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

Joyce A. O'Shaughnessy, Anthony Tolcher, David Riseberg, David Venzon, Jo Anne Zujewski, Marianne Noone, Michelle Gossard, David Danforth, Joan Jacobson, Victoria Chang, Barry Goldspiel, Patricia Keegan, Ruthann Giusti, Kenneth H Cowan

Research output: Contribution to journalArticle

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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 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.

Original languageEnglish (US)
Pages (from-to)2205-2211
Number of pages7
JournalBlood
Volume87
Issue number6
StatePublished - Mar 15 1996

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Chemotherapy
Leucovorin
Interleukin-3
Granulocyte-Macrophage Colony-Stimulating Factor
Combination Drug Therapy
Fluorouracil
Doxorubicin
Cyclophosphamide
Fusion reactions
Breast Neoplasms
Thrombocytopenia
Proteins
Drug Therapy
Platelets
Neutrophils
Platelet Transfusion
Chills
Skin
Blood Platelets
Cytokines

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

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. / O'Shaughnessy, Joyce A.; Tolcher, Anthony; Riseberg, David; Venzon, David; Zujewski, Jo Anne; Noone, Marianne; Gossard, Michelle; Danforth, David; Jacobson, Joan; Chang, Victoria; Goldspiel, Barry; Keegan, Patricia; Giusti, Ruthann; Cowan, Kenneth H.

In: Blood, Vol. 87, No. 6, 15.03.1996, p. 2205-2211.

Research output: Contribution to journalArticle

O'Shaughnessy, JA, Tolcher, A, Riseberg, D, Venzon, D, Zujewski, JA, Noone, M, Gossard, M, Danforth, D, Jacobson, J, Chang, V, Goldspiel, B, Keegan, P, Giusti, R & Cowan, KH 1996, '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', Blood, vol. 87, no. 6, pp. 2205-2211.
O'Shaughnessy, Joyce A. ; Tolcher, Anthony ; Riseberg, David ; Venzon, David ; Zujewski, Jo Anne ; Noone, Marianne ; Gossard, Michelle ; Danforth, David ; Jacobson, Joan ; Chang, Victoria ; Goldspiel, Barry ; Keegan, Patricia ; Giusti, Ruthann ; Cowan, Kenneth H. / 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. In: Blood. 1996 ; Vol. 87, No. 6. pp. 2205-2211.
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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 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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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

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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.

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