Pediatric CML: Imatinib Effective in the Front Line
Patients received imatinib 300 mg/m2, 400 mg/m2, and 500 mg/m2 for chronic phase, accelerated phase, and blast phase disease, respectively.
First-line imatinib is effective and safe among pediatric patients with chronic myeloid leukemia (CML), according to a study being presented at the 2017 American Society of Hematology Annual Meeting (ASH) in Atlanta, Georgia.1
For the prospective CML-PAED-II study, researchers enrolled 156 patients with newly diagnosed CML. Patients received imatinib 300 mg/m2, 400 mg/m2, and 500 mg/m2 for chronic phase (CML-CP), accelerated phase (CML-AP), and blast phase (CML-BP) disease, respectively. Of the enrolled patients, 148 had evaluable data.
The median follow-up was 25 months. Patients with CML-CP had an 18-month event-free survival rate of 97% (95% CI, 94.2%-99.9%).
Complete hematologic response at month 3 was observed in 98% of patients, complete cytogenic response (CCyR) at month 12 was observed in 63% of patients, and molecular response (MR3.0) at month 18 was observed in 59% of patients. After 3 years of receiving continuous first-line imatinib or 2nd-generation tyrosine kinase inhibitor (TKI) therapy, 86% and 74% of patients achieved CCyR and MR3.0, respectively.
Approximately 66% of patients reported at least 1 adverse event (AE); the most frequently reported AE of any grade was imatinib-related anemia and the most frequently reported grade 3 to 4 hematologic AE was neutropenia. Gastrointestinal and musculoskeletal AEs were also common.
Eighteen percent of patients had to suspend therapy and 6% of patients discontinued treatment because of intolerable AEs; 27% of patients failed therapy because of unsatisfactory response or intolerance. Nineteen percent of patients underwent stem cell transplantation (SCT), of which 3 patients died of relapse and 2 died of SCT-related complications.
The authors concluded that “[l]ong term outcome and effects of potentially life-long TKI treatment have to be registered in cooperation with adult hematologists in extended surveillance follow-up studies.”
Read more of Cancer Therapy Advisor's coverage of the American Society of Hematology (ASH) 2017 meeting by visiting the conference page.
- Suttorp M, Schulze P, Glauche I, et al. Response to front-line imatinib treatment in children and adolescents with CML – data from a large pediatric cohort. Poster presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.