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Post-Transplant Events

Lenograstim after autologous peripheral blood progenitor cell transplantation: results of a double-blind, randomized trial

Bone Marrow Transplantation volume 34, pages 955–962 (2004)Cite this article

Summary:

A phase III, randomized, double-blind, placebo-controlled, multi-center trial was conducted in order to compare the incidence of microbiologically defined infections occurring after high-dose chemotherapy (HDT) and ASCT in 98 patients given lenograstim (Granocyte®) and 94 patients given placebo after transplantation. Hematopoietic recovery, the use of i.v. antibiotics, the numbers of red blood cell and platelet transfusions, the days spent in hospital, and the days on parenteral nutrition were also compared. The incidence of infections until neutrophil recovery was significantly less in patients who received lenograstim after HDT and ASCT as compared to patients who received placebo (66 of 98 vs 86 of 94 patients, P<0.001). Lenograstim also significantly reduced the use of i.v. antibiotics (P<0.001) and the median duration of i.v. antibiotic treatment (8 days vs 10 days, P=0.04), improved neutrophil recovery (absolute neutrophil count >0.5 × 109/l: 11 days vs 15 days, P<0.001) and reduced the number of days spent in hospital (15 days vs 17 days, P<0.001). The administration of lenograstim after HDT and ASCT significantly reduces the incidence of microbiologically defined infections until neutrophil recovery. It also leads to less use of antibiotics and earlier discharge from hospital.

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Acknowledgements

We thank Kerstin Johanns and Stefan Wolf, AK St. Georg, Hamburg, for secretarial help with the manuscript. This work was supported by Chugai-Aventis, Antony, France.

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Authors and Affiliations

  1. Department of Hematology, AK St. Georg, Hamburg, Germany

    N Schmitz & R Sonnen

  2. Huddinge University Hospital, Stockholm, Sweden

    P Ljungman

  3. Hôpital Henri Mondor, Créteil, France

    C Cordonnier

  4. ICD, Ottrot, France

    C Kempf

  5. Medizinische Universitätsklinik, Graz, Austria

    W Linkesch

  6. Hospital Universitario de la Princesa, Madrid, Spain

    A Alegre

  7. Hospital Clinico Universitario, Valencia, Spain

    C Solano

  8. Akademiska Sjukhuset, University Hospital, Uppsala, Sweden

    B Simonsson

  9. Universität zu Köln, Germany

    V Diehl

  10. Universitätsklinikum Mainz, Mainz, Germany

    T Fischer

  11. Hospital Universitario, Salamanca, Spain

    D Caballero

  12. John Radcliffe Hospital Oxford, Oxford, UK

    T Littlewood

  13. Universitätsklinikum, Essen, Germany

    R Noppeney

  14. Universitätsklinikum Eppendorf, Hamburg, Germany

    P Schafhausen

  15. Department of Oncology, Universitätsspital Zürich, Switzerland

    L Jost

  16. CHUGAI AVENTIS, Antony, France

    F Delabarre

  17. Addenbrooke's NHS Trust, Cambridge, UK

    R Marcus

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  1. N Schmitz
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Corresponding author

Correspondence to N Schmitz.

Appendix

Appendix

The following investigators at the following institutions participated in the study:

Werner Linkesch, Medizinische Universitätsklinik, Graz, Austria.

Peter Kalhs, Universitätsklinik für Innere Medizin I, Wien, Austria.

Volker Diehl, Klinik I für Innere Medizin, Universität zu Köln, Germany.

Thomas Fischer, Universitätsklinikum Mainz, Mainz, Germany.

Mathias Freund, Klinik für Innere Medizin, Universität Rostock, Germany.

Rüdiger Hehlmann, Klinikum der Stadt Mannheim, Mannheim, Germany.

Ruth Sonnen, Allgemeines Krankenhaus St. Georg, Hamburg, Germany.

Michael Uppenkamp, Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Germany.

Philip Schafhausen, Universitätskrankenhaus Eppendorf, Hamburg, Germany.

Richard Noppeney, Universitätsklinikum Essen, Essen, Germany.

Norbert Schmitz, Universitätsklinikum Kiel, Kiel, Germany.

Per Ljungman, Huddinge University Hospital, Stockholm, Sweden.

Bengt Simonsson, University Hospital, Uppsala, Sweden.

Adrian Alegre, Hospital Universitario de la Princesa, Madrid, Spain.

Dolores Caballero, Hospital Universitario, Salamanca, Spain.

Carlos Solano, Hospital Clinico Universitario, Valencia, Spain.

Lorenz Jost, Abteilung Onkologie, Universitätsspital Zürich, Switzerland.

Tibor Kovacsovics, Centre Hospitalier, Universitaire Vaudois, Lausanne, Switzerland.

Robert Marcus, Addenbrooke's NHS Trust, Cambridge, United Kingdom.

Timothy Littlewood, John Radcliffe Hospital, Oxford, United Kingdom.

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Schmitz, N., Ljungman, P., Cordonnier, C. et al. Lenograstim after autologous peripheral blood progenitor cell transplantation: results of a double-blind, randomized trial. Bone Marrow Transplant 34, 955–962 (2004). https://doi.org/10.1038/sj.bmt.1704724

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