Dasatinib is a safe, effective treatment option and can lead to a deep molecular response among pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP), according to a study published in the Journal of Clinical Oncology.1
Imatinib — the first-line tyrosine kinase inhibitor (TKI) of choice for CML — is sometimes discontinued because of a poor response or toxicity. Previous studies showed that dasatinib may be an effective therapeutic alternative to imatinib.
For the phase 2 CA180-226 study (ClinicalTrials.gov Identifier: NCT00777036), researchers grouped 113 pediatric patients with CML into 1 of 3 cohorts: 29 patients with imatinib-resistant/intolerant CML-CP (1); 17 patients with imatinib-resistant/intolerant CML in accelerated/blast phase (AP/BP), or acute lymphoblastic leukemia (2); 84 patients with newly diagnosed CML-CP (3).
Groups 1 and 2 received dasatinib 60 mg/m2 and 80 mg/m2, respectively, and patients in group 3 were treated with dasatinib 60 mg/m2 or 72 mg/m2 power for oral solution.
Fourteen (48%) and 61 (73%) patients who were imatinib-resistant/intolerant and newly diagnosed with CML, respectively, remained on treatment at the time of analysis.
By 3 months, patients with imatinib-resistant/intolerant CML had a major cytogenetic response greater than 30%, and patients with newly diagnosed CML-CP had a greater than 55% complete cytogenetic response (CCyR) by 6 months.
By 12 months, patients in the imatinib-resistant/intolerant group had a CCyR of 76% and a major cytogenetic response of 41%, compared with patients with newly diagnosed CML-CP who had a CCyR of 92% and a major cytogenetic response of 52%.
The 4-year progression-free survival (PFS) rate was 78% vs 93% among patients with imatinib-resistant/intolerant disease vs newly diagnosed disease, respectively.
Grade 1 to 2 bone growth and development adverse events were observed in 4% of patients with CML-CP; no cases of dasatinib-related pleural or pericardial effusion, pulmonary edema, or pulmonary arterial hypertension were reported.
The authors concluded that “these results support dasatinib as a safe and effective first- or second-line option for the treatment of pediatric CML-CP.”
- Gore L, Kearns PR, de Marino Lee ML, et al. Dasatinib in pediatric patients with chronic myeloid leukemia in chronic phase: results from a phase II trial. J Clin Oncol. 2018 Mar 2. doi: 10.1200/JCO.2017.75.9597 [Epub ahead of print]