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.

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.

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 ( = .02) and S0530 ( = .002). In multivariable analyses, neither the proportion of patients with ECOG PS ≥ 2 ( = .12) nor the rate of grade 5 SAEs ( = .62) differed between groups. There was no difference in survival between eligible and ineligible patients ( = .25), and CR rates were similar, with the exception of S0325 ( < .001) and S0703 ( = .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.

To minimize adverse events (AEs) unrelated to drugs and maximize the likelihood of drug approvals, eligibility criteria for randomized controlled trials (RCTs) may be overly restrictive. The purpose of this study was to determine if RCTs in hematologic malignancies exclude patients irrespective of known toxicities or observed AEs. MEDLINE was searched from 1/2010 to 1/2015 for RCTs published in high-impact journals. Of 97 trials, 33% were conducted in leukemia, 28% in lymphoma, 34% in multiple myeloma and 5% in myelodysplastic syndromes or myelofibrosis. Expected toxicities at thresholds of ⩾10%, ⩾5% and <5% were not correlated with cardiac, hepatic or renal eligibility criteria (logistic regression). To explore this lack of correlation we tested the concordance of expected toxicities and eligibility criteria using a modified version of McNemar's test: at each threshold, hepatic, renal and cardiac expected toxicities were significantly discordant with eligibility criteria. Hepatic and renal eligibility criteria were also not correlated with observed AEs, P=0.69 and P=0.77, respectively, but a significant correlation was detected between cardiac eligibility criteria and observed AEs, P=0.02. Thus, the analyzed RCTs excluding patients with organ dysfunction do not reflect expected toxicities, based on prescription drug labels/prior experience, or reported AEs on the trials.