Originally published as JCO Early Release 10.1200/JCO.2005.03.099 on August 29 2005

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Impact of Five Prophylactic Filgrastim Schedules on Hematologic Toxicity in Early Breast Cancer Patients Treated With Epirubicin and Cyclophosphamide

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

Address reprint requests to Paola Papaldo, MD, Division of Medical Oncology "A," Regina Elena Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy; e-mail: p.papaldo{at}mclink.it

PURPOSE: To evaluate the comparative efficacy of varying intensity schedules of recombinant human granulocyte colony-stimulating factor (G-CSF; filgrastim) support in preventing febrile neutropenia in early breast cancer patients treated with relatively high-dose epirubicin plus cyclophosphamide (EC).

PATIENTS AND METHODS: From October 1991 to April 1994, 506 stage I and II breast cancer patients were randomly assigned to receive, in a factorial 2 x 2 design, epirubicin 120 mg/m² and cyclophosphamide 600 mg/m² intravenously on day 1 every 21 days for 4 cycles ± lonidamine ± G-CSF. The following five consecutive G-CSF schedules were tested every 100 randomly assigned patients: (1) 480 µg/d subcutaneously days 8 to 14; (2) 480 µg/d days 8, 10, 12, and 14; (3) 300 µg/d days 8 to 14; (4) 300 µg/d days 8, 10, 12, and 14; and (5) 300 µg/d days 8 and 12.

RESULTS: All of the G-CSF schedules covered the neutrophil nadir time. Schedule 5 was equivalent to the daily schedules (schedules 1 and 3) and to the alternate day schedules (schedules 2 and 4) with respect to incidence of grade 3 and 4 neutropenia (P = .79 and P = .89, respectively), rate of fever episodes (P = .84 and P = .77, respectively), incidence of neutropenic fever (P = .74 and P = .56, respectively), need of antibiotics (P = .77 and P = .88, respectively), and percentage of delayed cycles (P = .43 and P = .42, respectively). G-CSF had no significant impact on the delivered dose-intensity compared with the non–G-CSF arms.

CONCLUSION: In the adjuvant setting, the frequency of prophylactic G-CSF administration during EC could be curtailed to only two administrations (days 8 and 12) without altering outcome. This nonrandomized trial design provides support for evaluating alternative, less intense G-CSF schedules for women with early breast cancer.

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

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