title: Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups.
abstract: The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients >60 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9 mg/m2 as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8-32%). The CR/CRp rate in patients 61-75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61-75 years than in older individuals (P=0.05), and in CD33+ cases than in CD33- cases (P=0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.
authors.affiliation: Department of Hematology, University Tor Vergata, Rome, Italy. mc7673@mclink.it
authors.forename: S
authors.initials: S
authors.lastname: Amadori
authors.forename: S
authors.initials: S
authors.lastname: Suciu
authors.forename: R
authors.initials: R
authors.lastname: Stasi
authors.forename: R
authors.initials: R
authors.lastname: Willemze
authors.forename: F
authors.initials: F
authors.lastname: Mandelli
authors.forename: D
authors.initials: D
authors.lastname: Selleslag
authors.forename: C
authors.initials: C
authors.lastname: Denzlinger
authors.forename: P
authors.initials: P
authors.lastname: Muus
authors.forename: R
authors.initials: R
authors.lastname: Stauder
authors.forename: Z
authors.initials: Z
authors.lastname: Berneman
authors.forename: J
authors.initials: J
authors.lastname: Pruijt
authors.forename: F
authors.initials: F
authors.lastname: Nobile
authors.forename: V
authors.initials: V
authors.lastname: Cassibba
authors.forename: J-P
authors.initials: JP
authors.lastname: Marie
authors.forename: F
authors.initials: F
authors.lastname: Beeldens
authors.forename: L
authors.initials: L
authors.lastname: Baila
authors.forename: M
authors.initials: M
authors.lastname: Vignetti
authors.forename: T
authors.initials: T
authors.lastname: de Witte
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D005260:Female; D016330:Frail Elderly; D000079982:Gemtuzumab; D006801:Humans; D000922:Immunotoxins / Q000627:therapeutic use*; D007951:Leukemia, Myeloid / Q000145:classification / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000922:Immunotoxins; D000079982:Gemtuzumab