title: [Clinical evaluation of CGS16949A in advanced or recurrent breast cancer--a multi-institutional late phase II clinical trial].
abstract: A multi-institutional late-phase II clinical trial of CGS 16949A was conducted at the dose of 1 mg twice daily in postmenopausal patients with advanced or recurrent breast cancer. Seventy patients entered into the study; 65 were eligible and 53 were complete cases. There were 3 CR, 11 PR, 10 long-NC, 14 NC and 25 PD with an overall response rate of 22.2% in 63 evaluable cases. The median period of overall duration of responses was 327.5 days. There were 22 cases that drug was found useful or better, and global usefulness rate was 33.8%. Forty six (76.7%) of patients experienced no side effects in this therapy. Grade 2 toxicities included anorexia (1 pt.), feeling of distension of abdomen (1 pt.), vomiting (1 pt.), fatigue (1 pt.), and only one patient experienced Grade 3 toxicity (anorexia). Grade 2 laboratory abnormalities were confirmed in two patients; one with elevated gamma-GTP and another with elevated LDH, and both were in the absence of liver metastasis. From these results, it is concluded that CGS16949A seemed to be a useful hormonal agent in the treatment of postmenopausal breast cancer.
authors.affiliation: Dept. of Surgery, National Nagoya Hospital.
authors.forename: H
authors.initials: H
authors.lastname: Aoyama
authors.forename: K
authors.initials: K
authors.lastname: Asaishi
authors.forename: R
authors.initials: R
authors.lastname: Abe
authors.forename: T
authors.initials: T
authors.lastname: Kajiwara
authors.forename: K
authors.initials: K
authors.lastname: Enomoto
authors.forename: M
authors.initials: M
authors.lastname: Yoshida
authors.forename: Y
authors.initials: Y
authors.lastname: Ohasi
authors.forename: T
authors.initials: T
authors.lastname: Tominaga
authors.forename: O
authors.initials: O
authors.lastname: Abe
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D017316:Fadrozole / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017698:Postmenopause
chemical_list: D017316:Fadrozole