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Published on: September 18, 2013
[Early clinical trials in paediatric oncology in Spain: a nationwide perspective]
Francisco Bautista1, Soledad Gallego2, Adela Cañete3
1Unidad de Investigación Clínica CNIO-HNJ, Servicio de Hematología, Oncología y Trasplante de Progenitores Hematopoyéticos, Hospital Infantil Universitario Niño Jesús, Madrid, España.
Introduction:
Cancer is the leading cause of death between the first year of life and adolescence, and some types of diseases are still a major challenge in terms of cure. There is, therefore, a major need for new drugs. Recent findings in cancer biology open the door to the development of targeted therapies against individual molecular changes, as well as immunotherapy. Promising results in adult anti-cancer drug development have not yet been translated into paediatric clinical practice. A report is presented on the activity in early paediatric oncology trials (phase I-II) in Spain.
Material And Methods:
All members of the Spanish Society of Paediatric Haematology Oncology (SEHOP) were contacted in order to identify early clinical trials in paediatric cancer opened between 2005 and 2015.
Results:
A total of 30 trials had been opened in this period: 21 (70%) in solid tumours, and 9 (30%) in malignant haemopathies. A total of 212 patients have been enrolled. The majority was industry sponsored (53%). Since 2010, four centres have joined the international consortium of Innovative Therapies for Children with Cancer (ITCC), which has as its aim to develop novel therapies for paediatric tumours. A significant number of new studies have opened since 2010, improving the treatment opportunities for our children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents, and their benefits.
Conclusions:
The activity in clinical trials has increased in the years analysed. The SEHOP is committed to develop and participate in collaborative academic trials, in order to help in the advancement and optimisation of existing therapies in paediatric cancer.
Insights
Early phase clinical trials for paediatric cancers in Spain have increased since 2010, offering new treatment opportunities. This includes novel targeted therapies and immunotherapies, improving outcomes for children with malignant haemopathies and solid tumours.
Area of Science:
- Paediatric Oncology
- Clinical Trial Research
- Cancer Therapeutics
Background:
- Cancer remains a leading cause of death in children and adolescents, necessitating novel therapeutic strategies.
- Translating adult cancer drug development advancements to paediatric settings is crucial.
- Early-phase clinical trials are vital for introducing new anti-cancer drugs in children.
Purpose of the Study:
- To report on the activity and trends in early-phase (I-II) paediatric oncology clinical trials in Spain between 2005 and 2015.
- To assess the landscape of paediatric cancer research and treatment development in Spain.
Main Methods:
- A survey was conducted among members of the Spanish Society of Paediatric Haematology Oncology (SEHOP).
- Data collected focused on early clinical trials initiated in Spain from 2005 to 2015.
Main Results:
- Thirty early-phase clinical trials were identified, with 70% focusing on solid tumours and 30% on malignant haemopathies.
- A total of 212 patients were enrolled, with 53% of trials being industry-sponsored.
- Since 2010, increased trial activity and participation in international consortia like ITCC have been observed, introducing molecularly targeted agents.
Conclusions:
- Paediatric oncology clinical trial activity in Spain has significantly increased.
- Collaborative academic trials are essential for advancing and optimizing paediatric cancer therapies.
- Spanish investigators are contributing to the development and benefits of novel anti-cancer agents for children.
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