Title: Addition of bevacizumab to chemotherapy in acute myeloid leukemia at older age: a randomized phase 2 trial of the Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and the Swiss Group for Clinical Cancer Research (SAKK)
Authors: Ossenkoppele, Gert J ×
Stussi, Georg
Maertens, Johan
van Montfort, Kees
Biemond, Bart J
Breems, Dimitri
Ferrant, August
Graux, Carlos
de Greef, Georgine E
Halkes, C J M
Hoogendoorn, Mels
Hollestein, Rene M
Jongen-Lavrencic, Mojca
Levin, Mark D
van de Loosdrecht, Arjan A
van Marwijk Kooij, Marinus
van Norden, Yvette
Pabst, Thomas
Schouten, Harry C
Vellenga, Edo
Verhoef, Gregor E G
de Weerdt, Okke
Wijermans, Pierre
Passweg, Jakob R
Löwenberg, Bob #
Issue Date: Dec-2012
Publisher: W.B. Saunders
Series Title: Blood vol:120 issue:24 pages:4706-4711
Article number: 10.1182/blood-2012-04-420596
Abstract: An urgent need for new treatment modalities is emerging in elderly patients with acute myeloid leukemia (AML). We hypothesized that targeting VEGF might furnish an effective treatment modality in this population. Elderly patients with AML were randomly assigned in this phase 2 study (n = 171) to receive standard chemotherapy (3 + 7) with or without bevacizumab at a dose of 10 mg/kg intravenously at days 1 and 15. In the second cycle, patients received cytarabine 1000 mg/m(2) twice daily on days 1-6 with or without bevacizumab. The complete remission rates in the 2 arms were not different (65%). Event-free survival at 12 months was 33% for the standard arm versus 30% for the bevacizumab arm; at 24 months, it was 22% and 16%, respectively (P = .42). The frequencies of severe adverse events (SAEs) were higher in the bevacizumab arm (n = 63) compared with the control arm (n = 28; P = .043), but the percentages of death or life-threatening SAEs were lower in the bevacizumab arm (60% vs 75% of SAEs). The results of the present study show that the addition of bevacizumab to standard chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR904 in The Nederlands Trial Register (
ISSN: 0006-4971
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Cell and Gene Therapy Applications (-)
× corresponding author
# (joint) last author

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