title: Fractionated doses of gemtuzumab ozogamicin with escalated doses of daunorubicin and cytarabine as first acute myeloid leukemia salvage in patients aged 50-70-year old: a phase 1/2 study of the acute leukemia French association.
abstract: This Phase 1/2 study aimed to determine optimal doses of daunorubicin (DNR; mg/m(2)) and cytarabine (mg/m(2)) to be combined with fractionated doses of gemtuzumab ozogamicin (GO, Mylotarg(®); 3 mg/m(2) on day 1, 4, and 7) satisfying safety requirements. Three dose levels of DNR/AraC were investigated namely (45, 100), (60, 100), and (60, 200). Patients included were acute myeloid leukemia in first relapse, aged 50-70 years. Hematological recovery was 31 days for neutrophil and 32 days for platelet counts. A documented infectious episode > Grade 2 occurred in 11/20 patients (55%). None of the 20 patients had signs of veno-occlusive disease. Overall, eleven patients reached complete remission (CR), two CR with incomplete platelets recovery. The results showed that combination of fractionated GO doses with DNR at 60 mg/m(2)/d for 3 days and cytarabine at 200 mg/m(2)/d for 7 days is tolerable and could be further investigated in the front-line therapy.
authors.affiliation: Hopital de Versailles, Le Chesnay, France.
authors.forename: Hassan
authors.initials: H
authors.lastname: Farhat
authors.forename: Oumedaly
authors.initials: O
authors.lastname: Reman
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Celine
authors.initials: C
authors.lastname: Berthon
authors.forename: Cécile
authors.initials: C
authors.lastname: Pautas
authors.forename: Leila
authors.initials: L
authors.lastname: Kammoun
authors.forename: Sylvain
authors.initials: S
authors.lastname: Chantepie
authors.forename: Claude
authors.initials: C
authors.lastname: Gardin
authors.forename: Philippe
authors.initials: P
authors.lastname: Rousselot
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
authors.forename: Sylvie
authors.initials: S
authors.lastname: Castaigne
mesh_terms: D000368:Aged; 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; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D003561:Cytarabine; D000079982:Gemtuzumab; D003630:Daunorubicin