title: Adding low-dose gemtuzumab ozogamicin to fludarabine, Ara-C and idarubicin (MY-FLAI) may improve disease-free and overall survival in elderly patients with non-M3 acute myeloid leukaemia: results of a prospective, pilot, multi-centre trial and comparison with a historical cohort of patients.
abstract: We report the final results of a prospective multi-centre trial testing the combination of chemotherapy (fludarabine, cytosine arabinoside and idarubicin; FLAI) followed by low-dose gemtuzumab ozogamicin (GO), for induction treatment of patients with CD33+ acute myeloid leukaemia (AML). Forty-six consecutive patients were treated: the median age was 66 (range: 60-80) years; the karyotype was unfavourable in 12 patients (26%), intermediate in 33 (71%) and favourable in one (3%). Eleven major infectious complications were recorded. There was one early death. Of the 45 evaluable patients, 24 achieved a complete response (CR; 52%), 66% and 33% in good-intermediate/poor karyotype patients. Median duration of CR was 7 (3-24) months. The cumulative incidence of relapse was 37% with an actuarial 2-year survival of 54%. These results were compared with 47 patients matched for age and karyotype who received FLAI, without GO. The proportion of patients achieving CR was comparable. However, patients with de novo AML receiving GO (n = 26) had a significantly lower risk of relapse at 2 years when compared with patients not receiving GO (n = 35) (40% vs. 80%, P = 0.01) and significantly better overall 2-year survival (40% vs. 14%P = 0.02). Patients with secondary AML had comparable outcome whether or not they received GO. This GO-based induction chemotherapy has a good toxicity profile. In keeping with a recent prospective randomised trial, the addition of GO seems to prolong disease-free survival.
authors.affiliation: Department of Haematology and Oncology, University of Genova and S. Martino Hospital, Genova, Italy.
authors.forename: Marino
authors.initials: M
authors.lastname: Clavio
authors.forename: Luana
authors.initials: L
authors.lastname: Vignolo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Albarello
authors.forename: Riccardo
authors.initials: R
authors.lastname: Varaldo
authors.forename: Ivana
authors.initials: I
authors.lastname: Pierri
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Catania
authors.forename: Manuela
authors.initials: M
authors.lastname: Balocco
authors.forename: Gianluca
authors.initials: G
authors.lastname: Michelis
authors.forename: Maurizio
authors.initials: M
authors.lastname: Miglino
authors.forename: Annunziata
authors.initials: A
authors.lastname: Manna
authors.forename: Enrico
authors.initials: E
authors.lastname: Balleari
authors.forename: A Michele
authors.initials: AM
authors.lastname: Carella
authors.forename: Mario
authors.initials: M
authors.lastname: Sessarego
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Van Lint
authors.forename: Andrea
authors.initials: A
authors.lastname: Bacigalupo
authors.forename: Marco
authors.initials: M
authors.lastname: Gobbi
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003561:Cytarabine / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010865:Pilot Projects; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D003561:Cytarabine; D000079982:Gemtuzumab; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin