title: Continuous infusion idarubicin and intravenous busulphan as conditioning regimen to autologous stem cell transplantation for patients with acute myeloid leukaemia.
abstract: The current study aimed to evaluate the efficacy and toxicity of a combination of intravenous (iv) busulfan (Bu) and continuous infusion Idarubicin (IDA) as a conditioning regimen to autologous haematopoietic stem cell transplantation (ASCT) in patients with acute myeloid leukaemia (AML). The protocol included IDA at 20 mg/sqm daily as 3 days continuous infusion (from day -13 to -11) and intravenous BU at 3.2 mg/kg daily from day -5 to -2. Patients aged over 60 years received a reduced schedule (2 days IDA and 3 days BU at the same dose). Twenty-five patients with a median age of 51 years (28-72) were enrolled. All patients received peripheral blood stem cells (PBSC). The median interval between diagnosis and ASCT was 4 months. The median number of CD34+ cells infused was 5.9 x 10E6/kg. The median number of days to PMN >500/cmm and platelets >20000/cmm was 10 and 13, respectively. In order to perform a comparison in terms of haematological and non haematological toxicity, a group of 30 patients, who were previously autografted after conditioning with IDA and oral Bu was considered. Selection of factors for a matched pair analysis included median age, percentage of subjects aged over 60 years, median CD34+ cell received, cytogenetic and molecular findings and per cent of secondary AML. As compared to previous series, the occurrence of severe mucositis was dramatically reduced (80% vs. 12%, p < 0.0001). In addition, need and duration of total parenteral nutrition (TPN), iv antibiotic therapy and hospitalization were also significantly reduced. We conclude that replacement of oral with intravenous BU results in a more favourable toxicity profile. A longer follow-up is required to assess a potential advantage in terms of disease free survival (DFS).
authors.affiliation: Division of Hematology and Stem Cell Transplantation Unit, Cardarelli Hospital, Napoli, Italy. felicettoferrara@katamail.com
authors.forename: Felicetto
authors.initials: F
authors.lastname: Ferrara
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Mele
authors.forename: Salvatore
authors.initials: S
authors.lastname: Palmieri
authors.forename: Mariangela
authors.initials: M
authors.lastname: Pedata
authors.forename: Carolina
authors.initials: C
authors.lastname: Copia
authors.forename: Cira
authors.initials: C
authors.lastname: Riccardi
authors.forename: Tiziana
authors.initials: T
authors.lastname: Izzo
authors.forename: Clelia
authors.initials: C
authors.lastname: Criscuolo
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002066:Busulfan / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000009:adverse effects; D007262:Infusions, Intravenous; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D033581:Stem Cell Transplantation / Q000379:methods*; D019172:Transplantation Conditioning / Q000379:methods*; D014182:Transplantation, Autologous / Q000379:methods; D055815:Young Adult
chemical_list: D002066:Busulfan; D015255:Idarubicin