bluuebunny/crossref_metadata_2025_split huggingface dataset:
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]
Examining clinical trial eligibility for oncology patients with human immunodeficiency virus (HIV): A global cross-sectional analysis.
Authors: Abdullahi Umar , Shaya Sammy , Dinizulu Habana , Sampey Emily , Appleton David , Concannon Matthew , Graham Donna M. 
Published: June 2023

6554 Background: People Living with HIV (PLWH) are at higher risk of developing cancer, and malignancy is the most common cause of death in PLWH in the USA . In 2017 a joint research statement by the American Society of Clinical Oncology and Friends of Cancer Research (ASCO-FCR) examined trial inclusivity, stating PLWH should not be excluded from clinical trials due to HIV positivity alone without justification. It also provided guidance for designing trial inclusion criteria using CD4 count, use of antiretroviral therapy (ART), ART-related drug interactions and HIV-associated complications. To review incorporation of ASCO-FCR recommended wording and current compliance, we examined global eligibility for PLWH in clinical trials. Methods: Clinicaltrials.gov was searched on 15 Nov 2022 for open and recruiting trials worldwide, using terms ‘advanced cancer’ and ‘interventional’. Trials lacking systemic treatment were deemed non-evaluable. Evaluable studies’ eligibility criteria were manually reviewed for specific criterion excluding PLWH or diagnosis/history of immunodeficiency (outright exclusion). Therapy type and study phase were captured and their relationships to outright exclusion were significance tested using odds ratios (OR) with 95% confidence intervals (CI). Results: The search rendered 2388 evaluable clinical trials. Eligibility criteria outrightly excluded PLWH in 1194 (50%) , of which 1113 (93%) were early phase trials (Phase 0-2). 206 evaluable trials (8.6%) permitted inclusion of PLWH aligned with ASCO-FCR guidance, including 3 (0.1%) with a cohort for PLWH. AIDS-defining illness was an exclusion criterion in 27 trials (1%), and specific interactions to ART in 10 (0.4%). Early phase trials had a significantly higher likelihood of outright exclusion of PLWH when compared with late phase trials (OR 2.98; 95% CI 2.16-4.11, p<0.0001). Trials investigating immunomodulatory agents were more likely to outrightly exclude PLWH than those investigating other drug classes (OR 1.60; 95% CI 1.36-1.88, p<0.0001). Criteria which may implicitly exclude PLWH were identified, including 204 (8.5%) citing active/chronic/severe infection, 189 (7.9%) listing CYP and P-gp interaction criteria and 3 (0.1%) "immunodeficiency". Conclusions: Despite adequate time to incorporate, most currently recruiting oncology clinical trials do not use ASCO-FCR guidance for including PLWH. Half of evaluated trials excluded PLWH without reason. Early phase and immunotherapy trials were significantly more likely to exclude PLWH without exception, despite data to support immunotherapy use for PLWH. Covert inclusionary barriers exist in criteria that lack HIV-specific guidance, and this may further exclude PLWH. Consideration of recommendations and guidance in eligibility criteria for oncology trials is critical to address current inequities in care for PLWH and cancer.
The patient experience of prior authorization for cancer care: Anxiety, delays, and the erosion of trust.
Authors: Chino Fumiko , Baez Alexandra , Elkins Ivy Beth , Aviki Emeline Mariam , Thom Bridgette 
Published: June 2023

