SUN-063 Usefulness of a LHRH Test with Low Dose of Triptorelin Pamoate in the Diagnosis of Precocious Puberty in Girls

Objective : to determine diagnosis value of a new LHRH test for diagnosis or precocious puberty (PP) correlated with clinical and paraclinical pubertal changes. Methods:79 girls under age 10 years old were referred to our laboratory with diagnosis of precocious puberty went thought a physical exam and bone age /pelvic US review to classify them clinically in probably PP or unlikely PP. A LHRH test was performed with measurement of at least 3 times including baseline measurement of gonadotrophins (LH / FSH) and estradiol 0-24 hours after a dose of 100 mcg/m2 (max 100 mcg) of Triptorelin Pamoate. The results for LH greater than 8 uUI / L and estradiol of 80 pg / ml were considered positive - Results: From 79 girls, mean age 8,02 years old (+/- 2,2) 41 were classified as likely PP (group 1) and 38 unikely PP (group 2) On group 1, 39 patients (95,1 %) had results of LH above 8 uUI/L. In this group, 5 patients (12.1%) had estradiol results below 80 pg / ml. Of the positive test, 3 patients (7,6%) %) had LH peak time 60 min, 4 patients (10,2%) had LH peak time 90 min, 31 (79,4%) had LH peak at time 180 minutes. In group 2, 3 patients (7,89 %) had values of estradiol above 80 pg/ml and 1 patient had values above 8 uUI/ml. Sensitivity was 95,1% specificity 97,4%, predicted positive value 97,5% and negative predicted value 95%. Conclusion: Low dose LHRH test for precocious puberty with 100 mcg/m2 of Pamoate Triptorelin is a useful tool in the diagnosis of precocious puberty in girls, with high sensitivity and specificity and with lower cost than other diagnostic tools.

Health-related quality of life in patients with advanced prostate cancer undergoing treatment with TRIPTOrelin Pamoate SIX month formulation: Results of the non-interventional TRIPTOSIX study.

287 Background: Preserving quality of life (QoL) is an important therapeutic aim in advanced prostate cancer (PCa). The effects of treatment on QoL were studied in a non-interventional study performed from 2010 until 2012 evaluating 1 year of treatment with a LHRH agonist, triptorelin pamoate 6-month depot (TP 6M). Methods: Data of 564 patients with advanced PCa treates in 129 German urology outpatient clinics were analysed. Data on QoL were collected by EORTC questionnaires (QLQ-C30 and -PR25) at baseline, 6 months and 12 months. The QLQ-C30 assesses functional QoL, global health and symptoms of disease, the QLQ-PR25 covers PCa specific symptoms and sexual activity. A clinically relevant improvement, i.e. increase of ≥10 points in the QLQ-C30 global health status/QoL scale, defined treatment responders. Response at month 6 compared to baseline was the primary study endpoint. Results: GlobalHealth Related (HR) QoL was similar over the 1 year follow-up period with a mean (± SD) score of 60.9 (±21.8) at baseline and 61.7 (±22.2) at 12 months. Within the first 6 months, 24.0% of patients were identified as responders (i.e. a clinically relevant improvement in this parameter of ≥10 points). The responder rate was maintained at 12 months of treatment (25.5%). This trend in QoL was also seen in the QLQ-C30 subscales, which were generally similar over the study period. QLQ-PR25 scores were also found to be similar over 1 year, although some deterioration was reported by sexually active patients, as expected. Subgroup analyses on response rates identified age, risk group, pretreatment for PCa and baseline QoL scores as predictors of change in QoL. Conclusions: Treatment with TP 6M over 12 months is associated with few changes in HRQoL and might lead in some patients to clinically meaningful improvements of HRQoL.

Efficacy of triptorelin in lowering serum testosterone (sT) in patients with advanced prostate cancer.

162 Background: Medical castration using gonadotropin-releasing hormone (GnRH) agonists is the mainstay of treatment for advanced prostate cancer. Achievement and maintenance of castrate serum testosterone (sT) levels <50 ng/dL (1.735 nmol/mL) has been the goal of therapy. However, patients are able to achieve and maintain sT levels <15 ng/dL after surgical castration (Oefelein M et al. J Urology 2000; 56: 1021-4). Some authors have suggested that 20 ng/dL should be the target threshold for medical castration(Perachino M et al. BJU Int 2010; 105: 648-51) but the clinical relevance of achieving such low sT levels (<20 ng/dL) remains unknown. Methods: The efficacy and safety of sustained-release triptorelin pamoate 22.5 mg 6-month formulation was recently evaluated in a 12-month (48-week), multicentre, open-label, phase III study in 120 patients with locally advanced or metastatic prostate cancer and/or increased prostate specific antigen (PSA) after failed local therapy. Initial results based on the standard castration level of 50 ng/dL were previously presented in comparison to triptorelin 1- and 3-month formulations (Lundström E et al. Clin Drug Investig 2009; 29: 757-65). We report the proportions of patients achieving sT levels of <20 ng/dL with the triptorelin pamoate 1-, 3- and 6-month formulations. Results: With the 6-month formulation, sT levels of <20 ng/dL were achieved in >90% of patients on Day 169 (6 months after first triptorelin injection) and on Day 337 (6 months after second injection; Table). Similar sT levels were achieved with triptorelin 1- and 3-month formulations in a phase III study over 9 months (Table). Conclusions: A high proportion of patients receiving the 6-month triptorelin formulation achieve sT levels <20 ng/dL. This compares favorably to the triptorelin 1- and 3-month formulations. [Table: see text] [Table: see text]

Immunocytogenetic effects of gonadotropin releasing hormone analogue: Triptorelin Pamoate (Decapeptyl ®) during in vitro fertilization treatment

In this study, the immunocytogenetic effects of Decapeptyl ® (Triptorelin Pamoate) were assessed in the peripheral blood lymphocytes of females undergoing in vitro fertilization (IVF) treatment. Blood samples were taken from 34 females (23 treated and 11 controls), cultured and examined for sister chromatid exchanges (SCE) and cell replication index (CRI). The SCE frequency increased around ovulation time in the controls, and around the time of human chorionic gonadotropin administration in the IVF group. However, the SCE rate was significantly higher in the latter group. Furthermore, the white blood cells (WBC) count was significantly higher on the day of ovum pick up compared to the day preceding luteinizing hormone (LH) and follicle stimulating hormone (FSH) treatment. Similar observations were recorded with respect to phagocytic activity tested by nitroblue tetrazolium (NBT) assay. The nitric oxide production abilities of macrophages were not significantly changed in the LH, FSH-treated group relative to its control. Finally, the 50% complement hemolytic activity (CH50) assay results indicated that Decapeptyl lacks a significant potential to affect the complement system.