bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of demographic and clinician factors on patients' likelihood of pursuing hereditary cancer genetic testing.
Authors: Arida-Moody Liliana , Hanson Erika N. , Delacroix Emerson , Austin Sarah , Rizzo Elizabeth A. , Koeppe Erika , Griggs Jennifer J. , Resnicow Ken , Stoffel Elena Martinez 
Published: June 2024

e22538 Background: Hereditary cancer genetic testing (GT) is an essential tool for cancer screening and prevention. As indications for GT expand, we may consider whether patients are sufficiently informed and motivated to undergo testing. We surveyed people meeting criteria for GT to assess their likelihood to pursue GT. Methods: Individuals who met modified NCCN guidelines for GT based on self-reported personal/family cancer history were invited to participate in a clinical trial of interventions promoting uptake of GT. Participants completed a baseline survey assessing experiences and attitudes relating to GT. Respondents were asked to rate their perceived importance of GT and their readiness to receive GT (scale of 0-10). These outputs were averaged (Cronbach’s alpha = 0.841) into an index representing their likelihood of pursuing GT. Linear regression was performed to investigate the relationship between several independent variables and the likelihood of pursuing GT. Gender, age, and race were considered, as well as self-reported circumstantial factors including 1) whether the individual had previously heard of GT, 2) whether a biologic relative had previously received GT, 3) qualifying eligibility variable(s) (family vs personal history of cancer), and 4) whether the individual had received a clinical recommendation to undergo GT. Results: 312 participants completed the baseline survey. The mean age of respondents was 61.9 ± 14.47 years, 52% identified as male, and 91% were white. 53% of respondents qualified for the trial based on family history alone and 15% had a clinician recommendation for GT. Younger age was associated with higher likelihood of pursuing GT (p = 0.004) as was receiving a prior recommendation for GT from a clinician (p = 0.01). When clinician recommendation was added to the model, the R-squared value increased from 0.44 to 0.64, indicating that recommendation accounts for a large portion of variance. Gender, race, personal/family cancer history, having previously heard of GT, and a biologic relative having received GT were not statistically significant. Conclusions: Concordant with previous literature, clinician recommendation to undergo GT is a significant contributor to the likelihood of pursuing GT. Older individuals may have lower readiness for GT compared with their younger counterparts, which could have implications for clinicians’ approaches to genetic counseling. Given that indications for GT have expanded, clinicians should remain up to date with current clinical guidelines.
Public awareness of the association between the risk of breast cancer (BC) development and alcohol consumption (AC) among women aged 18–75 years.
Authors: Kaur Navneet , Brody Heather Mae 
Published: June 2024

e22547 Background: Worldwide, 4·4% of all new cases of female BC are attributable to alcohol use. Alcohol is recognized as a group 1 carcinogen, as classified by the International Agency for Research on Cancer. However, public awareness of the association remains low. We aim to look at the awareness of the association between AC and the risk of BC development among female employees of a community hospital in the United States. Methods: We sent an 8-item survey to 100 randomly selected adult females working in a community hospital via an online link. The survey was voluntary, with no incentives. We captured the following measures: age, alcohol use, awareness of AC as a BC risk factor, education level, screening for BC, and personal or family history(FH) of BC. Analyses examined correlates of associations between awareness and conceptual predictors. Results: Sixty females (60% response rate) responded to the survey. The age groups were: 28%(17): 18-39 years, 25%(15): 40-49 years, and 47%(28): 50-75 years. 22%(13) had a graduate(Gr), 56%(34) had an undergraduate(UG), and 22% (13) had a high school level of education. 33% (20/60) consumed alcohol. 61% (37/60) did not consider AC as a risk factor(RF) for BC development. 54% with Gr, 62% with UG, and 71% with a high school level of education did not consider AC to be a RF for BC. 41% among 18-39, 67% among 40-49, and 72% among 50-75 year-olds did not consider AC an RF for BC. 92% (55/60) never received education about the association of BC with alcohol intake. 23% with Gr, 5% with UG, and 0% with high school received education about the association of Alcohol and BC. 86% of 40-49 years and 75% of 50-75 years had undergone screening mammograms in the last three years. Mammogram rates were 75% in women with positive FH, compared to 45% without positive FH. Conclusions: The results revealed a low level of awareness of the risk of alcohol use with BC, with just 40% of females considering it as a risk factor. Younger age and higher academic levels were the variables that had the strongest association with better awareness. A further lower level of education was reported, with more than 90% never having received education about the association. We must orchestrate awareness of this association with attention to individuals with lower educational levels.
