Revisiting Exclusion of Prior Cancer in Clinical Trials of Male Breast Cancer

Background: Eligibility criteria for cancer clinical trials present challenges to enrollment. Many trials exclude patients with a prior cancer. This common practice may be especially detrimental to trials of rare cancers, such as male breast cancer, that struggle to accrue adequate numbers of participants. Objectives: to estimate prevalence of prior cancer among men newly diagnosed with breast cancer and describe characteristics of men with prior cancer compared to those without. Methods: We identified men diagnosed with breast cancer between 2011-2015 using population-based data from National Cancer Institute\u27s Surveillance, Epidemiology, and End Results program of cancer registries. We used sequence number and diagnosis year to identify cancers diagnosed prior to breast cancer (inclusive of prior breast, different, and unknown types of cancer). We compared sociodemographic, tumor, and treatment characteristics of men with and without prior cancer using chi-square tests. Results: Among 2317 men, nearly one quarter (24.3%) had any prior cancer, and the majority (58.7%) of these were of a different cancer type. A higher proportion of men with a prior cancer of a different type were older, had smaller (≤ 2 cm) breast tumors, were diagnosed with stage 0-1 breast cancer, and did not receive surgery compared to men without any prior cancer; there were no statistically significant differences by race and ethnicity, county median income, hormone receptor status, or surgery type. Conclusion: Given prevalence of prior cancer in this rare and understudied population of men diagnosed with breast cancer, including men with prior cancer in clinical trials may improve accrual

Exposures at Day Labor Corners: Using Existing Georeferenced Data to Describe Features of Urban Environments

PURPOSE: Latino day laborers are male immigrants from mainly Mexico and Central America who congregate at corners, that is, informal hiring sites, to solicit short-term employment. Studies describing the occupational environment of Latino day laborers traditionally measure jobsite exposures, not corner exposures. We sought to elucidate exposures at corners by describing their demographic, socioeconomic, occupational, business, built, and physical environmental characteristics and by comparing corner characteristics with other locations in a large urban county in Texas. METHODS: We used multiple publicly available data sets from the U.S. Census, local tax authority, Google\u27s Nearby Places Application Programming Interface, and Environmental Protection Agency at fine spatial scale to measure 34 characteristics of corners with matched comparison locations. RESULTS: Corners were located close to highways, high-traffic intersections, hardware and moving stores, and gas stations. Corners were in neighborhoods with large foreign-born and Latino populations, high rates of limited English proficiency, and high construction-sector employment. CONCLUSIONS: Publicly available data sources describe demographic, socioeconomic, occupational, business, built, and physical environment characteristics of urban environments at fine spatial scale. Using these data, we identified unique corner-based exposures experienced by day laborers. Future research is needed to understand how corner environments may influence health for this uniquely vulnerable population

Missed opportunities: Racial and neighborhood socioeconomic disparities in emergency colorectal cancer diagnosis and surgery

BackgroundDisparities by race and neighborhood socioeconomic status exist for many colorectal cancer (CRC) outcomes, including screening use and mortality. We used population-based data to determine if disparities also exist for emergency CRC diagnosis and surgery.MethodsWe examined two emergency CRC outcomes using 1992-2005 population-based U.S. SEER-Medicare data. Among CRC patients aged ≥66 years, we examined racial (African American vs. white) and neighborhood poverty disparities in two emergency outcomes defined as: 1) newly diagnosed CRC or 2) CRC surgery associated with: obstruction, perforation, or emergency inpatient admission. Multilevel logistic regression (patients nested in census tracts) analyses adjusted for sociodemographic, tumor, and clinical covariates.ResultsOf 83,330 CRC patients, 29.1% were diagnosed emergently. Of 55,046 undergoing surgery, 26.0% had emergency surgery. For both outcomes, race and neighborhood poverty disparities were evident. A significant race by poverty interaction (p < .001) was noted: poverty rate was associated with both outcomes among African Americans, but not whites. Compared to whites in low poverty (<10%) neighborhoods, African Americans in high poverty (≥20%) neighborhoods had increased odds of emergency diagnosis (AOR: 1.50, 95% CI: 1.38-1.63) and surgery (AOR: 1.63, 95% CI: 1.47-1.81).ConclusionsEmergency CRC outcomes are associated with high poverty residence among African Americans in this population-based study, potentially contributing to observed disparities in CRC morbidity and mortality. Targeted efforts to increase CRC screening among African Americans living in high poverty neighborhoods could reduce preventable disparities

Potential Impact of Revised Nci Eligibility Criteria Guidance: Prior Malignancy Exclusion in Breast Cancer Clinical Trials

