High dose cytarabine plus gemtuzumab ozogamicin for patients with relapsed or refractory acute myeloid leukemia: Cancer and Leukemia Group B study 19902

Richard M Stone, Barry Moser, Ben Sanford, Philip Schulman, Jonathan E Kolitz, Steven Allen, Wendy Stock, Ilene Galinsky, Ravi Vij, Guido Marcucci, David Hurd, Richard A Larson, Cancer and Leukemia Group B, Richard M Stone, Barry Moser, Ben Sanford, Philip Schulman, Jonathan E Kolitz, Steven Allen, Wendy Stock, Ilene Galinsky, Ravi Vij, Guido Marcucci, David Hurd, Richard A Larson, Cancer and Leukemia Group B

Abstract

Gemtuzumab ozogamicin (GO), an anti-CD33 immunoconjugate, was combined with high dose cytarabine (HiDAC; cytarabine 3g/m(2) over 3h daily for 5 days) for adults with relapsed or refractory AML. HiDAC plus GO 9mg/m(2) on day 7 and 4.5mg/m(2) on day 14 was not tolerated, but HiDAC followed by GO 9mg/m(2) on day 7 was safe: 12/37 (32%) patients with relapsed AML achieved complete remission. Median overall survival was 8.9 months. No grade 4 hepatic veno-occlusive disease was observed. This regimen merits further study, both in this setting and as a remission consolidation therapy.

Conflict of interest statement

Conflict of Interest: No authors have conflict of interest to report except for DH who owns Pfizer stock.

Copyright © 2010 Elsevier Ltd. All rights reserved.

Figures

Figure 1
Figure 1
Overall (Kaplan-Meier) Survival for the 37 Patients with Relapsed AML treated at the Recommended Phase II Dose of HiDAC + GO.

Source: PubMed

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