Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more: results of a multicenter phase 3 study

Bob Lowenberg*, Joachim Beck, Carlos Graux, Wim van Putten, Harry C. Schouten, Leo F. Verdonck, Augustin Ferrant, Pieter Sonneveld, Mojca Jongen-Lavrencic, Marie von Lilienfeld-Toal, Bart J. Biemond, Edo Vellenga, Dimitri Breems, Hilde de Muijnck, Ron Schaafsma, Gregor Verhoef, Hartmut Doehner, Alois Gratwohl, Thomas Pabst, Gert J. OssenkoppeleJohan Maertens, Dutch-Belgian Hematooncology Coope, German Austrian AML Study Grp, Clinical Canc Res Collaborative Gr

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

108 Citations (Scopus)

Abstract

In older patients with acute myeloid leukemia (AML), the prevention of relapse has remained one of the major therapeutic challenges, with more than 75% relapses after complete remission. The anti-CD33 immunotoxin conjugate gemtuzumab ozogamicin (GO) has shown antileukemic remission induction activity in patients with relapsed AML. Patients with AML or refractory anemia with excess blasts in first complete remission attained after intensive induction chemotherapy were randomized between 3 cycles of GO (6 mg/m(2) every 4 weeks) or no postremission therapy (control) to assess whether GO would improve outcome. The 2 treatment groups (113 patients receiving GO vs 119 control patients) were comparable with regard to age (60-78 years, median 67 years), performance status, and cytogenetics. A total of 110 of 113 received at least 1 cycle of GO, and 65 of 113 patients completed the 3 cycles. Premature discontinuation was mainly attributable to incomplete hematologic recovery or intercurrent relapse. Median time to recovery of platelets 50 x 10(9)/L and neutrophils 0.5 x 10(9)/L after GO was 14 days and 20 days. Nonhematologic toxicities were mild overall, but there was 1 toxic death caused by liver failure. There were no significant differences between both treatment groups with regard to relapse probabilities, nonrelapse mortality, overall survival, or disease-free survival (17% vs 16% at 5 years). Postremission treatment with GO in older AML patients does not provide benefits regarding any clinical end points. The HOVON-43 study is registered at The Netherlands Trial Registry (number NTR212) and at http://www.controlled-trials.com as ISRCTN77039377. (Blood. 2010;115(13):2586-2591)

Original languageEnglish
Pages (from-to)2586-2591
Number of pages6
JournalBlood
Volume115
Issue number13
DOIs
Publication statusPublished - 1-Apr-2010

Keywords

  • ACUTE MYELOID-LEUKEMIA
  • COLONY-STIMULATING FACTOR
  • ACUTE MYELOGENOUS LEUKEMIA
  • SOUTHWEST-ONCOLOGY-GROUP
  • LOW-DOSE CYTARABINE
  • OLDER PATIENTS
  • INDUCTION CHEMOTHERAPY
  • ELDERLY-PATIENTS
  • FINAL REPORT
  • EUROPEAN ORGANIZATION

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