bluuebunny/crossref_metadata_2025_split huggingface dataset:
Neighborhood socioeconomic disadvantage, tobacco use, and cessation indicators among adults with cancer in the United States: Results from 10 ECOG-ACRIN trials.
Authors: Walter Angela Wangari , Lee Ju-Whei , Gareen Ilana F. , Kircher Sheetal Mehta , Herman Benjamin A. , Streck Joanna M. , Kumar Shaji , Mayer Ingrid A. , Saba Nabil F. , Neal Joel W. , Atkins Michael B. , Hodi F. Stephen , Kyriakopoulos Christos , Tempany Clare , Shanafelt Tait D. , Wagner Lynne I. , Land Stephanie R. , Ostroff Jamie S. , Park Elyse R. 
Published: June 2022

6514 Background: Tobacco use is a modifiable risk factor for adverse outcomes among patients diagnosed with cancer. Despite ASCO’s recommendation for assessment and treatment of tobacco use, integration into cancer care is suboptimal. Socioeconomic contexts influence access and utilization of tobacco treatment, but little is known about the relationship between neighborhood socioeconomic disadvantage (NSD) and tobacco assessment, assistance, and cessation among cancer patients enrolled in clinical trials. Methods: The NCI Cancer Patient Tobacco Use Questionnaire (C-TUQ) was centrally administered to participants enrolled in 10 ECOG ACRIN clinical trials (9 therapeutic, 1 imaging). We examined associations of NSD with patient-reported rates of receiving brief tobacco cessation support (i.e., Ask, Assist (counseling)) and cessation (past 30d quit attempts and duration). NSD was measured using the national Area Deprivation Index (ADI) based on participant’s zip code. Associations between ADI (low, intermediate, and high) and tobacco variables were evaluated using logistic regression and ANOVA. Results: 740 patients, completing the C-TUQ between June 2017-October 2021, can be classified as 402 (54%) never smokers, 81 (11%) current smokers, and 257 (35%) former smokers. Patients were 70% male; 94% white; 3% Hispanic; mean age 58.8 (SD 9.0). Cancer diagnoses were 36% leukemia; 19% lymphoma, 18% prostate, 11% breast; 9% melanoma, 7% myeloma, and 0.5% head and neck. Patients were categorized into high (33%), intermediate (34%) and low (33%) disadvantaged neighborhoods. Patients in high (vs. low) disadvantaged neighborhoods were more likely to report being asked about smoking (OR = 3.90; 95% CI (confidence interval), 1.61 to 9.46; p = 0.0062) but less likely to report receiving counseling to help quit smoking (OR = 0.20; 95% CI, 0.06 to 0.73; p = 0.0234). Patients from high disadvantaged neighborhoods had the shortest quit duration, followed by patients from intermediate and low disadvantaged neighborhoods (mean = 145.78, 187.66, and 210.98 months, respectively, p = 0.0372). Conclusions: Greater socioeconomic neighborhood disadvantage was associated with increased assessment of tobacco use but decreased tobacco treatment referral, and the shortest quit duration. More research is needed to promote increased referral to tobacco treatment for individuals with cancer from disadvantaged neighborhoods to promote and sustain cessation.
Cancer risk factors and cancer in transgender versus cisgender people: Real-world data from a tertiary health care institution.
Authors: Alpert Ash B. , Sayegh Sabrina Jamileh , Strawderman Myla S. , Cunliffe Scott , Cupertino Ana Paula , Cerulli Catherine , Griggs Jennifer J. 
