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)

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; ... (2012). 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). Blood, 120(24), pp. 4706-11. Washington, D.C.: American Society of Hematology 10.1182/blood-2012-04-420596

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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).

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology
UniBE Contributor:	Pabst, Thomas Niklaus
ISSN:	0006-4971
Publisher:	American Society of Hematology
Language:	English
Submitter:	Factscience Import
Date Deposited:	04 Oct 2013 14:36
Last Modified:	02 Mar 2023 23:21
Publisher DOI:	10.1182/blood-2012-04-420596
PubMed ID:	23047822
Web of Science ID:	000313115300012
URI:	https://boris.unibe.ch/id/eprint/14277 (FactScience: 221153)