High-dose Cytarabine and Survival in AML
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|ClinicalTrials.gov Identifier: NCT01034839|
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : December 18, 2009
|Condition or disease|
|Acute Myeloid Leukemia|
Background In adults with acute myeloid leukemia, especially those < 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival. However, the appropriate dose has not been defined. We evaluated survival after cytarabine consolidation therapy at three different doses.
Design and Methods We conducted a single-center, retrospective study involving 499 acute myeloid leukemia patients, aged 18-92 years, all evaluated between 1978 and 2007. Of those 499 patients, 400 received curative treatment and 203 received cytarabine consolidation. The latter were divided into three groups: low-dose (receiving < 1.5 g/m2 of i.v. cytarabine, every 12 h, on 3 alternate days, for up to 4 cycles); medium-high-dose (< 45.45 g—the median dose—by the end of the cycles); and very-high-dose (≥ 45.45 g by the end of the cycles).
Results Among the 400 patients receiving curative treatment, five-year survival was 22.8% (91 patients). Cytarabine consolidation dose was an independent determinant of survival (significant differences were found among the groups), whereas age, karyotype, induction protocol, French-American-British classification and etiology were not. In comparison with the very-high-dose group, the risk of death was 3.871 times (95% CI, 1.043 to 14.370 times) higher in the high-dose group (p=0.043) and 9.775 times (95% CI, 2.493 to 38.320 times) higher in the low-dose group (p=0.001), assuming, in both cases, that age, karyotype, French-American-British classification and etiology of acute myeloid leukemia were constant.
Conclusions Consolidation therapy with high-dose cytarabine appears to improve survival in patients with acute myeloid leukemia.
|Study Type :||Observational|
|Actual Enrollment :||499 participants|
|Official Title:||Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With Acute Myeloid Leukemia|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2009|
acute myeloid leukemia, adults
Adults treated for acute myeloid leukemia in our hospital between 1978 and 2007
- Overall survival [ Time Frame: 5 years ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034839
|University of Sao Paulo|
|Sao Paulo, Brazil, 05430010|
|Study Director:||Pedro ED Llacer, MD, PhD||University of Sao Paulo|