Dasatinib confirmed as pediatric chronic phase CML option
medwireNews: The tyrosine kinase inhibitor dasatinib is effective and well tolerated as a first- or second-line therapy for children with chronic myeloid leukemia in the chronic phase (CML–CP), research confirms.
“[D]asatinib treatment produced early, deep, and durable responses of clinical importance in this largest prospective trial of pediatric patients with CML-CP to date”, report Lia Gore, from Children’s Hospital Colorado in Aurora, USA, and co-workers.
The phase II trial included 14 patients who had developed resistance to, or were intolerant of, imatinib therapy and 61 patients with a new diagnosis of CML–CP, all of whom were younger than 18 years.
The co-primary endpoint of a major cytogenetic response by over 30% of patients using second-line dasatinib was met within 3 months, while the cumulative rate of a complete cytogenetic response above 55% for first-line dasatinib was met within 6 months.
At 12 months, 41% of patients using second-line dasatinib had achieved a major molecular response and 7% a complete molecular response, rising to 55% and 17%, respectively, by 2 years. The corresponding values for the first-line dasatinib patients were 52% and 8% at 12 months, and 70% and 21% at 2 years.
And after 48 months, 78% of patients using second-line dasatinib and 93% of first-line users were free from progression, the researchers report in the Journal of Clinical Oncology.
A small number of patients (4%) experienced grade 1 or 2 bone growth or developmental adverse events but there were no cases of pleural or pericardial effusion, pulmonary edema, or pulmonary arterial hypertension linked to dasatinib use.
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