Clinical, demographic, and contextual determinants of older breast cancer survivors' reports of discussions about exercise with healthcare providers.
Authors: Wojcik Katie M. , Wilson Oliver W.A. , Kamil Dalya , Jayasekera Jinani 
Published: June 2024

e22549 Background: Exercise offers various benefits to older breast cancer survivors, but studies report that healthcare providers do not frequently engage in discussions about exercise in clinical practice. The purpose of this study was to evaluate the clinical, demographic, and contextual determinants of receiving exercise advice from healthcare providers among older breast cancer survivors in the U.S. Methods: Data were obtained from the Surveillance, Epidemiology, and End Results (SEER) cancer registries linked to the Medicare Health Outcomes Survey (MHOS). Participants included women diagnosed with histologically confirmed invasive breast cancer from 2008-2015 who were 65+ years of age and had completed a MHOS survey at least two years after diagnosis. Descriptive statistics were calculated. We conducted a multivariable logistic regression analysis to identify clinical, demographic, and contextual variables associated with the likelihood of receiving exercise advice from a healthcare provider. Results: The sample of breast cancer survivors (n = 1,836) included 960 who received exercise advice and 876 who did not. The median age of the women in the sample was 76.2 years (range: 67.0-100.6). Survivors who were American Indian/Alaska Native/Asian or Pacific Islander (Odds Ratio (OR): 1.54; 95% Confidence Interval (CI): 1.09-2.18) or who had overweight (OR: 1.50; 95% CI: 1.17-1.91) or obesity (OR: 1.71; 95% CI: 1.31-2.23) were significantly more likely to receive exercise advice. In contrast, survivors who were never married (OR: 0.60; 95% CI: 0.37-0.96), had a high school degree (OR: 0.73; 95% CI: 0.58-0.92) or less (OR: 0.55; 95% CI: 0.42-0.73), were underweight (OR: 0.59; 95% CI: 0.36-0.95), or who were older (OR: 0.98; 95% CI: 0.96-0.99) had lower odds of receiving advice about exercise. The associations varied by type of comorbidity. Conclusions: Individual clinical and contextual characteristics of breast cancer survivors were associated with the likelihood of receiving exercise advice in a clinical setting. The consideration of the patients’ full range of circumstances when discussing and advising about exercise could potentially improve the overall quality of survivorship care. A personalized clinical decision tool could support individualized discussions about exercise in clinical settings.
Cost effectiveness of colorectal cancer screening in the Dominican Republic.
Authors: Pumpalova Yoanna S. , Wagner Sophie , Agyekum Alice , Aziz Zainab , Reyes Andria , Mejia De la Cruz Dolores Magdalena , Cedeño María Fernanda , Rivas Julio , Ebrahim Omar , Pineda Karla Marie Disla , Sanchez De Rodriguez Ann Stephany , Hur Chin 
Published: June 2024

e23033 Background: Colorectal cancer (CRC) incidence in the Dominican Republic (DR) is increasing, and CRC now ranks as the third-most prevalent cancer in the DR. There are no national CRC screening guidelines in the DR, and CRC screening is not routinely performed. We evaluated the impact of nationwide CRC screening by comparing the cost-effectiveness of four CRC screening strategies to the current practice of no screening. Methods: We developed a Markov model comparing four CRC screening strategies to the current practice of no screening, or natural history (NH): colonoscopy every ten years (Colo); sigmoidoscopy every five years (Sig); fecal immunochemical test biennially (FIT); and fecal occult blood test biennially (FOBT). Model inputs for screening arms were derived from international randomized controlled trials whenever possible. Data from The Rosa Emilia Sánchez Pérez de Tavares National Cancer Institute in the DR was used to estimate baseline CRC incidence, stage distribution and mortality. Screening was implemented from age 45 to 75. We assumed a 60.6% adherence rate for each screening arm. The model was cross validated by comparing the estimated lifetime impact of each screening arm on CRC incidence and mortality to estimates derived from the MIcrosimulation SCreening Analysis (MISCAN) Colorectal Cancer Model in the US. The primary