Long-Term Safety of GM-CSF (Molgramostim) Administration After Allogeneic Bone Marrow Transplantation for Hematologic Malignancies: Five-Year Follow-Up of a Double-Blind Randomized Placebo-Controlled Study

References

• Masaoka T., Takaku F., Kato S., et al. Recombinant human granulocyte colony‐stimulating factor in allogeneic bone marrow transplantation. Exp. Hematol. 1989; 17: 1047–1050
   PubMed Web of Science ®Google Scholar
• Kitayama H., Ishikawa J., Yamagami T., et al. Granulocyte colony‐stimulating factor in allogeneic bone marrow transplantation. Jpn. J. Clin. Oncol. 1989; 19: 367–372
   PubMed Web of Science ®Google Scholar
• Powles R., Smith C., Milan S., et al. Human recombinant GM‐CSF in allogeneic bone‐marrow transplantation for leukaemia: double‐blind, placebo‐controlled trial. Lancet 1990; 336: 1417–1420
   PubMed Web of Science ®Google Scholar
• Masaoka T., Shibata H., Ohno R., et al. Double‐blind test of human urinary macrophage colony‐stimulating factor for allogeneic and syngeneic bone marrow transplantation: effectiveness of treatment and 2–year follow‐up for relapse of leukaemia. Br. J. Haematol. 1990; 76: 501–505
   PubMed Web of Science ®Google Scholar
• Atkinson K., Biggs J. C., Downs K., et al. GM‐CSF after allogeneic bone marrow transplantation: accelerated recovery of neutrophils, monocytes and lymphocytes. Aust. N. Z. J. Med. 1991; 21: 686–692
   PubMedGoogle Scholar
• Nemunaitis J., Buckner C. D., Appelbaum F. R., et al. Phase MI trial of recombinant human granulocyte‐macrophage colony‐stimulating factor following allogeneic bone marrow transplantation. Blood 1991; 77: 2065–2071
   PubMed Web of Science ®Google Scholar
• De Witte T., Gratwohl A., Van der, Lely N., et al. Recombinant human granulocyte‐macrophage colony‐stimulating factor accelerates neutrophil and monocyte recovery after allogeneic T‐cell‐depleted bone marrow transplantation. Blood 1992; 79: 1359–1365
   PubMed Web of Science ®Google Scholar
• Nemunaitis J., Anasetti C., Storb R., et al. Phase II trial of recombinant human granulocyte‐macrophage colony‐stimulating factor in patients undergoing allogeneic bone marrow transplantation from unrelated donors. Blood 1992; 79: 2572–2517
   PubMed Web of Science ®Google Scholar
• Vannucchi A. M., Bosi A., Grossi A., et al. Stimulation of erythroid engraftment by recombinant human erythropoietin in ABO‐compatible, HLA‐identical, allogeneic bone marrow transplant patients. Leukemia 1992; 6: 215–219
   PubMed Web of Science ®Google Scholar
• Link H., Brune T., Hubner G., et al. Effect of recombinant human erythropoietin after allogeneic bone marrow transplantation. Ann. Hematol. 1993; 67: 169–173
   PubMed Web of Science ®Google Scholar
• Locatelli F., Zecca M., Beguin Y., et al. Accelerated erythroid repopulation with no stem‐cell competition effect in children treated with recombinant human erythropoietin after allogeneic bone marrow transplantation. Br. J. Haematol. 1993; 84: 752–754
   PubMed Web of Science ®Google Scholar
• Anasetti C., Anderson G., Appelbaum F. R., et al. Phase III study of rhGM‐CSF in allogeneic marrow transplantation from unrelated donors. Blood 1993; 82(Suppl 1)454a
   Google Scholar
• Hiraoaka A., Masaoka T., Mizoguchi H., et al. Recombinant human non‐glycosylated granulocyte‐macrophage colony‐stimulating factor in allogeneic bone marrow transplantation: double‐blind placebo‐controlled phase III clinical trial. Jun. J. Clin. Oncol. 1994; 24: 205–211
