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)

Gert Jan Ossenkoppele*, Georg Stussi, Johan Maertens, Kees van Montfort, Bart J. Biemond, Dimitri Breems, August Ferrant, Carlos Graux, Georgine E. de Greef, C. J. M. Halkes, Mels Hoogendoorn, Rene M. Hollestein, Mojca Jongen-Lavrencic, Mark-David Levin, Arjan A. van de Loosdrecht, Marinus van Marwijk Kooij, Yvette van Norden, Thomas Pabst, Harry C. Schouten, Edo VellengaGregor E. G. Verhoef, Okke de Weerdt, Pierre Wijermans, Jakob R. Passweg, Bob Lowenberg

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

52 Citations (Web of Science)

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 (www.trialregister.nl).
Original languageEnglish
Pages (from-to)4706-4711
JournalBlood
Volume120
Issue number24
DOIs
Publication statusPublished - 6 Dec 2012

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