outcome was the incremental cost-effectiveness ratio (ICER) of each screening strategy. Secondary outcomes included life expectancy, total cost, CRC incidence and CRC-related mortality. The willingness to pay threshold (WTP) was set to the 2022 DR gross domestic product per person ($10,111.20/life year gained). Results: In the NH strategy, 2.3% of the population developed CRC, and 1.2% died from CRC, with a lifetime cost of 203.47 per person. Compared to NH, FIT prevented 27% of CRCs and 37% of CRC deaths, with a lifetime cost of 244.76 per person. Colo was more effective than FIT, preventing 33% and 43% of CRC cases and deaths, respectively, compared to NH. However, the ICER for Colo exceeded the WTP threshold. One-way sensitivity analyses showed that the model is most sensitive to test performance characteristics and test costs. Conclusions: Among the evaluated CRC screening strategies, FIT is the cost-effective option, averting a significant number of CRC cases and deaths, at an incremental cost that is well within the WTP threshold for the DR. Inclusion of local data on the effectiveness and acceptability of the tested CRC screening modalities would improve this model, and strengthen the credibility of our findings. [Table: see text]
Discrepancies in therapeutic indications for the same oncology drugs among FDA, EMA, and Brazilian agency.
Authors: Marchi Blatt Camila , Furlanetto Miranda Mario Henrique , Barreto Rafael Balsini , Uliana Bárbara Andressa , Bodnar Denize 
Published: June 2024

e23035 Background: Divergent marketing approvals for oncology drugs among prominent agencies can prompt questions, especially when they are grounded in the same evidence. The aim of this study was to evaluate and compare the assessment and approval processes for novel products and indications by the FDA, EMA, and the Brazilian Health Regulatory Agency (ANVISA). Methods: Therapeutic indications for FDA-approved anticancer drugs from January 2019 to December 2023 were identified. Data, including approval dates, details on authorization procedures and evidence presented, were extracted from the databases of the FDA, EMA, and ANVISA. Only approvals for non-hematologic solid tumors were considered. All data were publicly available, and ethical approval was not required. No patient involvement occurred in this study. Results: Between 2019 and 2023, the FDA granted approval for 154 therapeutic indications for marketing authorization, resulting from 148 pivotal trials. The predominant cancer types during this period were non-small cell lung cancer (31 approvals [20.1%]). Most trials were in phase III (66.8%) and randomized (68.1%). Additionally, 41 (26.6%) received accelerated approvals, with 6 subsequently obtaining regular approvals. Among the therapies, 66 trials (42.8%) involved active comparators, while 53 (34.4%) and 35 (22.7%) were single-arm and placebo-controlled trials, respectively. Approximately half (74 [48%]) of the therapies were approved for metastatic first-line treatment, 54 (35%) for second-line treatment, and the rest for neoadjuvant and/or adjuvant treatment. Regarding endpoint characteristics supporting approval, the most prevalent was a combination of objective response rate (ORR) + duration of response (DoR) (38 [24.6%]), followed by progression-free survival (PFS) + overall survival (OS) (31 [20.1%]). When comparing the 154 FDA-approved indications, 50 (32.4%) were not approved by EMA, and 60 (38.9%) were not approved by ANVISA. Furthermore, in 33 cases (21.4%), there were disparities in clinical indications between the FDA and EMA, primarily related to the target population specification, with 10 cases (6.4%) attributed to programmed death ligand-1 (PD-L1) expression. Notably, in these instances, the FDA approved the drug regardless of PD-L1 expression, while the EMA required a percentage of cells with PD-L1 expression. In all these cases, ANVISA aligned with the FDA's assessment. Conclusions: Significant clinical disparities were identified in the outcomes of the approval process for oncology products among the FDA, EMA, and ANVISA. Additional efforts are needed to standardize decision-making across regulatory systems.
Latin America and cancer clinical trials: Underrepresented region with significant growth potential.