   PubMed Web of Science ®Google Scholar
• Gisselbrecht C., Prentice H. G., Bacigalupo A., et al. Placebo‐controlled phase III trial of lenograstim in bone‐marrow transplantation [Erratum. Lancet 1994; 343: 804, Lancet, 343, 696–700
   Web of Science ®Google Scholar
• Mitus A. J., Antin J. H., Rutherford C. J., McGarigle C. J., Goldberg M. A. Use of recombinant human erythropoietin in allogeneic bone marrow transplant donor/recipient pairs. Blood 1994; 83: 1952–1957
   PubMed Web of Science ®Google Scholar
• Schriber J. R., Chao N. J., Long G. D., et al. Granulocyte colony‐stimulating factor after allogeneic bone marrow transplantation. Blood 1994; 84: 1680–1684
   PubMed Web of Science ®Google Scholar
• Gupta P., Tiley C., Powles R., Treleaven J., Millar J., Catalano J. No increase in relapse in patients with myeloid leukaemias receiving rhGM‐CSF after allogeneic bone marrow transplantation. Bone Marrow Transplant. 1992; 9: 491–493
   PubMed Web of Science ®Google Scholar
• Hiraoka A., Masaoka T., Shibata H., et al. Five years follow‐up of a randomized placebo‐controlled study with fil‐grastim (recombinant human granulocyte colony‐stimulating factor) in patients receiving allogeneic bone marrow transplantation. Blood 1995; 86(Suppl 1)222a
   Google Scholar
• Mehta J., Powles R., Horton C., Milan S., Singhal S., Treleaven J. The relationship between donor‐recipient blood group incompatibility and serum bilirubin after allogeneic bone marrow transplantation from HLA‐identical siblings. Bone Marrow Transplant. 1995; 15: 853–858
   PubMed Web of Science ®Google Scholar
• Kaplan E. L., Meier P. Nonparametric estimation from incomplete observations. J. Ant. Srat. Assoc. 1958; 53: 457–481
   Web of Science ®Google Scholar
• Peto R., Pike M. C., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples. Br. J. Cancer 1977; 35: 1–39
   PubMed Web of Science ®Google Scholar
• Vadhan‐Raj S., Keating M., LeMaistre A., et al. Effects of recombinant human granulocyte‐macrophage colony‐stimulating factor in patients with myelodysplastic syndromes. N. Engl. J. Med. 1987; 317: 1545–1552
   PubMed Web of Science ®Google Scholar
• Ganser A., Volkers B., Greher J., et al. Recombinant human granulocyte‐macropbage colony‐stimulating factor in patients with myelodysplastic syndromes—a phase I/II trial. Blood 1989; 73: 31–37
   PubMed Web of Science ®Google Scholar
• Naparstek E., Ohana M., Greenberger J. S., Slavin S. Continuous intravenous administration of rmGM‐CSF enhances immune as well as hematopoietic reconstitution following syngeneic bone marrow transplantation in mice. Exp. Hematol. 1993; 21: 131–137
   PubMed Web of Science ®Google Scholar
• Richard C., Alsar M. J., Calavia J., et al. Recombinant human GM‐CSF enhances T cell‐mediated cytotoxic function after ABMT for hematological malignancies. Bone Marrow Transplant. 1993; 11: 473–478
   PubMed Web of Science ®Google Scholar
• Wiltschke C., Krainer M., Wagner A., Linkesch W., Zielinski C. C. Influence of in vivo administration of GM‐CSF and G‐CSF on monocyte cytotoxicity. Exp. Hematol. 1995; 23: 402–406
   PubMed Web of Science ®Google Scholar
• Mehta J. Graft‐versus‐leukemia reactions in clinical bone marrow transplantation. Leuk. Lymphoma. 1993; 10: 427–432
   PubMed Web of Science ®Google Scholar