An informatics infrastructure to catalyze cancer control research and practice.

PURPOSE: A disconnect often exists between those with the expertise to manage and analyze complex, multi-source data sets, and the clinical, social services, advocacy, and public health professionals who can pose the most relevant questions and best apply the answers. We describe development and implementation of a cancer informatics infrastructure aimed at broadening the usability of community cancer data to inform cancer control research and practice; and we share lessons learned. METHODS: We built a multi-level database known as The Ohio Cancer Assessment and Surveillance Engine (OH-CASE) to link data from Ohio's cancer registry with community data from the U.S. Census and other sources. Space-and place-based characteristics were assigned to individuals according to residential address. Stakeholder input informed development of an interface for generating queries based on geographic, demographic, and disease inputs and for outputting results aggregated at the state, county, municipality, or zip code levels. RESULTS: OH-CASE contains data on 791,786 cancer cases diagnosed from 1/1/2006 to 12/31/2018 across 88 Ohio counties containing 1215 municipalities and 1197 zip codes. Stakeholder feedback from cancer center community outreach teams, advocacy organizations, public health, and researchers suggests a broad range of uses of such multi-level data resources accessible via a user interface. CONCLUSION: OH-CASE represents a prototype of a transportable model for curating and synthesizing data to understand cancer burden across communities. Beyond supporting collaborative research, this infrastructure can serve the clinical, social services, public health, and advocacy communities by enabling targeting of outreach, funding, and interventions to narrow cancer disparities.

The effect of Medicaid expansion among adults from low-income communities on stage at diagnosis in those with screening-amenable cancers.

BACKGROUND: Several states have opted to expand Medicaid under the Patient Protection and Affordable Care Act (ACA), which offers insurance coverage to low-income individuals up to 138% of the federal poverty level. This expansion of Medicaid to a medically vulnerable population potentially can reduce cancer outcome disparities, especially among patients with screening-amenable cancers. The objective of the current study was to estimate the effect of Medicaid expansion on the percentage of adults from low-income communities with screening-amenable cancers who present with metastatic disease. METHODS: Using state cancer registry data linked with block group-level income data, a total of 12,760 individuals aged 30 to 64 years who were diagnosed with incident invasive breast (female), cervical, colorectal, or lung cancer from 2011 through 2016 and who were uninsured or had Medicaid insurance at the time of diagnosis were identified. This sample was probability weighted based on income to reflect potential Medicaid eligibility under the ACA's Medicaid expansion. A multivariable logistic model then was fitted to examine the independent association between the exposure (pre-expansion [years 2011-2013] vs postexpansion [years 2014-2016]) and the outcome (metastatic vs nonmetastatic disease at the time of diagnosis). RESULTS: After adjusting for potential confounders, individuals who were diagnosed postexpansion were found to have 15% lower odds of having metastatic disease compared with those who were diagnosed pre-expansion (adjusted odds ratio, 0.85; 95% confidence interval, 0.77-0.93). As a control, a separate analysis that focused on individuals with private insurance who resided in high-income communities found nonsignificant postexpansion (vs pre-expansion) changes in the outcome (adjusted odds ratio, 1.02; 95% confidence interval, 0.96-1.09). CONCLUSIONS: Medicaid expansion is associated with a narrowing of a critical cancer outcome disparity in adults from low-income communities.

Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies.