6561 Background: Prior authorization (PA) requires healthcare providers to obtain pre-approval from insurance for medical care. While PA is intended to promote evidence-based standards and reduce unnecessary care, it requires clinicians and patients to navigate an often-complex approval process. Delays or denied care can be particularly problematic for patients with cancer and their experience with PA remains unexplored. Methods: Social media recruitment enrolled adult cancer patients with a self-reported personal experience with PA to an anonymous online survey of investigator-designed questions on their experience. Descriptive statistics and univariate tests characterized survey responses, and multivariable analysis, controlling for age, diagnosis, race/ethnicity, and education, assessed associations with healthcare and insurance trust and delays in care. Results: 178 patients completed the survey; they were mostly women (90%), non-Hispanic white (84%), college graduates (81%), young [18-39 (42%), 40-54 years old (34%)] with private insurance (86%). PA was most frequently required for imaging (71%), IV chemotherapy (48%), surgery (47%), radiation (34%). Most care was ultimately given as recommended (58%); however, 20% of respondents didn’t receive recommended care due to delays or denials, and 9% received recommended care but paid out-of-pocket. PA delayed 69% of care, with 51% of patients noting a delay ≥2 weeks. Delays did not vary by demographic, clinical, insurance, or treatment factors (all p > .05). 67% of patients had to personally get involved in the PA process by either calling their insurance (53%) or filing an appeal (25%); 20% of patients and/or their caregivers spent ≥11 hours dealing with PA issues. Overall PA experience was rated as “bad” (40%) or “horrible” (32%) for most respondents. Self-reported PA-related anxiety was significantly higher than self-reported baseline anxiety (mean = 74 vs mean = 37, 0-100 scale, t = 16.6, p < .001) and was significantly correlated with time spent on PA (ρ = .16, p = .04) and overall PA experience (ρ = .34, p < .001). While 18% felt PA made them trust their cancer team less, 89% said it made them trust their insurance company less, and 83% said it made them trust the healthcare system less. Patient involvement in the PA process (vs. healthcare team handling) was associated with higher-than-expected trust in their cancer team (χ2= 19.6, p < .001), and increased odds of distrusting their insurance company (β = 5.7, 95% CI: 1.8,17.6) and distrusting the healthcare system (β = 3.2, 95% CI: 1.3,7.9). Having to file appeal was associated with 2.9 increased odds (95% CI: 1.2,7.2) of experiencing a delay in care. Conclusions: PA practices may substantially delay care for patients with cancer increasing anxiety and eroding trust in healthcare. Streamlining the PA process could both allow optimal quality of care and improve the patient experience with cancer care.
Just ASK: A quality improvement project to enhance smoking assessment and treatment.
Authors: Warren Graham W. , Ostroff Jamie S. , Mullett Timothy , Adsit Robert , Burris Jessica , Darville Audrey , Fiore Michael C. , Hahn Ellen , Kirstein Laurie , McCarthy Danielle , Nelson Heidi , Reilly Eileen , Shelton Rachel C , Tong Elisa 
Published: June 2023

6571 Background: Persistent smoking after cancer diagnosis causes adverse clinical outcomes. ASCO and other organizations view smoking assessment and treatment as indicators of high-quality cancer care. Yet, adoption of clinical practice guidelines like the 3As (Ask, Advise and Assist) for smoking assessment and treatment has been slow and inconsistent in cancer care settings. Methods: Led by the American College of Surgeons Cancer Programs’ Commission on Cancer (CoC) and National Accreditation Program for Breast Centers (NAPBC), the “Just ASK” national quality improvement project focuses on enhancing smoking assessment and treatment in cancer care settings. All CoC/NAPBC programs (n~2000) were invited to participate, which consisted of educational webinars, online resources, and 3 online surveys (baseline, 6- and 12-month) collecting information on smoking assessment and treatment practices, plus other variables (e.g., organizational priority, implementation barriers). Program participation was incentivized by fulfillment of accreditation standards. Results: In total, 776 programs (731 CoC, 45 NAPBC), participated. At baseline, most programs strongly endorsed the importance of addressing smoking within cancer care and the majority of programs reported routinely assessing smoking (90%) and advising all patients reporting current smoking to quit (71%). However, routine delivery of evidence-based smoking cessation assistance (e.g., quitline referral, cessation medications, counseling services) was low (all < 30%). Program retention was excellent (91%). As shown in the table, the 12-month follow-up revealed marked improvements in evidence-based Ask, Advise and Assist, practices. Conclusions: At enrollment, the importance of addressing smoking was evident and high rates of smoking assessment were reported. At 12-month follow-up, marked improvement was reported in all quality indicators of the 3As. These findings guided the sharing of strategies for improving patient assessment, clinical workflow and documentation. Suboptimal delivery of smoking cessation assistance persisted despite overall improvements, which highlight persistent challenges and opportunities for implementing smoking assessment and treatment in cancer care settings. [Table: see text]
Incidence of infusion related reactions of daratumumab-hyaluronidase-fihj: Pre-post intervention study of premedication omission.
Authors: Padmaraju Kashyap , Kelly Kaitlin , Jakubowiak Andrzej J. , Derman Benjamin Avi 
Published: June 2023

