Annals of Hematology

, Volume 81, Issue 10, pp 570–574

Prospective randomized trial to evaluate two delayed granulocyte colony stimulating factor administration schedules after high-dose cytarabine therapy in adult patients with acute lymphoblastic leukemia

  •  W. Hofmann
  •  G. Seipelt
  •  S. Langenhan
  •  R. Reutzel
  •  D. Schott
  •  O. Schoeffski
  •  H. Illiger
  •  F. Hartmann
  •  L. Balleisen
  •  A. Franke
  •  F. Fiedler
  •  C. Huber
  •  H. Rasche
  •  L. Bergmann
  •  A. Ganser
  •  C. Pott
  •  R. Pasold
  •  C. Rudolph
  •  O. Ottmann
  •  N. Gökbuget
  •  D. Hoelzer
Original Article

DOI: 10.1007/s00277-002-0542-8

Cite this article as:
Hofmann, W., Seipelt, G., Langenhan, S. et al. Ann Hematol (2002) 81: 570. doi:10.1007/s00277-002-0542-8

Abstract.

In acute lymphoblastic leukemia (ALL), treatment with granulocyte colony stimulating factor (G-CSF) during remission induction shortens granulocytopenia and may decrease morbidity due to infections. However, the optimal timing of G-CSF administration after chemotherapy is not known. In a prospective randomized multi-center study, adult ALL patients were treated with high-dose ARA-C [HDAC, 3 g/m2 bid (1 g/m2 bid for T-ALL) days 1–4] and mitoxantrone (MI 10 mg/m2 days 3–5). They were randomized to receive recombinant human G-CSF (Lenograstim) 263 µg/day SC starting either from day 12 (Group 1) or day 17 (Group 2). Fifty-five patients (41 male, 14 female) with a median age of 34 years (range: 18–55 years) were enrolled into the study; 50 patients were evaluable. The median duration of neutropenia <500/µl after HDAC/MI was 12 days (range: 7–22 days) in the early G-CSF Group 1 and also 12 days (range: 4–22 days) in the late G-CSF Group 2; this was shorter than in the historical control group (15 days, range: 4–43 days, n=46) where the patients received identical cytotoxic treatment without G-CSF. Seventeen infections were observed in 14 patients in Group 1 (47%) and 13 infections in 10 patients in Group 2 (50%) compared to 27 infections in 49 patients of the historical control (54%). In Group 1, the patients received a median of 11 injections with G-CSF (range: 7–22) compared to 7 injections (range: 4–19) in Group 2. The total administered dose of G-CSF in Group 2 was significantly reduced by 40% (P<0.0001). The delayed start of G-CSF after HDAC/MI in ALL achieves the same clinical benefit compared to the earlier initiation of G-CSF. The reduction of treatment costs by reducing the total G-CSF dose may be important in future treatment with this hematopoietic growth factor.

Acute lymphoblastic leukemia Granulocyte-colony stimulating factor High-dose cytarabine Neutropenia

Copyright information

© Springer-Verlag 2002

Authors and Affiliations

  •  W. Hofmann
    • 1
  •  G. Seipelt
    • 1
  •  S. Langenhan
    • 2
  •  R. Reutzel
    • 1
  •  D. Schott
    • 3
  •  O. Schoeffski
    • 4
  •  H. Illiger
    • 5
  •  F. Hartmann
    • 6
  •  L. Balleisen
    • 7
  •  A. Franke
    • 8
  •  F. Fiedler
    • 9
  •  C. Huber
    • 10
  •  H. Rasche
    • 11
  •  L. Bergmann
    • 12
  •  A. Ganser
    • 13
  •  C. Pott
    • 14
  •  R. Pasold
    • 15
  •  C. Rudolph
    • 16
  •  O. Ottmann
    • 1
  •  N. Gökbuget
    • 1
  •  D. Hoelzer
    • 1
  1. 1.Department of Hematology and Oncology, Johann Wolfgang Goethe University Hospital, Theodor-Stern-Kai 7, 60596 Frankfurt/Main, Germany
  2. 2.Community Hospital, Miltenberg, Germany
  3. 3.Aventis Pharma, Bad Soden am Taunus, Germany
  4. 4.Chair for Health Management, University of Erlangen-Nuremberg, Germany
  5. 5.Community Hospital, Oldenburg, Germany
  6. 6.Department of Hematology/Oncology, University of Homburg/Saar, Germany
  7. 7.Evangelic Hospital, Hamm, Germany
  8. 8.Department of Hematology/Oncology, Magdeburg Medical School, Germany
  9. 9.Community Hospital, Chemnitz, Germany
  10. 10.Department of Hematology/Oncology, University of Mainz, Germany
  11. 11.Community Hospital, Bremen, Germany
  12. 12.Department of Hematology/Oncology, University of Ulm, Germany
  13. 13.Department of Hematology/Oncology, Hannover Medical School, Germany
  14. 14.Department of Hematology/Oncology, University of Kiel, Germany
  15. 15.Community Hospital, Potsdam, Germany
  16. 16.Community Hospital, Cottbus, Germany