bluuebunny/crossref_metadata_2025_split huggingface dataset:
Why aren’t more patients with breast cancer enrolled in clinical trials?
Authors: Lalor Fallon , Caston Nicole E. , Ingram Stacey A. , Wan Clara , Sussell Jesse , Patel Shilpen A. 
Published: September 2022

84 Background: Only 2-8% of adult patients with cancer participate in clinical trials, likely due to strict exclusion criteria as well as financial and access issues. The primary objective of this study is to understand the population of patients with breast cancer who are and are not offered a clinical trial and the impact of exclusion criteria on enrollment. Methods: Inclusion and exclusion criteria from study protocols housed in OnCore and ClinicalTrials.gov were obtained for breast cancer-specific, therapeutic clinical trials open at the University of Alabama at Birmingham (UAB) from 2016 to 2020. Patients with breast cancer receiving oncology services at UAB from 2016 to 2020 were identified from electronic health records. Race and ethnicity and address were abstracted. Address was utilized to characterize patients as living in areas of higher vs. lower deprivation (Area Deprivation Index) and rural communities (Rural-Urban Commuting Area). Chart abstraction was conducted to assess if patients were offered a trial, eligible for a trial, reason for ineligibility, and enrollment in trial vs standard of care treatment. Results: 518 patients were included; 387 were offered a trial and 131 were not. The median age of patients offered a trial was 57 years old, whereas the median age of patients who were not offered a trial was 61. The majority of patients offered a trial were more often White (72% vs. 24% African American), resided in areas of lower disadvantage (70% vs 17% most disadvantaged), and urban residents (75% vs 13% rural). Of the 387 patients offered a trial, 319 (82%) enrolled, 34 (9%) declined enrollment and chose standard of care, and the remaining 34 (9%) were interested in enrollment but later found to be ineligible. Reasons for ineligibility of the 34 patients who were offered a trial included comorbidities (n = 9), tumor size (n = 7), metastases (n = 5), and previous cancer history (n = 4). Additionally, 9 patients were ineligible for miscellaneous reasons (abnormal labs, age, prescription, trial closed to accrual, tumor characteristics). Of the 131 patients that were not offered a clinical trial, 77 (59%) were ineligible for enrollment. Reasons for ineligibility included: stage 1 disease (n = 35), tumor size and characteristics (n = 24), and comorbidities and abnormal labs (n = 18). The remaining 54 patients would have been eligible, but their provider did not offer a clinical trial. Conclusions: Most patients who are offered a clinical trial are willing to participate; physicians not offering a trial to patients appears to be a driver for low enrollment. Strict exclusion criteria related to comorbidities limit trial participation. Further work is needed to understand the relative importance of these eligibility criteria in relation to validity. Efforts should be made to include patients in clinical trials that reflect the diverse patient population that will receive the drug in the future.
Mammographic follow-up before and during the COVID-19 pandemic.
Authors: Manik Ritika , Grady Connor B. , Ginzberg Sara , Edmonds Christine E. , Elmore Leisha C , Lewandowski Julia T , Hubbard Rebecca A. , Fayanju Oluwadamilola Motunrayo 
Published: September 2022

122 Background: Mammography adapted during the COVID-19 pandemic to accommodate social-distancing guidelines and minimize risk of exposure, but it is unclear how these accommodations potentially provoked existing inefficiencies or illuminated opportunities to redress them. The goal of this study was to compare rates of (1) diagnostic follow-up after a BIRADS 0 (i.e., incomplete) screening mammogram and (2) biopsy following a BIRADS 4 or 5 (i.e., biopsy recommended) diagnostic mammogram before and after onset of the pandemic. Methods: We included women ≥18y who underwent a BIRADS 0 screening mammogram and/or BIRADS 4-5 diagnostic mammogram at our institution from 3/15/19-3/15/21. Given seasonal variation in care receipt, pre-COVID (3/15/2019-3/15/20) and COVID (3/15/20-3/15/21) time periods were compared at a quarterly level. Case-mix adjusted associations between time-to-follow-up and COVID vs pre-COVID quarters (Q1-4) were estimated using multivariate Cox proportional hazards models. Results: We identified 17,918 women (Asian: 985, Black: 4054, Hispanic: 840, White: 11,302) who received a total of 14,388 BIRADS 0 screening and 6410 BIRADS 4 or 5 diagnostic mammograms. There were far fewer diagnostic mammograms in COVID Q1 vs pre-COVID Q1 (Table), and they were more likely to be followed up with biopsy (HR 1.21 [95% CI 1.03-1.44], p = 0.023). COVID Q3 (HR 0.92 [95% CI 0.86-0.98], p = 0.002) and Q4 (HR 0.88 [95% CI 0.83-0.95], p < 0.001) screens were less likely to be followed up with diagnostic mammograms but volumes were higher vs the respective pre-COVID quarters (Table). However, COVID Q3 patients with BIRADS 4 or 5 mammograms were 18% more likely to undergo biopsy than their pre-COVID Q3 counterparts (HR 1.18 [95% CI 1.07-1.31], p < 0.0001, Table) despite higher COVID volumes. Conclusions: Early in the pandemic, patients were more likely to receive mammographic follow-up, potentially due to lower patient volumes and enforced strategies for more efficient, less time-intensive care delivery. These gains were lost with regards to diagnostic follow-up for screening mammograms but maintained with regards to performing biopsies. As volumes return to or surpass pre-pandemic levels, health systems must work to identify and preserve operational efficiencies gained during the early pandemic.[Table: see text]
Time to diagnosis and treatment initiation during the COVID-19 pandemic among rural patients with cancer.
Authors: Okado Izumi , Liu-Duerr Michelle , Elhajj Carry , Holcombe Randall F. 
Published: September 2022

