[A phase III trial of subcutaneous administration of rhG-CSF in the myelodysplastic syndromes].

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.

• Authors: Y Yoshida, M Okuma, T Suzuki, T Takahashi, M Nakagawa, K Kashima, T Abe, Y Sonoda, H Fujii, H Haruyama
• Journal: [Rinsho ketsueki] The Japanese journal of clinical hematology (Rinsho Ketsueki) Vol. 35 Issue 11 Pg. 1289-96 (Nov 1994) ISSN: 0485-1439 [Print] Japan
• PMID: 7529842 (Publication Type: Clinical Trial, Clinical Trial, Phase III, English Abstract, Journal Article, Multicenter Study)

Chemical References

• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor

Topics

• Adult
• Aged
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage, therapeutic use)
• Humans
• Injections, Subcutaneous
• Japan
• Male
• Middle Aged
• Myelodysplastic Syndromes (therapy)
• Recombinant Proteins (administration & dosage, therapeutic use)