Journal
BLOOD
Volume 122, Issue 20, Pages 3432-3439Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2013-06-506592
Keywords
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Categories
Funding
- Public Health Service (PHS)
- National Cancer Institute, National Institutes of Health, Department of Health and Human Services (DHHS) [CA32102, CA38926, CA46282, CA46136, CA27057, CA45377, CA14028, CA45807, CA86780, CA35176, CA11083, CA46441, CA12644, CA35431, CA45808, CA35178, CA63848, CA35261, CA67575, CA16385, CA58882]
- Celgene Corporation
- Pfizer, Inc.
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This trial tested the safety and efficacy of a regimen consisting of hydroxyurea followed by azacitidine, 75 mg/m(2) for 7 days, and gemtuzumab ozogamicin, 3 mg/m(2) on day 8, in older patients with newly diagnosed acute myeloid leukemia. Those achieving a complete remission received 1 consolidation treatment followed by 4 cycles of azacitidine. The patients were stratified into good-risk (age 60-69 years or performance status 0-1) and poor-risk (age >= 70 years and performance status 2 or 3) groups. Specific efficacy and safety goals were defined as being supportive of further study of the regimen. Eighty-three patients were registered in the good-risk cohort and 59 in poor-risk cohort, with median age of 71 and 75 years, respectively. In the good-risk group, 35 patients (44%) achieved a complete remission. Median relapse-free and overall survivals were 8 and 11 months, respectively. Six patients (8%) died within 30 days of registration. In the poor-risk group, 19 (35%) achieved a complete remission. Median relapse-free and overall survivals were 7 and 11 months, respectively. Seven patients (14%) died early. The results of this trial met predefined goals for efficacy and safety for the poor-risk cohort but not the good-risk group.
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