Patients may be deemed ineligible for a clinical trial for reasons that do not directly impact efficacy or safety. We identified reasons for ineligibility and compared outcomes of ineligible with eligible patients treated on Southwest Oncology Group (SWOG) Leukemia Committee protocols. Patients enrolled in SWOG phase 2, 2/3, or 3 protocols open since 2005 were analyzed for eligibility status, reasons for ineligibility, baseline characteristics, Eastern Cooperative Oncology Group (ECOG) performance status (PS), serious adverse events (SAEs), complete remission (CR) status, and overall survival. A total of 2361 patients were enrolled in the 13 included studies. Of these, 247 (10%) were deemed ineligible; 78 were excluded from analyses, and 169 were included. Of the 169 included in analyses, 60% (101/169) were excluded due to missing baseline documentation. Baseline characteristics comparing ineligible to eligible patients were similar, with the exception of ECOG PS for S0325 (P = .02) and S0530 (P = .002). In multivariable analyses, neither the proportion of patients with ECOG PS ≥ 2 (P = .12) nor the rate of grade 5 SAEs (P = .62) differed between groups. There was no difference in survival between eligible and ineligible patients (P = .25), and CR rates were similar, with the exception of S0325 (P < .001) and S0703 (P = .004). The findings of this study suggest that nonessential eligibility criteria can be less restrictive, thus expanding patient enrollment and avoiding protocol deviations. The clinical trials included in this study were registered at www.clincialtrials.gov as #NCT00085709, #NCT00066794, #NCT00070499, #NCT00109837, #NCT00093418, #NCT00492856, #NCT00337168, #NCT00352365, #NCT00658814, #NCT00792948, #NCT00945815, #NCT00840177, and #NCT01522976.

Male Breast Cancer: A Comparative Analysis from the National Cancer Database.

PURPOSE: Breast cancer (BC) in males accounts for <0.5% of all male cancer diagnoses and ~1% of all BCs in the United States. We sought to describe clinicopathologic characteristics among male and female BC patients and differences in overall survival (OS) through the National Cancer Database over 13 years (2004-2016). MATERIALS AND METHODS: Secondary to the 1:99 ratio of male to female BC cases, we randomly selected female cases for equal comparison to males cases by diagnosis year. Chi-square and t-tests compared demographic and tumor characteristics. OS was examined using Kaplan-Meier survival analysis. RESULTS: Among the ~2.7 million BC patients, 9 per 1,000 BCs were in males, the rate remained similar over time. The mean (SD) age was 64.9±13.0 years for males and 60.7±13.6 years for females. Most of the male BC cases were white (non-Hispanic) (n=19,015 [80.2%]), clinical stage I (n=7,353 [32.1%]) or stage II disease (n=7,923 [34.6%]), and tumors were moderate or poorly differentiated (84.5%). Males exhibited more comorbidities, presented with a larger proportion of disease, and decreased OS (p<0.005) than females. Male OS was >10% lower at 5-years and nearly 20% lower at 10-years for males. More males had primary BC tumors under the nipple; the 10-year OS rate for this site was 48.8%. CONCLUSIONS: This study reports clinicopathologic characteristics of a large cohort of male BC. Males present at older age, with a greater comorbidity index, at later stages of disease. Increased education regarding the continued risks of male breast cancer may be warranted.

Elucidating Determinants of Survival Disparities Among a Real-world Cohort of Metastatic Breast Cancer Patients: A National Cancer Database Analysis.

BACKGROUND: Disparities in breast cancer survival by race/ethnicity and socioeconomic status have been reported. However, it is unclear if these findings are reproducible among subpopulations. This study aimed to assess if socially oriented factors are predictive of overall survival (OS) among patients with hormone receptor-positive (HR+), human epidermal growth factor 2-positive (HER2+) metastatic breast cancer (MBC). PATIENTS AND METHODS: We analyzed patients with MBC included in the National Cancer Database diagnosed with HR+ and HER2+ disease treated between 2010 and 2015. Multivariate analyses describe the association between non-clinical prognostic factors and OS. A matched analysis, which balanced prognostic factors between whites and African Americans (AA), was also conducted. RESULTS: Of the 6200 patients analyzed, the majority were 50 years or older, white, and treated with hormonal therapy. Disparities in OS were observed; multivariate analysis revealed diminished survival was associated with low income (< $38K vs. ≥ $63K, hazard ratio [HR], 1.30; P < .001), having government insurance (government vs. private, HR, 1.55; P < .001), living closer to one's treatment facility (< 4 miles vs. ≥ 18 miles, HR, 1.16; P = .04), and being AA (AA vs. white, HR, 1.20; P = .006). The mortality disparity attributed to race was insignificant in the matched analysis (AA vs. white, HR, 1.13; 95% confidence interval, 0.98-1.30; P = .09). CONCLUSIONS: This study confirms that the known sociodemographic disparities in OS among patients with MBC are similar within the HR+/HER2+ subpopulation. The discordance of outcomes between matched and unmatched analysis demonstrate that there is a highly vulnerable subgroup of AAs. Further investigation is required to determine if the identified associations are independently causal of poor prognosis.

