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TAT 2019: Barriers to Clinical Trial Access for Adolescents vs Young Adults With Cancer

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Key Points

  • A total of 1,352 (99%) trials were uncovered that were available to young adults, compared to just 233 (17%) that were available for adolescents.
  • All 384 drugs were available for the treatment of young adults through trial inclusion, whereas less than one-third (108 drugs; 28%) of these therapies were available for the treatment of adolescents.
  • Of the 108 drugs investigated in adolescents for the designated malignancies, 59 were investigated first in adults, resulting in a median delay of 35 months until the drug trial was open to adolescents. No time trend in this delay was observed over the years of the study.

Compared to young adults, adolescents with the same types of cancer have far less access to immunotherapy and/or targeted therapies, according to findings presented at the TAT 2019–International Congress on Targeted Anticancer Therapies in Paris. In addition, young adults could be included in clinical trials of these novel drugs nearly 3 years earlier than adolescents. These findings were presented by de Rojas et al (Abstract 29O).

Lead author Teresa de Rojas, MD, PhD, of the Medical Department, European Organisation for Research and Treatment of Cancer, and colleagues conducted this study to determine the access of adolescents with cancer to targeted therapies and immunotherapies and to innovation, as measured in the number of mechanisms of action, compared to young adults. The investigators also aimed to describe the time lapse between the first adult trial for a specific drug and the first trial recruiting adolescents for that same drug.

Analysis Methods

The research team searched the U.S. National Library of Medicine’s ClinicalTrials.gov database to identify all clinical trials initiated between January 2007 and July 2018 that included patients with malignancies and that were relevant for adolescents and young adults (AYAs), including studies of Hodgkin lymphoma, anaplastic large cell lymphoma, extracranial germ cell tumors, medulloblastoma, rhabdomyosarcoma, synovial sarcoma, Ewing sarcoma, osteosarcoma, melanoma, and thyroid cancer. This analysis included only trials investigating immunotherapies and/or targeted therapies.

The trials, drugs, and mechanisms of action were categorized as “available for adolescents,” which was defined as patients 12 to 18 years old, and “available for young adults,” defined as patients 18 to 25 years old. Review of the database uncovered 2,765 trials. Of these, 1,369 trials investigating targeted therapies and/or immunotherapies were included in this analysis.

Findings

A total of 1,352 (99%) trials were uncovered that were available to young adults, compared to just 233 (17%) that were available for adolescents. The analysis comprised 384 novel drugs that were either targeted therapies or immunotherapies investigated in clinical trials. Of these, all 384 drugs were available for the treatment of young adults through trial inclusion, whereas less than one-third (108 drugs; 28%) of these therapies were available for the treatment of adolescents.

Of the 108 drugs investigated in adolescents for the designated malignancies, 59 were investigated first in adults, resulting in a median delay of 35 months (interquartile range = 23–60 months) until the drug trial was open to adolescents. No time trend in this delay was observed over the years of the study. All of the 184 investigated, mechanisms-of-action investigations were accessible to young adults compared to only 61 (33%) mechanisms-of-action investigations allowed to adolescents.

The authors concluded, “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.”

Disclosure: All authors have declared no conflicts of interest.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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