There is mounting evidence that supports the inclusion of adolescents (12-17 years) in adult early phase trials, without requiring preceding specific paediatric trials. However, only few adult early phase trials currently include adolescents. On the other hand, the classical arbitrary upper age limit in paediatric trials (18 or 21 years old), hinders appropriate access to trials to young adults (19-25 years) with paediatric disease types.
Review of all phase I/II trials opened in our institution for solid tumours/lymphomas, from 01/01/2012 to 31/12/2017. Systematic analysis of each protocol/synopsis by three independent (1 medical, 1 adolescent/young adult, 1 paediatric) oncologists, with the main objective to describe the current inclusion of adolescents in adult trials and young adults in paediatric trials.
During 6years, overall 465 phase 1/2 trials were open. Adolescents (12-17 years) were included in 65 trials (15%): 61/62 (98%) paediatric trials and 4/403 (1%) adult trials. In 11/403 (3%) adult trials, lower age limit was 15/16 years. Concerning the 389 trails that were not open for recruitment of adolescents, this population could have been potentially included in 212/389 (55%) trials. 28/389 (7%) trials targeted tumour types that are frequently found in adolescents such as sarcoma, lymphoma and germ cell tumours. Concerning the inclusion of young adults (19-25 years) in paediatric trials, 36 of the 62 paediatric trials did not recruit this age group (upper age limit 18 years in 22 trials, 21 years in 13 trials), while 10 of these (28%) trials targeted cohorts of tumour types that can be also found in this age group. 552 patients (12-25years) had progressive disease during this period, 290 were 12-17years and 262, 18-25years. 403 were included in an early phase trial.
Our data highlight the significant lack of adapted trials for the adolescent/young adult cancer population. A new lower age limit of 12 years for adult trials and an upper age limit of 25years for paediatrics trials should be individually discussed taken into account current evidence and international recommendations and would allow to improve the access to innovative treatment for these patients