Published: June 2022

6538 Background: Data are sparse regarding the prevalence of cancer and cancer risk factors among transgender people. Transgender people experience structural stigma and extreme rates of violence that may contribute to cancer through multiple mechanisms. The purpose of this study was to assess cancer risk factors and cancer in transgender people in a single institutional electronic health record (EHR) and compare the rates to those among cisgender, or non-transgender, people. Methods: Using a combination of structured gender identity data, diagnosis codes, and keyword searches, we identified a cohort of transgender people seen at our institution, a large tertiary care center. We next identified a cohort of cisgender people matched by age, year of first encounter in our EHR, and years of follow-up. Among these cohorts, we searched for cancer, premalignant lesions, human immunodeficiency virus (HIV), human papilloma virus (HPV), and hepatitis and assessed body mass index (BMI) and smoking status through structured EHR fields. Lastly, we compared the prevalence of cancer, premalignant lesions, and cancer risk factors between the two cohorts using chi-square tests. If expected cell sizes were <5, exact tests were used. Results: We identified cohorts of 923 transgender and 1846 cisgender people matched by age, follow-up time, and year of the first encounter. Rates of smoking (42 versus 34%, p < 0.0001), BMI ≥ 40 (21% versus 13%, p < 0.0001), and HIV (3 versus 0%, p < 0.0001) were significantly higher among transgender compared with cisgender people. Rates of premalignant lesions and cancer did not significantly differ between cohorts. Conclusions: In this large sample of patients seen at our institution, rates of several cancer risk factors were higher for transgender than cisgender people. No differences were demonstrated in prevalence of premalignant lesions and cancer between groups. These data require confirmation in larger national datasets. Interventions that decrease structural oppression and provide support for tobacco cessation, decreased transmission of HIV, and access to high-quality food and exercise are also called for. [Table: see text]
Disparities in delayed diagnosis, access to treatment, and treatment delays among Hispanic men with metastatic prostate cancer.
Authors: Swami Nishwant , Dee Edward Christopher , Mahal Brandon A 
Published: June 2022

6550 Background: Reporting racial/ethnic disparities in aggregate for Hispanics could obscure differences between subgroups given heterogeneity in social determinants of health. We sought to identify differences in delayed diagnosis, treatment status, and time to treatment among Hispanic subpopulations with metastatic prostate cancer. Methods: 2004-2017 data from the National Cancer Database (NCDB) was used to identify patients with prostate adenocarcinoma; patients were disaggregated by racial subgroup and Hispanic country-of-origin. Ordinal logistic regression defined adjusted odds ratios (aORs) with 95% CI of 1) presenting with Stage IV cancer, 2) receiving treatment, and 3) receiving delayed treatment (defined as treatment after 90 days). Sensitivity analysis was conducted for delayed treatment after 180 days. Results: Among 1,305,785 patients, Hispanic men had greater odds of presenting with stage IV prostate cancer compared with non-Hispanic White (NHW) men (aOR = 1.54 95% CI 1.50-1.58, p < 0.001). All Hispanic racial subgroups were more likely to present with stage IV cancer with highest odds observed in Hispanic Black men (aOR 1.68 95% CI 1.46-1.93, p < 0.001). Disparities were also observed in all country of origin subgroups, particularly for men of Mexican heritage (aOR 1.99 95% CI 1.86-2.12, p < 0.001). Among men with metastatic disease, Hispanic men were less likely to receive treatment than NHW men (aOR 0.60 95% CI 0.53-0.67, p < 0.001). Hispanic White patients were less likely to receive treatment compared with NHW men (Hispanic White aOR 0.58 95% CI 0.52-0.66, p < 0.001). Upon disaggregation by country of origin, disparities persisted, particularly for men of Dominican heritage (aOR 0.52 95%CI 0.28-0.98 p = 0.044). Hispanic men were more likely to experience treatment delays when compared to NHW men (aOR 1.38 95%CI 1.26-1.52 p < 0.001). All Hispanic racial subgroups experienced greater treatment delays, particularly Hispanic Black men (aOR 1.83 95%CI 1.22-2.75 p = 0.002). Men of Central or South American heritage had the greatest odds of treatment delays (aOR 1.48 95%CI 1.07-2.04 p = 0.018). Sensitivity analysis indicated consistent findings among Hispanic patients overall, Hispanic White patients, and patients of Mexican and Puerto Rican heritage. Conclusions: We found notable differences in stage IV cancer at presentation, treatment for metastatic disease, and delays in treatment when outcomes were stratified by racial subgroup and Hispanic country of origin. Future studies in Hispanic populations with disaggregated data are needed to characterize outcomes, study mediators of the observed variations, and develop targeted interventions.
Medicare expenditures for discarded oncology therapies.
Authors: Scheckel Caleb , Desai Aakash , Jensen Chelsee , Orme Jacob , Pritchett Joshua , Mahipal Amit , Khera Nandita , Go Ronald S. 
