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| Title: ÍPhase I study of bicalutamide (Casodex), a
nonsteroidal antiandrogen in patients with prostatic cancerÍ |
| Title Abreviation: Hinyokika Kiyo |
Date of Pub: 1996 Feb |
| Author: Kotake T; Usami M; Isaka S; Shimazaki J; Oishi K; Yoshida
O; Ozono S; Okajima E; Kanetake H; Saitoh Y; Tsukagoshi S; Akaza H; Koiso K; Kameyama S;
Honma Y; Aso Y; Nakano E; Okuyama A; Naito S; Kumazawa J; Niitani H; Taguchi T; |
| Issue/Part/Supplement: 2 |
Volume Issue: 42 |
Pagination: 143-53 |
| MESH Headings: Administration, Oral*; Aged*; Androgen Antagonists*;
Anilides*; Antineoplastic Agents*; English Abstract; Human; Male; Middle Age*; Prostatic
Neoplasms*; -PG-; |
| Journal Title Code: 27K |
Publication Type: CLINICAL TRIAL |
| Date of Entry: 960910N |
Entry Month: 9611 |
| Country: JAPAN |
Index Priority: 2 |
| Language: Jpn |
Unique Identifier: 96308086 |
| Unique Identifier: 96308086 |
ISSN: 0018-1994 |
| Abstract: A phase I study (open trial) of bicalutamide
(Casodex), a non-steroidal antiandrogen, was conducted on 16 patients with prostatic
cancer (stage C to D). The patients were given 10, 30, 50, 80 or 100 mg of bicalutamide
orally daily for 12 weeks. Adverse reactions were observed in 8 out of 16 patients, but
almost all were mild. Breast pain, gynecomastia and hot flushes were observed in 6
patients. Adverse reactions regarding liver function tests were observed in 3 patients.
These were increased glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase
(GPT), alkaliphosphatase (AL-P) or gamma guanosine 5'-triphosphate (gamma-GTP). However,
during or after the treatment period the elevated values were reversed to the pretreatment
level. In terms of efficacy, anti-tumor effect was observed in 1 or 2 patients at each
dose. Serum concentrations of luteinizing hormone (LH), follicle stimulating hormone
(FSH), testosterone and estradiol increased during treatment. Plasma concentrations of the
R (-) enantiomer, which has antiandrogenic activity, reached the steady state 6-8 weeks
after the initiation of treatment; its apparent plasma elimination half-life observed
following repeated administration was 8.4 +/- 1.1 days. In conclusion, bicalutamide
(10-100 mg od) is considered to be tolerated well enough to be administered to patients
with prostatic cancer and has shown evidence of anti-tumor effect. |
| Abstract By: Author |
| Address: Department of Urology, Center for Adult Diseases, Osaka,
Japan. |
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