TY - JOUR
T1 - 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
AU - O'Shaughnessy, Joyce A.
AU - Tolcher, Anthony
AU - Riseberg, David
AU - Venzon, David
AU - Zujewski, Jo Anne
AU - Noone, Marianne
AU - Gossard, Michelle
AU - Danforth, David
AU - Jacobson, Joan
AU - Chang, Victoria
AU - Goldspiel, Barry
AU - Keegan, Patricia
AU - Giusti, Ruthann
AU - Cowan, Kenneth H.
PY - 1996/3/15
Y1 - 1996/3/15
N2 - 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 μg/m2 twice a day subcutaneously, or GM-CSF, 250 μg/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/μL 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. This is a US government work. There are no restrictions on its use.
AB - 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 μg/m2 twice a day subcutaneously, or GM-CSF, 250 μg/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/μL 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. This is a US government work. There are no restrictions on its use.
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UR - http://www.scopus.com/inward/citedby.url?scp=5244233409&partnerID=8YFLogxK
U2 - 10.1182/blood.v87.6.2205.bloodjournal8762205
DO - 10.1182/blood.v87.6.2205.bloodjournal8762205
M3 - Article
C2 - 8630380
AN - SCOPUS:5244233409
SN - 0006-4971
VL - 87
SP - 2205
EP - 2211
JO - Blood
JF - Blood
IS - 6
ER -