Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium Journal Article


Authors: Gabrilove, J. L.; Jakubowski, A.; Fain, K.; Grous, J.; Scher, H.; Sternberg, C.; Yagoda, A.; Clarkson, B.; Bonilla, M. A.; Oettgen, H. F.; Alton, K.; Boone, T.; Altrock, B.; Welte, K.; Souza, L.
Article Title: Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium
Abstract: Recombinant human granulocyte colony-stimulating factor (rhG-CSF) was administered at a dose of 1-60 μg/kg of body weight to 22 patients with transitional cell carcinoma before chemotherapy as part of a Phase I/II study. In all patients, a specific dose-dependent increase in the absolute neutrophil count (ANC) of 1.8-12 fold was seen. In addition, this augmentation in the ANC was accompanied by an increase in leukocyte alkaline phosphatase, a marker of secondary granule formation. In six of eight patients analyzed, an increase in bone marrow myeloid to erythroid cell ratio was seen. Day 14 peripheral blood cell derived colony forming unit granulocyte macrophage were also increased by day 6 of rhG-CSF treatment. Circulating levels of eosinophils and basophils were unchanged; however, a 10-fold increase in monocytes was observed in patients treated at the highest doses. There was also a small increase in CD3+ lymphocytes that was not dose dependent. Hemoglobin, hematocrit, and platelet count remained near baseline throughout the period of rhG-CSF administration. These findings demonstrate that rhG-CSF is a potent stimulus for normal neutrophil proliferation and maturation.
Keywords: adult; clinical article; aged; urogenital tract cancer; transitional cell carcinoma; colony stimulating factor; human; priority journal
Journal Title: Journal of Clinical Investigation
Volume: 82
Issue: 4
ISSN: 0021-9738
Publisher: American Society for Clinical Investigation  
Date Published: 1988-10-01
Start Page: 1454
End Page: 1461
Language: English
DOI: 10.1172/jci113751
PUBMED: 2459163
PROVIDER: scopus
PMCID: PMC442704
DOI/URL:
Notes: Article -- Source: Scopus
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MSK Authors
  1. Howard Scher
    1130 Scher
  2. Herbert F Oettgen
    130 Oettgen
  3. Bayard Clarkson
    220 Clarkson
  4. Janice Gabrilove
    122 Gabrilove
  5. Mary Ann Bonilla
    32 Bonilla
  6. Katherine T Fain
    5 Fain
  7. Karl Welte
    77 Welte
  8. Alan Yagoda
    51 Yagoda