Authors: Nunes Filho Paulo Ricardo Santos , Brandalise Patrícia , Kannan Geoffrey Sumithran , Gandia Daniel , Berraondo Maria I. Ignacia , Vidal Boixader Laura , Berardocco Renata , Bartlett Giulietta , Morrison Kenneth Stephen , Chico Isagani , Saini Kamal S. 
Published: June 2024

e23038 Background: Latin America (LATAM) represents 8.4% of the world's population and has a growing cancer incidence compared with other regions. However, most clinical trials are conducted in high-income countries. The clinical research regulatory regimen in LATAM has been evolving consistently in the last decade and now is stable and mature, and data quality is comparable to other geographies. Enhanced LATAM involvement in global clinical trials would help these studies to meet recruitment goals, increase diversity, and reduce costs and perhaps timelines associated with clinical research. This abstract shows the current landscape of clinical research in LATAM trough data and experience of a global clinic research organization (CRO) (Fortrea). Methods: We obtained the 2020 cancer incidence in Brazil, Mexico, Argentina, Chile, Peru, Colombia, LATAM, and worldwide, from the World Health Organization’s GLOBOCAN database, as well as the information about ongoing, terminated, or completed clinical trials in these regions using Citeline’s database, from 2018 to 2023. We gathered LATAM countries' regulatory approval timelines from Fortrea’s database. Results: Overall, 7.7% of all cancer cases in 2020 were diagnosed in LATAM; however, only 3.64% of oncology trials were conducted there. The major disparities are in prostate cancer (15.2% vs 3.9% of cases and trials, respectively), followed by thyroid (10.8% vs 3.7%), cervix uteri (9.8% vs 4.6%), leukemia (8.1% vs 3.6%), and colorectal (7% vs 2.51%). Brazil had 3.1% of all cases but 1.9% of trials, while Mexico had 1% vs 1.3%, Argentina had 0.7% and 1.3%, Chile had 0.3% vs 0.7%, Peru had 0.4% vs 0.6%, and Colombia had 0.6% and 0.45% respectively. Regarding trial phases, 0.7% of Phase I trials were run in LATAM, 2.2% of Phase II, 15.6% of Phase III, and 2.8% of Phase IV. In the Table below, we present the proportion of clinical trials in LATAM in the past 5 years, based on the actual enrollment first date. Regulatory approval timelines in LATAM vary among countries, being 4.5 months in Argentina, 4 to 7 months in Brazil, 4.6 months in Chile, 7 months in Colombia, 2.8 months in Mexico, and 9 months in Peru. Conclusions: As a region, LATAM has been underrepresented in the clinical research scenario in the past five years, including in much-needed areas like prostate, colorectal, and cervical cancer. It is better represented in phase III studies but has almost negligible participation in other trial phases. There are differences among individual countries, with Brazil being underrepresented as opposed to Argentina and Mexico. Start-up timelines are variable among countries but overall comparable to other regions. We notice a significant potential to increase the number of clinical trials in LATAM. [Table: see text]
Influence of sociodemographic factors on time to diagnosis and treatment among members of a large national payor diagnosed with lung cancer.
