Association of Patient Demographic Characteristics and Insurance Status With Survival in Cancer Randomized Clinical Trials With Positive Findings

Abstract

IMPORTANCE Few new treatments tested in phase 3 cancer randomized clinical trials show an overall survival benefit. Although understanding whether the benefits are consistent among all patient groups is critical for informing guideline care, individual trials are designed to assess the benefits of experimental treatments among all patients and are too small to reliably determine whether treatment benefits apply to demographic or insurance subgroups. OBJECTIVE To systematically examine whether positive treatment effects in cancer randomized clinical trials apply to specific demographic or insurance subgroups. DESIGN, SETTING, AND PARTICIPANTS Cohort study of pooled patient-level data from 10 804 patients in SWOG Cancer Research Network clinical treatment trials reported from 1985 onward with superior overall survival for those receiving experimental treatment. Patients were enrolled from 1984 to 2012. Maximum follow-up was 5 years. MAIN OUTCOMES AND MEASURES Interaction tests were used to assess whether hazard ratios (HRs) for death comparing standard group vs experimental group treatments were associated with age (Ն65 vs <65 years), race/ethnicity (minority vs nonminority populations), sex, or insurance status among patients younger than 65 years (Medicaid or no insurance vs private insurance) in multivariable Cox regression frailty models. Progression-or relapse-free survival was also examined. Data analyses were conducted from August 2019 to February 2020. RESULTS In total, 19 trials including 10 804 patients were identified that reported superior overall survival for patients randomized to experimental treatment. Patients were predominantly younger than 65 years (67.3%) and female (66.3%); 11.4% were black patients, and 5.7% were Hispanic patients. There was evidence of added survival benefits associated with receipt of experimental therapy for all groups except for patients with Medicaid or no insurance (HR, 1.23; 95% CI, 0.97-1.56;

The Impact of COVID-19 on Cancer Screening: Challenges and Opportunities

“…Results show that patients who have poor social determinants of health, such as lack of insurance, low income, and living in a deprived neighborhood, are often less likely to adopt cancer screening [ 28 - 30 ]. Evidence from randomized clinical trials further indicates that, compared to patients with private insurance, patients with Medicaid or with no insurance received reduced benefits from the same intervention program [ 31 ]. These combined insights may help explain why screenings for cancers have dropped significantly since January 2020 (eg, breast cancer screening has dropped by 94%) [ 21 ].…”

Impact of insurance and neighborhood socioeconomic status on clinical outcomes in therapeutic clinical trials for breast cancer

“…Scant literature exists on the relationship of insurance and outcomes in clinical trial settings. In a recent study by Unger et al, in clinical trials that lengthened survival, Medicaid and uninsured patients derived no survival benefit compared to the privately insured 9 . Additionally, the association between insurance, progression, or relapse free survival and overall survival persisted for up to 7.5 years 9 .…”

“…In a recent study by Unger et al, in clinical trials that lengthened survival, Medicaid and uninsured patients derived no survival benefit compared to the privately insured 9 . Additionally, the association between insurance, progression, or relapse free survival and overall survival persisted for up to 7.5 years 9 . Even in settings with homogeneity in disease stage, tumor biology, and prescribed treatments, our results show disparities in outcomes preferentially affecting those with less generous insurance types at trial registration.…”

“…Research on SDH and clinical trials have focused on patient enrollment, demonstrating that participants are more likely to be younger, white, have high SES and are privately insured 7,8 . There are few studies evaluating the effect of SDH on continued trial participation, treatment completion, and clinical outcomes such as survival 9 . This knowledge gap is significant as clinical trials provide a population of patients with similar tumor biology access to healthcare and equivalent treatment modalities.…”

“…7,8 There are few studies evaluating the effect of SDH on continued trial participation, treatment completion, and clinical outcomes such as survival. 9 This knowledge gap is significant as clinical trials provide a population of patients with similar tumor biology access to healthcare and equivalent treatment modalities. Hypothetically, clinical trials should provide an environment that can be leveraged to mitigate the effects of SDH, reduce disparities in clinical outcomes and create health and healthcare equity.…”