Published: June 2022

6552 Background: Significant amounts of expensive oncology drugs are discarded resulting in waste and financial consequences for patients. Beginning in 2023, the Infrastructure Investment and Jobs Act (IIJA) will require drug manufacturers to refund Medicare for any single-use drugs where greater than 10% of the drug is wasted. We explored potential IIJA-associated savings through assessment of patterns in spending for discarded oncology agents between 2017-2020. Methods: We utilized the Medicare Part B Discarded Drug Units database from 2017-2020. Using J codes, we extracted spending and reimbursement data for discarded medications for antineoplastic and classical hematology therapies. The primary outcome was identification of therapies with high percentage of waste and the economic impact of retroactive application of the IIJA for discarded therapies. Results: Medicare Part B utilization data was extracted for a median 77 (64-152) oncologic therapies per year with median reimbursement for discarded treatments of $590 M ($566-616). From 2017-2020, bortezomib, romiplostim, and nab-paclitaxel were consistently among the top 5 therapies by value of wasted product. Pembrolizumab waste by value declined significantly after 2017 following transition to fixed dosing. In 2020, the top 5 therapies by value of wasted product were bortezomib, nab-paclitaxel, trastuzumab, romiplostim, and cabazitaxel with a value of $278 M. In 2020, the agents with the highest percentage of wasted product were bortezomib (27%), cabazitaxel (28%), decitabine (23%), topotecan (23%), and azacitidine (22%) with a collective discarded value of $160 M. Notably, these agents have weight-based dosing and single-use vials. Based upon the average number of drug claims per recipient and volume of product discarded, eliminating drug waste would allow an additional 6564 patients to receive treatment with discarded bortezomib. The number of additionally treated patients for the other top 5 agents: cabazitaxel (1216), decitabine (1509), topotecan (291), and azacitidine (2682). Retroactive application of IIJA policy would have impacted a median 20 (12-26) oncology agents resulting in median annual cost savings of $153 M (142-157) and the median annual spending on wasted oncology therapies would decline to $440 M (410-466). Conclusions: The IIJA would have yielded a median annual savings of $153 M in Medicare spending if applied retroactively. Given a 10% waste cutoff, a limited number of agents would be targeted by this legislation. In our study, we observe that drugs associated with weight-based dosing and single-use drug vials account for most drug waste. Strategies to minimize discarded units (through storage of unused product, approval of multi-dose vial formulations, or fixed-dose therapies) could yield substantial savings while enabling health equity in collaboration with communities with difficult access to these drugs.
Updated health-related quality of life of patients with TRK-fusion cancer treated with larotrectinib in clinical trials.
Authors: Kummar Shivaani , Shen Lin , van Tilburg Cornelis Martinus , Tan Daniel S.W. , Doz Francois , McDermott Raymond S. , Zwaan C. Michel , Keating Karen N. , Chirila Costel , Norenberg Ricarda , Fellous Marc Mardoche , Brega Nicoletta , Xu Rui-hua , Laetsch Theodore Willis , Drilon Alexander E. , Hong David S. 
Published: June 2022

6563 Background: NTRK gene fusions have been identified as oncogenic drivers in patients (pts) with TRK fusion cancer across multiple solid tumors. Larotrectinib, a highly selective, CNS-active TRK inhibitor has shown high response rates, durable disease control, and a favorable safety profile in pts with TRK fusion cancer and is approved in over 40 countries. Larotrectinib has demonstrated rapid health-related quality of life (HRQOL) improvement in a group of 57 adult and pediatric pts (Kummar et al, Curr Prob Canc 2021). Here, we report updated HRQOL results for larger group of pts treated with larotrectinib. Methods: HRQOL data were collected in two ongoing trials (NCT02576431, NCT02637687) of larotrectinib in pts with TRK-fusion cancer using the EORTC QLQ-C30, EQ-5D-5L questionnaires and were analyzed descriptively and longitudinally. Scores from the EORTC QLQ-C30 Global Health Status (GHS), EQ-5D-5L VAS range from 0 to 100, with higher scores indicating better QOL. We also calculated the proportion of pts with either below normal or normal and above normal HRQOL scores against values in the literature for the US general population. Results: By July 2021, 113 adults with TRK-fusion cancer had received larotrectinib and completed the baseline (BL) and ≥ 1 post-BL questionnaire. The majority of pts had clinically meaningful HRQOL improvements during treatment (Table). For EORTC QLQ-C30 GHS, most adults maintained or improved scores from BL at or above the normal population level category. HRQOL improvements (change from BL > 0) occurred after ̃2 months of treatment in 75% of adults. Median duration of pts with sustained improvement in EORTC QLQ-C30 GHS, and EQ-5D-5L VASs was 12.5 months (range, 1.8-34.1), and 12.9 months (range, 1.8-34.0), respectively. HRQOL results were consistent across multiple data cuts. Conclusions: Patients with TRK-fusion cancer treated with larotrectinib continued to have rapid, clinically meaningful, and sustained improvements in HRQOL. Clinical trial information: NCT02576431, NCT02122913, NCT02637687.
