The 18-years-old age limit for inclusion in clinical trials constitutes a major hurdle for adolescents and young adults (AYAs) with cancer that the main stakeholders are advocating to overthrow. The purpose of this study was 1) to analyze the access for adolescents with cancer to targeted therapies and immunotherapies and to innovation (measured in number of mechanisms of action –MoA-), when compared to young adults; and 2) to describe the time lapse between the first adult trial for a specific drug and the first trial recruiting adolescents for that same drug.
ClinicalTrials.gov was searched to identify all the clinical trials including patients with malignancies relevant for AYAs (Hodgkin lymphoma, anaplastic large cell lymphoma, extracranial germ cell tumors, medulloblastoma, rhabdomyosarcoma, synovial sarcoma, Ewing sarcoma, osteosarcoma, melanoma, thyroid cancer), starting between Jan/2007-Jul/2018. Only trials investigating immunotherapies and/or targeted therapies were included. The trials, drugs, and MoA were categorized as “available for adolescents” (including patients 12-18 years old) and “available for young adults” (18-25 years).
Out of 2765 identified trials, 1369 were included: 1352 (99%) available for young adults vs 233 (17%) available for adolescents. A total of 384 novel drugs (target therapies or immunotherapies) were investigated, all 384 available for young adults vs 108 (28%) for adolescents. All 184 investigated MoA were accessible for young adults vs 61 (33%) for adolescents. Out of the 108 drugs investigated in adolescents for the included malignancies, 59 were investigated first in adults, with a median delay of 35 months (IQR 23-60). No time trend in this delay was observed over the years of the study.
There is a major gap in the access to novel drugs and innovation between adolescents and young adults, with the 18-years-old limit posing a large barrier. There is also a prominent delay in the opening of trials for adolescents, with no improvement observed over the last decade. Greater efforts are needed to improve clinical research for AYAs with cancer.
EORTC.
Has not received any funding.
All authors have declared no conflicts of interest.