Following a pre-phase treatment regimen of prednisone and intrathecal methotrexate, a total of 3,655 children (ages 1 to 17) with acute lymphoblastic leukemia were randomized to receive induction therapy consisting of either prednisone (60 mg/m2/d) or dexamethasone (10 mg/m2/d) in addition to vincristine, daunorubicine, and L-asparaginase combination therapy. Post-induction therapy was also given to patients.
Six-year event-free survival reached 84.1 percent in patients who received dexamethasone as compared with 79.1 percent of those who received prednisone in the induction phase. The six-year cumulative incidence of relapse was 11 percent and 18 percent for patients randomized to dexamethasone and prednisone, respectively. The difference between the two groups was observed for bone marrow relapses (8 percent versus 12 percent), central nervous system relapses (2 percent versus 4 percent), and other relapses (2 percent versus 3 percent) in dexamethasone as compared with prednisone.
Higher toxicity was seen in those treated with dexamethasone. The cumulative incidence for death in the induction phase was 2 percent for dexamethasone compared with 0.9 percent for prednisone; however, the cumulative incidence of death during remission was similar between the two treatment groups (2 percent for dexamethasone and 1.6 for prednisone).
PROPEL: A Multicenter Phase II Open-Label Study of Prala
Contact: Laura Stark
American Society of Hematology
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