. A quality improvement intervention was initiated that consisted of 1) dissemination of baseline measure performance and regular reporting of practice and state-level performance to MOQC practices, 2) information support through sharing of guidelines at biannual meetings (2019, 2022) and state-wide CINV education to improve prescriber knowledge and beliefs and support the practices in updating prepopulated antiemetic order sets, and 3) addition of value-based reimbursement in 2021 to encourage practice change. Measure performance was assessed using ASCO’s Quality Oncology Practice Initiative (QOPI) program. Results: The patient sample included 5,703 patients. MOQC practices increased the guideline-concordant prescribing of olanzapine as part of a 4-drug antiemetic regimen in patients receiving HEC round over round from R1 2019 to R1 2022 (p<0.0001). Conclusions: MOQC has facilitated increased use of olanzapine as part of a 4-drug antiemetic regimen in patients receiving HEC through practice education, reporting, and value-based reimbursement. Ongoing work will focus on practices with low uptake and on demonstrating the impact of this important practice change on patient outcomes. [Table: see text]
Curating clinical trials: Helping patients find hope by exploring clinical trial opportunities.
Authors: Abdel-Nabi Rhonda , Hossami Mahmoud , Touma Kayla , Nassar Renee , Paunic Milica , Hilal Olla , Zaib Farwa , Rim Claire , Hirmiz Roaa , Hamm Caroline M.
Published: June 2023

6521

Background: Clinical trials are essential to the advancement of clinical therapies. However, only 5% of cancer patients enroll in clinical trials (CTs) due to limited accessibility. Given that greater participation in CTs is associated with better patient outcomes, patients from smaller centres are at a disadvantage. The Clinical Trials Navigators (CTN) program was established by Hamm (2022) to help patients in smaller communities navigate and enrol in CTs, resulting in clinical trial enrolment of 7% of patients. This study will provide updated results on the impact of the CTN program as it has expanded. Methods: Between March 2019 to September 2022, 241 patients were enrolled in the CTN program. Five Clinical Trials Navigators (CTNs) receive referrals from various sources: physicians, patients, and patient support groups. CTNs review medical information submitted and search five CT registries. Eligibility criteria is scrutinized. A second review of the CT list is conducted by two physicians to ensure accuracy. The number of potential trials is recorded at each step of review. Data collected includes: patient disease, stage, and number of prior therapies, time from referral to death, number of potential trials, number of trials that were phase I or phase II / III / IV, number of outgoing referrals, locations of the identified trials, and successful enrolment onto CTs. Patient information and results were inputted and analysed using REDCap. REB Category A approval has been granted on August 31, 2022. REB approval number is 22-439. Results: 41 Canadian cancer patients used the CTN program. The updated study found that 75.9% of patients were in stage IV of their disease, and 51% had at least two prior lines of therapy. 61.4% of patients deceased at last follow up, with a range of 0.3-37.5 months from CTN program referral to death, and a median of 5.9 months. CTNs identified a range of zero to 26 trials for each patient with a median of three trials: a range of zero to 10 phase I trials were found, and a range of one to eight phase II / III / IV trials were found. 25.5% of patients referred to a CT enrolled onto the recommended trial. The expanded CTN program resulted in CT enrolment of 8.5% of patients that follow-up information is available for. Conclusions: One quarter of patients referred to a CT by the CTN program were successfully enrolled, highlighting the CTN program as a successful tool to identify CTs for cancer patients and improve CT accrual. 8.5% of all patients with available follow-up information that participated in the CTN program were enrolled onto clinical trials. Further investigation into reasoning for early high mortality rates should be assessed. New initiatives to improve uptake of the CTN program are ongoing.
Healthcare coverage, access, and affordability among adult immigrant cancer survivors in the United States.
Authors: Santos Patricia Mae Garcia , Barnes Justin Michael , Shah Kanan , Nogueira Leticia M , Yabroff Robin , Chino Fumiko
Published: June 2023