Representation of therapy-related myelodysplastic syndrome in clinical trials over the past 20 years.

Therapy-related myelodysplastic syndrome (t-MDS), defined as MDS occurring after previous exposure to chemotherapy or radiotherapy, constitutes 10% to 20% of all MDS diagnoses. t-MDS patients tend to have higher-risk disease and worse outcomes than de novo MDS patients and are often excluded from therapeutic clinical trials. To explore this further, we extracted clinical trials across all status types registered on ClinicalTrials.gov from 1999 to 2018 studying untreated MDS patients. Using these specific search criteria, we analyzed 317 therapeutic MDS trials based on study status, therapeutic indication, eligibility criteria, and sponsor type to examine if these factors influenced t-MDS patient inclusion. Only 18 studies (5.7%) accrued 231 t-MDS patients in total, representing 3.2% of the total accrued MDS trial patient population. Fewer t-MDS patients were accrued in therapeutic trials sponsored by pharmaceutical sponsors vs nonpharmaceutical sponsors (2.8% vs 4.0%; P = .0073). This pattern of exclusion continues in actively enrolling trials; only 5 (10%) of 49 studies specifically mention the inclusion of t-MDS patients in their eligibility criteria. Our results indicate that therapeutic MDS trials seem to exclude t-MDS patients, rendering study results less applicable to this subset of MDS patients, who often have poor outcomes. Our study emphasizes the importance of the recent focus by National Cancer Institute cooperative groups and societies to broaden eligibility criteria for all patients.

Real-world Treatment Patterns and Outcomes in HR+/HER2+ Metastatic Breast Cancer Patients: A National Cancer Database Analysis.

Treatment patterns and outcomes are unclear for metastatic breast cancer (MBC) patients diagnosed with hormone receptor-positive (HR+), human epidermal growth factor 2-positive (HER2+) disease. This study aimed to: (1) examine the utilization of first-line therapy among HR+/HER2+/MBC patients and (2) compare overall survival (OS) between the identified regimens. We analyzed National Cancer Database patients (HR+/HER2+/MBC) who were treated between 2010 and 2015. Multivariable logistic and Cox regression were used to: (1) identify independent predictors of treatment receipt and (2) determine significant prognostic factors for OS. Kaplan-Meier method and log-rank test were used to estimate and evaluate OS, respectively. Propensity scores were added to all multivariate OS models, thereby accounting for bias in treatment receipt. Of 6,234 patients analyzed, 3770 (60.5%) received hormonal therapy and 2464 (39.5%) received chemotherapy. Receipt of hormonal therapy was associated with older age, grade 1/grade 2 disease, no visceral involvement, higher comorbidity scores, and being white. Multivariate analysis suggest patients receiving hormonal therapy + anti-HER2 experienced improved OS, when compared to chemotherapy + anti-HER2 (HR: 0.74, p = 0.004). Overall, the cohort receiving hormonal therapy + anti-HER2 reported the highest 5-year OS (hormonal + anti-HER2: 47.5% vs. chemotherapy + anti-HER2: 39.8% vs. hormonal: 38.5% vs. chemotherapy: 36.3%, p < 0.001). Our findings suggest de-escalated therapy may be the preferred and potentially more effective care path for HR+/HER2+/MBC patients, signaling a need for randomized studies.