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[Statutory pediatric informations available for anticancer drugs: inventory and proposals]
C Thouvenel1, M S Gény, S Demirdjian
1Département de pédiatrie, institut Gustave-Roussy, 94805 Villejuif, France.
Insights
Official information on pediatric cancer drug use is lacking, despite extensive clinical research. Improved documentation and targeted studies are needed for better pediatric cancer treatment.
Area of Science:
- Pediatric Oncology
- Pharmacology
- Drug Development
Background:
- Many pediatric medicines are prescribed off-label due to insufficient clinical studies in children.
- A European directive is proposed to incentivize pediatric medicine development, mirroring US policies.
Purpose of the Study:
- To evaluate the availability and quality of pediatric information for cytotoxic chemotherapy agents.
- To assess the extent of documented pediatric use in official drug compendia.
Main Methods:
- Analysis of pediatric information in the Vidal 2000 dictionary for 76 cytotoxic chemotherapy products.
- Examination of drug indications, posology, and warnings for pediatric use documentation.
Main Results:
- Only 29% of evaluated anticancer drugs had a stated pediatric indication.
- Pediatric use was mentioned in posology for 56% and warnings for 17%; 21% lacked any pediatric information.
- Despite poor official documentation, extensive research protocols are used in pediatric oncology.
Conclusions:
- Official pediatric information for anticancer drugs is insufficient despite substantial research.
- Further clinical studies are required for optimal dosing in infants, long-term effects, and suitable formulations.
- Incentives are crucial to improve access to and development of oncologic therapies for children.
Unlabelled:
Paediatric medicines are often prescribed off label because appropriate clinical and pharmacological studies have not been conducted in children. A European directive is being written to promote the development of paediatric medicines through incentives to pharmaceutical companies, as is already the case in the US.
Method:
In order to evaluate the status of anticancer drugs, we analyzed the paediatric information available in the Vidal 2000 dictionary for cytotoxic chemotherapy.
Results:
Among the 76 products, 48 were currently used to treat children with cancer. An indication for paediatric use was described in only 29% of them. Paediatric use was mentioned in the posology chapter in 56% of cases, and in the warning or contra-indication chapter in 17% of cases. Ten products (21%) were devoid of paediatric information.
Discussion:
The paucity of this official paediatric information contrasts with the number of clinical and pharmacological studies that have been conducted and published by paediatric oncology societies and groups. Indeed, almost 80% of children with cancer are treated using prospective therapeutic research protocols. In conclusion, anticancer medicines have been evaluated in children, but official paediatric information is poor. This situation can be significantly improved with the literature currently available. On the other hand, prospective clinical studies are needed to better define the optimal dose in children under one year of age, to evaluate long-term sequelae in cured patients and to provide appropriate galenic forms for oral chemotherapy.
Conclusion:
Incentives are urgently needed to facilitate access to therapeutic innovations in oncology and their development in children with cancer.