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AZA-AML-001

International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts

Phase 3N = 488NCT01074047

Population
Newly diagnosed AML with more than 30% bone marrow blasts, age 65 years or older
Design
Multicenter, randomized (1:1), open-label phase 3 trial. Before randomization, a conventional care regimen (standard induction chemotherapy, low-dose cytarabine, or supportive care only) was preselected for each patient; patients assigned to conventional care received their preselected treatment. Primary end point: overall survival (full text, PMC4504945).
Primary endpoint
OS
Arms
  • Azacitidine (experimental, n = 241): Azacitidine
  • Conventional care regimens (control, n = 247): Preselected standard induction chemotherapy, low-dose cytarabine, or supportive care only
People
Dombret H
OSHR 0.85 (95% CI 0.69–1.03)Δ median OS+3.9 monthsΔ 12-month OS+12.3 pointsOSHR 0.76 (95% CI 0.60–0.96)Δ median OS+5.2 months
Show the numbers
Results reported for AZA-AML-001
EndpointAnalysisAzacitidineConventional care regimensEffect
OSITT (N = 488)primaryDombret 2015median 10.4 months (8.0–12.7)median 6.5 months (5.0–8.6)HR 0.85 (95% CI 0.69–1.03)P=.1009 (stratified log-rank)The abstract describes median OS as increased with azacitidine; the stratified log-rank test did not reach statistical significance at the .05 level.
OSITT (N = 488)primaryDombret 201546.5% at 12 mo34.2% at 12 moDifference 12.3% (95% CI 3.5% to 21.0%). One-year survival was a secondary end point (full text).
OSITT (N = 488), with censoring at subsequent AML treatmentexploratoryDombret 2015median 12.1 months (9.2–14.2)median 6.9 months (5.1–9.6)HR 0.76 (95% CI 0.60–0.96)P=.0190 (stratified log-rank)Prespecified analysis censoring patients who received AML treatment after discontinuing study drug, as the abstract describes.
Results reported for AZA-AML-001
EndpointAnalysisAzacitidineConventional care regimensEffect
OSITT (N = 488)primaryDombret 2015median 10.4 months (8.0–12.7)median 6.5 months (5.0–8.6)HR 0.85 (95% CI 0.69–1.03)P=.1009 (stratified log-rank)The abstract describes median OS as increased with azacitidine; the stratified log-rank test did not reach statistical significance at the .05 level.
OSITT (N = 488)primaryDombret 201546.5% at 12 mo34.2% at 12 moDifference 12.3% (95% CI 3.5% to 21.0%). One-year survival was a secondary end point (full text).
OSITT (N = 488), with censoring at subsequent AML treatmentexploratoryDombret 2015median 12.1 months (9.2–14.2)median 6.9 months (5.1–9.6)HR 0.76 (95% CI 0.60–0.96)P=.0190 (stratified log-rank)Prespecified analysis censoring patients who received AML treatment after discontinuing study drug, as the abstract describes.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.850.69–1.03
OS0.760.6–0.96
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Azacitidine (experimental)
  • Conventional care regimens (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAzacitidineConventional care regimens
0100.0%100.0%
762.7%47.4%
1342.0%25.0%
2026.4%11.9%
2617.7%6.3%
Illustrative — modelled from reported values, not trial data. OS, exploratory.
0%25%50%75%100%051015202530Months (modelled)
  • Azacitidine (experimental)
  • Conventional care regimens (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAzacitidineConventional care regimens
0100.0%100.0%
863.2%44.8%
1542.3%22.2%
2326.8%9.9%
3017.9%4.9%
Primary publication: Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015;126(3):291-9. PubMedDOI

Appears in

Sources

  1. Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015;126(3):291-9.

    PubMedDOI