[Late phase II study of CGS16949A, a new aromatase inhibitor--a multicentral cooperative study (Western Japan Group)].
A late phase II study of a new non-steroidal aromatase inhibitor CGS16949A was performed in postmenopausal patients with advanced or recurrent breast cancer. The drug was given orally, 1 mg twice daily for 12 weeks or more. Of 72 evaluable cases, there were 1-CR, 10-PR, 17-"long NC", 12 NC and 32-PD, with "long NC" defined as disease stabilization for more than 6 months. Median time to the onset of PR and median duration of objective tumor responses were 85 and 278 days, respectively. Maximum and median duration of long NC were 471 and 243 days, respectively. Adverse effects were observed in 5 (7.8%) of 64 cases. In laboratory evaluations, slight abnormalities were observed in 11 (17.2%) of 64 cases. No adverse effect and laboratory abnormality was found worse than Grade 1 toxicity. As for Global Utility Rating, treatment with CGS16949A was considered to be useful or better in 24 (32.9%) of 73 cases. Plasma estradiol and estrone concentrations at one month after initiation of the treatment decreased significantly in comparison with pre-treatment levels. Plasma cortisol, testosterone and androstenedione was not changed. Thus, CGS16949A showed good efficacy, tolerability and usefulness in postmenopausal patients with advanced or recurrent breast cancer.
Wada
T
T
First Dept. of Surgery, Kinki University School of Medicine.
Nomura
Y
Y
Oohashi
Y
Y
Abe
O
O
Koyama
H
H
Takashima
S
S
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004958:Estradiol / Q000097:blood; D004970:Estrone / Q000097:blood; D017316:Fadrozole / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017698:Postmenopause
D004970:Estrone; D004958:Estradiol; D017316:Fadrozole