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

• Published in: Supportive care in cancer Vol. 23; no. 4; pp. 1137 - 1143
• Main Authors: Kosaka, Yoshimasa, Rai, Yoshiaki, Masuda, Norikazu, Takano, Toshimi, Saeki, Toshiaki, Nakamura, Seigo, Shimazaki, Ryutaro, Ito, Yoshinori, Tokuda, Yutaka, Tamura, Kazuo
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.04.2015; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Breast cancer; Breast Neoplasms - drug therapy; Cancer patients; Cancer prevention; Care and treatment; Chemotherapy; Chemotherapy, Adjuvant; Chemotherapy-Induced Febrile Neutropenia - drug therapy; Chemotherapy-Induced Febrile Neutropenia - prevention & control; Clinical trials; Cyclophosphamide; Cyclophosphamide - adverse effects; Double-Blind Method; Doxorubicin - adverse effects; Drug therapy; Female; Filgrastim; Granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - administration & dosage; Humans; Macrophage colony stimulating factor; Medicine; Medicine & Public Health; Middle Aged; Neutropenia; Nursing; Nursing Research; Oncology; Original; Original Article; Pain Medicine; Polyethylene Glycols; Product development; Prognosis; Recombinant proteins; Recombinant Proteins - administration & dosage; Rehabilitation Medicine; Risk; Risk factors; Side effects; Survival Rate; Taxoids - adverse effects; Treatment Outcome; Granulocyte colony-stimulating factor (G-CSF); Pegfilgrastim; Breast cancer; Docetaxel/cyclophosphamide therapy; Adjuvant therapy; Febrile neutropenia
• ISSN: 0941-4355; 1433-7339; 1433-7339
• DOI: 10.1007/s00520-014-2597-1

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.