Laura is the editorial director of The American Journal of Managed Care® (AJMC®) and all its brands, including The American Journal of Accountable Care®, Evidence-Based Oncology™, and The Center for Biosimilars®. She has been working on AJMC® since 2014 and has been with AJMC®'s parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.
Advances in Hodgkin lymphoma treatment has led to high survival rates, but adolescents and young adults, who represent the largest age group affected by the disease, face lifelong morbidities from clinical trials. New analytic methods could help inform future protocol changes.
Although adolescents and young adults (AYAs) represent the largest age group affected by Hodgkin lymphoma (HL), they are the age group least likely to be enrolled in clinical trials. Due to their age and the lack of AYA-specific clinical trials, they are split between pediatric and adult trials based on their geographical location at the time of initial presentation.
Advances in HL treatment has led to high survival rates, but the presence of lifelong morbidities means that there has to be a “prioritization of late effect—oriented objectives for clinical studies.” A new study published in Blood, the journal of the American Society of Hematology, analyzed the burdens facing AYAs with HL. Studies held between the 1960s and 1990s found HL survivors had an increased risk of early mortality up to 28 years after diagnosis, the authors noted.
“Pediatric clinical trials for HL now have survivorship objectives, as well as a reduction in therapy intensity, as their main priorities,” the authors explained. As a result, there is a variation in the standard of care between adult and pediatric groups that affects some AYAs who are considered too old for pediatric trials. However, older AYAs are still young enough that they have decades of life remaining.
According to the researchers, a lack of enrollment of the AYA population in clinical trials—just 10% to 15% of those aged 15 to 19 and <2% for those aged 20 to 39—corresponds with a lag in the reduction of cancer mortality rates for this population. While 5-year survival rates have increased >1.5% for all patients with HL, the increase for patients 15 to 24 years has been <0.5% and there has been no improvement for patients aged 25 to 34 years.
The authors recommend that future trial designs either use HL-specific data from older trials or “innovate the application of survivorship data when selecting objectives.” For instance, the cumulative burden metric is a new approach that quantifies disease burden within large observational cohorts.
“The cumulative burden approach provides a new, more comprehensive perspective of total disease burden and patterns of illness within a population of interest that can inform decisions for future trials,” the authors concluded. “Further efforts are needed to ensure that the burden of choice for AYA patients it not greater than the burden of their disease.”
Flerlage JE, Metzger ML, Bhakta N. The management of Hodgkin lymphoma in adolescents and young adults: burden of disease or burden of choice? Blood. 2018;132(:376-384. doi: https://doi.org/10.1182/blood-2018-01-778548.