6529

Background: Cancer is a leading cause of morbidity and mortality among US immigrants; however, barriers to care remain understudied. This study assessed disparities in health insurance, health care access, and affordability among immigrant cancer survivors in the United States. Methods: Adult cancer survivors aged ≥18 years who participated in the 2019-2022 National Health Interview Survey were classified as 1) natives 2) foreign-born (FB) citizens or 3) noncitizens. Logistic regression tested for associations between nativity/citizenship and insurance, access (i.e., urgent care, emergency room [ER], hospital admissions), and affordability (assessed by social determinants of health [SDoH]: financial hardship, food insecurity, housing assistance). Separate models adjusted for demographics, socioeconomic status, and comorbidities. Results: A total of 8,923 adults (90% natives, 7% FB citizens, 3% noncitizens) were included in the study. There were baseline differences in age <65 (42% natives vs 61% FB citizens vs 76% noncitizens), female sex (57% vs 59% vs 73%), non-White race (15% vs 64% vs 77%), and Hispanic ethnicity (31% vs 62% vs 5%) between groups (all p<0.05). More noncitizens had household incomes <125% of the federal poverty line (12% vs 18% vs 35%). On adjusted analysis, noncitizens were 3x as likely as natives to be uninsured (2.99 [1.36-6.53]; p=0.006) and FB citizens were 2x as likely to have Medicaid (2.10 [1.35-2.35]; p=0.001). Financial hardship was 1.5x more common among FB citizens (1.50 [1.18-1.91]; p<0.001) while receipt of housing assistance was >2x more common among FB citizens (2.98 [1.82-4.88]; p<0.001) and noncitizens (2.37 [1.08-5.22]; p=0.03). While more FB citizens (18%) and noncitizens (33%) were food insecure (vs. 11%), there were no associations with nativity/citizenship (Table). There were no significant differences in health care access across groups. Conclusions: In this nationwide analysis of adult cancer survivors, although there were no differences in health care access/utilization, immigrants and foreign-born citizens had higher rates of uninsurance and affordability concerns—suggestive of barriers to care. This may portend worse health outcomes in cancer survivorship. [Table: see text]
Associations of loneliness and mortality risk among cancer survivors in the United States.
Authors: Zhao Jingxuan , Reese Jennifer B. , Han Xuesong , Yabroff Robin
Published: June 2023

6531

Background: Loneliness (i.e., the subjective feeling of being isolated from others), has been linked to multiple adverse health outcomes, including chronic conditions such as heart disease, mental health disorders, and higher risk for early mortality. However, associations between loneliness and worse health outcomes have not been thoroughly examined in cancer survivors. This study examined associations between loneliness and mortality risk among cancer survivors in the U.S. Methods: Cancer survivors were identified from the 2008-2018 Health and Retirement Study, a nationally representative longitudinal survey conducted biannually among individuals aged ≥50 years, with follow-up was through December 31, 2020. Loneliness was measured at every 4 years using an abbreviated 11-item version of the UCLA Loneliness Scale Version 3. Example items include feelings of lacking companionship and isolation from others. Items were summed to create total loneliness scores, which were categorized into four levels: 11-12 (low/no loneliness), 13-15 (mild loneliness), 16-19 (moderate loneliness), and 20-33 (high loneliness). Time-varying Cox proportional hazard models were used to examine the association of loneliness and mortality risk among cancer survivors, while accounting for measurements at multiple time points. Sex, marital status, educational attainment, number of health conditions other than cancer, and year since cancer diagnosis were included in multivariable models. Results: Among 5808 person-years, there were 724 deaths during the study period. Compared to the low/no loneliness group, survivors reporting greater loneliness had higher hazard ratios (HR), indicating higher mortality risks; the highest HR observed was among the high loneliness group (HR:1.90, 95%CI:1.58-2.29), following a dose-response association (Table). HRs were attenuated after adjusting for sociodemographic characteristics, but findings were largely unchanged, and HRs remained highest for the high loneliness group (HR:1.71, 95%CI:1.39-2.12). Conclusions: Any elevated loneliness was associated with higher mortality risks among cancer survivors. Programs to screen for loneliness among cancer survivors and to provide social support to those in need are warranted. [Table: see text]
The association between continuity of Medicaid enrollment and cancer survival in young adults diagnosed with cancer.
Authors: Johnson Kimberly J. , Brown Derek J , King Allison A. , Thompson Tess
Published: June 2023

