Originally published as JCO Early Release 10.1200/JCO.2005.02.9488 on June 12 2006

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Papaldo, P. Articles by Cognetti, F. Search for Related Content PubMed PubMed Citation Articles by Papaldo, P. Articles by Cognetti, F. Related Articles Related Editorial

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

From the Department of Medical Oncology; Biostatistics Unit; Department of Surgery; Department of Pathology, Regina Elena Cancer Institute; Department of Medical Oncology, S. Andrea Hospital; Department of Medical Oncology, University "La Sapienza" School of Medicine; and the Division of Medical Oncology, S. Eugenio Hospital, Rome, Italy

Address reprint requests to Gianluigi Ferretti, MD, PhD, Division of Medical Oncology "A", Regina Elena Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy; e-mail: gia.fer{at}flashnet.it

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.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Related Editorial

• Can Granulocyte-Colony Stimulating Factor Worsen Anemia?
  Chau Dang and Clifford Hudis
  JCO 2006 24: 2985-2986 [Full Text]

This article has been cited by other articles:

				G. Ferretti, M. Lopez, E. Terzoli, E. Cortesi, M. Antimi, P. Marolla, D. Giannarelli, F. Cognetti, and P. Papaldo Myeloid Toxicity in Breast Cancer Patients Receiving Adjuvant Chemotherapy: What Is the Appropriate Use of Filgrastim? J. Clin. Oncol., December 10, 2006; 24(35): 5618 - 5619. [Full Text] [PDF]

				C. Dang and C. Hudis Can Granulocyte-Colony Stimulating Factor Worsen Anemia? J. Clin. Oncol., July 1, 2006; 24(19): 2985 - 2986. [Full Text] [PDF]