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Acute Non Lymphocytic Leukemia

Gemtuzumab ozogamicin (Mylotarg®) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups

Leukemia volume 19, pages 1768–1773 (2005)Cite this article

Abstract

The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients >60 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9?mg/m2 as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8–32%). The CR/CRp rate in patients 61–75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61–75 years than in older individuals (P=0.05), and in CD33+ cases than in CD33− cases (P=0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.

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Acknowledgements

This work was supported in part by grants from the Wyeth Pharmaceuticals and the National Cancer Institute (grant numbers 5U10-CA11488-29 through 5U10-CA11488-35). Its contents are solely the responsibility of the authors and do not represent the official views of the National Cancer Institute (Bethesda, MD, USA). We thank Dr Jay Feingold for his advice and support. The following investigators are acknowledged for their participation in this study: Dr G Fillet, Liège (Belgium), and Dr X Thomas (Lyon, France).

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Authors and Affiliations

  1. Department of Hematology, University Tor Vergata, Rome, Italy

    S Amadori

  2. EORTC Data Center, Brussels, Belgium

    S Suciu, F Beeldens & L Baila

  3. Hematology Unit, Regina Apostolorum Hospital, Albano Laziale, Italy

    R Stasi

  4. Department of Hematology, University Hospital, Leiden, The Netherlands

    R Willemze

  5. Department of Hematology, University La Sapienza, Rome, Italy

    F Mandelli

  6. Department of Hematology, St Jan Hospital, Brugge, Belgium

    D Selleslag

  7. Department of Hematology, University Hospital, Tubingen, Germany

    C Denzlinger

  8. Department of Hematology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

    P Muus & T de Witte

  9. Department of Hematology, University Hospital, Innsbruck, Austria

    R Stauder

  10. Department of Hematology, University Hospital, Edegem, Belgium

    Z Berneman

  11. Department of Hematology, Jeroen Bosch Ziekenhuis, ‘s-Hertogenbosch, The Netherlands

    J Pruijt

  12. Department of Hematology, General Hospital, Reggio Calabria, Italy

    F Nobile

  13. Department of Hematology, General Hospital, Bolzano, Italy

    V Cassibba

  14. Department of Hematology, Hotel-Dieu Hospital, Paris, France

    J-P Marie

  15. GIMEMA Data Center, Rome, Italy

    M Vignetti

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  1. S Amadori
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Correspondence to S Amadori.

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Amadori, S., Suciu, S., Stasi, R. et al. Gemtuzumab ozogamicin (Mylotarg®) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups. Leukemia 19, 1768–1773 (2005). https://doi.org/10.1038/sj.leu.2403901

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