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Population Pharmacokinetics of Inotuzumab Ozogamicin in Pediatric Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Results of Study ITCC-059
JH. Wu, E. Pennesi, F. Bautista, M. Garrett, K. Fukuhara, E. Brivio, ACJ. Ammerlaan, F. Locatelli, IM. van der Sluis, C. Rossig, C. Chen-Santel, B. Bielorai, A. Petit, J. Starý, C. Díaz-de-Heredia, S. Rives, A. O'Marcaigh, C. Rizzari, G....
Jazyk angličtina Země Švýcarsko
Typ dokumentu časopisecké články, multicentrická studie
NLK
ProQuest Central
od 2007-06-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 2007-06-01 do Před 1 rokem
- MeSH
- biologické modely MeSH
- dítě MeSH
- dospělí MeSH
- inotuzumab ozogamicin * farmakokinetika aplikace a dávkování MeSH
- kojenec MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- pre-B-buněčná leukemie * farmakoterapie krev MeSH
- předškolní dítě MeSH
- protinádorové látky imunologicky aktivní * farmakokinetika aplikace a dávkování terapeutické užití MeSH
- recidiva MeSH
- senioři MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- kojenec MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
BACKGROUND AND OBJECTIVE: Inotuzumab ozogamicin is an antibody-drug conjugate approved for treating relapsed/refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in adults. Pediatric pharmacokinetic data of inotuzumab ozogamicin are lacking. This study is the first to examine the population pharmacokinetics of inotuzumab ozogamicin in pediatric patients with relapsed/refractory BCP-ALL. METHODS: From 531 adult patients with B-cell non-Hodgkin's lymphoma, 234 adult patients with BCP-ALL, and 53 pediatric patients with BCP-ALL, 8924 inotuzumab ozogamicin serum concentrations were analyzed using non-linear mixed-effects modeling. A published adult inotuzumab ozogamicin population-pharmacokinetic model, a two-compartment model with linear and time-dependent clearance, was adapted to describe the pediatric data. RESULTS: Modifications in this analysis, compared to the published adult model, included: (i) re-estimating pharmacokinetic parameters and covariate effects; (ii) modifying covariate representation; and (iii) introducing relevant pediatric covariate effects (age on the decay coefficient of time-dependent clearance and ALL effect (disease type and/or different bioanalytical analysis methods) on initial values of time-dependent clearance). For patients with relapsed/refractory BCP-ALL, increasing age was associated with a decreasing decay coefficient of time-dependent clearance, reflecting that the target-mediated drug clearance declines more rapidly in children. In pediatric BCP-ALL, the median [interquartile range] cumulative area under the concentration-time curve was significantly higher among responders (n = 42) versus non-responders (n = 10) at the end of the first cycle (26.1 [18.9-35.0] vs 10.1 [9.19-16.1], × 103 ng*h/mL, p < 0.001). From simulations performed at the recommended pediatric phase II dose, inotuzumab ozogamicin exposure reached a similar level as observed in responding pediatric trial participants. CONCLUSIONS: The pharmacokinetic profile of inotuzumab ozogamicin in pediatric patients with relapsed/refractory BCP-ALL was well described in this study. No dose adjustment is required clinically for pediatric patients with BCP-ALL based on the simulated inotuzumab ozogamicin exposure at the recommended pediatric phase II dose, promising efficacy and acceptable tolerability.
Children's Health Ireland at Crumlin Dublin Ireland
Department of Clinical Pharmacy University Medical Center Utrecht Utrecht The Netherlands
Department of Pediatric Hematology and Oncology University Hospital Motol Prague Czech Republic
Department of Pediatric Oncology and Hematology Hospital Niño Jesús Madrid Spain
Department of Pharmacy and Pharmacology Netherlands Cancer Institute Amsterdam The Netherlands
Division of Pediatric Hematology and Oncology Hospital Universitari Vall d'Hebron Barcelona Spain
Division of Pediatric Hematology and Oncology Sheba Medical Center Ramat Gan Israel
Institut de Recerca Sant Joan de Déu Barcelona Spain
Pediatric Hematology and Oncology University Children's Hospital Muenster Muenster Germany
Pediatric Hematology Hôpital Jeanne de Flandre CHRU de Lille Lille France
Pediatric Oncology and Hematology Department Hospital Sant Joan de Déu de Barcelona Barcelona Spain
Pediatrics 3 University Hospital Essen German Cancer Consortium Site Essen Essen Germany
Pfizer Global Pharmacometrics San Diego CA USA
Pfizer R and D Japan Tokyo Japan
Princess Máxima Center for Pediatric Oncology Utrecht The Netherlands
Service d'Hématologie Immunologie Oncologie Hôpital des Enfants CHU Toulouse Toulouse France
Service Onco Hématologie Pédiatrique Hôpital Mère Enfant Nantes University Hospital Nantes France
St Anna Children's Hospital Medical University of Vienna Vienna Austria
Citace poskytuje Crossref.org
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