Granulocyte-macrophage colony-stimulating factor (GM-CSF) allows acceleration and dose intensity increase of CEF chemotherapy: a randomised study in patients with advanced breast cancer

A. Ardizzoni, M. Venturini, M. R. Sertoli, P. G. Giannessi, F. Brema, M. Danova, F. Testore, G. L. Mariani, M. C. Pennucci, P. Queirolo, S. Silvestro, P. Bruzzi, R. Lionetto, F. Latin, R. Rosso

Research output: Contribution to journalArticle

Abstract

A randomised study was conducted in 62 patients with advanced breast cancer to assess whether granulocyte-macrophage colony-stimulating factor (GM-CSF) would yield an increase in the dose intensity of a standard-dose CEF regimen through an acceleration of chemotherapy administration. Patients received CEF (cyclophosphamide 600 mg m-2 epidoxorubicin 60 mg m-2 and fluorouracil 600 mg m-2) i.v. on day 1 or the same chemotherapy, plus GM-CSF 10 pg kg-1 s.c. starting from day 4, repeated as soon as haematopoietic recovery from nadir occurred. Patients in the CEF + GM-CSF group received chemotherapy at a median interval of 16 days compared with 20 days in the control group. This led to a significant increase (P = 0.02) in the dose intensity actually administered in the third, fourth and sixth cycles: +28%, +25%, +20% respectively. Non-haematological toxicity was mild. GM-CSF had to be reduced or suspended in 50% of patients because of toxicity. Haematological toxicity, mainly cumulative anaemia and thrombocytopenia, was manageable. An increase in response rate for patients with measurable disease, of borderline statistical significance (P = 0.088, P for trend = 0.018), from 42% in the CEF group to 69% in the CEF + GM-CSF group, was observed. This randomised trial indicates that GM-CSF is useful for chemotherapy acceleration. Accelerated CEF + GM-CSF is a moderately dose-intensive regimen that can be administered in an outpatient clinic and is associated with a high objective response.

Original languageEnglish
Pages (from-to)385-391
Number of pages7
JournalBritish Journal of Cancer
Volume69
Issue number2
Publication statusPublished - Feb 1994

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Ardizzoni, A., Venturini, M., Sertoli, M. R., Giannessi, P. G., Brema, F., Danova, M., Testore, F., Mariani, G. L., Pennucci, M. C., Queirolo, P., Silvestro, S., Bruzzi, P., Lionetto, R., Latin, F., & Rosso, R. (1994). Granulocyte-macrophage colony-stimulating factor (GM-CSF) allows acceleration and dose intensity increase of CEF chemotherapy: a randomised study in patients with advanced breast cancer. British Journal of Cancer, 69(2), 385-391.