title: Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin.
abstract: We report the results of a prospective, randomized phase 3 trial evaluating the use of gemtuzumab ozogamicin (GO) in an intensive consolidation approach in 657 patients 17-60 years of age. Patients in first complete remission (CR1) after cytarabine and standard- or high-dose daunorubicin induction received 2 cycles of consolidation with high-dose cytarabine followed by peripheral blood progenitor cell collection. The 352 patients who entered consolidation were randomized to receive GO (n = 132) or not (n = 138) and then proceeded to autologous hematopoietic cell transplantation (HCT). GO was given to 67 patients. Median follow-up was 50.9 months. Results of the intention-to-treat analysis demonstrated a 4-year disease-free survival (DFS) of 33.6% versus 35.9% (P = .54) and an overall survival (OS) of 41.3% versus 41.9% (P = .52) for those randomized to receive GO versus no GO, respectively. Patients with favorable- and intermediate-risk acute myeloid leukemia (AML) treated with high-dose daunorubicin and autologous HCT had 4-year DFS rates of 60% and 40% and OS rates of 80% and 49.3%, respectively. For younger AML patients in CR1, autologous HCT should be considered in favorable- and intermediate-cytogenetic risk patients who do not have an allogeneic donor. The addition of a single dose of GO in this setting did not improve outcomes.
authors.affiliation: Moffitt Cancer Center and Research Institute, 12902 Magnolia Dr., Tampa, FL 33612, USA. hugo.fernandez@moffitt.org
authors.forename: Hugo F
authors.initials: HF
authors.lastname: Fernandez
authors.forename: Zhuoxin
authors.initials: Z
authors.lastname: Sun
authors.forename: Mark R
authors.initials: MR
authors.lastname: Litzow
authors.forename: Selina M
authors.initials: SM
authors.lastname: Luger
authors.forename: Elisabeth M
authors.initials: EM
authors.lastname: Paietta
authors.forename: Janis
authors.initials: J
authors.lastname: Racevskis
authors.forename: Gordon
authors.initials: G
authors.lastname: Dewald
authors.forename: Rhett P
authors.initials: RP
authors.lastname: Ketterling
authors.forename: Jacob M
authors.initials: JM
authors.lastname: Rowe
authors.forename: Hillard M
authors.initials: HM
authors.lastname: Lazarus
authors.forename: Martin S
authors.initials: MS
authors.lastname: Tallman
mesh_terms: D000293:Adolescent; D000328:Adult; D000617:Aminoglycosides / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015703:Antigens, CD / Q000378:metabolism; D015214:Antigens, Differentiation, Myelomonocytic / Q000378:metabolism; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D020732:Cytogenetic Analysis; D018572:Disease-Free Survival; D005260:Female; D000079982:Gemtuzumab; D005819:Genetic Markers; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D053208:Kaplan-Meier Estimate; D015470:Leukemia, Myeloid, Acute / Q000235:genetics / Q000276:immunology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual / Q000628:therapy; D011446:Prospective Studies; D012307:Risk Factors; D063268:Sialic Acid Binding Ig-like Lectin 3; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D015703:Antigens, CD; D015214:Antigens, Differentiation, Myelomonocytic; D000970:Antineoplastic Agents; C571163:CD33 protein, human; D005819:Genetic Markers; D063268:Sialic Acid Binding Ig-like Lectin 3; D000079982:Gemtuzumab