6538

Background: Disparities in young adult cancer survival between individuals with Medicaid and private insurance have been reported. To further understand the association between insurance-related access to healthcare and young adult cancer survival, we used Surveillance, Epidemiology, and End Results (SEER)-Medicaid linked data to test two hypotheses: 1) Those linked to Medicaid have lower cancer survival than those not linked, and 2) those with discontinuous enrollment in Medicaid around the time of diagnosis have lower survival than those with continuous enrollment. Methods: SEER-Medicaid linked data from 2006 to 2013 were obtained. Follow-up for vital status was through 2018. We included individuals diagnosed with a first malignant primary cancer diagnosed between 20 to 39 years. We excluded individuals who were linked to Medicaid enrollment records in multiple states during the same year. Individuals were defined as Medicaid-linked if they were linked to Medicaid in any U.S. state or the District of Columbia from 2006 to 2013. Medicaid enrollment was classified as continuous (enrolled within both the three months before and after diagnosis) and discontinuous (enrolled only within the 3 months before or after diagnosis or only at diagnosis). We used survival analysis methods including Kaplan-Meier (KM) curves and Cox Proportional Hazards (PH) regression models to evaluate survival differences in association with Medicaid linkage and enrollment timing after adjusting for race and a measure of census tract poverty. Results: Our analytic dataset included 137,259 young adults, among which there were 22,955 cancer deaths. KM curves showed consistently lower survival probabilities over time in young adults who linked vs. those not linked to Medicaid and in those with discontinuous vs. continuous enrollment (p < .0001). Adjusted Cox PH regression models indicated that those who linked to Medicaid had a 2.19 (95% CI 2.14-2.25) times higher hazard of death vs. those who did not link. Those with continuous and discontinuous Medicaid enrollment had a 1.91 (95% CI 1.84 to 1.99) and 3.32 (95% CI 3.19 to 3.45) times higher hazard of death, respectively, vs. those not linked to Medicaid. Similar patterns were consistently observed for specific cancer types. Conclusions: These results confirm an insurance-associated disparity in a national sample of young adult cancer patients and provide additional information on risks in association with Medicaid enrollment continuity. These results further support the critical need for consistent health insurance coverage in young adults and for additional research to understand social, economic, and access-related factors leading to lower survival in the Medicaid population. Lowering administrative burdens for Medicaid enrollment, eligibility, and renewal are potentially important strategies for improving cancer outcomes.
Depression, systemic inflammation, and exposure to discrimination among sexual and gender minority (SGM) cancer survivors.
Authors: Kamen Charles Stewart , McFarland Daniel Curtis , Lin Po-Ju , Mustian Karen Michelle , Peppone Luke Joseph , Morrow Gary R. , Janelsins Michelle Christine
Published: June 2023

6544

Background: Our prior research shows that SGM cancer survivors experience high rates of depression, due in part to exposure to discrimination. Depression among cancer survivors in general has been linked to markers of systemic inflammation including peripheral blood interleukin (IL)-6, tumor necrosis factor alpha (TNFα), and C-reactive protein (CRP). To date, no studies have examined the association of these markers with depression among SGM cancer survivors in the context of discrimination. Methods: Cross-sectional patient-reported data and serum samples were collected from 66 SGM cancer survivors (see Table). Depression was assessed by the Patient Health Questionnaire (PHQ)-9, discrimination by the Harassment, Rejection, and Discrimination Scale (HHRDS), IL6 and TNFα by multiplex assay, and CRP by ELISA. We used a clinical cut-point for depression of 10 on the PHQ-9, indicating moderate depressive symptoms, and assessed associations between continuous variables using bivariate correlations and multivariate linear regressions. Results: More SGM cancer survivors exceeded the clinical cut-point for depression (15.9%) than cancer survivors in prior general population samples (11.3%). Higher depression among SGM cancer survivors was associated with higher levels of exposure to discrimination (r=0.28, p=0.03), TNFα (r=0.30, p=0.02), and CRP (r=0.39, p=0.002); exposure to workplace discrimination, specifically, was associated with higher levels of CRP (r=0.32, p=0.02). In multivariate models controlling for demographic and clinical characteristics, CRP remained a significant predictor of depression (β=0.34, p=0.01). Conclusions: This study replicates prior findings of high levels of depression among SGM cancer survivors. It provides preliminary evidence that markers of inflammation, specifically CRP, are uniquely predictive of depression among SGM cancer survivors in the context of exposure to discrimination. These findings need to be replicated in larger samples and evaluated for potential use in providing supportive cancer care to SGM survivors. [Table: see text]