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JOURNAL OF CLINICAL ONCOLOGY
卷 23, 期 28, 页码 6908-6918出版社
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2005.03.099
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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/m(2) and cyclophosphamide 600 mg/m(2) 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 mu g/d subcutaneously days 8 to 14; (2) 480 mu g/d days 8, 10, 12, and 14; (3) 300 mu g/d days 8 to 14; (4) 300 mu g/d days 8, 10, 12, and 14; and (5) 300 mu g/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.
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