Does granulocyte colony-stimulating factor worsen anemia in early breast cancer patients treated with epirubicin and cyclophosphamide?

Paola Papaldo, Gianluigi Ferretti, Serena Di Cosimo, Diana Giannarelli, Paolo Marolla, Massimo Lopez, Enrico Cortesi, Mauro Antimi, Edmondo Terzoli, Paolo Carlini, Patrizia Vici, Claudio Botti, Luigi Di Lauro, Giuseppe Naso, Cecilia Nisticò, Marcella Mottolese, Franco Di Filippo, Enzo Maria Ruggeri, Anna Ceribelli, Francesco Cognetti

Research output: Contribution to journalArticlepeer-review


Purpose: We report on the effects of granulocyte colony-stimulating factor (G-CSF) on hemoglobin (Hb) value in early breast cancer patients receiving high-dose epirubicin and cyclophosphamide (EC) adjuvant treatment. Methods: Five hundred and six stage I or stage II female breast cancer patients were treated with E 120 mg/m2 and C 600 mg/m2 with or without G-CSF and randomly assigned to receive in a factorial 2 x 2 design: EC; EC + lonidamine; EC + G-CSF; EC + lonidamine + G-CSF. Five consecutive G-CSF schedules tested 100 randomly assigned patients each: (1) 480 μg subcutaneously on days 8 to 14; (2) 480 μg on days 8, 10, 12, 14; (3) 300 μg on days 8 to 14; (4) 300 μg on days 8, 10, 12, and 14; and (5) 300 μg on days 8 and 12. The mean Hb level of 246 patients receiving EC plus G-CSF was compared with that of 240 patients receiving EC alone. The data presented are derived from an exploratory hypothesis-generating analysis. Results: The EC dose intensity did not statistically differ between the G-CSF and the control arm. From the third cycle onward, the mean Hb value resulted significantly lower in G-CSF arm compared with control at each time point of each cycle (P <.0001). No statistically significant difference in the mean Hb level was observed between schedule 5 and control. Of interest, from the second course onward, the mean Hb level tended to be lower in patients receiving seven or four G-CSF injections compared with those patients who received only two injections. Conclusion: Our data suggest that a G-CSF dose-related effect may play a role in worsening anemia in patients receiving adjuvant EC.

Original languageEnglish
Pages (from-to)3048-3055
Number of pages8
JournalJournal of Clinical Oncology
Issue number19
Publication statusPublished - Jul 1 2006

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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