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.

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/m(2) and cyclophosphamide 600 mg/m(2) 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.

• Authors: Yoshimasa Kosaka, Yoshiaki Rai, Norikazu Masuda, Toshimi Takano, Toshiaki Saeki, Seigo Nakamura, Ryutaro Shimazaki, Yoshinori Ito, Yutaka Tokuda, Kazuo Tamura
• Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 23 Issue 4 Pg. 1137-43 (Apr 2015) ISSN: 1433-7339 [Electronic] Germany
• PMID: 25576433 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Taxoids
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Doxorubicin
• Cyclophosphamide
• Filgrastim

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Breast Neoplasms (drug therapy)
• Chemotherapy, Adjuvant
• Chemotherapy-Induced Febrile Neutropenia (drug therapy, prevention & control)
• Cyclophosphamide (adverse effects)
• Double-Blind Method
• Doxorubicin (adverse effects)
• Female
• Filgrastim
• Granulocyte Colony-Stimulating Factor (administration & dosage)
• Humans
• Middle Aged
• Polyethylene Glycols
• Prognosis
• Recombinant Proteins (administration & dosage)
• Risk
• Survival Rate
• Taxoids (adverse effects)
• Treatment Outcome