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)

• Published in: Blood Vol. 120; no. 24; pp. 4706 - 4711
• Main 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
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 06-12-2012; Americain Society of Hematology
• Subjects: Acute Disease; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Belgium; Bevacizumab; Biological and medical sciences; Biomedical Research; Disease-Free Survival; Drug Administration Schedule; Female; Hematologic and hematopoietic diseases; Hematologic Neoplasms - diagnosis; Hematologic Neoplasms - therapy; Humans; International Cooperation; Length of Stay; Leukemia, Myeloid - drug therapy; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Male; Medical sciences; Middle Aged; Netherlands; Remission Induction; Switzerland; Time Factors; Treatment Outcome; Netherlands; Belgium; Switzerland; Europe; Human; Antineoplastic agent; Acute myelogenous leukemia; Hematology; Clinical research; Malignant hemopathy; Monoclonal antibody; Malignant tumor; Bevacizumab; Chemotherapy; Randomization; Treatment; Cancerology; Vascular endothelium growth factor; Phase II trial; Clinical trial; Antiangiogenic agent; Elderly; Age; Cancer
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2012-04-420596

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/m2 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).