132 Background: Time to diagnosis (TTD) and treatment initiation (TTI) are important measures of access and quality of cancer care, but little is known about TTD and TTI for rural cancer patients. Rural residents experience disproportionate burdens of cancer including higher incidence and mortality, and many rural patients face challenges in health care access. Further understanding of TTD and TTI in rural areas is essential to improving the quality of cancer care delivery and cancer outcomes in rural areas. In this study, we describe TTD and TTI among rural cancer patients in Hawaii during the COVID-19 pandemic. Methods: Information about TTD and TTI was collected from 80 rural cancer patients enrolled on a care coordination study between Sept. 2020 and Dec. 2021. Participants were receiving active treatment for any cancer and residing in rural areas in Hawaii. We used descriptive statistics to describe TTD and TTI for the overall sample and specifically for those with breast and GI cancers, the two most common cancers in this study sample. Results: Participants were 56% female, with the mean age of 63 (SD = 12.1). 43% were White/Caucasian, 30% Native Hawaiian, and 25% two or more race. Reporting of symptoms to a healthcare provider led to diagnosis for 61.6% of the overall sample, whereas 38.4% received diagnosis following screening. For breast cancer, 36.8% indicated symptoms led to diagnosis, and 63.2% by screening. Among those with GI cancer, 76.5% reported symptoms led to diagnosis, and 23.5% by screening. Overall, 62.5% of participants reported TTD of within one month (< = 30 days) of screening or reporting symptoms to a healthcare provider (30-day TTD 62.5% for breast and 60.0% for GI). Median TTI for the overall sample was 60.6 days (IQR 30-62). For those with breast and GI cancers, median TTI was 61.0 (IQR 31-70) and 31.0 (IQR 0-61) days, respectively. Conclusions: Our results demonstrate that although TTD in this rural sample was comparable to other studies, TTI overall, and particularly for those with breast cancer, was nearly twice the TTI reported in other population-based studies. Delays in cancer treatment initiation have been associated with worse survival for breast and other cancers, especially among underserved populations. Our findings indicate that during the COVID-19 pandemic, rural residents in Hawaii experienced substantial delays in cancer treatment initiation. This study highlights the importance of addressing timely healthcare system access to minimize delays in treatment initiation and to improve health outcomes for rural cancer patients.
Tele-chemotherapy and related outcomes to improve rural cancer care.
Authors: Thota Ramya , Mullalley Megan , Gill David Michael , Rowett Kimberlee , Reese Zachary , Haslem Derrick S. 
Published: September 2022

