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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References
Gisselbrecht C, Prentice HG, Bacigalupo A et al. Placebo-controlled phase III trial of lenograstim in bone-marrow transplantation. Lancet 1994; 343: 696–700.
Schmitz N, Dreger P, Zander AR et al. Results of a randomised, controlled, multicentre study of recombinant human granulocyte colony-stimulating factor (filgrastim) in patients with Hodgkin's disease and non-Hodgkin's lymphoma undergoing autologous bone marrow transplantation. Bone Marrow Transplant 1995; 15: 261–266.
Stahel RA, Jost LM, Cerny T et al. Randomized study of recombinant human granulocyte colony-stimulating factor after high-dose chemotherapy and autologous bone marrow transplantation for high-risk lymphoid malignancies. J Clin Oncol 1994; 12: 1931–1938.
Spitzer G, Adkins DR, Spencer V et al. Randomized study of growth factors post-peripheral-blood stem-cell transplant: neutrophil recovery is improved with modest clinical benefit. J Clin Oncol 1994; 12: 661–670.
Klumpp TR, Mangan KF, Goldberg SL et al. Granulocyte colony-stimulating factor accelerates neutrophil engraftment following peripheral-blood stem-cell transplantation: a prospective, randomized trial. J Clin Oncol 1995; 13: 1323–1327.
McQuaker IG, Hunter AE, Pacey S et al. Low-dose filgrastim significantly enhances neutrophil recovery following autologous peripheral-blood stem-cell transplantation in patients with lymphoproliferative disorders: evidence for clinical and economic benefit. J Clin Oncol 1997; 15: 451–457.
Linch DC, Milligan DW, Winfield DA et al. G-CSF after peripheral blood stem cell transplantation in lymphoma patients significantly accelerated neutrophil recovery and shortened time in hospital: results of a randomized BNLI trial. Br J Haematol 1997; 99: 933–938.
Ojeda E, Garcia-Bustos J, Aguado MJ et al. A prospective randomized trial of granulocyte colony-stimulating factor therapy after autologous blood stem cell transplantation in adults. Bone Marrow Transplant 1999; 24: 601–607.
Hornedo J, Sola C, Solano C et al. The role of granulocyte colony-stimulating factor (G-CSF) in the post-transplant period. Bone Marrow Transplant 2002; 29: 737–743.
Weaver CH, Schwartzberg LS, Hainsworth J et al. Treatment-related mortality in 1000 consecutive patients receiving high-dose chemotherapy and peripheral blood progenitor cell transplantation in community cancer centers. Bone Marrow Transplant 1997; 19: 671–678.
Toora AA, van Burik JA, Weisdorf DJ et al. Infections during mobilizing chemotherapy and following autologous stem cell transplantation. Bone Marrow Transplant 2001; 28: 1129–1134.
The Immunocompromised Host Society. The design, analysis, and reporting of clinical trials on the empirical antibiotic management of the neutropenic patient. JID 1990; 161: 397–401.
Ozer H, Armitage JO, Bennett CL et al. 2000 Update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. J Clin Oncol 2000; 18: 3558–3585.
Pagliuca A, Carrington PA, Pettengell R, et al., on behalf of the Haemato-Oncology Task Force for the British Committee for Standards in Haematology. Guidelines on the use of colony-stimulating factors in haematological malignancies. Br J Haematol 2003; 123: 22–33.
Cordonnier C, Buzyn A, Leverger G et al. Epidemiology and risk factors for gram-positive coccal infections in neutropenia: toward a more targeted antibiotic strategy. Clin Infect Diseases 2003; 36: 149–158.
Ninin E, Milpied N, Moreau P et al. Longitudinal study of bacterial, viral, and fungal infections in adult recipients of bone marrow transplants. Clin Infect Diseases 2001; 33: 41–47.
Gratwohl A, Baldomero H, Horisberger B et al. Current trends in hematopoietic stem cell transplantation in Europe. Blood 2002; 100: 2374–2386.
Langouet AM, Brice P, Simon D et al. Factors affecting hematopoietic recovery after autologous peripheral blood progenitor-cell transplantation in aggressive non-Hodgkin's lymphoma: a prospective study of 123 patients. THJ 2001; 2: 81–86.
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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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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DOI: https://doi.org/10.1038/sj.bmt.1704724
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