Patients with acute myeloid leukemia (AML) who receive high doses of Cerubidine® (daunorubicin) live significantly longer than patients who receive a standard dose of the same drug, according to preliminary results of a large, randomized clinical trial sponsored by the National Cancer Institute and conducted by the Eastern Cooperative Oncology Group (ECOG).
Acute myeloid leukemia (AML) is a cancer of the bone marrow and blood characterized by the rapid, uncontrolled growth of immature white blood cells known as myelocytes. The disease is more common in adults than in children; the average age at diagnosis is older than 65 years.
Treatment of AML often begins with induction therapy where chemotherapy is used to produce a complete remission (the disappearance of leukemia cells in the bone marrow and normalization of the white blood cell, red blood cell, and platelet levels). After induction therapy, patients generally receive additional treatment (consolidation therapy) to reduce the likelihood of a leukemia recurrence.
This study included 633 patients with non-promyelocytic AML who had not previously received chemotherapy. Patients enrolled in the study between December 2004 and September 2008 and were assigned to receive either high-dose therapy with Cerubidine plus cytarabine or standard-dose Cerubidine plus cytarabine.
The Data Monitoring Committee overseeing the trial has recommended that the results of the preliminary analysis be made public because the study has met its primary endpoint of demonstrating improved overall survival. These results indicate that patients who received the high-dose Cerubidine experienced a median overall survival of approximately 24 months compared with approximately 15 months for patients treated with the standard dose. This survival difference is highly statistically significant. Notably, the rate of serious treatment-related toxicities observed was similar between the high-dose and standard-dose groups. Thus far, 334 patients have proceeded to consolidation therapy.
Because Cerubidine is already FDA-approved for the treatment of AML, the results of this study could have immediate implications for the treatment and outcomes of patients with AML. Patients with AML are encouraged to speak with their physicians about high-dose therapy with Cerubidine.
 National Cancer Institute Press Release: cancer.gov/newscenter/pressreleases/AMLdaunorubicin