Front-line imatinib treatment in children and adolescents with chronic myeloid leukemia: results from a phase III trial
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't
PubMed
29925908
DOI
10.1038/s41375-018-0179-9
PII: 10.1038/s41375-018-0179-9
Knihovny.cz E-resources
- MeSH
- Biomarkers MeSH
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy mortality pathology MeSH
- Child MeSH
- Imatinib Mesylate administration & dosage adverse effects therapeutic use MeSH
- Protein Kinase Inhibitors administration & dosage adverse effects therapeutic use MeSH
- Infant MeSH
- Combined Modality Therapy MeSH
- Bone Marrow pathology MeSH
- Humans MeSH
- Adolescent MeSH
- Treatment Failure MeSH
- Child, Preschool MeSH
- Prognosis MeSH
- Disease Progression MeSH
- Antineoplastic Agents administration & dosage adverse effects therapeutic use MeSH
- Neoplasm Staging MeSH
- Neoplasm Grading MeSH
- Treatment Outcome MeSH
- Check Tag
- Child MeSH
- Infant MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Biomarkers MeSH
- Imatinib Mesylate MeSH
- Protein Kinase Inhibitors MeSH
- Antineoplastic Agents 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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