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| Title: ÍClinical early phase II study of bicalutamide
(Casodex) in patients with prostatic cancerÍ |
| Title Abreviation: Hinyokika Kiyo |
Date of Pub: 1996 Feb |
| Author: Kotake T; Usami M; Isaka S; Shimazaki J; Nakano E; Okuyama
A; Okajima E; Kanetake H; Saitoh Y; Kumamoto Y; Orikasa S; Sakata Y; Hosaka M; Akaza H;
Koiso K; Honma Y; Aso Y; Oishi K; Yoshida O; Naitoh S; Kumazawa J; Koyanagi T; Yachiku S;
Shiraiwa Y; Tsukagoshi S; |
| Issue/Part/Supplement: 2 |
Volume Issue: 42 |
Pagination: 157-68 |
| MESH Headings: Administration, Oral*; Aged*; Aged, 80 and over*;
Androgen Antagonists*; Anilides*; Antineoplastic Agents*; English Abstract; Human; Male;
Middle Age*; Prostatic Neoplasms*; Tumor Markers, Biological*; -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: 96308087 |
| Unique Identifier: 96308087 |
ISSN: 0018-1994 |
| Abstract: To investigate the efficacy and safety of bicalutamide
(Casodex) with its clinically recommended dose, the randomized early phase II study was
performed in 124 patients with prostatic cancer (stage C, D). The patients were given 50,
80 or 100 mg of bicalutamide orally once a day in fixed doses for 12 weeks; 122 patients
were eligible for evaluation. The overall response rate was 50.0% (20/40), 61.0% (25/41)
and 53.7% (22/41) in the 50 mg, 80 mg and 100 mg groups, respectively. The response rate
in prostate lesion, bone and lymph node metastases was slightly higher in the 80 mg group
than in the 50 mg and 100 mg groups. The proportion of patients showing a response with
regard to serum PSA (CR and PR) was 84.2, 92.7 and 97.6% in the 50, 80 and 100 mg groups,
respectively. The incidence of adverse reactions was 65.0, 61.0 and 61.0% in the 50, 80
and 100 mg groups, respectively, and there was no significant difference in overall safety
rating in the three groups. Frequent adverse reactions were gynecomastia and breast pain.
Only one patient in the 80 mg group was withdrawn due to shortness of breath. Serum
concentrations of LH, testosterone and estradiol increased significantly after treatment. Bicalutamide
was concluded to be effective and well tolerated in patients with prostatic cancer, and
its recommended dose was 80 mg once daily. |
| Abstract By: Author |
| Address: Department of Urology, Center for Adult Diseases, Osaka,
Japan. |
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