Send to

Choose Destination
See comment in PubMed Commons below
J Clin Oncol. 2013 Dec 10;31(35):4424-30. doi: 10.1200/JCO.2013.49.0771. Epub 2013 Oct 14.

Sequential combination of gemtuzumab ozogamicin and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia: results of a randomized phase III trial by the EORTC and GIMEMA consortium (AML-17).

Author information

Sergio Amadori and Adriano Venditti, Tor Vergata University Hospital; Paolo De Fabritiis, St Eugenio Hospital; Roberto Latagliata, University Sapienza; Paola Fazi and Marco Vignetti, Gruppo Italiano Malattie Ematologiche dell'Adulto, Roma; Franca Falzetti, University Hospital, Perugia; Domenico Magro, Pugliese Hospital, Catanzaro; Giorgina Specchia, University Hospital, Bari, Italy; Stefan Suciu and Matthias Karrasch, European Organisation for Research and Treatment of Cancer, Brussels; Dominik Selleslag, Algemeen Ziekenhuis St Jan, Brugge; Zwi Berneman, University Hospital, Antwerp, Belgium; Roberto Stasi, St George's Hospital, London, United Kingdom; Helmut R. Salih, University Hospital, Tubingen; Anthony D. Ho, University Hospital, Heidelberg; Michael Lübbert, Albert Ludwigs University, Freiburg, Germany; Petra Muus and Theo de Witte, Radboud University Medical Centre, Nijmegen; Constantijn J.M. Halkes and Roel Willemze, University Medical Center, Leiden, the Netherlands; Xavier Thomas, Edouard Herriot Hospital, Lyon; Jean-Pierre Marie, St. Antoine Hospital, Paris, France; and José E. Guimaraes, University Hospital, Porto, Portugal.



This randomized trial evaluated the efficacy and toxicity of sequential gemtuzumab ozogamicin (GO) and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia (AML).


Patients (n = 472) age 61 to 75 years were randomly assigned to induction chemotherapy with mitoxantrone, cytarabine, and etoposide preceded, or not, by a course of GO (6 mg/m(2) on days 1 and 15). In remission, patients received two consolidation courses with or without GO (3 mg/m(2) on day 0). The primary end point was overall survival (OS).


The overall response rate was comparable between the two arms (GO, 45%; no GO, 49%), but induction and 60-day mortality rates were higher in the GO arm (17% v 12% and 22% v 18%, respectively). With median follow-up of 5.2 years, median OS was 7.1 months in the GO arm and 10 months in the no-GO arm (hazard ratio, 1.20; 95% CI, 0.99 to 1.45; P = .07). Other survival end points were similar in both arms. Grade 3 to 4 hematologic and liver toxicities were greater in the GO arm. Treatment with GO provided no benefit in any prognostic subgroup, with the possible exception of patients age < 70 years with secondary AML, but outcomes were significantly worse in the oldest age subgroup because of a higher risk of early mortality.


As used in this trial, the sequential combination of GO and standard chemotherapy provides no benefit for older patients with AML and is too toxic for those age ≥ 70 years.


[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons


    Supplemental Content

    Full text links

    Icon for Atypon
    Loading ...
    Support Center