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).
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).
authors.affiliation: Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands. g.ossenkoppele@vumc.nl
authors.forename: Gert J
authors.initials: GJ
authors.lastname: Ossenkoppele
authors.forename: Georg
authors.initials: G
authors.lastname: Stussi
authors.forename: Johan
authors.initials: J
authors.lastname: Maertens
authors.forename: Kees
authors.initials: K
authors.lastname: van Montfort
authors.forename: Bart J
authors.initials: BJ
authors.lastname: Biemond
authors.forename: Dimitri
authors.initials: D
authors.lastname: Breems
authors.forename: August
authors.initials: A
authors.lastname: Ferrant
authors.forename: Carlos
authors.initials: C
authors.lastname: Graux
authors.forename: Georgine E
authors.initials: GE
authors.lastname: de Greef
authors.forename: C J M
authors.initials: CJ
authors.lastname: Halkes
authors.forename: Mels
authors.initials: M
authors.lastname: Hoogendoorn
authors.forename: Rene M
authors.initials: RM
authors.lastname: Hollestein
authors.forename: Mojca
authors.initials: M
authors.lastname: Jongen-Lavrencic
authors.forename: Mark D
authors.initials: MD
authors.lastname: Levin
authors.forename: Arjan A
authors.initials: AA
authors.lastname: van de Loosdrecht
authors.forename: Marinus
authors.initials: M
authors.lastname: van Marwijk Kooij
authors.forename: Yvette
authors.initials: Y
authors.lastname: van Norden
authors.forename: Thomas
authors.initials: T
authors.lastname: Pabst
authors.forename: Harry C
authors.initials: HC
authors.lastname: Schouten
authors.forename: Edo
authors.initials: E
authors.lastname: Vellenga
authors.forename: Gregor E G
authors.initials: GE
authors.lastname: Verhoef
authors.forename: Okke
authors.initials: O
authors.lastname: de Weerdt
authors.forename: Pierre
authors.initials: P
authors.lastname: Wijermans
authors.forename: Jakob R
authors.initials: JR
authors.lastname: Passweg
authors.forename: Bob
authors.initials: B
authors.lastname: Löwenberg
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001530:Belgium; D000068258:Bevacizumab; D035843:Biomedical Research; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D019337:Hematologic Neoplasms / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D007391:International Cooperation; D007902:Length of Stay; D007951:Leukemia, Myeloid / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D012074:Remission Induction; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab