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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).

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1
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.

Abstract

PURPOSE:

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 AND METHODS:

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).

RESULTS:

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.

CONCLUSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00052299.

PMID:
24127442
DOI:
10.1200/JCO.2013.49.0771
[Indexed for MEDLINE]
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