40 / 49
SIOPEN has built with COG and neuro-
blastoma groups from Japan, China and
Australia a large clinical and biological
database of more than 9,000 neuro-
blastoma patients in order to define and
validate new staging system and new
biological prognostic biomarkers through
the International Neuroblastoma Research
Group [9] [22].
Groups such as the SIOP-Renal Tumours
Study Group support clinical trials groups
in other continents that run studies using
the same standard treatment backbones,
adapted to local circumstances.
The COG and the European Inter-group
for Childhood non Hodgkin lymphoma
(EICNHL) are currently running a
randomised phase III clinical trial to evaluate
the addition of rituximab, an anti CD20
monoclonal antibody, on standard intensive
chemotherapy treatment in high-risk
Burkitt’s lymphoma.
The European and American Osteosarcoma
Study Group (EURAMOS) has successfully
completed a large phase III study with
partners, which included the COG, the
European Osteosarcoma Intergroup, the
Cooperative Osteosarcoma Study Group,
and the Scandinavian Sarcoma Group.
The EURAMOS Strategy Group, made
up of these four multi-national groups,
as well as the relevant Australasian,
French, Italian, Japanese, and Spanish
osteosarcoma groups, is exploring options
for collaboration on an even larger platform.
In the next 10 years, international coope-
ration will be reinforced to evaluate
innovative targeted drugs within
extremely small and rare groups (defined
by biomarkers), such as children with
B-RAF mutated malignancies. Even in
less rare clinical situations, international
randomised clinical trials will be considered
more regularly to speed up evaluation of
innovative therapies.
Partnership with industry
For the last 50 years, progress has been
made in curing paediatric cancers by running
academic trials using anti-cancer drugs
that are available in hospital pharmacy
departments. Pharmaceutical companies
have not developed their anti-cancer agents
in the paediatric population, and nearly
half of drugs used daily to cure cancer in
children and adolescents do not have the
regulatory official authorisation, stated in
the ‘Summary of Product Characteristics’.
In Europe this situation has significantly
changed over the last five years because
regulatory initiatives, first in the U.S. and
then in Europe, obliged pharmaceutical
companies to test their drugs in the
paediatric population when relevant.
THE SIOPE STRATEGIC PLAN
40