title: Age related randomized comparison of sequentially applied high-dose versus intermediate dose cytosine arabinoside in combination with mitoxantrone (S-HAM) in the treatment of relapsed and refractory acute myeloid leukemia: study design and preliminary results.
abstract: In a prospective randomized trial, the pending question was addressed whether Cytosine arabinoside (Ara-C) should be applied at high or intermediate dose to patients with relapsed or refractory acute myeloid leukemia. Based upon the previously established regimen of the sequential application of Ara-C and Mitoxantrone (S-HAM) patients below 60 years of age were randomized to receive Ara-C at either 3.0 g/m2 vs 1.0 g/m2 per dose while older patients were randomly assigned to either 1.0 g/m2 or 0.5 g/m2 Ara-C. At the present early stage 51 patients have entered the study and 37 are currently evaluable for response and toxicity. Complete remissions were achieved in 14 of 28 patients below 60 years of age and in 3 of 8 older cases. Predominant side effects consisted of nausea and vomiting, diarrhea and stomatitis. Further recruitment of patients and longer follow-up is required for the assessment of the various treatment arms.
authors.affiliation: Medizinische Universitätsklinik, Münster, FRG.
authors.forename: W
authors.initials: W
authors.lastname: Hiddemann
authors.forename: C
authors.initials: C
authors.lastname: Aul
authors.forename: G
authors.initials: G
authors.lastname: Maschmeyer
authors.forename: B
authors.initials: B
authors.lastname: Lathan
authors.forename: H
authors.initials: H
authors.lastname: Köppler
authors.forename: R
authors.initials: R
authors.lastname: Hoffmann
authors.forename: T
authors.initials: T
authors.lastname: Grüneisen
authors.forename: R
authors.initials: R
authors.lastname: Donhuijsen-Ant
authors.forename: W D
authors.initials: WD
authors.lastname: Ludwig
authors.forename: L
authors.initials: L
authors.lastname: Balleisen
mesh_terms: D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003561:Cytarabine / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D011897:Random Allocation
chemical_list: D003561:Cytarabine; D008942:Mitoxantrone