title: Leuprorelin acetate depot: results of a multicentre Japanese trial. TAP-144-SR Study Group.
abstract: The clinical efficacy and safety of 3.75 or 7.5 mg leuprorelin acetate depot given subcutaneously once every 4 weeks was evaluated in a collaborative study of 81 patients with untreated prostatic cancer. Efficacy of treatment was assessed using criteria based on a meeting of the Prostatic Cancer Study Group funded by the Japanese Ministry of Health and Welfare and using National Prostatic Cancer Project criteria. Japanese criteria enabled evaluation of individual parameters, unlike the National Prostatic Cancer Project system which classified a patient as unevaluable if one evaluation parameter was unavailable. Leuprorelin acetate depot suppressed serum luteinizing hormone, follicle stimulating hormone and testosterone concentrations. Objective response rates of the prostate, bone metastases, serum prostatic acid phosphatase and soft tissue metastases, and subjective dysuria and pain responses were comparable to those found with conventional hormone therapy. Leuprorelin acetate depot was well tolerated, with no significant differences in response to the two doses.
authors.affiliation: Department of Urology, Faculty of Medicine, University of Tokyo, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Akaza
authors.forename: Y
authors.initials: Y
authors.lastname: Aso
authors.forename: K
authors.initials: K
authors.lastname: Koiso
authors.forename: H
authors.initials: H
authors.lastname: Fuse
authors.forename: K
authors.initials: K
authors.lastname: Isurugi
authors.forename: K
authors.initials: K
authors.lastname: Okada
authors.forename: M
authors.initials: M
authors.lastname: Usami
authors.forename: T
authors.initials: T
authors.lastname: Kotake
authors.forename: T
authors.initials: T
authors.lastname: Ohashi
authors.forename: T
authors.initials: T
authors.lastname: Ueda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D005640:Follicle Stimulating Hormone / Q000097:blood; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007279:Injections, Subcutaneous; D007564:Japan; D016729:Leuprolide; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D013739:Testosterone / Q000097:blood
chemical_list: D000970:Antineoplastic Agents; D003692:Delayed-Action Preparations; D007987:Gonadotropin-Releasing Hormone; D013739:Testosterone; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D016729:Leuprolide