- 【Updated on May 12, 2025】 Integration of CiNii Dissertations and CiNii Books into CiNii Research
- Trial version of CiNii Research Knowledge Graph Search feature is available on CiNii Labs
- 【Updated on June 30, 2025】Suspension and deletion of data provided by Nikkei BP
- Regarding the recording of “Research Data” and “Evidence Data”
Clinical effects of a 3-month formulation LH-RH agonist, TAP-144-SR (3M) in prostate cancer patients
-
- Koiso, Kenkichi
- Senpo Tokyo Takanaka Hospital.
Bibliographic Information
- Other Title
-
- 前立腺癌(既治療例)に対する3ヵ月徐放性LH-RH agonist,TAP-144-SR(3M)(リュープリンSR注射用キット11.25)の臨床効果の検討
Search this article
Description
A randomized, multicenter, double-blind, parallel-group study was conducted in order to evaluate the hormonal kinetics, pharmacokinetics, efficacy and safety of TAP-144-SR (3M) a three-month sustained-release injectable preparation of leuprorelin acetate, a highly active luteinizing hormone-releasing hormone (LH-RH) derivative by comparing the treatment with two subcutaneous doses of the test medication TAP-144-SR (3M) and the treatment with six subcutaneous doses of the reference medication TAP-144-SR (1M), a 1-month sustained-release injectable preparation. Study participants were 103 patients with prostate cancer in whom a stable anti-tumor effect had been obtained with Leuplin Injection 3.75. The hormonal kinetics revealed that the proportion of the patients "maintaining the castration level of serum testosterone (maximum serum testosterone level during treatment below the castration level [100 ng/dl])" was 100% in both treatment groups. With regard to the efficacy, the proportions of the patients in whom the anti-tumor effects (> or = Stable) of the baseline treatment prior to the initiation of the treatment with the study medication were maintained during the study treatment period (6 months) were comparable; 84.0% with TAP-144-SR (1M) and 80.4% with TAP-144-SR (3M). On evaluation of the pharmacokinetics, the mean value of AUC1-12w of the serum TAP-144 concentration (including the metabolite M-I) for the treatment with TAP-144-SR (3M) was 77.0% that of the treatment with TAP-144-SR (1M). Adverse events were similar in the subjects on TAP-144-SR (3M) and in those on TAP-144-SR (1M). There existed no big differences in kind, incidence or time of occurrence of adverse events between two groups. TAP-144-SR (3M) showed no clinically relevant findings in particular. These results indicate that one dose of TAP-144-SR (3M) is comparable to three doses of the already approved Leuplin injection 3.75 in serum testosterone level-inhibitory effect, efficacy and safety. Hence, it is considered that TAP-144-SR (3M) is a drug suitable for treatment of prostate cancer over a prolonged period of time.
Journal
-
- Hinyokika Kiyo
-
Hinyokika Kiyo 48 (12), 781-795, 2002-12
泌尿器科紀要刊行会
- Tweet
Keywords
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Hormonal/administration & dosage/pharmacokinetics
- Delayed-Action Preparations
- Double-Blind Method
- Gonadotropin-Releasing Hormone/agonists
- Humans
- Injections, Subcutaneous
- Leuprolide/administration & dosage/pharmacokinetics
- Male
- Middle Aged
- Prostatic Neoplasms/blood/drug therapy
- Testosterone/blood
- Time Factors
- Treatment Outcome
Details 詳細情報について
-
- CRID
- 1050001335665604352
-
- NII Article ID
- 120002142387
- 120002142386
-
- NII Book ID
- AN00208315
-
- ISSN
- 00181994
-
- HANDLE
- 2433/114877
- 2433/114878
-
- Text Lang
- ja
-
- Article Type
- departmental bulletin paper
-
- Data Source
-
- IRDB
- CiNii Articles