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[A phase III trial of subcutaneous administration of rhG-CSF in the myelodysplastic syndromes].
- Source :
-
[Rinsho ketsueki] The Japanese journal of clinical hematology [Rinsho Ketsueki] 1994 Nov; Vol. 35 (11), pp. 1289-96. - Publication Year :
- 1994
-
Abstract
- To evaluate the safety and efficacy of subcutaneous administration of recombinant human granulocyte colony-stimulating factor in the myelodysplastic syndromes (MDS), 20 patients were given a daily dose of 50 micrograms/m2 of KRN8601 for 4 weeks. When the blood neutrophil count did not reach 2,000/microliters within 2 weeks, the dose was increased to 100 micrograms/m2. A marked neutrophilic response was obtained in 17 of the 18 evaluable patients (94.4%), irrespective of the MDS disease type. Five patients showed a platelet increase, 3 of which also showed an erythroid improvement. To maintain neutrophil levels greater than 1,000/microliters, 12 patients were treated with KRN8601 for 4 weeks. A dose of 25 to 50 micrograms/m2 3-4 times a week served to this end in 8 patients and 100 micrograms/m2 three times a week or daily in the remaining 4 patients. One patient with RAEB progressed to acute myeloid leukemia 8 weeks after KRN8601. The treatment was well-tolerated in the majority of patients with no severe toxicities. These results suggest that subcutaneous administration of KRN8601 is safe and useful in the treatment of cytopenias in MDS.
- Subjects :
- Adult
Aged
Female
Granulocyte Colony-Stimulating Factor administration & dosage
Humans
Injections, Subcutaneous
Japan
Male
Middle Aged
Recombinant Proteins administration & dosage
Recombinant Proteins therapeutic use
Granulocyte Colony-Stimulating Factor therapeutic use
Myelodysplastic Syndromes therapy
Subjects
Details
- Language :
- Japanese
- ISSN :
- 0485-1439
- Volume :
- 35
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- [Rinsho ketsueki] The Japanese journal of clinical hematology
- Publication Type :
- Academic Journal
- Accession number :
- 7529842