bluuebunny/crossref_metadata_2025_split huggingface dataset:
Age-based disparities in clinical trials supporting FDA approval of therapies for solid tumors.
Authors: Gajra Ajeet , Zettler Marjorie E. 
Published: June 2021

e18534 Background: Cancer of any site is most frequently diagnosed among adults age 65 years and older, however older adults have historically been under-represented in clinical trials for oncology drugs (difference in median age [DMA] −6.49 years among clinical trials for breast, prostate, lung and colorectal cancer from 1994-2015 [Ludmir et al, JAMA Oncology 2019]). Representation in registrational trials, which are the basis for drug approval and inform the prescribing information, is of particular importance as age‐related differences may affect response and toxicity. We conducted an analysis of the trials supporting recent Food and Drug Administration approvals of new therapies for the treatment of solid tumors to assess the median age of participants and compare it to the median age of patients in the real world for each malignancy. Methods: Prescribing information for novel therapies that received primary approval for solid tumor indications between 2015 and 2019 was reviewed, and the median age in the evaluable population of the supporting clinical trials was abstracted. Median age estimates among adults for each indication in the general population were obtained from the Surveillance, Epidemiology and End Results database or the published literature. The DMA was calculated for each trial by subtracting the median age in the real-world population from the median age in the trial. Characteristics of trial protocols were obtained from approval packages accessed in the Drugs@FDA database. Data are presented using descriptive statistics. Results: A total of 35 solid tumor drugs were approved based on 38 trials, with 15859 patients in the evaluable populations. Less than half of the trials were phase 3 (16; 42%) or were randomized with a control group (18; 47%). On average, the median age of the trial participants was 2.6 years younger than the median age of the disease populations (95% CI: -1.4, -3.9 years; p < 0.01). For indications with > 1 trial, those with the greatest disparities were in melanoma (mean DMA -6.5), urothelial carcinoma (-5.8), and lung cancer (-4.1). The DMA among phase 3 trials was -1.8, vs. -3.2 among phase 1 and 2 trials. None of the protocols for the trials specified upper age limits, however 23 (61%) required an ECOG performance status (PS) ≤1, and all trials had eligibility restrictions related to organ function or comorbidities. Conclusions: In this contemporary analysis of registrational trials across all solid tumor indications, we found that the median age of clinical trial participants was nearly 3 years younger than their real-world counterparts. No trial protocols had upper age limits, however most restricted PS, organ impairment or the presence of comorbidities, which may have impacted older patients’ eligibility to participate. Although inclusion of older adults in clinical trials appears to have improved in recent years, changes to trial design may help to ensure adequate representation.
Association of rurality and race with surgical treatment and outcomes for nonmetastatic colon cancer.
Authors: Ramkumar Niveditta , Colla Carrie , Wong Sandra L. , Wang Qianfei , Brooks Gabriel A. 
Published: June 2021

e18536 Background: Rural cancer patients face limited access to care due to greater travel distance and lack of specialty cancer care. Little is known about the intersection of rurality with well-documented racial disparities in colon cancer treatment and outcomes. Methods: We used fee-for-service Medicare claims to study patients age 65+ diagnosed with incident colon cancer without evidence of metastases who underwent cancer-directed surgery between 04/01/2016 and 09/30/2018. The primary exposure was rurality of patient’s residence categorized as metropolitan (metro), micropolitan, and small town/rural. Outcomes were non-elective surgery (emergency department visit or transfer within 2 days of surgery), receipt of minimally invasive surgery (laparoscopic or robotic), 90-day surgical complications, and 90-day mortality. Logistic regression adjusted for patient demographics, cancer side (right vs left), comorbidities, and Area Deprivation Index. We assessed effect modification by race/ethnicity. Results: Of 57,710 patients with incident non-metastatic colon cancer, 37,691 (65%) underwent surgery. In this surgical cohort, small town/rural and micropolitan residents were more likely to be older, white, and Medicare-Medicaid dual-eligible than metro residents. After risk adjustment, patients in small town/rural areas had higher odds of non-elective surgery (OR=1.24, 95% CI:1.13-1.36) and lower odds of minimally invasive surgery (OR=0.75, 95% CI:0.71-0.80) than patients living in metro areas. Similar results were seen for micropolitan areas. The association between rurality and 90-day outcomes differed by race/ethnicity (p-interaction=0.001 for surgical complications and mortality, see Table). Hispanics and other races had higher odds of 90-day surgical complications in non-metro versus metro areas but there was no notable difference for white patients. Likewise, compared to metro areas, racial/ethnic minorities had higher odds of 90-day mortality in small town/rural areas but white patients had lower odds. Conclusions: Small town/rural-residing Medicare beneficiaries undergoing surgery for non-metastatic colon cancer were less likely to receive optimal surgical management and worse outcomes, especially among non-white patients. The compounded effect of sociodemographic factors should be further studied to develop targeted policies and improve care for rural cancer patients.[Table: see text]
Neighborhood area-level social determinants and receipt of mammography screening in an area with high deprivation: A retrospective cohort study.
Authors: Dhahri Amina , Azargoon Sam , Buchongo Portia , Chicas Tatiana , Singh Amrik , Meshkat Razavi Gity , Gopakumar Smitha , Chhabra Gurdeep Singh 
Published: June 2021

