title: [Safety and Tolerance of Dose-Dense Epirubicin and Cyclophosphamide (EC) with Pegfilgrastim for Japanese Patients with Early Breast Cancer].
abstract: With the approval of pegfilgrastim, the use of dose-dense epirubicin and cyclophosphamide (EC) for breast cancer has become acceptable in Japan. Thus, we aimed to evaluate its safety and tolerability in Japanese patients. Nine breast cancer patients with a high risk of preoperative or postoperative recurrence received EC therapy(epirubicin 90 mg/m(2) and cyclo- phosphamide 600 mg/m(2))for 4 cycles every 2 weeks in combination with a subcutaneous injection of pegfilgrastim (3.6 mg) on day 2 of each cycle. Treatment was discontinued in 1 and extended in 1 of the 9 patients, and the mean relative dose intensity(RDI)was good at 0.93. No serious adverse events were observed, indicating good tolerability. The regimen has potential for use in cases in which the treatment dose needs to be increased. grade 4 neutropenia was observed in all the 9 patients on day 8, with 6 patients developing febrile neutropenia. In Japan, data on changes in neutrophil count associated with pegfilgrastim administration under anthracycline-based chemotherapy are currently insufficient, and further study is required.
authors.affiliation: Dept. of Breast Surgery, Hokkaido Cancer Center.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Watanabe
authors.forename: Masako
authors.initials: M
authors.lastname: Sato
authors.forename: Mitsugu
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Mayuko
authors.initials: M
authors.lastname: Ikarashi
authors.forename: Kanako
authors.initials: K
authors.lastname: Hagio
authors.forename: Nobumoto
authors.initials: N
authors.lastname: Tomioka
authors.forename: Shinya
authors.initials: S
authors.lastname: Tamaki
authors.forename: Yumi
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Masato
authors.initials: M
authors.lastname: Takahasi
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004361:Drug Tolerance; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D003520:Cyclophosphamide; D000069585:Filgrastim