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Supportive Care in Cancer
Published in: Supportive Care in Cancer 4/2015

Open Access 01-04-2015 | Original Article

Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy

Authors: Yoshimasa Kosaka, Yoshiaki Rai, Norikazu Masuda, Toshimi Takano, Toshiaki Saeki, Seigo Nakamura, Ryutaro Shimazaki, Yoshinori Ito, Yutaka Tokuda, Kazuo Tamura

Published in: Supportive Care in Cancer | Issue 4/2015

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Abstract

Purpose

Pegfilgrastim is a pegylated form of filgrastim, a recombinant protein of granulocyte colony-stimulating factor, that is used to reduce the risk of febrile neutropenia (FN). Here, we report the results of a phase III trial of pegfilgrastim in breast cancer patients receiving docetaxel and cyclophosphamide (TC) chemotherapy.

Methods

We conducted a double-blind, placebo-controlled, randomized trial to determine the efficacy of pegfilgrastim in reducing the risk of FN in early-stage breast cancer patients. A total of 351 women (177 in the pegfilgrastim group and 174 in the placebo group) between 20 and 69 years of age with stage I–III invasive breast carcinoma who were to receive TC chemotherapy (docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 every 3 weeks) as either neoadjuvant or adjuvant therapy were enrolled; 346 of these patients were treated with either pegfilgrastim (n = 173) or placebo (n = 173).

Results

The incidence of FN was significantly lower in the pegfilgrastim group than in the placebo group (1.2 vs. 68.8 %, respectively; P < 0.001). In addition, patients in the pegfilgrastim group required less hospitalization and antibiotics for FN. Most adverse events were consistent with those expected for breast cancer subjects receiving TC chemotherapy.

Conclusions

Pegfilgrastim is safe and significantly reduces the incidence of FN in breast cancer patients.
Appendix
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Metadata
Title
Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy
Authors
Yoshimasa Kosaka
Yoshiaki Rai
Norikazu Masuda
Toshimi Takano
Toshiaki Saeki
Seigo Nakamura
Ryutaro Shimazaki
Yoshinori Ito
Yutaka Tokuda
Kazuo Tamura
Publication date
01-04-2015
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 4/2015
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-014-2597-1

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