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Prospective, randomized trial of 5-fluorouracil, leucovorin, doxorubicin, and cyclophosphamide chemotherapy in combination with the interleukin-3/granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion protein (PIXY321) versus GM-CSF in patients with advanced breast cancer.
- Source :
-
Blood [Blood] 1996 Mar 15; Vol. 87 (6), pp. 2205-11. - Publication Year :
- 1996
-
Abstract
- We conducted a prospective randomized trial to evaluate the ability of the interleukin-3/granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion protein, PIXY321, to ameliorate cumulative thrombocytopenia after multiple cycles of 5-fluorouracil, leucovorin, doxorubicin, cyclophosphamide (FLAC) chemotherapy compared with GM-CSF in patients with advanced breast cancer. Fifty-three patients were randomized to receive either PIXY321. 375 microg/m2 twice a day subcutaneously, or GM-CSF, 250 microg/m2 daily subcutaneously after FLAC chemotherapy. PIXY321 was less well tolerated than GM-CSF, with more patients developing chills and local skin reactions and more patients stopping PIXY321 due to intolerance. While no difference in the neutrophil nadirs was seen with the two cytokines, the duration of the absolute neutrophil count less than 1,000/muL for all cycles was significantly longer with PIXY321 than with GM-CSF. Fifty percent of patients treated with multiple cycles of FLAC chemotherapy on both study arms developed dose-limiting thrombocytopenia. No differences in platelet nadirs, duration of thrombocytopenia, or need for platelet transfusions were observed with PIXY321 versus GM-CSF. The average delivered doses of FLAC chemotherapy were somewhat higher in the GM-CSF study arm. PIXY321 was not superior to GM-CSF in ameliorating the cumulative thrombocytopenia observed with multiple cycles of FLAC chemotherapy and was less well tolerated.
- Subjects :
- Antineoplastic Combined Chemotherapy Protocols adverse effects
Breast Neoplasms pathology
Combined Modality Therapy
Cyclophosphamide administration & dosage
Cyclophosphamide adverse effects
Doxorubicin administration & dosage
Doxorubicin adverse effects
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
Humans
Leucovorin administration & dosage
Leucovorin adverse effects
Middle Aged
Neutropenia chemically induced
Platelet Transfusion
Prospective Studies
Thrombocytopenia chemically induced
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms drug therapy
Immunologic Factors therapeutic use
Neutropenia therapy
Thrombocytopenia therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0006-4971
- Volume :
- 87
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Blood
- Publication Type :
- Academic Journal
- Accession number :
- 8630380