A chemotherapy-free regimen was safe and effective in pediatric patients with newly diagnosed acute promyelocytic leukemia (APL), according to results from a prospective study.
The 2-year overall survival (OS) rate among all 114 patients in the study was 99.1%, reported Franco Locatelli, MD, PhD, of IRCCS Bambino Gesù Children's Hospital in Rome, during a session at the European Hematology Association annual congress in Stockholm.
The 2-year OS rates were 100% for standard-risk patients who received all-trans retinoic acid and arsenic trioxide and 97.4% for high-risk patients who also received gemtuzumab ozogamicin (Mylotarg).
In addition, 2-year event-free survival rates were 96.9% in the overall cohort, 98% in standard-risk patients, and 94.3% in high-risk patients.
Locatelli observed that the survival outcomes seen in this trial -- ICC-APL-02 -- were better than those reported in ICC-APL-01, which tested a risk-adapted combination of all-trans retinoic acid and chemotherapy in newly diagnosed pediatric patients with this rare, aggressive subtype of acute myeloid leukemia.
