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Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With Acute Myeloid Leukemia

18 Years
92 Years
Not Enrolling
Acute Myeloid Leukemia

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Trial Information

Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With 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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Overall survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Pedro ED Llacer, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

University of Sao Paulo


Brazil: Ethics Committee

Study ID:




Start Date:

January 2006

Completion Date:

December 2009

Related Keywords:

  • Acute Myeloid Leukemia
  • acute myeloid leukemia
  • prognosis
  • cytarabine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid