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Phase III randomized study comparing 5 or 10 μg per kg per day of filgrastim for mobilization of peripheral blood progenitor cells with chemotherapy, followed by intensification and autologous transplantation in patients with nonmyeloid malignancies

Authors

  • Marc André,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Etienne Baudoux,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Dominique Bron,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Jean-Luc Canon,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Véronique D'Hondt,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Marie-France Fassotte,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Lionel D'Hondt,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Georges Fillet,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Yves Humblet,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Guy Jerusalem,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Philippe Vermeulen,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Michel Symann,

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • Yves Beguin

    1. From the Groupe Oncologie UCL, Saint-Luc Academic Hospital, Brussels;
    2. Departments of Hematology and Medical Oncology, Sart Tilman Academic Hospital, Liège;
    3. Department of Hematology, Bordet Institute, Brussels;
    4. Department of Hematology-Oncology, La Tourelle Regional Hospital Center, Verviers, Belgium.
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  • ABBREVIATIONS:

    FEC = 5-Fluorouracil-epirubicin-cyclophosphamide; HDCT = high-dose chemotherapy; PBPC = peripheral blood progenitor cell.

  • This work was conducted under the auspices of the National Fund for Scientific Research (Brussels, Belgium). Yves Beguin is a research director of the National Fund for Scientific Research.

Address reprint requests to: Marc André, MD, CHNDRF, Grand-Rue 3, 6000 Charleroi, Belgium; e-mail: andre . marc@chndrf.be .

Abstract

BACKGROUND : It is not known whether increasing the dose of filgrastim after mobilizing chemotherapy improves collection of peripheral blood progenitor cells (PBPC) and leads to faster hematopoietic engraftment after autologous transplantation.

STUDY DESIGN AND METHODS : A randomized, open-label, multicenter trial was carried out in patients with breast cancer, multiple myeloma, and lymphoma, in which patients were randomized to receive 5 or 10 μg per kg per day of filgrastim after standard chemotherapy to mobilize PBPCs. After high-dose chemotherapy, the components from the first two leukapheresis procedures were returned, and all patients received 5 μg per kg day of filgrastim after transplantation.

RESULTS : A total of 131 patients were randomized, of whom 128 were mobilized (Group A, 5 μg/kg, n = 66; Group B, 10 μg/kg, n = 62) and 112 were transplanted. Only six patients were not transplanted because of insufficient CD34+ cell numbers. The median number of CD34+ cells collected in the first two leukapheresis procedures tended to be higher in Group B than in Group A (12.0 vs. 7.2 × 10 6 /kg, NS), but after transplantation there was no significant difference in median times to platelet (9 days in both groups) or neutrophil (8 days in both groups) engraftment or the number of platelet transfusions (three in both groups). A subsequent subgroup analysis separating patients transplanted after first- or second-line chemotherapy also showed no measurable impact of filgrastim dose on the median CD34+ cell yield or on platelet engraftment in either subgroup.

CONCLUSION : PBPC mobilization with chemotherapy and 5 μg per kg of filgrastim is very efficient, and 10 μg per kg of filgrastim does not provide additional clinical benefit.

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