title: [CGS20267 (Letrozole), a new aromatase inhibitor: late phase II study in postmenopausal women with advanced or recurrent breast cancer (no. 2)--evaluation of efficacy and safety at the recommended clinical dose CGS20267 Study Group].
abstract: In the first part of this late phase II study, we determined the recommended clinical dose of CGS20267 to be 1.0 mg once daily for the treatment of postmenopausal women with advanced or recurrent breast cancer. To further evaluate the efficacy and safety of CGS20267 at the derived or recommended clinical dose, 30 more patients were enrolled in the second part of the study, and were added to the patients treated at 1.0 mg in the first part. As a result of putting the first and second parts together, the objective response rate at 1.0 mg was found to be 38.3%, which was almost equal to that of the early phase II study (40.7%). Drug-related adverse events occurred in 35.4% of the patients at 1.0 mg, and all of the events were of grade 2 or lower. These results demonstrated that CGS20267 1.0 mg once daily is effective and well tolerated in the treatment of postmenopausal women with advanced or recurrent breast cancer.
authors.affiliation: Dept. of Surgery II, Fukushima Medical College.
authors.forename: Izo
authors.initials: I
authors.lastname: Kimijima
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tominaga
authors.forename: Tadashi
authors.initials: T
authors.lastname: Nomizu
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nomura
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
authors.forename: Hiroki
authors.initials: H
authors.lastname: Koyama
authors.forename: Muneaki
authors.initials: M
authors.lastname: Sano
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Tohge
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ueo
authors.forename: Seiyo
authors.initials: S
authors.lastname: Ikeda
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D047072:Aromatase Inhibitors; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D004967:Estrogens / Q000097:blood; D005260:Female; D006801:Humans; D000077289:Letrozole; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000627:therapeutic use; D017698:Postmenopause; D015996:Survival Rate; D014230:Triazoles / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors; D004791:Enzyme Inhibitors; D004967:Estrogens; D009570:Nitriles; D014230:Triazoles; D000077289:Letrozole