e18550 Background: Early detection through screening mammography has been shown to decrease breast cancer mortality. Screening mammography rates remains low among racial/ethnic minorities and patients with socioeconomic deprivation (SED). Most studies evaluating the role of area-level social determinants of health and breast cancer screening have included only a small number of variables; in this study, a comprehensive and granular measure of socioeconomic deprivation (SED) which included 17 variables was used to determine an association with screening mammogram completion. Methods: A retrospective cohort study was conducted at an academic hospital system between 2014-2020 to identify asymptomatic female patients who received screening mammogram referrals in their primary care clinic after they were deemed eligible per screening guidelines. Patients were assessed for mammogram completion at their annual visits. SED was evaluated using the area deprivation index (ADI), a measure of 17 variables including education, housing, and income at the census block group level. Other covariates analyzed were insurance status, age, and race. Chi-square test, Kruskal-Wallis test and a multivariate logistic regression model were used for statistical analysis. Results: 856 women were referred for screening mammography. 324 (38%) underwent mammogram. Patients with high, moderate, and low SED comprised 69 (8%), 287 (34%) and 500 (58%) of the cohort, respectively. In multivariable analysis, SED and race were not associated with higher screening rates. Uninsured and self-pay patients had the lowest odds of screening mammography completion (AOR 0.22; 95% 0.08, 0.60) and Medicare patients had decreased odds of mammogram completion relative to privately insured patients (AOR 0.64; 95% CI 0.43, 0.97). Older age was associated with a slightly higher odds of mammography completion (AOR 1.02; 95% CI 1.00, 1.04). Conclusions: The receipt of screening mammography was low among all patients relative to previously published rates. Uninsured/self-pay status was the strongest indicator for completion of mammography. Additional research is needed to understand the barriers that may influence mammography completion in this population with high socioeconomic deprivation. Multivariate Logistic Regression Estimates for Associations Between Mammogram Completion and SED category.[Table: see text]
Racial, ethnic, and socioeconomic disparities in diagnosis, treatment, and survival of patients with breast cancer.
Authors: Azin Arash , Tahmasebi Houman , Brar Amanpreet , Azin Sam , Ko Gary T. , Covelli Andrea , Cil Tulin D. 
Published: June 2021

