Addition of bevacizumab to chemotherapy in acute myeloid leukemia at older age: a randomized phase II trial of HOVON/SAKK
Mené sur 171 patients âgés atteints d'une leucémie myéloïde aiguë, cet essai de phase II évalue, du point de vue du taux de réponse complète, l'ajout de bevacizumab à une chimiothérapie de référence
An urgent need for new treatment modalities is emerging in patients with elderly AML. We hypothesized that targeting VEGF might furnish an effective treatment modality in AML. Elderly patients with AML or RAEB and an IPSS of 1.5 or higher were randomly assigned in this Phase II study (n=171) to receive standard chemotherapy (3+7) with or without bevacizumab at adose of 10 mg/kg iv in 60 minutes at days 1 and 15. In the second cycle patients received cytarabine 1000 mg/m2 twice daily on days 1- 6 plus or minus bevacizumab. The primary endpoint was CR. The CR rates in both arms were not different (65%). The EFS at 12 months was 33% for the standard arm vs 30% for the bevacizumab arm and at 24 months 22% vs 16% (p=0.42). The frequencies of severe AEs (SAE) were higher in the bevacizumab arm (63) as compared to the control arm (28; p=0.043), but the percentages of death or life threatening SAEs were lower in the bevacizumab arm (60% vs 75% of SAEs). Although it is feasible the addition of bevacizumab to standard chemotherapy does not improve the therapeutic outcome of AML at older age. (NTR904 www.trialregister.nl)