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Bending the Curve Trial by Trial
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Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia

Phase 3N = 113

Population
Elderly patients (median age 70 years) with WHO-defined AML and a low bone marrow blast count (20% to 30%); 86% considered unfit for intensive chemotherapy
Design
Analysis of the subgroup of a phase 3 randomized trial (azacitidine versus conventional care regimens in intermediate-2 and high-risk myelodysplastic syndromes) whose patients met WHO criteria for AML (20% to 30% marrow blasts). Conventional care regimens: best supportive care only, low-dose cytarabine, or intensive chemotherapy. Registry number of the parent trial is not stated in the abstract.
Arms
  • Azacitidine (experimental, n = 55): Subcutaneous azacitidine 75 mg/m2 per day
  • Conventional care regimens (control, n = 58): Best supportive care only (47%), low-dose cytarabine (34%) or intensive chemotherapy (19%)
People
Fenaux P
OSHR 0.47 (95% CI 0.28–0.79)Δ median OS+8.5 monthsΔ 24-month OS+34 points
Show the numbers
Results reported for Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia
EndpointAnalysisAzacitidineConventional care regimensEffect
OSAML subgroup (WHO criteria, 20% to 30% marrow blasts), n = 113exploratorymedian follow-up 20.1 monthsFenaux 2010median 24.5 monthsmedian 16 monthsHR 0.47 (95% CI 0.28–0.79)P=.005Subgroup analysis of a trial designed in myelodysplastic syndromes.
OSAML subgroup (WHO criteria, 20% to 30% marrow blasts), n = 113exploratoryFenaux 201050% at 2 y16% at 2 yP=.001
Results reported for Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia
EndpointAnalysisAzacitidineConventional care regimensEffect
OSAML subgroup (WHO criteria, 20% to 30% marrow blasts), n = 113exploratorymedian follow-up 20.1 monthsFenaux 2010median 24.5 monthsmedian 16 monthsHR 0.47 (95% CI 0.28–0.79)P=.005Subgroup analysis of a trial designed in myelodysplastic syndromes.
OSAML subgroup (WHO criteria, 20% to 30% marrow blasts), n = 113exploratoryFenaux 201050% at 2 y16% at 2 yP=.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.470.28–0.79
Illustrative — modelled from reported values, not trial data. OS, exploratory.
0%25%50%75%100%0102030405060Months (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%
1565.4%52.2%
3141.6%26.1%
4627.2%13.6%
6117.8%7.1%
Primary publication: Fenaux P, Mufti GJ, Hellström-Lindberg E, Santini V, Gattermann N, Germing U, et al. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010;28(4):562-9. PubMedDOI

Appears in

Sources

  1. Fenaux P, Mufti GJ, Hellström-Lindberg E, Santini V, Gattermann N, Germing U, et al. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010;28(4):562-9.

    PubMedDOI