e18551 Background: Racial disparities in breast cancer are well established. However, there is a paucity of literature assessing the interaction of patient, socioeconomic, and community factors on outcomes. The objective of this study was to determine the influence of race/ ethnicity, socioeconomic status (SES), and insurance status on disease presentation, access to care, and survival in breast cancer. Methods: A retrospective analysis was performed of Non-Hispanic Black (NHB), Non-Hispanic White (NHW), and Hispanic patients with non-metastatic breast cancer in the SEER cancer registry between 2007 and 2016. Multivariable binary logistic regression and Cox regression analyses were conducted. Results: A total of 382,975 patients were identified; 289,074 (75.5%) NHW, 45,821 (12.0%) NHB, and 48,080 (12.6%) Hispanic patients. On multivariate analysis (see table), NHB (OR 1.18, 95%CI: 1.15-1.20) and Hispanic (OR 1.20, 95%CI: 1.17-1.22) patients were more likely to present with higher stage disease than NHW patients. There was an increased likelihood of not undergoing primary resection in NHB (OR 1.56, 95%CI: 1.49-1.65) and Hispanic (OR 1.41, 95%CI: 1.34-1.48) patients compared to NHWs. Similarly, NHB and Hispanic patients had increased odds of not undergoing breast reconstruction following mastectomy (OR 1.07, 95%CI: 1.03-1.11 and OR 1.60, 95%CI 1.54-1.66, respectively). NHB patients had increased hazard for all-cause mortality (HR: 1.13, 95%CI 1.10-1.16) and breast cancer-specific mortality (HR: 1.20, 95%CI 1.16-1.24). All-cause mortality increased across SES categories (lower SES: HR 1.33, 95%CI 1.30-1.37, middle SES: HR 1.20, 95%CI 1.17-1.23) in NHBs. Conclusions: This population-based analysis confirms worse disease presentation, access to surgical therapy, and survival across racial, ethnic, and socioeconomic factors. These disparities were compounded across worsening SES, suggesting structural racism may partly account for our findings.[Table: see text]
The impact of COVID-19 on patients with cancer: A qualitative study.
Authors: Kumar Dhanya , Khateeb Sana , Patel Manali I. 
Published: June 2021

e18559 Background: The SARS‐CoV‐2/COVID‐19 pandemic greatly impacted the health of many patients with cancer. We conducted in-depth interviews with patients across the United States to better understand the effect of the COVID-19 pandemic on their cancer care, emotional and mental health, and to solicit suggestions for how health care providers could mitigate these concerns. Methods: We contacted respondents from the Impact of COVID-19 on Cancer parent study. The parent study used a snowball sampling approach to survey patients nationally regarding cancer delays between April 2020 and October 2020. We invited all respondents who volunteered for future studies to participate in a 40-minute interview regarding their experiences and suggestions for how health care providers could mitigate COVID19-related concerns. Interviews were conducted between August 2020 and October 2020, recorded, transcribed and analyzed using qualitative thematic content analysis. Results: A total of 34 participants were contacted and consented to participate in this study. Four overarching themes were identified: (1) significant concern regarding infection risk; (2) concerns regarding care changes, such as delays, worsening cancer outcomes; (3) concern regarding loss of employment, health insurance, and transportation on cancer treatment, affordability, and prognosis; and (4) worsening emotional and mental health due to social isolation. Suggestions for the clinical team included: 1) specific and direct guidance from health care providers on how to mitigate infection risk; 2) screening for and access to mental health services; 3) continuation of cancer treatment, surveillance, and clinical trials without delays and 4) allowing caregivers to attend appointments. Conclusions: In this national qualitative study of patients with cancer, participants identified that COVID-19 and modifications to their cancer care worsened their emotional and mental health with growing concerns about the impact of the virus and socioeconomic status on their cancer outcomes. Specific suggestions for health care providers, such as anticipatory guidance, access to mental health services, and expanded visitation should be considered to improve patient experiences with care during the pandemic.
The timeliness of lung cancer care: A systematic review of systematic/scoping reviews on risk factors and interventions.
Authors: Zhang Jianrong , Oberoi Jasmeen , Karnchanachari Napin , Druce Paige , IJzerman Maarten J. , Emery Jon D. 
Published: June 2021

