Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
499 participants
OBSERVATIONAL
2006-01-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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acute myeloid leukemia, adults
Adults treated for acute myeloid leukemia in our hospital between 1978 and 2007
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* age 18 years or above
* must have been treated with potentially curative therapy
Exclusion Criteria
* palliative therapy
18 Years
92 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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University of Sao Paulo, General Hospital
Principal Investigators
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Pedro ED Llacer, MD, PhD
Role: STUDY_DIRECTOR
University of Sao Paulo
Locations
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University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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mcazevedo01
Identifier Type: -
Identifier Source: org_study_id