High-dose Cytarabine and Survival in AML
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Purpose
In adults with acute myeloid leukemia, especially those < 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival, but the appropriate dose has not been defined.
| Condition |
|---|
|
Acute Myeloid Leukemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With Acute Myeloid Leukemia |
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 499 |
| Study Start Date: | January 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
acute myeloid leukemia, adults
Adults treated for acute myeloid leukemia in our hospital between 1978 and 2007
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 92 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Acute myeloid leukemia in adults treated in the University of Sao Paulo between 1978 and 2007
Inclusion Criteria:
- clinical diagnosis of acute myeloid leukemia
- age 18 years or above
- must have been treated with potentially curative therapy
Exclusion Criteria:
- children or age less than 18 years
- palliative therapy
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Murilo Chermont Azevedo, University of Sao Paulo, General Hospital |
| ClinicalTrials.gov Identifier: | NCT01034839 History of Changes |
| Other Study ID Numbers: | mcazevedo01 |
| Study First Received: | December 16, 2009 |
| Last Updated: | December 16, 2009 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo General Hospital:
|
acute myeloid leukemia prognosis cytarabine |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013