title: Mobilization-driven postconsolidation therapy in elderly patients with acute myeloid leukemia: feasibility and efficacy of autologous stem cell transplantation versus low-dose gemtuzumab ozogamicin.
abstract: We prospectively evaluated 2 postconsolidation strategies, administered according to the mobilization outcome, in 72 acute myeloid leukemia (AML) fit elderly patients, achieving complete remission after the first high-dose cytarabine-based induction. Autologous stem cell transplantation (ASCT) was performed in patients collecting ≥3 × 10(6) CD34(+)/kg and low-dose gemtuzumab ozogamicin (GO) was performed in poor mobilizers (collecting <3 × 10(6) CD34(+)/kg). Fifty-five patients (76.3%) underwent peripheral blood stem cell (PBSC) mobilization, after first consolidation, and 24 of 55 (44%) collected >3 × 10(6) CD34(+) cells/kg. Among the 55 patients eligible for PBSC mobilization, 7 did not receive the planned treatment, 23 were allocated for ASCT, and 25 were allocated for GO on an intention-to-treat basis. With a median follow-up of 70 months (range, 24 to 124), 20 of 55 patients are alive, 18 of them in continuous complete remission. The 8-year overall survival (OS) and disease-free survival (DFS) are, respectively, 35.9% (95% confidence interval [CI] 24% to 49.8%) and 31.2% (95% CI, 21% to 43.8%), median OS and DFS were 22 and 16 months, respectively. In multivariate analysis, postconsolidation treatment and hyperleukocytosis (WBC > 50,000/μL) significantly predicted OS and DFS, whereas secondary AML was significantly associated with a higher relapse rate (83.4% versus 54% of de novo AML). Patients with hyperleukocytosis had 0% 3-year OS versus the 46% (at 8 years) in patients without hyperleukocytosis (P = .01); 57% of patients in the GO arm are alive at 8 years, compared with 25.4% of patients in the ASCT arm, who had an overall relative risk (RR) of death of 2.6 (95% CI, 1.2 to 5.8; P = .02). DFS at 8 years was 45.3% in patients receiving GO, compared with 26% in ASCT arm (RR, 2.1; 95% CI, 1 to 4.3; P = .05). Our study outlines low feasibility and efficacy of ASCT in elderly AML patients, whereas postconsolidation with GO appears safe and effective in this unfavorable setting. The study was registered at Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Debora
authors.initials: D
authors.lastname: Capelli
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Chiarucci
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Poloni
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Saraceni
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Mancini
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Trappolini
authors.affiliation: Hematology Department, Ospedale Mazzoni, Ascoli Piceno, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Troiani
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Montanari
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Scortechini
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Rupoli
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Scortechini
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Gini
authors.affiliation: Cytogenetic Laboratory, Ospedale Salesi, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Discepoli
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
authors.affiliation: Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy. Electronic address: attiliolivieri@inwind.it.
authors.forename: Attilio
authors.initials: A
authors.lastname: Olivieri
mesh_terms: D000617:Aminoglycosides / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D000079982:Gemtuzumab; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011446:Prospective Studies; D019172:Transplantation Conditioning / Q000379:methods*
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000079982:Gemtuzumab
keywords: Acute myeloid leukemia; Autologous transplantation; Gemtuzumab ozogamicin