Journal of Clinical Oncology, Vol 23, No 6 (February 20), 2005: pp. 1178-1184
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.09.102
First and Subsequent Cycle Use of Pegfilgrastim Prevents Febrile Neutropenia in Patients With Breast Cancer: A Multicenter, Double-Blind, Placebo-Controlled Phase III Study
Charles L. Vogel,
Marek Z. Wojtukiewicz,
Robert R. Carroll,
Sergei A. Tjulandin,
Luis Javier Barajas-Figueroa,
Brian L. Wiens,
Theresa A. Neumann,
Lee S. Schwartzberg
From the Cancer Research Networks, Inc, Plantation; Gainesville, FL; Amgen Inc, Thousand Oaks, CA; The W Clinic, Memphis, TN; Regional Oncology Centre and Department of Oncology, Medical University, Bialystok, Poland; Russian Cancer Research Center, Moscow, Russia; and Hospital General de Occidente, Zapopan, Jalisco, Mexico
Address reprint requests to Charles L. Vogel, MD, 150 NW 84th Ave, Ste 300, Plantation, FL 33324; e-mail: drcvogel{at}aol.com
PURPOSE: We evaluated the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia associated with docetaxel in breast cancer patients.
PATIENTS AND METHODS: Patients were randomly assigned to either placebo or pegfilgrastim 6 mg subcutaneously on day 2 of each 21-day chemotherapy cycle of 100 mg/m2 docetaxel. The primary end point was the percentage of patients developing febrile neutropenia (defined as body temperature  38.2°C and neutrophil count < 0.5 x 109/L on the same day of the fever or the day after). Secondary end points were incidence of hospitalizations associated with a diagnosis of febrile neutropenia, intravenous (IV) anti-infectives required for febrile neutropenia, and the ability to maintain planned chemotherapy dose on time. Patients with febrile neutropenia were converted to open-label pegfilgrastim in subsequent cycles.
RESULTS: Nine hundred twenty-eight patients received placebo (n = 465) or pegfilgrastim (n = 463). Patients receiving pegfilgrastim, compared with patients receiving placebo, had a lower incidence of febrile neutropenia (1% v 17%, respectively; P < .001), febrile neutropenia–related hospitalization (1% v 14%, respectively; P < .001), and use of IV anti-infectives (2% v 10%, respectively; P < .001). The percentage of patients receiving the planned dose on time was similar between patients receiving pegfilgrastim and patients who initially received placebo (80% and 78%, respectively), as would be expected of the study design. Pegfilgrastim was generally well tolerated and safe, and the adverse events reported were typical of this patient population.
CONCLUSION: First and subsequent cycle use of pegfilgrastim with a moderately myelosuppressive chemotherapy regimen markedly reduced febrile neutropenia, febrile neutropenia–related hospitalizations, and IV anti-infective use.
Supported by Amgen Inc, Thousand Oaks, CA.
Presented at the Multinational Association of Supportive Care in Cancer Meeting, June 2004, Miami Beach, FL; and submitted at the European Society for Medical Oncology Meeting, October 2004, Vienna, Austria; and the San Antonio Breast Cancer Symposium, December 2004, San Antonio, TX.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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