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 Schwartzberg

Research output: Contribution to journalArticle

375 Citations (Scopus)

Abstract

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 × 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.

Original languageEnglish (US)
Pages (from-to)1178-1184
Number of pages7
JournalJournal of Clinical Oncology
Volume23
Issue number6
DOIs
StatePublished - Feb 20 2005
Externally publishedYes

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Febrile Neutropenia
Placebos
Breast Neoplasms
docetaxel
Hospitalization
Drug Therapy
pegfilgrastim
Incidence
Body Temperature
Neutrophils
Fever

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer : A multicenter, double-blind, placebo-controlled phase III study. / Vogel, Charles L.; Wojtukiewicz, Marek Z.; Carroll, Robert R.; Tjulandin, Sergei A.; Barajas-Figueroa, Luis Javier; Wiens, Brian L.; Neumann, Theresa A.; Schwartzberg, Lee.

In: Journal of Clinical Oncology, Vol. 23, No. 6, 20.02.2005, p. 1178-1184.

Research output: Contribution to journalArticle

Vogel, Charles L. ; Wojtukiewicz, Marek Z. ; Carroll, Robert R. ; Tjulandin, Sergei A. ; Barajas-Figueroa, Luis Javier ; Wiens, Brian L. ; Neumann, Theresa A. ; Schwartzberg, Lee. / First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer : A multicenter, double-blind, placebo-controlled phase III study. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 6. pp. 1178-1184.
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abstract = "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 × 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.",
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T2 - A multicenter, double-blind, placebo-controlled phase III study

AU - Vogel, Charles L.

AU - Wojtukiewicz, Marek Z.

AU - Carroll, Robert R.

AU - Tjulandin, Sergei A.

AU - Barajas-Figueroa, Luis Javier

AU - Wiens, Brian L.

AU - Neumann, Theresa A.

AU - Schwartzberg, Lee

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N2 - 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 × 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.

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