Wednesday, December 3, 2008

More teens needed for trials

A new UK study has highlighted the small number of teenagers who are enrolled in clinical trials for cancer, despite the benefits of being involved. Inclusion in studies has been shown to improve cancer survival, because it provides access to new drugs, better quality of care through frequent monitoring and access to a wider group of specialists. The results of the work have been published in the 1st December online edition of the British Journal of Cancer (10.1038/sj.bjc.6604751).

Scientists from University College London analysed enrolment in Phase III trials from April 2005 to March 2007 involving teenagers and young adults (TYA), as well as children. All of the young patients involved in trials had been diagnosed with leukaemia, lymphoma, brain and central nervous system, bone sarcomas or male germ cell tumours. The researchers found that only 25.2 per cent of 15 to 19-year-olds and 13.1 per cent of 20 to 24-year-olds were enrolled in clinical trials, compared with 43.2 per cent of ten to 14-year-olds. Rates increased among ten to 14-year-olds and 15 to 19-year-olds during April 2006 to March 2007 compared with the previous 12 months, but fell among 20 to 24-year-olds.

The investigators noted that there were four trials available for patients with CNS tumours, yet no over-16s were enrolled in these trials. They also observed that over-15s were much less likely to take part in clinical trials in England than children and younger teenagers. The variations in open trials, trial age eligibility criteria and extent of trial activation in treatment centres in part explain this observation. However, other possible influences, such as difficulties associated with the consent of TYA require further evaluation.

Study leader Dr Lorna Fern, who co-ordinates research into TYA with cancer at the National Cancer Research Institute has said that the US and Australia had also reported a similar trend. Young people are constantly falling through the gap between paediatric and adult cancer specialists and there are not enough trials for the types of cancers that affect them. This is an important study that can be used as the base on which progress is measured in the UK. Before now, it was not known how many young people with cancer were recruited onto clinical trials. It is hoped that in the future, closer dialogue between those involved in planning and running trials for children and for adults will improve trial availability and recruitment.

Amending the age eligibility criteria is one possible solution, although it may not completely address the problem of recruiting TYA. In the EURAMOS-1 trial (an international osteosarcoma trial), a fall off in recruitment has been seen beyond the age of 15, despite an age eligibility criteria which spans the whole paediatric and TYA population. Average accrual to EURAMOS-1 in England, Scotland and Wales has demonstrated a decline in accrual from 42.7 per cent for patients aged ten to 14 years, 38.3 per cent for those aged 15 to 19, and 15.7 per cent of patients aged 20 to 24 from 2005 to 2008.

It is feared that significant improvements in outcomes from cancer for TYA will remain elusive without a coalition of forces including funders, policy makers, biologists, clinicians and patients.

Matthew Dennis - Editor, Cancer Drug News

No comments: