More than 90 percent of children younger than 10 years of age who are diagnosed with cancer are treated at cancer centers that participate in National Cancer Institute (NCI)-sponsored clinical trials, and more than half of them are enrolled onto a study. This helps explain the dramatic improvements in survival rates for pediatric cancers over the past three decades. Meanwhile, the majority of adolescent cancer patients between 15 – 19 years of age are not treated at NCI-sponsored cancer centers, and only 10 percent enroll onto a clinical trial. And when compared to children less than 15 years of age, survival rates among adolescents remain stagnant.
I'm working with the Centers for Disease Control and Prevention to tackle the reasons why this unique situation exists. Over the course of our project, we identified five issues as the most important barriers:
- Low Referral Rates
It's reported that 70 – 80 percent of cancer patients 15 –19 years of age receive their care at cancer centers that do not participate in NCI-sponsored pediatric clinical trials. In the state of Utah, for example, Dr. Karen Albritton (director of AYA Oncology Program at the University of North Texas and Cook Children’s Hospital) and her colleagues determined that two thirds of adolescents 15 – 19 years of age were never seen at a pediatric institution and the referral of adolescents with cancer to a pediatric oncology center greatly diminished with age. With the majority of adolescents in Texas referred to a center that did not offer an appropriate clinical trial, this study helps explain why adolescents have the smallest proportion of clinical trial enrollment compared to other pediatric age groups.
- Limited Availability
A recent analysis of available clinical trials for adolescents with lymphoma illustrated that, despite the relative frequency of this cancer among older adolescents, the number of treatment trials are limited. Very few trials are explicitly designed to address unique aspects of the adolescent and young adult patient or disease. And it is challenging to design clinical trials around adolescent and young adult diseases, especially when the disease crosses over age groups. Trials that may be available for adult patients are limited to those who are usually 18 or older.
- Physician-related Barriers
Despite the higher incidence of cancer among adolescents compared to the younger pediatric population, cancer is still rare in this age group. It's recognized that delays exist in diagnosing young adults and adolescents with cancer. Perhaps due to physician perceptions of adolescents and cancer risk, they are referred to non-cancer hospitals. Over time, this results in a lack of adolescents enrolling onto clinical trials.
- Regulatory and Institutional Barriers
Regulatory and cooperative group rules may prevent adolescents from participating in a Children's Oncology Group (COG) clinical trial or other clinical trials. The COG is an NCI-supported clinical trials group. It is the largest research organization devoted just to pediatric and adolescent cancer research. Like all cooperative groups and cancer centers , it is subject to numerous regulations starting within the member institutions and encompassing several federal regulatory bodies. While all the regulations are put in place to protect patients and the quality of research, at times these rules prevent patients from receiving optimal care, especially for young adults with pediatric type malignancies. The good news is that the NCI is introducing the National Clinical Trials Network (NCTN). The NCTN will include the COG and adult cooperative groups so that any provider who is a member of the NCTN will have access to clinical trials offered by any of these cooperative groups.
- Unique Psychosocial Needs
It is recognized that adolescence is a unique and complex period in psychosocial development and being diagnosed with cancer has been noted to be more stressful for adolescents than pediatrics. Do older adolescents understand what a clinical trial is? Are clinical trials presented to adolescents in an age-appropriate manner? Adherence issues are a significant problem among young adults and this could have an impact on clinical trial outcomes.
The challenge is letting this age group know what their options are. We need to improve how we communicate with them and how to engage them in their care.
Fortunately, Roswell Park treats both adults and pediatrics. Our adolescent patients have access to applicable in trials either through pediatric cooperative groups, or adult cooperative groups. Our Adolescent and Young Adult Program strives to help AYAs navigate through the cancer journey and increase awareness of available resources, fertility counseling and peer support.
Also, this past year, the National Comprehensive Cancer Network (NCCN) published AYA Guidelines which emphasizes the importance of referring young adults and adolescents to cancer centers, and encourages enrolling these patients onto available clinical trials. Additionally, in July 2013, the Institute of Medicine’s National Cancer Policy Forum will host a workshop on “Addressing the Needs of Adolescents and Young Adults with Cancer.” Ongoing national attention on AYA needs should help us learn more about AYAs, their diseases, and their outcomes.