title: Gemtuzumab ozogamicin (GO) in relapsed/refractory patients with acute myeloid leukemia.
abstract: OBJECTIVE
  Gemtuzumab ozogamicin (GO) is a humanized anti-CD33 antibody, linked to calicheamicin, which has been approved in Japan recently. We conducted to evaluate the efficacy and toxicity of GO in our patients with relapsed or refractory AML retrospectively.
  
  
  METHODS
  Data were collected between March 1, 2000, and March 1, 2006, on 10 patients with relapsed or refractory AML(excluding FAB: M3). Scheduled treatment was two doses of GO monotherapy, 14-28 days apart.
  
  
  RESULTS
  Of the 10 assessable patients, two patients achieved CR. CR duration of one patient lasted for 52 months with post-remission treatment. Grade 4 neutropenia occurred in 9 patients, and the incidence of grade 3 or 4 thrombocytopenia was 100%, with no severe bleeding events. Two patients developed infusion-related adverse events that included grade 3 allergic reaction with shock status. Liver damage (grade 3 or 4) were observed in 40% of patients after GO treatment. No patient developed hepatic veno-occlusive disease including 2 patients who underwent HSCT.
  
  
  CONCLUSIONS
  GO is a valuable new treatment option for relapsed or refractory AML patients, however, the benefit from single agent appears insufficient. On going clinical trials including combination with other antileukemic agents might better define the role of GO.
authors.affiliation: Department of Oncology and Hematology, Jikei University School of Medicine, Komae-shi, Tokyo, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Yamaguchi
authors.forename: Noriko
authors.initials: N
authors.lastname: Usui
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Dobashi
authors.forename: Shingo
authors.initials: S
authors.lastname: Yano
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Yahagi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takei
authors.forename: Katsunori
authors.initials: K
authors.lastname: Sugiyama
authors.forename: Yoji
authors.initials: Y
authors.lastname: Ogasawara
authors.forename: Takeshi
authors.initials: T
authors.lastname: Saito
authors.forename: Jiro
authors.initials: J
authors.lastname: Minami
authors.forename: Tatsunosuke
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Katsube
authors.forename: Yutaro
authors.initials: Y
authors.lastname: Kamiyama
authors.forename: Tomohito
authors.initials: T
authors.lastname: Machishima
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Morikawa
authors.forename: Hiroko
authors.initials: H
authors.lastname: Otsubo
authors.forename: Ken
authors.initials: K
authors.lastname: Kaito
authors.forename: Osamu
authors.initials: O
authors.lastname: Asai
authors.forename: Keisuke
authors.initials: K
authors.lastname: Aiba
mesh_terms: D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D056486:Chemical and Drug Induced Liver Injury; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000079982:Gemtuzumab