- Barriers exist to the inclusion of 12 to 25-year-olds in both adult and paediatric early phase clinical trials.
- More tailored approaches would give such patients better access to therapeutic innovation.
Why this matters
- Girls can develop breast cancer, for which there are no paediatric trials.
- Some lymphomas or sarcomas in adolescents resemble adult disease much more closely than paediatric disease.
- A review of all phase 1 and 2 trials opened at Gustave Roussy Institut de Cancérologie for solid tumours and lymphomas, from 2012 to 2017.
- A systematic analysis of each protocol was performed by three independent oncologists (medical, adolescent/young adult, paediatric).
- Over a 6-year period, 465 trials were opened, but only 65 (15%) included patients aged 12-17: 61/62 (98%) paediatric trials and 4/403 (1%) adult trials. In 11/403 (3%) adult trials, the lower age limit was 15 or 16 years.
- 55% of the 389 trials forbidden to adolescents could have been relevant for them: 28 (7%) targeted tumours like sarcoma, lymphoma and germ cell tumours.
- 36 of the 62 paediatric trials did not recruit young adults (upper age limit 18 years in 22 trials, 21 years in 13 trials), while 10 (28%) targeted tumour types that are found in this population.
- Inclusion of minors in adult clinical trials poses specific issues in terms of informed consent and patient selection.
- High-grade side effects could affect patients for life.
“Raising the age bar for paediatric trials to 25 years would clearly make sense. But the more pressing issue is the current age limit in adult trials. This has already been done successfully in the US, where the minimum age has been lowered to 12 years." Giannis Mountzios, ESMO Chair of the joint ESMO/SIOPE Working Group on Cancer in Adolescents and Young Adults.