Authors: Reddy Shirisha , Byrd Brooke , Craig Kelly , Zaleski Amanda , Rutter Cliff , McKeever Shannon , Bhandari Meghana , Dalton Karla , Altieri-Alger Leah , Verbrugge Dorothea J. , Avalos-Reyes Elisea , Johnson Kjel Andrew , Brito Rogelio 
Published: June 2024

e23048 Background: Diagnostic and treatment delays may be associated with later stage lung cancer diagnosis. This study explores the time from lung cancer screening to biopsy and biopsy to treatment in members of a national health plan diagnosed with lung cancer. Methods: De-identified administrative records of Medicare, Medicaid and Commercial fully-insured (C-FI) members with a claim for lung cancer between January 2020 and December 2022 were retrospectively analyzed. Poisson regression modeling determined duration (days) from screening to biopsy and biopsy to treatment initiation by insurance type group controlling for covariates. Between-group differences in duration was estimated by exponentiating the model estimate and converting to a percentage change, which was then applied to the mean days to event. Time-to-event modelling was conducted with Cox Proportional and Aelen’s Additive Hazard models. P< 0.05 was considered significant. Results: 8,221 members (C-FI: 402; Medicare: 7,103; Medicaid: 716) with a diagnosis of lung cancer were evaluated. Mean duration between screening and biopsy was 34.3 days (95% confidence interval [CI]: 32.8-35.8). Compared to C-FI members, Medicaid and Medicare members experienced shorter duration between screening to biopsy by -14.0 days (95% CI: 13.1-14.9) and -18.9 days (95% CI: 18.2-19.5), respectively (both P< 0.0001). Gender, language, age, and race were associated with time to biopsy (all P< 0.001). Mean duration between biopsy and treatment was 37.9 days (95% CI: 36.8-39.0). Compared to C-FI members, Medicare and Medicaid members experienced a longer duration between biopsy to treatment by +14.6 days (95% CI: 12.1-17.3) and +22.5 days (95% CI: 19.4-25.8), respectively (both P< 0.0001). Compared to C-FI members, Medicaid members had a higher risk of not receiving treatment (Hazard ratio [HR] = 0.831; 95% CI: 0.735-0.939; P= 0.003). Among the total sample, males were more likely to receive treatment at any time compared to females (HR = 1.067; 95% CI: 1.021-1.114; P= 0.0035). Conclusions: This real-world evaluation suggests that insurance type is associated with the timeline of screening to biopsy and biopsy to treatment initiation. Medicaid and Medicare members had a shorter time from screening to biopsy compared to C-FI; however, a longer duration from biopsy to treatment initiation was experienced. Future studies will explore if these differences translate to variations in health outcomes and identify potential interventions that aim to improve time from biopsy to treatment initiation.
The predictive value of the MASCC score in patients with febrile neutropenia.
Authors: Anderson Zackary , Plowman Keegan , Ahsan Mohammed , Rasnake Mark , Kubiak Michal J. , Grossman Joel Scott 
Published: June 2024

e23059 Background: Febrile neutropenia (FN) is a life-threatening complication in patients receiving cytotoxic chemotherapy. Guidelines classify FN as a one-time oral temperature of greater than 38.3°C or sustained temperature greater than 38°C for ≥ 1 hour with an absolute neutrophil count (ANC) of less than 500 cells/μL or an ANC expected to decrease to less than 500 cells/μL within a 48-hour period. This condition has a high rate of hospitalization and mortality. Currently, the Multinational Association of Supportive Care in Cancer (MASCC) risk score is used to classify patients as high or low risk. The current study outlines the predictive role of MASCC scoring in risk stratifying patients with FN at our institution. Methods: This is a single-center, retrospective observational study. IRB approval was obtained for this study. Electronic medical record data was reviewed to record mortality, length of stay (LOS), and antimicrobial use as primary outcomes with age at time of admission, sex, race, type of malignancy, any confirmed infection diagnosis, MASCC risk score, and subspecialist consultation as predictors of outcomes. Results: 220 records of possible FN episodes were screened, 160 were excluded leaving a total of 60 patients for review. The median age was 72.5 with 28 males and 32 females. Overall mortality rate was 10%.33 patients (55%) did not have an identifiable source of infection. Among the 27 patients with confirmed infection, 7 were associated with COVID-19, 12 had gram negative rod (GNR) sepsis and 8 were other bacterial infections. Patients with GNR sepsis had the highest mortality risk in which 4 of the 12 (33%) died. LOS was also significantly longer in patients with GNR sepsis. Lower MASCC scores were associated with identification of GNR sepsis. Of the patients with MASCC score of < 24, significantly more patients 7/20 (35%) developed GNR sepsis compared to 5/40 (12.5%) of those with MASCC score of 24 or greater (p = .004). Patients with GNR sepsis received a mean 5.7 days of broad spectrum antibiotics compared to 3 days in those without, (p < 0.001). Those with no identified infection had significantly lower LOS (4.5 days) compared to the groups with GNR sepsis (11.1 days) or other bacterial infections (10.1 days). Conclusions: Febrile neutropenia is a complication of cytotoxic chemotherapy that warrants special attention due to high mortality rates. We found lower MASCC scores were associated with GNR sepsis and that in the setting of FN these patients had higher mortality rates and longer LOS. This highlights the importance of risk stratification with MASCC index scoring as early recognition and treatment of high risk patients could lead to improved patient outcomes.