Front-line imatinib treatment in children and adolescents with chronic myeloid leukemia: results from a phase III trial
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, práce podpořená grantem
PubMed
29925908
DOI
10.1038/s41375-018-0179-9
PII: 10.1038/s41375-018-0179-9
Knihovny.cz E-zdroje
- MeSH
- biologické markery MeSH
- chronická myeloidní leukemie farmakoterapie mortalita patologie MeSH
- dítě MeSH
- imatinib mesylát aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- inhibitory proteinkinas aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- kojenec MeSH
- kombinovaná terapie MeSH
- kostní dřeň patologie MeSH
- lidé MeSH
- mladiství MeSH
- neúspěšná terapie MeSH
- předškolní dítě MeSH
- prognóza MeSH
- progrese nemoci MeSH
- protinádorové látky aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- staging nádorů MeSH
- stupeň nádoru MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- Názvy látek
- biologické markery MeSH
- imatinib mesylát MeSH
- inhibitory proteinkinas MeSH
- protinádorové látky MeSH
A total of 156 patients (age range 1.3-18.0 years, median 13.2 years; 91 (58.3%) male) with newly diagnosed CML (N = 146 chronic phase (CML-CP), N = 3 accelerated phase (CML-AP), N = 7 blastic phase (CML-BP)) received imatinib up-front (300, 400, 500 mg/m2, respectively) within a prospective phase III trial. Therapy response, progression-free survival, causes of treatment failure, and side effects were analyzed in 148 children and adolescents with complete data. Event-free survival rate by 18 months for patients in CML-CP (median follow-up time 25 months, range: 1-120) was 97% (95% CI, 94.2-99.9%). According to the 2006 ELN-criteria complete hematologic response by month 3, complete cytogenetic response (CCyR) by month 12, and major molecular response (MMR) by month 18 were achieved in 98, 63, and 59% of the patients, respectively. By month 36, 86% of the patients achieved CCyR and 74% achieved MMR. Thirty-eight patients (27%) experienced imatinib failure because of unsatisfactory response or intolerance (N = 9). In all, 28/148 patients (19%) underwent stem cell transplantation (SCT). In the SCT sub-cohort 2/23 patients diagnosed in CML-CP, 0/1 in CML-AP, and 2/4 in CML-BP, respectively, died of relapse (N = 3) or SCT-related complications (N = 2). This large pediatric trial extends and confirms data from smaller series that first-line imatinib in children is highly effective.
Belarus Research Center for Pediatric Oncology Hematology and Immunology Minsk Belarus
Department of Human Genetics Hannover Medical School Hannover Germany
Department of Pediatrics 3 University Hospital University of Duisburg Essen Duisberg Germany
Department of Pediatrics BMT Unit Comenius University Children's Hospital Bratislava Slovakia
Dutch Childhood Oncology Group The Hague The Netherlands
Institute of Pathology Hannover Medical School Hannover Germany
Medical Department 1 University Hospital Carl Gustav Carus TU Dresden Dresden Germany
Paediatric Hematology and Oncology Hannover Medical School Hannover Germany
Pediatric Hematology and Oncology Helios KlinikenBerlin Buch Berlin Germany
Pediatric Hematology and Oncology University Children's Hospital Charité Berlin Germany
Pediatric Hematology and Oncology University Children's Hospital Cologne Germany
Pediatric Hematology and Oncology University Children's Hospital Erlangen Germany
Pediatric Hematology and Oncology University Children's Hospital Groningen The Netherlands
Pediatric Hematology and Oncology University Children's Hospital Kiel Germany
Pediatric Hematology and Oncology University Children's Hospital Münster Germany
Pediatric Oncology Hematology and Immunology University Children's Hospital Heidelberg Germany
Shriners Hospitals for Children Montréal Canada
University Children's Hospital Ludwig Maximilians University Munich Germany
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