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A Novel Effective and Safe Consolidation for Patients Over 60 Years with Acute Myeloid Leukemia

Intermediate Dose Cytarabine (2 x 1 g/m² on Days 1, 3, and 5)

¹ Department of Internal Medicine I, Division of Hematology & Hemostaseology, ² Institute of Medical Biology, and ³ Institute of Medical and Laboratory Medicine, Medical University of Vienna, Vienna, Austria

ABSTRACT

Purpose: High-dose intermittent cytarabine is an effective postremission treatment for patients with acute myeloid leukemia (AML). This regimen is a safe approach in patients < 60 years but produced severe neurotoxicity in the elderly.

Experimental Design: We have established a dose-reduced age-adapted consolidation using intermediate dose (IDAC; 2 x 1 g/m² i.v., days 1, 3, and 5) for AML patients 60 years. Forty-seven de novo AML patients in complete remission (CR; median age, 70 years) were scheduled to receive four consolidation cycles of IDAC.

Results: In 25 of 47 patients (53%), all four cycles were administered: 9 (19%) received three cycles; 7 (15%) received two cycles; and 6 patients (12%) one cycle. Treatment was well tolerated without neurotoxicity. The median number of days with severe neutropenia (absolute neutrophil count < 500/µl) was 9. Neutropenic fever occurred in 22 of 47 patients (49%) during the first cycle, in 24 of 41 (60%) during the second, in 15 of 34 (44%) during the third, and in 18 of 25 (72%) during the fourth cycle. Only 1 patient died during consolidation (cardiac failure). The median overall survival, disease-free survival, and continuous CR were 10.6, 15.5, and 15.9 months, respectively. The probability of overall survival, disease-free survival, and continuous CR at 5 years were 18, 22, and 30%, respectively.

Conclusions: IDAC is a safe and effective postremission therapy for elderly patients with AML.

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