Lisocabtagene maraleucel (liso-cel) as second-line (2L) treatment (tx) for R/R large B-cell lymphoma (LBCL) in patients (pt) not intended for hematopoietic stem cell transplantation (HSCT): Patient-reported outcomes (PRO) from the phase 2 PILOT study.
Authors: Gordon Leo I. , Hoda Daanish , Shi Ling , Guo Shien , Liu Fei Fei , Braverman Julia , Dubowy Ronald L. , Peng Lily , Sehgal Alison 
Published: June 2022

6567 Background: PILOT (NCT03483103) evaluated liso-cel, an autologous, CD19-directed, CAR T cell product, as 2L tx in pts with R/R LBCL not intended for HSCT. We analyzed changes in health-related quality of life (QOL) with respect to functioning and symptoms in PILOT. Methods: Adults with R/R LBCL after first-line tx were eligible. Pts were deemed not candidates for high-dose chemotherapy and HSCT by their physician and met ≥ 1 frailty criteria: age ≥ 70 yr, ECOG PS = 2, DLCO ≤ 60%, LVEF < 50%, CrCl < 60 mL/min, or ALT/AST > 2 × ULN. Pts completed EORTC QLQ-C30, FACT-LymS, and EQ-5D-5L (health utility index [HUI] and VAS) at screening (baseline [BL]), pre-tx (within 7 days before lymphodepletion), preinfusion on day of liso-cel infusion (Day 1), post-tx on Days 29, 60, 90, 180, 270, 365, 545, and 730/end of study, or at PD. The PRO-evaluable set included all pts with BL and ≥ 1 post-BL assessments. Linear mixed-effects models for repeated measures assessed the least squares (LS) mean change from BL for visits with ≥ 10 pts. Meaningful change from BL was calculated using responder definitions (in points): 10 for EORTC QLQ-C30, 3 for FACT-LymS, 0.08 for EQ-5D-5L HUI, and 7 for EQ-VAS. Results: Among the PRO-evaluable set, completion rates were high (≥ 80%) across most visits for all measures. For EORTC QLQ-C30, mean BL fatigue was meaningfully worse than in a general noncancer population (difference of > 10 points). Overall LS mean changes through Day 545 showed significant improvements in EORTC QLQ-C30 fatigue and pain, FACT-LymS, and EQ-VAS (Table). Improvement for lymphoma symptoms was also clinically meaningful. Fatigue improvement was clinically meaningful with a more sensitive minimal important difference of 4 (Cocks et al, 2012). Significant worsening was not observed for any outcome. In individual patient-level analysis, 70% of pts demonstrated meaningful improvement in FACT-LymS at month 6. Conclusions: Liso-cel meaningfully improved fatigue and FACT-LymS scores without negatively impacting other QOL measures. These data support the clinical evidence of liso-cel as a potential new 2L tx in pts with R/R LBCL not intended for HSCT. Clinical trial information: NCT03483103. [Table: see text]
Polypharmacy and premature aromatase inhibitor (AI) discontinuation in older women with breast cancer.
