title: Efficacy and safety of gemtuzumab ozogamicin in patients with poor-prognosis acute myeloid leukemia.
abstract: The objective of this work was to determine the safety and efficacy of gemtuzumab ozogamicin in patients with poor prognosis acute myeloid leukemia (AML). Patients with the following diagnoses/characteristics were treated with 1-3 infusions of gemtuzumab ozogamicin at a dose of 9 mg/m2: (1) relapse of AML < or = 6 months of first complete remission (CR); (2) AML refractory to chemotherapy at initial induction or at first relapse; (3) AML in second or greater relapse; (4) myeloid blast crisis of chronic myeloid leukemia (CML); (5) untreated patients > or = 70 years or > or = 55 years with abnormal cytogenetics (excluding inv 16, t(15;17) and t(8;21)) and/or an antecedent hematologic disorder; (6) refractory anemia with excess blasts in transformation (RAEBT). Forty-three patients, ages 19-84 (mean 62), were treated, including 7 patients with untreated AML age > 70 years, 2 with untreated RAEBT, 14 with AML first salvage (first remission 0-6 months), 15 with AML > or = second salvage and 14 with myeloid blast phase of CML. The overall response rate was 14%, with 4/43 (9%) patients achieving CR and 2/43 (5%) achieving CR without platelet recovery. The most significant toxicity was neutropenic fever, which occurred in 84% of patients. In conclusion, in patients with relapsed/refractory AML, gemtuzumab ozogamicin has a comparable response rate to single-agent chemotherapy and may offer a more favorable toxicity profile.
authors.affiliation: Division of Hematology and Oncology, Weill Medical College of Cornell University and The New York Presbyterian Hospital, New York, NY 10021, USA. gar2001@med.cornell.edu
authors.forename: G J
authors.initials: GJ
authors.lastname: Roboz
authors.forename: M A
authors.initials: MA
authors.lastname: Knovich
authors.forename: R L
authors.initials: RL
authors.lastname: Bayer
authors.forename: M W
authors.initials: MW
authors.lastname: Schuster
authors.forename: K
authors.initials: K
authors.lastname: Seiter
authors.forename: B L
authors.initials: BL
authors.lastname: Powell
authors.forename: R D
authors.initials: RD
authors.lastname: Woodruff
authors.forename: R T
authors.initials: RT
authors.lastname: Silver
authors.forename: A E
authors.initials: AE
authors.lastname: Frankel
authors.forename: E J
authors.initials: EJ
authors.lastname: Feldman
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000633:toxicity; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000633:toxicity; D061067:Antibodies, Monoclonal, Humanized; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D007951:Leukemia, Myeloid / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012074:Remission Induction; D018570:Risk Assessment; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000079982:Gemtuzumab