According to results recently presented at the 47th annual meeting of the American Society of Hematology (ASH), the addition of low doses of Cytosar-U® (cytarabine) to Clolar® (clofarabine) is more effective than treatment with Clolar alone for patients 50 years of age or older with acute myeloid leukemia.
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; average age at diagnosis is more than 65 years.
Treatment of AML often begins with induction therapy, which includes chemotherapy to produce a complete remission (defined as 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 leukemia recurrence.
There have been relatively large improvements in survival of younger patients with AML over the past two decades due to increased dose-intensity of therapy (this includes stem cell transplants). However, since elderly patients often cannot tolerate aggressive therapy, there has been little if any improvement in the treatment of elderly patients with AML.
Researchers from the M.D. Anderson Cancer Center recently conducted a clinical trial to evaluate the addition of low doses of the chemotherapy agent cytarabine to the chemotherapy agent Clolar as induction therapy for the treatment of elderly patients diagnosed with AML.
Clolar is currently approved for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) whose cancer has progressed following at least two prior treatment regimens. Recent studies have focused on evaluating its use in elderly patients with AML since it appears to be well tolerated.
The current trial included patients who were 50 years of age or older with AML who had not received prior therapy. Sixteen patients were treated with Clolar alone, and 60 were treated with Clolar plus low-dose cytarabine. Patients treated with the combination of Clolar and cytarabine had improved outcomes.
- Complete disappearances of detectable cancer (complete response) occurred in 63% of patients treated with Clolar/cytarabine, compared to 31% of patients treated with Clolar alone.
- Deaths related to treatment occurred in 31% of patients treated with Clolar alone, compared with 17% of patients treated with Clolar/cytarabine.
- Most deaths were related to complications associated with infection.
- The median survival for patients treated with Clolar/cytarabine who achieved a complete response was almost two years.
- The median survival of all patients treated with Clolar/cytarabine was 10.3 months.
The researchers concluded that, for patients with AML over the age of 50 years, the addition of low doses of cytarabine to Clolar appears to improve responses while not adding additional side effects compared to treatment with Clolar alone.
This chemotherapy combination needs to be compared to other treatment options to determine its true clinical effectiveness for treatment of AML. Clolar is also being evaluated in combination with other chemotherapy agents and with different dosing schedules to determine the optimal regimen for the treatment of elderly with AML.
Reference: Faderi S, Ravandi F, Ferrajoli A, et al. Clofarabine plus low-dose cytarabine superior to clofarabine alone in elderly treatment-naïve patients with acute myeloid leukemia. Proceedings from the 47th annual meeting of the American Society of Hematology. Blood. 2005;106:786a, abstract 2804.
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