e18575 Background: Lung cancer is the leading cause of cancer death worldwide, and over half of lung cancer cases are diagnosed with advanced stage, indicating an urgent need to improve the timeliness of lung cancer services. In this systematic review of systematic and scoping reviews, we summarize the current evidence of risk factors and interventions on diagnostic and treatment intervals. Methods: Eligible articles were published systematic or scoping reviews and meta-analyses that used systematic searching to investigate risk factors for longer time intervals or interventions aimed to reduce time intervals in original studies on lung cancer, based on at least one interval involving the date of diagnosis as the start or end point. Articles were searched via PubMed, Embase, Web of Science, and the Cochrane Library; the date range of the search was from database inception to 6 August 2020 (PROSPERO identifier: CRD42020203530). Results: A total of 16 systematic/scoping reviews published in 2002-2020 were included (10 on risk factors and 9 on interventions). According to these reviews, we found that risk factors had intersected impacts on the increase of diagnostic and treatment intervals. However, these factors could be summarized based on tumor, patient, healthcare provider and healthcare system levels as: (tumor level) adenocarcinoma, small size; (patient level) living in a rural area, lower education level, lower-income level, longer travel distance, non-specific symptom, non-white race (in the USA), fear and lack of knowledge about lung cancer; (healthcare provider level) low index of suspicion, multiple consultations for diagnosis, missed diagnosis; (healthcare system level) long waiting time for hospitalization, health system’s incapacity to treat all patients, high cost, inaccessibility or lack of diagnostic tools/investigations, poor organization and management of health services. To reduce time intervals, these reviews indicated that effective interventions include multidisciplinary teams or clinics, lung-specific clinics, nurse navigation or other care coordination program. In these reviews, we found that the types of time intervals used in original studies were poorly reported. Conclusions: Therisk factors identified from the current reviews indicate disparities in timely access to lung cancer services, as well as potential for improvements to reduce waiting time at the patient, healthcare provider and healthcare system levels. To reduce waiting time, effective interventions suggested from the current reviews should be considered for implementation.
Association of social support with overall survival and health care utilization in patients with aggressive hematologic malignancies.
Authors: Markovitz Netana H. , Gray Tamryn , Bhatt Sunil Mahesh , Nipp Ryan David , Ufere Nneka , Rice Julia , Reynolds Matthew J. , Lavoie Mitchell W. , Topping Carlisle E. W. , Clay Madison A. , Lindvall Charlotta , El-Jawahri Areej , Johnson Patrick Connor 
Published: June 2021

e18582 Background: Social support plays a crucial role for patients with aggressive hematologic malignancies as they navigate their illness course. We examined associations of social support with overall survival and health care utilization in this population. Methods: We conducted a cross sectional secondary analysis using data from a prospective longitudinal cohort study of 251 hospitalized patients with aggressive hematologic malignancies at Massachusetts General Hospital from 2014 through 2017. We utilized Natural Language Processing (NLP) to identify extent of patients’ social support (limited versus adequate as defined by NLP-aided chart review of the Electronic Health Record (EHR)). We used multivariable regression models to examine associations of social support with: 1) overall survival; 2) death or readmission within 90 days of discharge from index hospitalization; 3) time to readmission within 90 days; and 4) index hospitalization length of stay. Results: Patients had a median age of 64 (range: 19-93) years, and most were white (89.6%), male (68.9%), and married (65.3%). A plurality of patients had leukemia (42.2%) followed by lymphoma (37.9%) and myelodysplastic syndrome/myeloproliferative neoplasm (19.9%). Using NLP, we identified that 8.8% (22/251) of patients had limited social support. In multivariable analyses, limited social support was associated with worse overall survival (HR = 2.00, p = 0.042) and higher likelihood of death or readmission within 90 days of discharge (OR = 3.11, P = 0.043), but not with time to readmission within 90 days, or index hospital length of stay. Conclusions: In this cohort of hospitalized patients with aggressive hematologic malignancies, we found associations of limited social support with lower overall survival and higher likelihood of death or readmission within 90 days of hospital discharge. These findings underscore the utility of NLP for evaluating extent of social support and the need for larger studies evaluating social support in patients with aggressive hematologic malignancies.
Nutritional status and outcomes of veterans undergoing curative surgery for colorectal cancer.
Authors: Mitbander Urvashi , Frankel Timothy , Dobrosotskaya Irina Y. 
Published: June 2021