142 Background: We previously reported the safety and feasibility of tele-chemotherapy with remote administration of chemotherapy (chemo) in rural hospitals using experienced chemo nurses with direct supervision from medical oncologist at a tertiary site. Herein we report the detailed overview of types of cancers treated, chemo-regimens administered and associated outcomes within an integrated health system. Methods: We retrospectively analyzed 200 patients who received chemotherapy remotely in 4 rural health hospitals in the state of Utah between 2017- 2022. Data collected included age of administration of chemo, gender, cancer type, insurance, chemotherapy regimen, number of cycles, emergency visits, hospitalizations, and infusion reactions. Results: 200 pts received chemotherapy at 4 rural hospitals including Sevier Valley Hospital, Cassia Regional Hospital, Sanpete Valley Hospital, and Heber Valley Hospital in Utah and Idaho. Median age of administration was 53 yrs (11- 96 yrs). Majority were male (n = 118; 59%). Insurances that covered these services included Medicare, Medicaid, Regence Blue Cross, United Healthcare, Tricare and Select Health. The most common cancer types treated included – Colorectal (n = 31), Breast (n = 24), Lung (n = 15), Lymphoma (n = 21), Multiple Myeloma (n = 11), Melanoma (n = 9), Bladder (n = 7), and other benign conditions (n = 25). 47 unique chemo regimens including 1085 cycles were administered. Chemo regimens and cycles detailed below. Among 69 pts with outcomes data available, ED visits noted in 33% (n = 23), hospitalization rate was 17% (n = 12) and infusion reaction rate was 7% (n = 5). Total mileage saved by pts receiving chemotherapy closer to home was 47,955 miles. Conclusions: Tele-chemotherapy is safe, feasible and provides improved access to cancer care in rural areas. Future design of pragmatic clinical trials where remote administration of standard of care treatments closer to home will allow the rural pts access cutting edge clinical trials closer to home.[Table: see text]
Disparities in overall survival (OS) outcomes based on treating facility volume in pancreatic neuroendocrine tumors.
Authors: Tella Sri Harsha , Kommalapati Anuhya , Desai Aakash , McGarrah Patrick Walsh , Hobday Timothy J. , Halfdanarson Thorvardur Ragnar 
Published: September 2022

150 Background: Pancreatic neuroendocrine tumors (pNETs) comprise less than 5% of all pancreatic tumors and 7% of all neuroendocrine tumors (NETs). There has been considerable progress in understanding the biology of pNETs and numerous therapeutic options emerged, especially with the collaboration of various specialties in the multidisciplinary setting. In this this study, we sought to analyze the association of facility volume, treatment modalities offered, and different risk adjusted outcomes in pNETs. Methods: We extracted data from National Cancer Data Base (NCDB) that covers 70% of all newly diagnosed cancer cases in the U.S and Puerto Rico. Patients with pNETs diagnosed between 2004 & 2017 were included and classified into tertiles based on hospital volume. Volume–outcome relationship was determined by using Cox regression adjusting for patient demographics, comorbidities, tumor characteristics, insurance type and therapy received. Kaplan Meier estimates of OS were compared with log-rank test. The primary predictor of interest was the facility volume defined as number of pNETs treated/year. A total of 7202 patients with pathologically confirmed pNETS were treated at 840 facilities. The median annual facility volume was 5patients/year. Facilities were classified into (T:mean cases/year) T1: < 3; T2:4-8; T3:≥9 cases/year. Results: A total of 7202 pNET patients were treated at 840 facilities. The median annual facility volume was 5 patients/year. Facilities were classified into (T: mean cases/year) T1:<3; T2:4-8; T3:≥9 cases/year. The unadjusted median OS by facility volume was: T1: 71 months (m), T2: 136 m, and T3: not-reached (p < 0.001). On multivariable analysis, compared with patients treated at T3 facilities, patients treated at lower-tertile facilities had higher risk of death [T2 hazard ratio (HR), 1.17 (95% CI, 1.03-1.33); T1 HR, 1.45 (CI, 1.30-1.67), p < 0.0001] and such a difference in OS was more pronounced in stage IV disease (Table). Patients at T3 facilities (vs T1) were more likely to receive surgical resection of the primary tumor (75 vs 49%), lymph node dissection performed at the time of surgery (70 vs 42%), and a better R0 resection (72 vs 46%) (p < 0.01). Conclusions: Patients who were treated for pNETs at high-volume centers (> 9cases/year) had significantly higher OS and were more likely to receive surgical resection along with lymph node dissection and R0 resection. There was a 45% increased risk of death in patients treated at low volume centers (< 3/year) as compared to high-volume centers (> 9/year). While OS difference was noticed in all stages, the difference was more pronounced in stage IV disease demonstrating the importance of multi-disciplinary approach in pNETs management and incorporating such quality measures in low-volume facilities.[Table: see text]
Social vulnerability and cancer-related mortality among U.S. counties, 2013 to 2019.
Authors: Hussaini S. M. Qasim , Chen Krista Y. , Blackford Amanda L. , Quick Harrison , Sedhom Ramy , Gupta Arjun , Laheru Dan 
Published: September 2022

