title: Fractionated gemtuzumab ozogamicin combined with intermediate-dose cytarabine and daunorubicin as salvage therapy in very high-risk AML patients: a bridge to reduced intensity conditioning transplant?
abstract: Outcome of patients with primary refractory/relapsed (R/R) acute myeloid leukemia (AML) remains dismal. Herein, we present a retrospective monocentric study of 24 very high-risk AML patients who received a combination of fractionated gemtuzumab ozogamicin (GO) with intermediate-dose cytarabine and daunorubicin as salvage therapy. Median age was 55.3 years. Diagnostic was secondary AML for 33% of them. Seven patients had favorable risk, 8 had intermediate-1 or intermediate-2, and 6 had unfavorable risk of AML according to the European LeukemiaNet prognostic index. Complete remission was achieved in 50% of cases (46% in refractory and 55% in relapsed AML) without excessive toxicity. Thirteen patients could be referred for transplant. Only allogeneic hematopoietic stem cell transplantation provided a benefit in this patient cohort with a 1-year overall survival of 50.7 versus 18.1% in the absence of transplantation. Patients treated with reduced intensity conditioning (RIC) showed a longer survival as compared to those undergoing myeloablative conditioning regimen mainly because of decreased toxicity.Our data suggest that salvage therapy with fractionated GO combined with intermediate-dose cytarabine and daunorubicin in very high-risk patients may serve as a potential bridge therapy to RIC transplant.
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France. etienne.paubelle@chu-lyon.fr.|Faculté de Médecine Lyon-Sud Charles Mérieux, Université de Lyon, Pierre Bénite, France. etienne.paubelle@chu-lyon.fr.
authors.forename: Etienne
authors.initials: E
authors.lastname: Paubelle
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Ducastelle-Leprêtre
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Labussière-Wallet
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France.|INSERM U1052, Centre de Recherche de Cancérologie de Lyon, Lyon, France.
authors.forename: Franck Emmanuel
authors.initials: FE
authors.lastname: Nicolini
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France.
authors.forename: Fiorenza
authors.initials: F
authors.lastname: Barraco
authors.affiliation: Department of Biology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Bénite, France.
authors.forename: Adriana
authors.initials: A
authors.lastname: Plesa
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Salles
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France.|Faculté de Médecine Lyon-Sud Charles Mérieux, Université de Lyon, Pierre Bénite, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Wattel
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495-cedex, Pierre-Bénite, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
mesh_terms: D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D015331:Cohort Studies; D003561:Cytarabine / Q000008:administration & dosage*; D003630:Daunorubicin / Q000008:administration & dosage*; D005260:Female; D000079982:Gemtuzumab; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D016879:Salvage Therapy / Q000379:methods*; D019172:Transplantation Conditioning / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D003561:Cytarabine; D000079982:Gemtuzumab; D003630:Daunorubicin
keywords: Acute myeloid leukemia; Bridge to allogeneic stem cell transplantation; Gemtuzumab ozogamicin; Refractory; Relapse; Salvage