HealthDay News — For children and young adults with high-risk B-acute lymphoblastic leukemia, high-dose methotrexate is associated with superior 5-year event-free survival (EFS) compared with Capizzi methotrexate, according to a study published online April 25 in the Journal of Clinical Oncology.
For the study, Eric C. Larsen, MD, from the Maine Children’s Cancer Program in Scarborough, and colleagues enrolled 3,154 participants aged 1 to 30 years with newly-diagnosed high-risk B-acute lymphoblastic leukemia. A total of 2,914 patients were randomized to receive dexamethasone (14 days) or prednisone (28 days) during the induction phase and to receive high-dose methotrexate versus Capizzi escalating-dose methotrexate plus pegaspargase during interim maintenance 1.
The researchers found that high-dose methotrexate regimens were superior in planned interim monitoring, which exceeded the predefined boundary and led to cessation of enrollment. At this point, patients randomized to high-dose methotrexate during interim maintenance 1 had a 5-year EFS of 82%, compared to 75.4% for those assigned to Capizzi methotrexate (P = 0.006). The mature final data 5-year EFS rates were 79.6 and 75.2%, respectively (P = 0.008). Both marrow and central nervous system recurrences were decreased with high-dose methotrexate. A superior outcome was seen for patients aged 1 to 9 years who received dexamethasone and high-dose methotrexate versus the other 3 regimens (P = 0.015).
“High-dose methotrexate is superior to Capizzi methotrexate for the treatment of high-risk B-acute lymphoblastic leukemia, with no increase in acute toxicity,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.