Comparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer

dc.contributor.authorHeyns C.F.
dc.contributor.authorSimonin M.-P.
dc.contributor.authorGrosgurin P.
dc.contributor.authorSchall R.
dc.contributor.authorPorchet H.C.
dc.date.accessioned2011-05-15T16:15:43Z
dc.date.available2011-05-15T16:15:43Z
dc.date.issued2003
dc.description.abstractOBJECTIVE: To compare the efficacy of monthly administrations of the luteinizing hormone-releasing hormone agonists triptorelin pamoate and leuprolide acetate to induce and maintain castrate levels of serum testosterone in men with advanced prostate cancer. PATIENTS AND METHODS: Men with advanced prostate cancer were randomly assigned to receive triptorelin 3.75 mg or leuprolide 7.5 mg. The agent was injected intramuscularly every 28 days for nine injections. Primary endpoints were the percentages of men whose serum testosterone concentrations declined to and were maintained at or below castrate levels (≤ 1.735 nmol/L or ≤500 ng/L) during 9 months (253 days) of treatment. Secondary endpoints were luteinizing hormone levels, bone pain, prostate specific antigen levels, quality of life, testosterone pharmacodynamics, survival, and safety variables. RESULTS: In all, 284 men received either triptorelin (140) or leuprolide (144). The percentage of men with castrate levels of serum testosterone was lower at 29 days for triptorelin than for leuprolide (91.2% vs 99.3%; point estimate -8.0, 95% confidence interval -16.9% to -1.4%), but equivalent at 57 days (97.7% vs 97.1%). The mean (98.8% vs 97.3%) and cumulative (96.2% vs 91.2%) castration maintenance rates between 29 and 253 days were equivalent between the treatment groups. Secondary endpoints were equivalent between treatment groups except for the 9-month survival rate, which was significantly higher for triptorelin than for leuprolide (97.0% vs 90.5%; P = 0.033). Both treatments were well tolerated. CONCLUSION: Triptorelin reduced testosterone concentrations less rapidly, but maintained castration as effectively as leuprolide. There was no evidence that the slower onset of castration caused deleterious effects.
dc.description.versionArticle
dc.identifier.citationBJU International
dc.identifier.citation92
dc.identifier.citation3
dc.identifier.issn14644096
dc.identifier.other10.1046/j.1464-410X.2003.04308.x
dc.identifier.urihttp://hdl.handle.net/10019.1/13455
dc.subjectleuprorelin
dc.subjectluteinizing hormone
dc.subjectprostate specific antigen
dc.subjecttestosterone
dc.subjecttriptorelin
dc.subjecttriptorelin pamoate
dc.subjectunclassified drug
dc.subjectadult
dc.subjectadvanced cancer
dc.subjectaged
dc.subjectarticle
dc.subjectbone pain
dc.subjectcancer survival
dc.subjectclinical trial
dc.subjectconfidence interval
dc.subjectconstipation
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectheadache
dc.subjecthormone determination
dc.subjecthot flush
dc.subjecthuman
dc.subjectinjection pain
dc.subjectinjection site
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectpharmacodynamics
dc.subjectpriority journal
dc.subjectprostate carcinoma
dc.subjectquality of life
dc.subjectrandomized controlled trial
dc.subjectskin bruising
dc.subjectskin edema
dc.subjecttestosterone blood level
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectAnalgesics
dc.subjectAntineoplastic Agents, Hormonal
dc.subjectCastration
dc.subjectGonadotropin-Releasing Hormone
dc.subjectHumans
dc.subjectLeuprolide
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectProstatic Neoplasms
dc.subjectSurvival Analysis
dc.subjectTestosterone
dc.subjectTreatment Outcome
dc.subjectTriptorelin
dc.titleComparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer
dc.typeArticle
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