The effects of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) on platelet recovery in breast cancer patients undergoing autologous bone marrow transplantation
| Autor: | Camille N. Abboud, Michael Macri, Scott E. Cruickshank, Dora Menchaca, Debra Frei-Lahr, Edmund K. Waller, Michael W. Schuster, Roy A. Beveridge, Jeannine T. Holden |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Blood Platelets Cancer Research medicine.medical_specialty Transplantation Conditioning Breast Neoplasms Filgrastim Transplantation Autologous Gastroenterology Carboplatin Polyethylene Glycols Double-Blind Method Megakaryocyte Internal medicine Antineoplastic Combined Chemotherapy Protocols Genetics medicine Humans Platelet Treatment Failure Cyclophosphamide Molecular Biology Bone Marrow Transplantation Platelet Count business.industry Cell Biology Hematology Combined Modality Therapy Thrombocytopenia Effective dose (pharmacology) Recombinant Proteins Surgery Transplantation Platelet transfusion medicine.anatomical_structure Thrombopoietin Absolute neutrophil count Female Bone marrow business Thiotepa medicine.drug |
| Zdroj: | Experimental Hematology. 30:1044-1050 |
| ISSN: | 0301-472X |
| DOI: | 10.1016/s0301-472x(02)00878-0 |
| Popis: | To assess the safety and efficacy of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) administered after autologous bone marrow transplantation (ABMT).Two randomized, double-blind, placebo-controlled studies were done. In the phase 1/2 study, 75 breast cancer patients underwent a bone marrow harvest and myeloablative STAMP V chemotherapy and were randomized to receive placebo or one of three doses of PEG-rHuMGDF. In the phase 3 study, 64 patients were randomized to receive placebo or the minimally effective dose of PEG-rHuMGDF. The study drug was administered daily starting on the day of bone marrow infusion until the platelet count was greater than or equal to 50 x 10(9)/L (without transfusion) or for a maximum of 28 days. All patients received 10 microg/kg/day filgrastim starting on day 2 until neutrophil count recovery.PEG-rHuMGDF appeared to be safe and well tolerated. No significant differences were noted in mortality or disease progression rates. Antibodies to MGDF were not observed. In the phase 1/2 study, the time to platelet recovery to greater than or equal to 20 x 10(9)/L and platelet transfusion requirements were significantly reduced for patients treated with PEG-rHuMGDF compared with placebo (p0.05). In the phase 3 study, no significant differences in the kinetics of early thrombopoiesis or platelet transfusions after ABMT were observed.PEG-rHuMGDF was not consistently efficacious in reducing the duration of severe thrombocytopenia. The maximum platelet counts for PEG-rHuMGDF-treated patients occurred a median of 2 weeks after the last dose of drug, suggesting that the biologic effects of this hematopoietic cytokine are delayed compared with other hematopoietic cytokines. |
| Databáze: | OpenAIRE |
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