Journal
LEUKEMIA
Volume 19, Issue 10, Pages 1768-1773Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.leu.2403901
Keywords
acute myeloid leukemia; gemtuzumab ozogamicin; elderly; frail
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Funding
- NCI NIH HHS [5U10-CA11488-29, 5U10-CA11488-35] Funding Source: Medline
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The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients 460 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9mg/m(2) as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8-32%). The CR/CRp rate in patients 61-75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61-75 years than in older individuals (P = 0.05), and in CD33+ cases than in CD33- cases (P = 0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.
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