6574 Background: Daratumumab-hyaluronidase-fihj subcutaneous (Dara-SQ) is utilized frequently in the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM). Initially approved as an intravenous formulation, daratumumab (Dara-IV) showed significant infusion related reactions (IRRs), requiring premedication (acetaminophen, diphenhydramine, dexamethasone, and some add montelukast) prior to each dose. Dara-SQ was shown to be noninferior to Dara-IV with significantly fewer IRRs. Despite the reduced IRR risk, indefinite premedication is also recommended in the package insert for Dara-SQ. Given that IRRs are rare after the first dose of Dara-SQ and premedication extends the time for patients in an infusion center, we investigated whether premedication may be safely omitted after the first cycle. Methods: This pre-post interventional quality improvement study included all patients aged 18 years or older diagnosed with MM or amyloidosis that received at least one dose of Dara-SQ between July 1st, 2020 – December 31st, 2022. Omission of premedication (excluding dexamethasone) after four doses of Dara-SQ was introduced June 1st, 2022. The pre-interventional arm followed standard of care with premedication continued (Arm 1) and post-interventional arm included patients with premedication omitted after fourth dose (Arm 2). Patient demographics, prior therapy, Dara-IV exposure, and premedication usage were collected to evaluate the primary endpoint: incidence of IRR after premedication omission. Secondary analysis included any IRR prior to intervention, timing of reaction, reaction management, and post-reaction management. Results: A total of 102 patients (63 in Arm 1 and 39 in Arm 2) were included in the study, with a median age of 69 (38-86) years old; 52% African American and 54% male. IRR prior to fourth dose occurred in 1.6% (1/63) for Arm 1 vs. 5.1% (2/39) for Arm 2 [ p= 0.6], Dara-IV exposure was 52.4% (33/63) in Arm 1 vs. 10.2% (4/39) in Arm 2 [ p= 0.02], and indication was newly diagnosed MM in 21% (13/63) of Arm 1 vs. 41% (16/39) of Arm 2 [ p= 0.03]. For the primary objective, there were zero reactions in both arms. All three reactions prior to fourth dose occurred after the first dose of Dara-SQ, with a median time to reaction of 4.8 hours. These were all grade 2 per CTCAE v5.0, with all patients discharged home after reaction, and all patients received subsequent Dara-SQ without issues. For the two reactions prior to fourth dose in Arm 2, premedication was omitted after 6 doses in one patient and 8 doses in the other with no further issues on subsequent doses. Estimated therapy time saved was 194 hours, with an estimated savings of $145,500 thus far. Conclusions: IRRs to Dara-SQ occur early, are rare, and mild in course. Omitting premedication after a minimum of four Dara-SQ doses is safe and carries substantial time savings for patients and infusion centers.
The association of HIV and other risk factors with triple-negative breast cancer in South African women.
Authors: Dubner Jacob , Neugut Alfred I. , Joffe Maureen , O'Neil Daniel , Ayeni Oluwatosin , Chen Wenlong Carl , Buccimazza Ines , Čačala Sharon , Stopforth Laura , Farrow Hayley , Nietz Sarah , Phakathi Boitumelo , Jacobson Judith , Crew Katherine D. , Ruff Paul , Cubasch Herbert , Pumpalova Yoanna S 
Published: June 2023

6583 Background: Breast cancer (BC) mortality in South Africa (SA) is double that of the United States. The aggressive triple-negative breast cancer (TNBC) subtype comprises 20.9% of BC cases among Black women in Southern Africa. SA has the second highest HIV prevalence worldwide, but if and how HIV affects the risk of developing TNBC is not well understood. Methods: Using the South African Breast Cancer and HIV Outcomes (SABCHO) prospective cohort of newly diagnosed BC patients from six public hospitals in SA, we evaluated the association of HIV with risk of TNBC relative to other BC subtypes. We developed multivariable logistic regression models to test for this association while adjusting for key demographic and reproductive risk factors. Results: Of 3,883 women with BC, 16.4% had TNBC and 23.0% were HIV-positive. The overall median age of BC diagnosis was 55 years. Among HIV positive patients, the median age of BC diagnosis was 45 years, without a difference between TNBC and non-TNBC cases (p = 0.244). Only 7.2% of women were nulliparous (4.6% in TNBC and 7.6% in non-TNBC subgroups). Of women who had at least 1 full-term pregnancy, 11.2% did not breastfeed, without a difference between TNBC and non-TNBC cases (p = 0.292). In our final multivariable logistic regression model, HIV-positive status was associated with increased risk of TNBC relative to non-TNBC (OR: 1.40; 95% CI: 1.12-1.74, compared to HIV-negative with BC). Parity without breastfeeding was also associated with increased risk of TNBC relative to non-TNBC (OR: 1.72; 95% CI: 1.07-2.84, compared to nulliparous with BC). HIV status and the combined parity/breastfeeding variable had no statistically significant interaction. In exploratory analyses, measures of HIV control at time of BC diagnosis were not associated with BC subtype. Conclusions: In this large prospective case-only study conducted in SA, we found that women living with HIV were more likely than HIV-negative women to have TNBC (relative to other BC subtypes), regardless of the extent of HIV control. Whether this relationship is mediated by immune mechanisms or other factors should be the focus of future research. Our findings highlight the importance of rigorous BC screening and early detection among HIV-positive women given their increased relative risk of developing TNBC. [Table: see text]
Real-world analysis of cardiac, gastrointestinal, and hematologic toxicities between commonly used antiemetics in everyday oncology clinical practice.
Authors: Beedupalli Kavitha , Ananthaneni Anil , Findakly Dawood 
Published: June 2023