162 Background: Substantial differences exist among US counties with regards to cancer-related mortality. Social determinants of health (SDOH) can predispose underserved communities to poor cancer outcomes. We investigated the impact of county-level social vulnerability on age-adjusted cancer mortality rates (AAMRs). Methods: We linked cancer-related deaths across US counties from 2013 to 2019 in the CDC WONDER database to county-level Social Vulnerability Index (SVI) data from the CDC/ATSDR. Scores for overall SVI and its 4 subcomponents (socioeconomic status; household composition and disability; minority status and language; housing type and transportation) were calculated using 15 SDOH attributes. These were presented as percentile rankings by county and classified into quartiles based on their distribution among US counties (1st [least vulnerable] = 0 - 0.25; 4th [most vulnerable = 0.75 - 1.00]). AAMRs per 100,000 individuals across US counties were compared between 1st and 4th SVI quartiles using robust linear regression models with a log scale. Results: There were 4,107,273 deaths with overall AAMR 173 per 100,000 individuals. Highest AAMRs were noted among older adults > 65 years, men, non-Hispanic Black, and rural counties. AAMRs increased proportionally when moving from least to most vulnerable counties. Counties in 4th SVI quartile had 20% higher AAMRs compared to 1st SVI quartile (rate ratio; RR 1.08, 95% CI [1.08, 1.09], p < 0.001). This was pronounced for ages 45-65 (42% increase; RR 1.21, 95% CI [1.12 – 1.24]), Hispanic race (26% increase; RR 1.11, 95% CI [1.06, 1.16]), and rural counties (21% increase; RR 1.17, 95% CI [1.15, 1.19]). Increase in AAMR between 1st and 4th SVI quartile from vulnerable socioeconomic status was most pronounced in rural counties (RR 1.17; 95% CI [1.15, 1.2]), women (RR 1.17; 95% CI [1.15, 1.2]) and ages 45-65 (RR 1.15; 95% CI [1.09, 1.14]). Vulnerable household composition/disability was most pronounced for rural residents (RR 1.12; 95% CI [1.09, 1.14]), and housing/transportation barriers for Hispanic individuals (RR 1.15; 95% CI [1.09, 1.21]). Conclusions: This study highlights the most socially vulnerable US counties have higher cancer mortality rates than the least vulnerable US counties. Furthermore, non-Hispanic blacks, older adults, and rural counties face highest risks of health inequities. Our findings inform ongoing congressional deliberations on transportation, telehealth, and rural infrastructure to achieve geographic parity.[Table: see text]
Racial/ethnic disparities in HPV-associated anogenital cancers among males in the United States (2005-2016): A population-based retrospective cohort study.
Authors: Villalona Seiichi , Sukhdeo Simone , Reinoso Daisy , Stroup Antoinette , Ferrante Jeanne 
Published: September 2022

163 Background: Among the HPV-associated cancers, research has primarily focused on understanding prevention and outcomes among females with cervical cancer. Limited data is available on health outcomes of male HPV-associated anogenital cancers, particularly among racial/ethnic minority groups. Methods: This population-based retrospective cohort study included 39,601 males diagnosed with HPV-associated invasive penile and anorectal cancers between 2005-2016 in the North American Association of Central Cancer Registries. Outcomes included: age-adjusted incidence, late-stage diagnosis, survival, and cancer-specific mortality. We evaluated association of race/ethnicity with outcomes using multivariable logistic regression, adjusted survival curves, and Cox proportional hazard modeling, adjusting for age, insurance, residential characteristics (metropolitan/non-metropolitan, area poverty, and geographic region), stage, and treatment. Results: Hispanic and Non-Hispanic (NH) Black males had the highest age-adjusted incidence of penile and anorectal cancer, respectively. Higher odds of late-stage penile cancer were observed among NH Black (adjusted odds ratios [aOR] 1.22, 95% CI 1.07-1.39) and Hispanic males (aOR 1.17, 95% CI 1.04-1.31). Higher odds of late-stage anorectal cancer were observed among NH Black (aOR 1.25, 95% CI 1.14-1.36) and NH Other males (aOR 1.29, 95% CI 1.01-1.66). Compared to all other groups, NH Black males had the lowest cumulative and mean survival of both cancers and higher cancer-specific mortality (penile adjusted hazards ratios [aHR] 1.23, 95% CI 1.01-1.49; anorectal aHR 1.25, 95% CI 1.10-1.42). Adjusting for treatment attenuated associations but did not eliminate the observed cancer-specific mortality. Conclusions: Hispanic males had the highest incidence of penile cancer and were diagnosed at later stages than non-Hispanic (NH) White counterparts. NH Black males had the highest incidence of anorectal cancers, and regardless of anatomic site, they had the highest rates of late-stage diagnosis and mortality even when controlling for all other covariates, including treatment. The findings highlight the necessity of interventions to increase HPV vaccination rates, early detection, and treatment of anogenital cancers in males, particularly among men of color.
Differences in patient and caregiving partner responses to individual items on the FACIT-COST questionnaire.
Authors: Rivers Zachary , Shankaran Veena , Porter Laura S , Langer Shelby 
Published: September 2022

