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Enrollment of AYA Patients Into NCI-Sponsored Clinical Trials: 25-Year Analysis


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Adolescent and young adult (AYA) patients with cancer have not seen the same improvements in survival over the years as their pediatric and older adult counterparts. Some evidence has suggested that this may in part be a result of low AYA participation in clinical trials, limiting advances in treatment for this group of patients.

However, an analysis of 25 years of publicly funded adult cancer clinical trials has found that 8.4% of patients enrolled were in the AYA age range (15–39 years)—more than double the 3.8% rate of AYA patients among all adults with cancer nationally. These findings were published by Joseph Unger, PhD, MS, and colleagues in the journal Cancer.

Joseph Unger, PhD, MS

Joseph Unger, PhD, MS

“We were surprised to find representation of adolescent and young adult patients to be as high as it was,” said Dr. Unger, a SWOG biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center. “AYA patients are consistently regarded as being underrepresented in adult clinical trials.” 

Enrollment Data Analysis

The research looked at enrollment data from 444 cancer treatment trials conducted from 1996 to 2020 by the SWOG Cancer Research Network, a cancer clinical trials group funded by the National Cancer Institute (NCI), part of the National Institutes of Health.

Although average survival times for AYA patients with cancer have been improving, they have not kept pace with the survival gains seen for children with cancer or for adults aged 40 years and older. Over the period from 1975 to 2014, survival estimates for these other two groups increased by approximately 0.9% per year, while survival for AYA patients increased by only about 0.5% per year.

To gain insight into trial participation by this age group, the study team examined patterns of AYA enrollment to phase I, II, and III treatment trials in the 29 cancer types into which SWOG enrolled 100 or more patients during the 25-year period. The team also analyzed demographic factors and cancer types and compared these to data for older patients and for AYA patients with cancer in the larger population.

Results

Over the 25-year period, SWOG enrolled 84,219 patients to the treatment trials examined, with 7,109 of those patients, or 8.4%, classified as being in the AYA age range. Cancer clinical trial patients in general tend to be younger than the overall population of patients with cancer, and in fact, patients with cancer who are aged 65 years or older are consistently underrepresented in trials.

KEY POINTS

  • An analysis of 25 years of publicly funded adult cancer clinical trials has found that 8.4% of patients enrolled were in the AYA age range (15–39 years).
  • The AYA patient population enrolled in the trials was more racially and ethnically diverse than the population of older patients enrolled in those trials, although it was less diverse than the AYA cancer population overall in the United States.

Researchers also found that the AYA patient population enrolled in the trials was more racially and ethnically diverse than the population of older patients enrolled in those trials, although it was less diverse than the AYA cancer population overall in the United States. Some 25.0% of enrolled AYA patients were identified as belonging to a racial or ethnic minority group, as compared to 17.2% of enrolled patients aged 40 years and older. An estimated 29.2% of the overall U.S. AYA cancer population belong to a minority group.

“The greater diversity among adolescent and young adult patients is consistent with population trends more broadly,” Dr. Unger said. “If these trends represent a greater willingness on the part of diverse populations to participate in trials, this could be promising for improving diversity in trials in future years.”

The most common cancers among AYA participants in these 444 clinical trials were Hodgkin lymphoma (67.6% of participants were in the AYA age range), acute lymphocytic leukemia (51.6%), and acute promyelocytic leukemia (37.1 %). The cancer type with the greatest overall number of AYA participants in clinical trials was breast cancer; 3,032 patients accounted for 42.9% of all AYA participants over the time period.

Dr. Unger indicated that even though AYA patients were well represented in SWOG trials, their overall numbers may not be enough for a single NCI network group to conduct AYA studies quickly.

“It will still be important for the groups to collaborate going forward,” he said.

Disclosure: For full disclosures of the study authors, visit acsjournals.onlinelibrary.wiley.com.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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