e18585 Background: Malnutrition is highly prevalent within the cancer population. Malnourishment has various negative surgical and oncologic impacts. The Veterans Health Administration (VHA) provides comprehensive care to patients in a single-payer system allowing for capture of peri-operative data and the opportunity for focused pre-operative (pre-op) interventions to improve outcomes. We sought to study the effect of pre-op weight and albumin on post-operative (post-op) complications in a contemporaneous group of veterans with colorectal cancer (CRC) at a tertiary care Veterans Affairs (VA) hospital. Methods: This is a retrospective review of 105 patients with colorectal malignancies treated with curative intent surgery at the VA Ann Arbor Healthcare System between January 2015 and January 2020. Patients with distant metastatic disease, neoadjuvant therapy, non-adenocarcinoma histology, or those receiving majority of care outside of the VHA were excluded. We examined BMI trends from one year prior to one year post surgery, rates of nutrition consults, and post-op complications defined as abnormal clinical developments such as, but not limited to, infection and delayed wound healing. Fisher’s exact test was used for analysis. Results: At time of CRC diagnosis, the mean age was 70.3 ± 9.1 and the median stage was T2N0. Surgical resections were 65% (n = 68) laparoscopic. Pre-op weight loss from 6 months prior to diagnosis to time of surgery was observed in the majority of patients (n = 47, 64%). Significant weight loss, defined as ≥3% weight reduction, was seen in 45% (n = 33) of patients. A quarter of patients were identified to have a low pre-op albumin of less than 3.5 (n = 25, 25%). Significant weight loss and low pre-op albumin were each independently associated with increased post-op complications (p < 0.01). Post-op weight loss was seen in 81% (n = 73) and 69% (n = 48) of patients at 30- and 60-days post-op, respectively, and was not associated with post-op complications. Inpatient post-op nutrition consultation was performed in 96% (n = 101) of patients; nutritional supplements were recommended in only 23% (n = 23) of cases. In patients with significant weight loss, pre-op nutrition evaluation was performed in 15% (n = 5) of cases and post-op outpatient nutrition follow up occurred in 18% (n = 6) of cases. Conclusions: 45% of patients had ≥3% weight loss 6 months prior to diagnosis of CRC and 25% of patients had low albumin levels. These led to greater post-operative complications. An intensive nutrition pre-habilitation program to address weight loss and low albumin prior to surgery for CRC is needed and may reduce associated complications.
Practice patterns of platinum chemotherapy use in a population-based cohort of women with nonmetastatic triple-negative breast cancer.
Authors: King Tess , Fedorenko Catherine R. , Li Li , Yung Rachel Lynn 
Published: June 2021

e18590 Background: The use of platinum agents (PT) in neoadjuvant chemotherapy (CTX) for triple negative breast cancer (TNBC) has been debated in research and practice guidelines. In high risk patients, the addition of PT to standard anthracycline and taxane regimens improves pathological complete response without definitive evidence of survival benefit (Korde JCO 2021). Due to PT’s toxicities and unclear benefit in early stage breast cancer, this study aimed to elucidate the real world practice patterns of PT use and overuse in breast cancer patients. Methods: The cohort was defined as women with stage I-III TNBC (ER, PR, and Her2 negative) who received curative intent surgery between 2011-2018. We utilized the Hutchinson Institute for Cancer Outcomes Research (HICOR) database, which links enrollment and claims records from commercial and public health insurance plans with clinical information from Washington state cancer registries (Manohar JACR 2020). We hypothesized there was overuse of PT CTX in this cohort. Overuse was defined as PT use in stage I, in the adjuvant period (NCCN 2020), and in nonstandard CTX regimens (PT use without taxane and anthracycline (NCCN 2020)). Results: Of the 910 women in the cohort, average age was 63, 90% were white, 682 (75%) received CTX, and 36% had commercial insurance, versus 53% with public insurance (Medicare 45%, Medicaid 8%). Of those receiving CTX, 39% received neoadjuvant and 67% adjuvant. Of those receiving CTX, 85 (13%) received PT, and 28 (4%) received PT without anthracycline. Of those receiving PT, 20% had stage I disease, and of those receiving adjuvant CTX, 43 (9%) received PT in the adjuvant period. Conclusions: We found there was overuse and nonstandard use of PT in this real world data. This overuse was demonstrated by the fact that 20% of women receiving PT had low risk stage I disease, and 9% of women receiving adjuvant CTX received PT in the adjuvant period. Additionally, there was nonstandard use, with 4% of women getting CTX receiving PT without anthracycline. Next steps in this research are to evaluate factors influencing overuse and nonstandard use, as well as complication rates with PT use and overuse.[Table: see text]