title: De novo AML patients with favourable-intermediate karyotype may benefit from the addition of low-dose gemtuzumab ozogamicin (GO) to fludarabine, Ara-C and idarubicin (FLAI): a contribution to the reopened "GO question".
abstract: We report the final results of a prospective trial testing the combination of fludarabine, Ara-C and idarubicin (FLAI) followed by low-dose gemtuzumab ozogamicin (FLAI-GO) in 85 patients aged 60 years or more with CD33+ acute myeloid leukaemia (AML). Median age was 68 years (60-82); karyotype was unfavourable in 21 patients (24%), intermediate in 63 (74%) and favourable in 1 (2%). There were five therapy-related deaths. Of the 80 evaluable patients, 47 achieved complete response (CR) (58%); CR rates were 65 and 32% in good-intermediate/poor karyotype patients, respectively. Median length of CR was 7 months (3-76). The cumulative incidence of relapse was 84% with an actuarial survival of 50.3% at 1 year and 14.4% at 2 years. The study control population is an unselected consecutive historic cohort of 104 patients treated with the FLAI regimen, who were matched for age and prognostic factors. CR rates after FLAI-GO and FLAI were comparable. However, patients with de novo AML and intermediate-favourable karyotype receiving GO had a significantly lower risk of relapse at 2 years as compared to patients not receiving GO (n = 77) (40 vs 80%, p = 0.01) and significantly better disease-free survival (p = 0.018) and overall survival (p = 0.022).
authors.affiliation: Clinical Hematology, IRCCS AOU S. Martino-IST, Genoa, Italy. claviom@unige.it
authors.forename: Marino
authors.initials: M
authors.lastname: Clavio
authors.forename: Fabio
authors.initials: F
authors.lastname: Cruciani
authors.forename: Paola
authors.initials: P
authors.lastname: Minetto
authors.forename: Fabio
authors.initials: F
authors.lastname: Guolo
authors.forename: Filippo
authors.initials: F
authors.lastname: Ballerini
authors.forename: Carlo
authors.initials: C
authors.lastname: Marani
authors.forename: Enrico
authors.initials: E
authors.lastname: De Astis
authors.forename: Sara
authors.initials: S
authors.lastname: Aquino
authors.forename: Micaela
authors.initials: M
authors.lastname: Bergamaschi
authors.forename: Laura
authors.initials: L
authors.lastname: Mitscheunig
authors.forename: Raffaella
authors.initials: R
authors.lastname: Grasso
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Colombo
authors.forename: Chiara
authors.initials: C
authors.lastname: Ghiggi
authors.forename: Davide
authors.initials: D
authors.lastname: Lovera
authors.forename: Giordana
authors.initials: G
authors.lastname: Pastori
authors.forename: Daniele
authors.initials: D
authors.lastname: Avenoso
authors.forename: Maurizio
authors.initials: M
authors.lastname: Miglino
authors.forename: Marco
authors.initials: M
authors.lastname: Gobbi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003561:Cytarabine / Q000627:therapeutic use*; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D015255:Idarubicin / Q000627:therapeutic use*; D059785:Karyotype; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014740:Vidarabine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D003561:Cytarabine; D000079982:Gemtuzumab; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin