A phase III study of gemtuzumab ozogamicin during induction and post-consolidation therapy in younger patients with acute myeloid leukemia.

Publication Type:

Journal Article

Source:

Blood (2013)

Keywords:

2013, Clinical Research Division, May 2013, Public Health Sciences Division

Abstract:

This randomized phase III clinical trial evaluated the potential benefit of the addition of gemtuzumab ozogamicin (GO) to standard induction and post-consolidation therapy in patients with acute myeloid leukemia. Patients were randomized to receive daunorubicin (45 mg/m(2)/day on days 1,2,3) and cytarabine (100 mg/m(2)/day by continuous infusion (CI) days 1-7) and GO (6 mg/m(2) day 4) (DA+GO) versus standard induction therapy with daunorubicin (60 mg/m(2)/day on days 1,2,3) and cytarabine alone (DA). Patients who achieved a complete remission (CR) received 3 courses of high dose cytarabine. Those remaining in CR after consolidation were randomized to receive no additional therapy versus 3 doses of GO (5 mg/m(2) every 28 days). From August, 2004, until August, 2009, 637 patients were registered for induction. The CR rate was 69% for DA+GO and 70% for DA, p=0.59. Among those who achieved a CR, the 5 yr relapse-free survival rate was 43% in the DA+GO arm and 42% in the DA arm (p=0.40). The 5 yr overall survival (OS) was 46% in the DA+GO arm and 50% in the DA arm (p=0.85). One hundred seventy-four patients in CR after consolidation underwent the post-consolidation randomization. Disease-free survival (DFS) was not improved with post-consolidation GO (HR=1.48, p=0.97). In this study, the addition of GO to induction or post-consolidation therapy failed to show improvement in CR rate, DFS or OS. This trial is registered with ClinicalTrials.gov. Identifier: NCT00085709.