Journal
PEDIATRIC BLOOD & CANCER
Volume 57, Issue 1, Pages 56-62Publisher
WILEY
DOI: 10.1002/pbc.23031
Keywords
imatinib therapy; pediatric chronic myelogenous leukemia
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Funding
- Chair's Grant [U10 CA98543-08]
- National Cancer Institute, National Institutes of Health, Bethesda, MD, USA [U10 CA98413-08]
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Purpose. To determine the efficacy of imatinib in children with newly diagnosed chronic phase (CP) chronic myelogenous leukemia (CML). Methods. This was an open label, multi-center phase II clinical trial. Courses were defined as consecutive 28-day intervals. Oral imatinib was administered daily at 340 mg/m(2) without interruption in the absence of toxicity. Results. Fifty-one children received 978 28-day courses of imatinib. The most common toxicities encountered were hematologic. Forty-one patients (80%) achieved a complete hematologic response by the end of course 2. Nineteen children (38%) obtained a complete cytogenetic response (CCyR) at the end of course 3. Overall, 72% achieved CCyR at a median time of 5.6 months. The rate of complete molecular response (> 3 log reduction) was 27%. Progression-free and overall survival at 3 years were 72% +/- 6.4% and 92% +/- 3.9%, respectively. Conclusions. Daily oral imatinib at a dose of 340 mg/m(2) is well tolerated in children. In addition, imatinib therapy is effective in inducing a high percent of hematologic, cytogenetic and molecular responses, comparable to adults with CML. (This study was registered at ClinicalTrials.gov under identifier NCT00030394.) Pediatr Blood Cancer 2011;57:56-62. (C) 2011 Wiley-Liss, Inc.
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