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Clinical trial enrollment of adolescents, young adults lacking
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A significantly smaller number of adolescents and young adults aged 15 to 22 are being enrolled into treatment trials compared with patients aged younger than 15, according to a recent study published in the Journal of Pediatric Hematology/Oncology.
Although patients aged younger than 15 have seen an improvement in cure rates throughout the last 30 years, cure rates in adolescents and young adults have remained steady.
According to researchers at the Children’s Hospital of Pittsburgh, a lack of open clinical trial enrollment for young adults and adolescents might be the main reason for the discrepancy.
“In this study these adolescents and young adult oncology patients had a lower rate of being enrolled on therapeutic clinic trials than younger pediatric cancer patients, even when they are treated at a children’s hospital,” Peter H. Shaw, MD, assistant professor of pediatrics, University of Pittsburgh School of Medicine, division of hematology/oncology, Children’s Hospital of Pittsburgh, told HemOnc Today.
The findings of the study highlight the fact that pediatric oncologists need to open more clinical trials to address older patients’ malignancies, Shaw said.
The researchers retrospectively examined data on 640 newly-diagnosed oncology patients (139 patients aged 15 to 22; 501 patients aged 15 or younger) admitted to the hospital between July 2001 and June 2006.
The data showed that 36% of all patients were placed in a clinical trial (27% of older patients, 38% of younger patients; P=.03). No clinical trial was available for the enrollment of 41% of patients in the younger arm and 57% of patients in the older arm (P=.04).
“Hopefully the data will encourage the average pediatric oncologist to both do their best to enroll these adolescents and young adult patients on those clinical trials available and also lobby the government to increase funding to the National Cancer Institute,” Shaw said.
Cutbacks in National Cancer Institute funding have filtered down to the Children’s Oncology Group, which is in charge of national protocols, according to Shaw. “With less funding, we cannot open all of studies we want and the adolescents and young adult population of patients that have the rarer pediatric malignancies usually suffer,” he said. – by Paul Burress
For more information:
- Shaw PH, Ritchey K. Different rates of clinical trial enrollment between adolescents and young adults aged 15 to 22 years old and children under 15 years old with cancer at a children’s hospital. J Pediatr Hematol Oncol. 2007;29:811-814.
Decreased survival gains in adolescent and young adult oncology patients have received increasing attention in recent years, particularly their decreased participation in clinical trials. In this retrospective study, researchers take a closer look at “real-life” clinical trial enrollment rates in one pediatric oncology program. The researchers’ finding of significantly decreased enrollment in patients aged 15 years or younger confirms that of other researchers in the United States and Europe. The findings add to the literature by revealing that several of the proposed barriers to clinical trial enrollment (patient refusal, physicians’ fears of non-compliance) played a much smaller role compared with the simple lack of available trials. There is now a large body of literature emphasizing the importance of specialized care for the adolescent and young adult population, and a growing demand for open clinical trials. The research community must now move toward studies to evaluate and compare physician and community education interventions to improve referral patterns and ensure patient access to the adolescent and young adult clinical trials of the near future.
– Sarah O’Brien, MD, MSc
Pediatric Hematologist
Nationwide Children’s Hospital, Ohio State University