6587 Background: Antiemetics are highly effective in chemotherapy-induced nausea and vomiting. We utilized Food and Drug Administration Adverse Event Reporting System (FAERS) database to evaluate adverse events (AEs) caused by selected antiemetics commonly used in outpatient oncology practice. Methods: We analyzed the FAERS database to assess the cardiac, gastrointestinal (GI), and hematologic AEs for metoclopramide, olanzapine, ondansetron, and promethazine from 2013 through 2022. The disproportionality signal was analyzed by calculating Reporting Odds Ratio (ROR) with a 95% confidence interval (CI)—considered significant when the lower limit of 95% CI was > 1. Results: A total of 20,302 AEs were identified, out of which 8,135 (40.1%) were cardiac—arrhythmia and QTc prolongation; 8,656 (42.5%) were GI—nausea/vomiting, constipation/diarrhea, abdominal pain/discomfort, and dyspepsia; and 3,511 (17.3%) were hematologic—leukopenia, thrombocytopenia, anemia, and pancytopenia. Compared to other antiemetics, promethazine and olanzapine had higher cardiac and hematologic AEs, respectively, whereas metoclopramide, followed by ondansetron had higher GI AEs (Table). Conclusions: Antiemetics are readily available and effective, yet the preference for a particular drug or drug combination varies. Our study highlights selected antiemetics AEs in order to help individualize treatment for this often challenging and frequently encountered entity. [Table: see text]
Real-world evidence to inform clinical insights on tissue-agnostic approvals of therapies.
Authors: Sledge George W. , Yoshino Takayuki , Xiu Joanne , Helmstetter Anthony , Klimov Sergey , Gilg Brady , Oberley Matthew James , Radovich Milan , Abraham Jim , Spetzler David 
Published: June 2023

6589 Background: Many tissue-agnostic (TA) approvals were based on clinical trials with limited patient numbers without covering all tissue types (TT), raising the question of whether these indications were truly tissue agnostic. Real world evidence (RWE) offers an opportunity to investigate TTs not included in clinical trials/studies to answer this question. Herein we investigate the seven TA approvals to date in a large real world database and report clinical outcomes. Methods: A total of 186,581 tumors from over 35 TTs tested with comprehensive molecular profiling including NextGen sequencing of DNA and RNA were investigated for TA alterations (TMB-High (≥10 mutations/MB), MSI-H/MMRd, BRAF V600E mutations and NTRK1/2/3/RET fusions) at Caris Life Sciences (Phoenix, AZ). Time-on-treatment (TOT) from RWE was obtained from insurance claims and calculated from treatment start to finish. Kaplan-Meier estimates were calculated for molecularly defined patient cohorts. Significance was determined as p values of <0.05. Results: Among all tumors, 21.2% carried at least one TA alteration, 17.2%, 3.4% and 0.6% had 1, 2 or 3 alterations, respectively. TMB-H in 18.7%, MSI-H/dMMR was seen in 3.9%, BRAF V600E in 2.8% of tumors, NTRK1/2/3 and RET fusion seen in 0.16% and 0.23%. TA alterations were most prevalent in BCC (86%) & SCC (82%) of skin, MEL (71%), THCA (51%) and NSCLC (44%) and least in liposarcoma (0), meningioma (0.7%) and GIST (1.4%). Among tumors treated based on TA indications, substantial variability of TOT among TTs was observed (see table). Looking at TTs included (INC) and not included (nINC) in KEYNOTE-158 and other studies for TMB-H and pembro, median TOT for nINC was similar to INC (N=242 vs 2322, 6.1 m vs 6.3 m, p = 0.55). Nevertheless, statistically significant differences in median TOTs were seen across nINC when comparing TMB-H vs. TMB-L (6.1m vs. 2.9m, HR: 0.58 [95% CI: 0.50-0.67], p<0.001) and in a subset of 838 MSS tumors (4.9m vs. 2.8m, p<0.001). Conclusions: RWE data adds substantially to our understanding of the demographics of TA indications and suggests that some TA treatment benefits may be tissue-specific. Recent TA indications will require further accumulation of cases to draw meaningful conclusions regarding whether TA indications are, in fact, tissue agnostic. [Table: see text]