BACKGROUND: Many individuals with cancer have survived a prior cancer and for this reason may have been excluded from clinical trials. Recent NCI guidance recommends including these individuals, especially when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low. Using breast cancer as an example, we determined the potential effect this policy change may have on clinical trial accrual. PATIENTS AND METHODS: We reviewed protocols of NCI-sponsored breast cancer clinical trials activated in 1991 through 2016. We quantified prevalence of prior cancer-related exclusion criteria and assessed the association with trial characteristics using Fisher\u27s exact tests. Using SEER data, we estimated the prevalence and timing of prior primary (nonbreast) cancer diagnoses among patients with breast cancer. RESULTS: Among 87 clinical trials (total target enrollment, 137,253 patients), 77% excluded individuals with prior cancer, most commonly (79%) within the preceding 5 years. Among trials with radiographic response or toxicity endpoints, 69% excluded prior cancer. In SEER data, the prevalence of a prior (nonbreast) cancer diagnosis ranged from 5.7% to 7.7%, depending on breast cancer stage, of which 39% occurred within 5 years of the incident breast cancer. For trials excluding prior cancer, the estimated proportion of patients excluded for this reason ranged from 1.3% to 5.8%, with the estimated number of excluded patients ranging from 1 to 288. CONCLUSIONS: More than three-fourths of NCI-sponsored breast cancer clinical trials exclude patients with prior cancer, including almost 70% of trials with response or toxicity endpoints. Given that \u3e5% of patients with breast cancer have a history of prior cancer, in large phase III trials this practice may exclude hundreds of patients. Following recent NCI eligibility guidance, the inclusion of patients with prior cancer on breast cancer trials may have a meaningful impact on accrual

Racism and Cancer Screening among Low-income, african american Women: a Multilevel, Longitudinal analysis of 2-1-1 Texas Callers

Although racism is increasingly being studied as an important contributor to racial health disparities, its relation to cancer-related outcomes among African Americans remains unclear. The purpose of this study was to help clarify the relation between two indicators of racism-perceived racial discrimination and racial residential segregation-and cancer screening. We conducted a multilevel, longitudinal study among a medically underserved population of African Americans in Texas. We assessed discrimination using the Experiences of Discrimination Scale and segregation using the Location Quotient for Racial Residential Segregation. The outcome examined was any cancer screening completion (Pap test, mammography, and/or colorectal cancer screening) at follow-up (3-10 months post-baseline). We tested hypothesized relations using multilevel logistic regression. We also conducted interaction and stratified analyses to explore whether discrimination modified the relation between segregation and screening completion. We found a significant positive relation between discrimination and screening and a non-significant negative relation between segregation and screening. Preliminary evidence suggests that discrimination modifies the relation between segregation and screening. Racism has a nuanced association with cancer screening among African Americans. Perceived racial discrimination and racial residential segregation should be considered jointly, rather than independently, to better understand their influence on cancer screening behavior

Associations Between Perceived Racial Discrimination, Racial Residential Segregation, and Cancer Screening adherence among Low-income african americans: a Multilevel, Cross-Sectional analysis

OBJECTIVES: African Americans suffer disproportionately from cancer compared to their White counterparts. Racism may be an important determinant, but the literature on its association with cancer screening is limited. We examine associations between racism and cancer screening among a sample of African Americans. DESIGN: Guided by the Public Health Critical Race Praxis and the Behavioral Model of Health Services Use, we conducted a multilevel, cross-sectional study using cancer risk assessment data collected from 405 callers to the 2-1-1 Texas helpline. We merged these data with contextual data from the U.S. Census Bureau. We assessed perceived racial discrimination using the Experiences of Discrimination Scale and racial residential segregation using the Location Quotient for Racial Residential Segregation. We used multilevel regression models to test hypothesized associations between each indicator of racism and four cancer screening adherence outcomes (Pap test, mammography, colorectal cancer screening [CRCS], and any cancer screening). RESULTS: Participants were 18-83 years old (mean = 45 years). Most (81%) were non-adherent to at least one recommended screening. Approximately 42% reported experiencing discrimination and 73% lived in a segregated neighborhood. Discrimination was non-significantly related to lower odds of mammography (aOR = 0.68; 95%CI: 0.38-1.22), CRCS (aOR = 0.79; 95%CI: 0.41-1.52), and any cancer screening adherence (aOR = 0.88; 95%CI: 0.59-1.32). Segregation was related to greater odds of mammography (non-significant; aOR = 1.43; 95%CI: 0.76-2.68) and CRCS (significant; aOR = 2.80; 95%CI: 1.21-6.46) but not associated with any cancer screening. Neither indicator of racism was associated with Pap test screening adherence. CONCLUSIONS: Racism has a nuanced association with cancer screening among low-income, medically underserved African Americans. Specifically, discrimination appears to be associated with lower odds of screening, while segregation may be associated with higher odds of screening in certain situations. Future research is needed to better explicate relations between indicators of racism and cancer screening among African Americans

Adverse Birth Outcomes of adolescent and Young adult Women Diagnosed With Cancer During Pregnancy

