FDA Urges Researchers to Enroll Adolescents in Adult Oncology Trials

Adolescents (12 to 17 years old) who have “adult-type” cancers should be enrolled in relevant clinical trials to improve access for this population of patients, officials from the FDA recommend in an article published in Clinical Cancer Research.

Studies have shown that only about 10% of 15- to 19-year-old patients with cancer enroll in clinical trials, which is significantly lower than the enrollment rate in pediatric trials. According to Archie Bleyer, MD, from Oregon Health and Science University, an important reason for this is the poor referral rate of adolescent and young adult patients to academic medical centers. To tackle this problem, the National Community Oncology Research Program (NCORP) was established in 1983—when it was called the NCI Community Clinical Oncology program (CCOP)—to increase access in the community setting.

However, in a recent article in the Journal of Oncology Practice, Bleyer wrote that CCOP/NCORP has not had the expected impact on recruitment rates. He wrote that trials conducted by the Children’s Oncology Group have not received a greater proportion of referrals from CCOP. “The CCOP program was unable to increase adolescent and young adult study enrollment despite the fact that 30% of CCOP sites had both pediatric and medical oncologists on their roster,” he wrote.

“With pediatric clinical trials, patient enrollment decreases with age—a 17-year-old is less likely to be enrolled than a 2-year-old,” Karen Albritton, MD, medical director, Adolescent and Young Adult Program, Cook Children’s Hematology and Oncology Center, told Evidence-Based Oncology™.

According to FDA experts, adolescents often have cancers that are similar to adult cancers, including soft tissue and bone sarcomas, central nervous system tumors, leukemias, lymphomas, and melanoma. They point out that participation in clinical trials has been recognized to have had a significant impact on the increase (more than 50%) in overall survival of childhood cancer patients since 1975. Based on these factors, the authors recommend the inclusion of adolescents in disease- and target-appropriate adult oncology trials. They do recommend the need to monitor safety, pharmacokinetics, and ethics when conducting such trials.

The FDA’s recommendations mirror the thoughts expressed by Albritton who believes that all stakeholders—the patient, the primary care provider, and the oncologist—need to be educated about and should advocate for the importance of clinical trials in this age group.