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| |  Triptorelin 6-Month Formulation Safe, Effective in Patients With Advanced Prostate Cancer: Presented at EMUC By Chris Berrie BARCELONA, Spain -- December 1, 2009 -- The new 6-month formulation of triptorelin pamoate, a synthetic decapeptide gonadotropin-releasing hormone analogue, is both safe and effective for induction and maintenance of castration in patients with advanced prostate cancer. This multicentre, open-label, noncomparative, phase 3 study was presented here on November 27 by Eija Lundström, MD, Debiopharm SA, Lausanne, Switzerland, at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC). “The triptorelin 1-month and 3-month formulations have already been marketed for more than 20 years in the treatment of advanced prostate cancer,” said Dr. Lundström; therefore, the main objective of this study was to evaluate the efficacy of this new 6-month formulation for achieving and maintaining castration levels of serum testosterone (<=1.735 nmol/L) 4 weeks following the first injection in these patients. The range of secondary objectives included changes in prostate-specific antigen (PSA) levels and safety. The inclusion criteria were locally advanced or metastatic prostate cancer, as staged at T3-4NxMx, TxN1Mx, or TxNxM1, or rising PSA levels after failed local therapy (surgery or radiation). A serum testosterone of >5 nmol/L and an expected survival >18 months also were required. The 120 patients enrolled underwent 2 intramuscular injections (22.5 mg each) of the triptorelin 6-month formulation, one on day 1 and the other on day 169 (after 24 weeks), with patient assessment through week 48. These assessments included monitoring of serum testosterone, luteinising hormone (LH), and PSA levels, plus adverse events (AEs) and serum triptorelin concentrations. In all, 97.5% of the patients reached castration testosterone levels by day 29, with 94.1% maintaining this from month 2 to month 9. These levels compared favourably with the previous 1-month (92.7% castration; 94.2% maintenance from month 2 to 9) and 3-month (97.7%; 94.4% maintenance) formulations of triptorelin. Serum LH levels to >1.0 IU/L were seen in 100% of the patients on first triptorelin injection, but only 2.7% following the second injection on day 169. Median relative decreases in PSA levels from baseline were 96.9% by month 6 and in 96.4% by month 12. In all, 14.2% of the patients experienced a serious AE, and the most common drug-related AEs were hot flushes (72%), erectile dysfunction (10%), and testicular atrophy (8%). Local tolerance was also good, with mainly mild injection-site AEs seen in 6.7% of the patients. Dr. Lundström concluded that “the efficacy and safety [of this new formulation] are very similar to the existing formulations, meaning fewer injections and more convenience.” This study was funded by Debiopharm Group. EMUC was co-organised by the European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), and the European Society for Therapeutic Radiology and Oncology (ESTRO). [Presentation title: New Triptorelin 6-Month Formulation Shows High Level of Efficacy and Safety in Patients With Advanced Prostate Cancer. Abstract P056]
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