title: Induction therapy of AML with ara-C plus daunorubicin versus ara-C plus gemtuzumab ozogamicin: a randomized phase II trial in elderly patients.
abstract: BACKGROUND
  Chemotherapy for elderly patients with acute myeloid leukemia (AML) results in a median overall survival (OS) of ≤ 1 year. Elderly patients often present with cardiac comorbidity. Gemtuzumab ozogamicin (GO) is active in elderly (≥ 60 years) patients with relapsed AML with low cardiac toxicity.
  
  
  METHODS
  This randomized phase II study compared a standard combination of ara-C and daunorubicin (DNR; 7+3) versus ara-C plus gemtuzumab ozogamicin (7+GO) as the first course of induction therapy. Primary objectives were comparison of blast clearance on day 16, event-free survival (EFS), and remission duration. OS, complete remission (CR), and tolerability were secondary objectives.
  
  
  RESULTS
  One hundred and nineteen patients with de novo AML, treatment-related AML, AML with a history of myelodysplastic syndrome (MDS), or high-risk MDS entered the study. Median age of 115 patients (intent-to-treat population) was 69 years. Protocol outlined a second course 7+3 for patients without blast clearance and two courses of high-dose ara-C consolidation upon CR. Both treatments were equally effective in blast clearance, CR, EFS, remission duration, or OS (median: 7+3, 9 months; 7+GO, 10 months). Induction death rate was higher in the GO group due to veno-occlusive disease.
  
  
  CONCLUSIONS
  The study did not show significant superiority of 7+GO over standard 7+3.
authors.affiliation: Department of Medicine, Hematology and Oncology, University Hospital Frankfurt, Frankfurt, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Brunnberg
authors.forename: M
authors.initials: M
authors.lastname: Mohr
authors.forename: R
authors.initials: R
authors.lastname: Noppeney
authors.forename: H A
authors.initials: HA
authors.lastname: Dürk
authors.forename: M C
authors.initials: MC
authors.lastname: Sauerland
authors.forename: C
authors.initials: C
authors.lastname: Müller-Tidow
authors.forename: U
authors.initials: U
authors.lastname: Krug
authors.forename: S
authors.initials: S
authors.lastname: Koschmieder
authors.forename: T
authors.initials: T
authors.lastname: Kessler
authors.forename: R M
authors.initials: RM
authors.lastname: Mesters
authors.forename: C
authors.initials: C
authors.lastname: Schulz
authors.forename: M
authors.initials: M
authors.lastname: Kosch
authors.forename: T
authors.initials: T
authors.lastname: Büchner
authors.forename: G
authors.initials: G
authors.lastname: Ehninger
authors.forename: U
authors.initials: U
authors.lastname: Dührsen
authors.forename: H
authors.initials: H
authors.lastname: Serve
authors.forename: W E
authors.initials: WE
authors.lastname: Berdel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D060828:Induction Chemotherapy; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D003561:Cytarabine; D000079982:Gemtuzumab; D003630:Daunorubicin