183 Background: The financial impacts of cancer diagnosis and treatment extend beyond patients to affect intimate partners. Understanding how both members of the dyad experience financial toxicity (FT) can help inform dyadic interventions to address FT. We compare patient and partner responses to items on the Functional Assessment of Chronic Illness Therapy (FACIT)-COST, a patient-reported outcome measure of cancer-related financial distress. Methods: Adult patients with stage II-IV breast, lung, or colorectal cancer and their spouse/ cohabiting partner independently completed the 11-item FACIT-COST. Correlations between responses by both members were calculated using Pearson’s correlation coefficient. Results: There were 336 dyads (median patient age 53, 45% stage IV, 84% white) included in the analysis. Both members of the dyad had similar FT experiences in 74% of cases (26% and 48% reported FT and no FT respectively) while 26% diverged in their experience of FT. Responses to items 3, 6, 7, 10, and 11 (Table) were highly correlated (r > 0.6) while responses to questions 4 (I feel I have no choice about the amount of money we spend on care) and 5 (I am frustrated that I cannot work or contribute as much as I usually do) were weakly correlated (0.3 > r > 0), with patients generally reporting worse scores than partners on these items. Conclusions: Within-couple correlation between FACIT-COST items varies, with multiple responses weakly correlated. Future research should assess the impact of this variation on psychosocial functioning and explore approaches to facilitate dyadic communication around this important issue.[Table: see text]
Oncologists’ attitudes and practices regarding fertility preservation at a tertiary academic center.
Authors: Ragavan Meera Vimala , Kennedy Vanessa Elaine , Banerjee Rahul , Lin Amy M. , Velazquez Manana Ana I. 
Published: September 2022

190 Background: Infertility is a significant long-term consequence of cancer treatment and can negatively impact health related quality of life. As the incidence of cancer rises in younger populations and an increasing number of patients are prescribed systemic therapy in the neoadjuvant and adjuvant settings, the proportion of patients at risk for infertility will rise in tandem. Referrals for fertility preservation (FP), however, are low nationally and at our institution. Our study aimed to characterize oncologist attitudes and practices around FP and identify barriers to FP in patients with cancer. Methods: We developed a 21-item anonymous survey informed by literature review and input from FP stakeholders. The survey was distributed electronically to all faculty and fellows (n = 103) within our division of hematology/oncology during a division-wide conference on FP and subsequently emailed to all faculty and fellows, with three weekly follow up reminder emails. Results: 41 respondents completed the survey (response rate 40%), including faculty (46%) and fellows (39%). Respondents were predominantly male (49%), aged 25-40 (51%), white (44%), and non-Hispanic (73%). Most respondents agreed that FP should be offered to all patients with cancer receiving cytotoxic therapy (95%), however fewer respondents agreed that FP should be offered if it would cause a treatment delay by 2 weeks or more (63%). Respondents felt more comfortable counseling male patients (65%) than female patients (54%) and a larger proportion (41%) knew how to make referrals for sperm preservation (compared to 22% for oocyte preservation). The top barriers to counseling were patient past childbearing age (41%), provider did not remember to discuss (37%), and need for urgent treatment initiation (32%). The top barriers for an interested patient to undergo FP were perceived cost by patient (61%), need for urgent treatment initiation (59%), and patient was too overwhelmed to proceed with FP (42%). Conclusions: Oncologists agreed that FP is an important part of cancer care. However, many stated that cancer treatment initiation was often too time sensitive to counsel patients regarding fertility risks and make FP referrals. The FP referral process was not clear to many respondents. Clinic-level interventions are warranted to ensure timely patient access to FP. Based on the results of this study, we will launch a fellow-led Plan-Do-Study-Act Quality Improvement intervention to increase FP referrals in our clinics.