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Front-line imatinib treatment in children and adolescents with chronic myeloid leukemia: results from a phase III trial.
- Source :
-
Leukemia [Leukemia] 2018 Jul; Vol. 32 (7), pp. 1657-1669. Date of Electronic Publication: 2018 Jun 20. - Publication Year :
- 2018
-
Abstract
- 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/m <superscript>2</superscript> , 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.
- Subjects :
- Adolescent
Antineoplastic Agents administration & dosage
Antineoplastic Agents adverse effects
Biomarkers
Bone Marrow pathology
Child
Child, Preschool
Combined Modality Therapy
Disease Progression
Female
Humans
Imatinib Mesylate administration & dosage
Imatinib Mesylate adverse effects
Infant
Leukemia, Myelogenous, Chronic, BCR-ABL Positive mortality
Male
Neoplasm Grading
Neoplasm Staging
Prognosis
Protein Kinase Inhibitors administration & dosage
Protein Kinase Inhibitors adverse effects
Treatment Failure
Treatment Outcome
Antineoplastic Agents therapeutic use
Imatinib Mesylate therapeutic use
Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive pathology
Protein Kinase Inhibitors therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1476-5551
- Volume :
- 32
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Leukemia
- Publication Type :
- Academic Journal
- Accession number :
- 29925908
- Full Text :
- https://doi.org/10.1038/s41375-018-0179-9