Clinical early phase II study of bicalutamide (Casodex) in patients with prostatic cancer

Clinical early phase II study of bicalutamide (Casodex) in patients with prostatic cancer

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 1...

Ausführliche Beschreibung

Bibliographische Detailangaben
Veröffentlicht in:Hinyokika kiyo. Acta urologica Japonica. - 1962. - 42(1996), 2 vom: 23. Feb., Seite 157-68
1. Verfasser: Kotake, T (VerfasserIn)
Weitere Verfasser: 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
Format: Aufsatz
Sprache:Japanese
Veröffentlicht: 1996
Zugriff auf das übergeordnete Werk:Hinyokika kiyo. Acta urologica Japonica
Schlagworte:Clinical Trial Clinical Trial, Phase II English Abstract Journal Article Multicenter Study Randomized Controlled Trial Androgen Antagonists Anilides Antineoplastic Agents Biomarkers, Tumor mehr... Nitriles Tosyl Compounds bicalutamide A0Z3NAU9DP
LEADER 01000naa a22002652 4500
001 NLM086841912
003 DE-627
005 20231222070435.0
007 tu
008 231222s1996 xx ||||| 00| ||jpn c
028 5 2 |a pubmed24n0290.xml 
035 |a (DE-627)NLM086841912 
035 |a (NLM)8712092 
040 |a DE-627  |b ger  |c DE-627  |e rakwb 
041 |a jpn 
100 1 |a Kotake, T  |e verfasserin  |4 aut 
245 1 0 |a Clinical early phase II study of bicalutamide (Casodex) in patients with prostatic cancer 
264 1 |c 1996 
336 |a Text  |b txt  |2 rdacontent 
337 |a ohne Hilfsmittel zu benutzen  |b n  |2 rdamedia 
338 |a Band  |b nc  |2 rdacarrier 
500 |a Date Completed 10.09.1996 
500 |a Date Revised 19.11.2015 
500 |a published: Print 
500 |a Citation Status MEDLINE 
520 |a 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 
650 4 |a Clinical Trial 
650 4 |a Clinical Trial, Phase II 
650 4 |a English Abstract 
650 4 |a Journal Article 
650 4 |a Multicenter Study 
650 4 |a Randomized Controlled Trial 
650 7 |a Androgen Antagonists  |2 NLM 
650 7 |a Anilides  |2 NLM 
650 7 |a Antineoplastic Agents  |2 NLM 
650 7 |a Biomarkers, Tumor  |2 NLM 
650 7 |a Nitriles  |2 NLM 
650 7 |a Tosyl Compounds  |2 NLM 
650 7 |a bicalutamide  |2 NLM 
650 7 |a A0Z3NAU9DP  |2 NLM 
700 1 |a Usami, M  |e verfasserin  |4 aut 
700 1 |a Isaka, S  |e verfasserin  |4 aut 
700 1 |a Shimazaki, J  |e verfasserin  |4 aut 
700 1 |a Nakano, E  |e verfasserin  |4 aut 
700 1 |a Okuyama, A  |e verfasserin  |4 aut 
700 1 |a Okajima, E  |e verfasserin  |4 aut 
700 1 |a Kanetake, H  |e verfasserin  |4 aut 
700 1 |a Saitoh, Y  |e verfasserin  |4 aut 
700 1 |a Kumamoto, Y  |e verfasserin  |4 aut 
700 1 |a Orikasa, S  |e verfasserin  |4 aut 
700 1 |a Sakata, Y  |e verfasserin  |4 aut 
700 1 |a Hosaka, M  |e verfasserin  |4 aut 
700 1 |a Akaza, H  |e verfasserin  |4 aut 
700 1 |a Koiso, K  |e verfasserin  |4 aut 
700 1 |a Honma, Y  |e verfasserin  |4 aut 
700 1 |a Aso, Y  |e verfasserin  |4 aut 
700 1 |a Oishi, K  |e verfasserin  |4 aut 
700 1 |a Yoshida, O  |e verfasserin  |4 aut 
700 1 |a Naitoh, S  |e verfasserin  |4 aut 
700 1 |a Kumazawa, J  |e verfasserin  |4 aut 
700 1 |a Koyanagi, T  |e verfasserin  |4 aut 
700 1 |a Yachiku, S  |e verfasserin  |4 aut 
700 1 |a Shiraiwa, Y  |e verfasserin  |4 aut 
700 1 |a Tsukagoshi, S  |e verfasserin  |4 aut 
773 0 8 |i Enthalten in  |t Hinyokika kiyo. Acta urologica Japonica  |d 1962  |g 42(1996), 2 vom: 23. Feb., Seite 157-68  |w (DE-627)NLM012631779  |x 0018-1994  |7 nnns 
773 1 8 |g volume:42  |g year:1996  |g number:2  |g day:23  |g month:02  |g pages:157-68 
912 |a GBV_USEFLAG_A 
912 |a SYSFLAG_A 
912 |a GBV_NLM 
912 |a GBV_ILN_20 
912 |a GBV_ILN_22 
912 |a GBV_ILN_40 
912 |a GBV_ILN_60 
912 |a GBV_ILN_72 
912 |a GBV_ILN_120 
912 |a GBV_ILN_350 
912 |a GBV_ILN_2001 
912 |a GBV_ILN_2003 
912 |a GBV_ILN_2005 
912 |a GBV_ILN_2006 
912 |a GBV_ILN_2008 
912 |a GBV_ILN_2010 
912 |a GBV_ILN_2012 
912 |a GBV_ILN_2018 
951 |a AR 
952 |d 42  |j 1996  |e 2  |b 23  |c 02  |h 157-68