Organizers of cancer clinical trials are neglecting teenagers and young adults
Jun 9, 2008 - 4:00:00 AM
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Dr Whelan said: The problem is not teenagers not wanting to take part in clinical trials, but actually teenagers not being offered the chance to participate.
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By Teenage Cancer Trust,
[RxPG]
London, UK: Teenagers and young adults with cancer are being failed by medical researchers who are not designing clinical trials with the 13-24 age group in mind and who are not recruiting sufficient numbers of young people to those trials that do exist, according to new figures announced today (Monday).
Dr Lorna Fern, from University College Hospital, London, told Teenage Cancer Trust's Fifth International Conference on Teenage and Young Adult Cancer Medicine that young people aged between 15 and 24 were particularly neglected, with an average of just 16.6% joining clinical trials between April 2005 and March 2008, compared to 44.1% of 5-14 year-olds who joined trials over the same period.
Improvements in cancer treatments and outcomes for the older age group will continue to stagnate until this situation changes and more teenagers and young adults (TYAs) are recruited into clinical trials, said Dr Fern, who is research and development co-ordinator for the National Cancer Research Institute's Teenagers and Young Adult Clinical Studies Development Group.
Our figures show there was considerable variation in the proportion of newly diagnosed patients entering trials between cancer types and between years. Some cancers had particularly poor accrual rates: in England, up until 2006/07, no young people over 16 years had been recruited to cancer treatment trials for brain tumours despite four trials being open during the study period, However, the new data for 2007/08 show that two patients have been entered in the past year, perhaps as a consequence of highlighting this issue. Brain tumours are one of the commonest causes of cancer from which young people die and as reported earlier in the conference, the incidence of some types is rising.
Dr Fern analysed 23 trials of 4,429 patients aged 0-59 years recruited between April 2005 and March 2008 in England, Scotland and Wales. Accrual rates fell considerably for patients aged 20-24 years in all three years. In 2005/6, 42.6% of 10-14 year olds with cancer were recruited to clinical trials, 22.9% of 15-19 year-olds and 13.4% of 20-24 year-olds. In 2006/7, there were slight increases in accrual rates for 15-19 year olds (41.3% aged 10-14, 27.3% aged 15-19), but a drop for 20-24 year-olds to 10.9%. Dr Fern expressed concern that these trends would continue as analysis of the 2007/08 data suggested that recruitment of 20-24 year olds has fallen to approximately 7.5%, compared to 39.7% of 10-14 year olds and 25.4% of 15-19 years.
She said: There are a number of reasons for the low level of recruitment of teenagers and young adults to trials, particularly for the 20-24 year-olds. These include inappropriate trial design, poor accessibility to trials for TYAs, and too many young people not being treated by specialist cancer teams.
At present, the design and age eligibility criteria for trials tend to reflect whether the trial organisers treat children or adult patients, rather than the biology of the particular cancer, and the age group which it is mostly likely to occur in. Traditionally, trials will have an age cut off between 16 and 20. TYAs are constantly falling through the gap created by the tendency for paediatricians to treat the younger ages, and for the older ages to be treated in adult cancer wards.
If we are to see improvements in the treatments and outcomes for TYAs with cancer, there needs to be closer dialogue between research groups when they are planning cancer trials. They should give particular consideration to the specific needs of this over-looked age group so that a more appropriate trial portfolio for TYAs can be established in the UK.
Dr Fern said she thought that particular effort was needed to improve the recruitment of 20-24 year-olds to clinical trials. One of the reasons why there is a relatively higher level of 10-14 year-olds entering trials is because they tend to be treated in specialised paediatric units, which, in the UK, run Children's Cancer and Leukaemia Group (CCLG) trials. No such co-ordinated body exists for teenagers and young adults aged 17-24 years. They will most likely be treated in an adult ward and so access to CCLG trials is limited or non existent.
However, amending the age eligibility criteria of trials may not completely address the problem of recruiting teenagers and young adults to trial. Dr Jeremy Whelan, Chief Investigator of the EURAMOS-1 trial (an international osteosarcoma trial) and a consultant medical oncologist at UCH, spoke of a fall off in recruitment beyond the age of 15 despite an age eligibility criteria which spans the whole paediatric and TYA population. Average accrual to EURAMOS-1 in Accrual to EURAMOS-1 in England, Scotland and Wales has demonstrated a decline in accrual from 42.7% for patients aged 10-14 years, 38.3% for those aged 15-19, and 15.7% of patients aged 20-24 during the 2005-2008.
Differences in gaining consent for entering a trial between children and teenagers and young adults has been cited as a reason for poor accrual of teenagers and young adults. However, there are currently no data to show whether gaining consent for trial participation is harder to achieve with teenagers and young adults than for adults or children through proxy of their parents, but Whelan believes it should be no different.
Dr Whelan said: The problem is not teenagers not wanting to take part in clinical trials, but actually teenagers not being offered the chance to participate.
Dr Whelan and Dr Fern feared that significant improvements in outcomes from cancer for teenagers and young adults would remain elusive without a coalition of forces including funders, policy makers, biologists, clinicians and patients.
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