Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting.
Adolescent
Adult
Aged
Aged, 80 and over
Antiemetics
/ administration & dosage
Antineoplastic Agents
/ adverse effects
Aprepitant
/ administration & dosage
Child
Child, Preschool
Clinical Trials as Topic
Data Interpretation, Statistical
Dose-Response Relationship, Drug
Drug Dosage Calculations
Female
Granisetron
/ administration & dosage
Humans
Infant
Male
Middle Aged
Nausea
/ chemically induced
Neurokinin-1 Receptor Antagonists
/ administration & dosage
Ondansetron
/ administration & dosage
Palonosetron
/ administration & dosage
Treatment Outcome
United States
United States Food and Drug Administration
Vomiting
/ chemically induced
Young Adult
CINV
antiemetic
drug development
extrapolation
pediatrics
Journal
Journal of clinical pharmacology
ISSN: 1552-4604
Titre abrégé: J Clin Pharmacol
Pays: England
ID NLM: 0366372
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
04
09
2019
accepted:
11
12
2019
pubmed:
23
1
2020
medline:
22
6
2021
entrez:
23
1
2020
Statut:
ppublish
Résumé
Chemotherapy-induced nausea and vomiting (CINV) is a common treatment-related adverse event that negatively impacts the quality of life of cancer patients. During pediatric drug development, extrapolation of efficacy from adult to pediatric populations is a pathway that can minimize the exposure of children to unnecessary clinical trials, improve efficiency, and increase the likelihood of success in obtaining a pediatric indication. The acceptability of the use of extrapolation depends on a series of evidence-based assumptions regarding the similarity of disease, response to intervention, and exposure-response relationships between adult and pediatric patients. This study evaluated publicly available summaries of data submitted to the US Food and Drug Administration for drugs approved for CINV to assess the feasibility of extrapolation for future development programs. Extracted data included trial design, emetogenic potential of chemotherapy, primary end points, participant enrollment criteria, and antiemetic pharmacokinetics. Adult and pediatric clinical trial designs for assessment of efficacy and safety shared key design elements. Antiemetic drugs found to be efficacious in adults were also efficacious in pediatric patients. Systemic drug concentrations at approved doses were similar for ondansetron, granisetron, and aprepitant, but an exposure-response analysis of palonosetron in children suggested that higher palonosetron systemic exposure is necessary for the prevention of CINV in the pediatric population. For 5-hydroxytryptamine-3 and neurokinin-1 receptor antagonist antiemetic drugs, efficacy in adults predicts efficacy in children, supporting the extrapolation of effectiveness of an antiemetic product in children from adequate and well-controlled studies in adult patients with CINV.
Substances chimiques
Antiemetics
0
Antineoplastic Agents
0
Neurokinin-1 Receptor Antagonists
0
Aprepitant
1NF15YR6UY
Ondansetron
4AF302ESOS
Palonosetron
5D06587D6R
Granisetron
WZG3J2MCOL
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
775-784Informations de copyright
© 2020, The American College of Clinical Pharmacology.
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