BACKGROUND: We examined adverse birth outcomes among adolescent and young adult women diagnosed with cancer (AYA women, ages 15-39 years) during pregnancy. METHODS: We linked data from the Texas Cancer Registry, vital records, and Texas Birth Defects Registry to identify all singleton births to AYA women diagnosed during pregnancy from January 1999 to December 2016. We compared prevalence of adverse live birth outcomes between AYA women and women without cancer (matched 1:4 on age, race and ethnicity, and year). Among AYA women, we used log-binomial regression to identify factors associated with these outcomes. Statistical tests were 2-sided. RESULTS: AYA women had 1271 singleton live births and 20 stillbirths. AYA women (n = 1291) were 33.3% Hispanic and 9.8% non-Hispanic Black and most commonly had breast (22.5%), thyroid (19.8%), and gynecologic (13.3%) cancers. Among live births, AYA women had a higher prevalence of low birth weight offspring (30.1% vs 9.0%), very preterm (5.7% vs 1.2%), and preterm birth (25.1% vs 7.2%); cesarean delivery (44.3% vs 35.2%); and low Apgar score (2.7% vs 1.5%), compared with women without cancer (n = 5084) (all P \u3c .05). Prevalence of any birth defect by age 12 months did not statistically differ (5.2% vs 4.7%; P = .48), but live births to AYA women more often had heart and circulatory system defects (2.2% vs 1.3%; P = .01). In adjusted models, cancer type and chemotherapy were associated with adverse live birth outcomes. CONCLUSIONS: AYA women diagnosed during pregnancy have higher prevalence of adverse birth outcomes and face difficult decisions in balancing treatment risks and benefits

Physicians, Clinics, and Neighborhoods: Multiple Levels of Influence on Colorectal Cancer Screening

This article describes variability in colorectal cancer (CRC) test use and compares the performance of novel cross-classified and traditional hierarchical models

Ethnic Disparities in Early-Onset Gastric Cancer: a Population-Based Study in Texas and California

BACKGROUND: Incidence rates of gastric cancer are increasing in young adults (age \u3c50 \u3eyears), particularly among Hispanic persons. We estimated incidence rates of early-onset gastric cancer (EOGC) among Hispanic and non-Hispanic White persons by census tract poverty level and county-level metro/nonmetro residence. METHODS: We used population-based data from the California and Texas Cancer Registries from 1995 to 2016 to estimate age-adjusted incidence rates of EOGC among Hispanic and non-Hispanic White persons by year, sex, tumor stage, census tract poverty level, metro versus nonmetro county, and state. We used logistic regression models to identify factors associated with distant stage diagnosis. RESULTS: Of 3,047 persons diagnosed with EOGC, 73.2% were Hispanic White. Incidence rates were 1.29 [95% confidence interval (CI), 1.24-1.35] and 0.31 (95% CI, 0.29-0.33) per 100,000 Hispanic White and non-Hispanic White persons, respectively, with consistently higher incidence rates among Hispanic persons at all levels of poverty. There were no statistically significant associations between ethnicity and distant stage diagnosis in adjusted analysis. CONCLUSIONS: There are ethnic disparities in EOGC incidence rates that persist across poverty levels. IMPACT: EOGC incidence rates vary by ethnicity and poverty; these factors should be considered when assessing disease risk and targeting prevention efforts

Racial and ethnic disparities in cervical cancer screening from three U.S. healthcare settings

INTRODUCTION: This study sought to characterize racial and ethnic disparities in cervical cancer screening and follow-up of abnormal findings across 3 U.S. healthcare settings. METHODS: Data were from 2016 to 2019 and were analyzed in 2022, reflecting sites within the Multi-level Optimization of the Cervical Cancer Screening Process in Diverse Settings & Populations Research Center, part of the Population-based Research to Optimize the Screening Process consortium, including a safety-net system in the southwestern U.S., a northwestern mixed-model system, and a northeastern integrated healthcare system. Screening uptake was evaluated among average-risk patients (i.e., no previous abnormalities) by race and ethnicity as captured in the electronic health record, using chi-square tests. Among patients with abnormal findings requiring follow-up, the proportion receiving colposcopy or biopsy within 6 months was reported. Multivariable regression was conducted to assess how clinical, socioeconomic, and structural characteristics mediate observed differences. RESULTS: Among 188,415 eligible patients, 62.8% received cervical cancer screening during the 3-year study period. Screening use was lower among non-Hispanic Black patients (53.2%) and higher among Hispanic (65.4%,) and Asian/Pacific Islander (66.5%) than among non-Hispanic White patients (63.5%, all p\u3c0.001). Most differences were explained by the distribution of patients across sites and differences in insurance. Hispanic patients remained more likely to screen after controlling for a variety of clinical and sociodemographic factors (risk ratio=1.14, CI=1.12, 1.16). Among those receiving any screening test, Black and Hispanic patients were more likely to receive Pap-only testing (versus receiving co-testing). Follow-up from abnormal results was low for all groups (72.5%) but highest among Hispanic participants (78.8%, p\u3c0.001). CONCLUSIONS: In a large cohort receiving care across 3 diverse healthcare settings, cervical cancer screening and follow-up were below 80% coverage targets. Lower screening for Black patients was attenuated by controlling for insurance and site of care, underscoring the role of systemic inequity. In addition, it is crucial to improve follow-up after abnormalities are identified, which was low for all populations