Cancer patients without insurance or Medicaid don’t experience the same benefits of clinical trials

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Cancer patients with no health insurance or those enrolled in Medicaid see smaller survival benefits from experimental therapies in clinical trials, according to a study published April 30 in JAMA Network Open.

The SWOG Cancer Research Network study is the first to examine whether treatment effects from randomized cancer clinical trials with positive findings apply to important demographic and insurance subgroups. The finding that cancer clinical trial patients with no or low insurance do not get the same benefits of experimental therapies as patients with private insurance—regardless of sex, age or race or ethnicity—supports efforts in Congress to expand insurance coverage.

These efforts include the Clinical Treatment Act, a bipartisan bill introduced in February in the House of Representatives that guarantees coverage of the routine care costs of clinical trial participation for Medicaid enrollees with a life-threatening condition. Nearly 20% of Americans receive health insurance through Medicaid.

The American Society of Clinical Oncology, the American Cancer Society, and the American Medical Association support the bill.

“A patient’s insurance coverage seems to be related to the extent to which they benefit from new experimental treatments tested in trials,” study lead Joseph Unger, a SWOG health services researcher and biostatistician based at Fred Hutchinson Cancer Research Center, said in a statement. “Our findings highlight the importance of policies that would provide more Americans insurance coverage, and underline the importance of improving that coverage.”

Unger and his team examined data from 19 SWOG phase III randomized treatment trials that enrolled patients between 1984 and 2012 and followed those patients up to five years after their trial treatment. The 19 trials tested drugs for a number of cancers, including breast and lung.

The analysis included 10,804 patients. The team then assessed whether the overall survival rates, progression- or relapse-free survival rates, differed by age, sex, race and ethnicity, and insurance status.

Patients 65 or older, younger than 65, male, female, minority, non-minority, and with private insurance who received experimental trial drugs all, on average, lived longer compared to patients who received standard treatment. Uninsured patients or those enrolled in Medicaid did not have a strong survival benefit.

“People with fewer financial resources have access to fewer healthcare resources, which can have a persistent, negative influence on their health,” Unger said. “Patients in trials having no or limited insurance may not have the financial means to pay for the extra supportive treatments or post-trial cancer treatments that help people live longer. This could be especially meaningful for understanding treatment benefits if experimental therapy requires more supportive care or is more difficult to adhere to than standard treatment.”

The SWOG study was funded by the NIH through NCI grant awards CA189974, CA180888, CA180819. The Hope Foundation for Cancer Research also supported the study through a Dr. Charles A. Coltman Jr. Fellowship Award to Unger, as well as direct funding to the SWOG Statistics and Data Management Center based at Fred Hutch, funding which supports research infrastructure, trial design, and data analysis.

Along with Unger, the SWOG team includes Charles D. Blanke, of Oregon Health & Science University, the SWOG group chair; Michael LeBlan, of the SWOG Statistics and Data Management Center and Fred Hutch, the SWOG group statistician; William Barlow, of the SWOG Statistics and Data Management Center and Fred Hutch; Riha Vaidya, of the SWOG Statistics and Data Management Center and Fred Hutch; Scott D. Ramsey, of Fred Hutch; and Dawn L. Hershman, of NewYork-Presbyterian/Columbia University Irving Medical Center, and the SWOG vice chair for NCORP research.

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