Authors: Joyce Elizabeth , Kidwell Kelley M. , Stearns Vered , Hayes Daniel F. , Storniolo Anna Maria , Henry Norah Lynn 
Published: June 2022

6568 Background: Treatment with AI therapy for at least five years is recommended to reduce risk of cancer recurrence in postmenopausal women with hormone-positive breast cancer, but up to 50% prematurely discontinue their AI. Prior studies have demonstrated higher rates of nonadherence in older patients. Higher rates of comorbidities are also present in older patients, many of which require treatment with prescription medications. However, in prior studies, the impact of polypharmacy on AI persistence in older women has been variable. We evaluated the relationship between use of prescription and over-the-counter (OTC) medications and AI discontinuation in older women in a randomized controlled trial of AI therapy. Methods: In the Exemestane and Letrozole Pharmacogenetics (ELPh) trial, postmenopausal women with stage 0-III hormone-positive breast cancer were randomized to receive exemestane or letrozole and followed for two years. Prescription medication and OTC supplement usage was prospectively collected. Only enrolled participants at least 65 years of age were included in this analysis. Univariate and multivariable Cox proportional hazards models evaluated the association between baseline prescription medications, OTC medications, initial assigned AI medication, and time to discontinuation of initial AI. Results: 131 women at least 65 years old with baseline medication and OTC supplement information were identified. The average age was 70.4 (SD 5). 58 participants (44%) were randomized to exemestane and 73 (56%) to letrozole. 21% had previously received tamoxifen and 18% received taxane-based chemotherapy. The average number of prescription medications at AI initiation was 4.95, and 127 patients reported taking at least one. The average number of OTC medications was 3.23, and 107 patients reported taking at least one. There was no difference in number of prescription medications or OTC medications by study arm. As previously reported, exemestane was associated with premature discontinuation (HR 1.92 [95%CI 1.06-3.50], p = 0.032). Controlling for AI, the risk of discontinuation decreased by 12% for every additional prescription medication (HR 0.88 [95%CI 0.78-0.99], p = 0.038). OTC medication use was not significantly associated with AI duration. Conclusions: Increased prescription medication usage at AI initiation was associated with decreased risk of premature discontinuation of AI. Further research is needed to evaluate this interaction and identify characteristics that impact AI persistence in older women with breast cancer. Clinical trial information: NCT00228956.
Implementation of a precision medicine thoracic (PREDICT) service using reflex testing in a large academic-community practice network.
Authors: Bruno Debora S. , Donner Andrea Lynn , Kopp Shelby Rose , Yoest Jennifer , Mneimneh Wadad , Margevicius Seunghee , Shanahan John , Fu Pingfu , Hsu Melinda Laine , Dowlati Afshin , Sadri Navid 
Published: June 2022

6572 Background: Broad genomic testing is necessary for treatment of patients with stage IV non-small cell lung cancer (NSCLC). This quality improvement initiative aims to implement a precision medicine service for NSCLC patients at a hybrid academic-community practice oncology network. Methods: Following IRB approval, network tumor registries were queried for retrospective newly diagnosed stage IV NSCLC from 01/2016 through 12/2018. PREDICT was implemented in 08/2021. It consists of: 1) system-wide reflex testing of newly diagnosed stage IV NSCLC patients by an in-house solid tumor focused assay (hybrid DNA/RNA next-generation sequencing (NGS) panel previously reported) and PD-L1 testing, 2) PREDICT navigator, 3) molecular tumor board (MTB), 4) integrated information portal for real-time updates on samples processing, results and treatment recommendations by the MTB. We compared prospective data (08/2021 through 01/2022) after PREDICT with retrospective practice assessment. Comparisons between the groups were conducted using independent samples t-test / Wilcoxon rank sum test for continuous variables and Chi-square test/Fisher’s exact test for categorical variables. Results: Of 861 retrospective patients identified in the compiled registry of stage IV NSCLC, 626 were eligible. Since PREDICT launch in 08/2021, 103 eligible prospective patients have been identified. Prospective patients are slightly older (mean age 70.9 vs 68 years old; p = 0.013), with no other significant demographic or clinical differences identified. Rates of NGS testing obtained within 90 days of biopsy date (BxD) increased significantly (94.1% vs 60.8%; p < 0.0001) after PREDICT. Turnaround times (TAT) from BxD to test results were significantly shorter for both NGS (12 vs 18 days; p < 0.0001) and PD-L1 (7 vs 10 days; p = 0.007) after PREDICT. A trend towards higher rates of actionable alterations (EGFR, ALK, ROS1, RET, BRAF, MET14 skipping, NTRK1/2/3) was noted: 19.6% vs 13% (p = 0.071). Targeted therapy use increased from 6.8% to 15.6% (p = 0.002) in the overall cohort. No differences in time to treatment initiation (TTI) after PREDICT have been identified to this point, with a median of 34 and 35 days for the prospective and retrospective groups, respectively. Conclusions: Implementing a precision medicine service for thoracic oncology patients has led to significantly higher rates of NGS testing for patients with stage IV NSCLC in a large hybrid academic-community practice network. Launching of this initiative resulted in significantly shorter TAT for both NGS and PD-L1 test results. A trend towards higher rates of actionable alterations has been identified. Targeted therapy use has increased significantly overtime, potentially due to higher availability of precision medicine drugs in the current era.