A new pharmaceutical form of leuprorelin acetate for the treatment of advanced prostate cancer: Clinical experience from a non-interventional study

Thyroff-Friesinger, Ursula; Geiges, G.; Engert, Zoltán Vendel

doi:10.1016/j.jgo.2012.10.107

Cited by 3 publications

(5 citation statements)

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“…Further evidence for the good tolerability of the leuprorelin implants is available from two large post-marketing surveillance studies. In the first of these, 1148 patients with advanced hormone-dependent prostate cancer were treated with three injections of the 3-month implant [Thyroff-Friesinger et al 2012a]; 98% of patients assessed the tolerability of the implant as very good/good/satisfactory. The second study assessed 818 patients with advanced hormone-dependent prostate cancer who were treated with three injections of either the 1-month or 3-month implant; while injection-site pain was one of the most frequently reported AEs during the course of treatment, both physicians and patients rated the tolerability of the implants as very good or good in more than 90% of cases (Sandoz data on file; manuscript in preparation).…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Geiges¹,

Schapperer

Thyroff-Friesinger

et al. 2012

Therapeutic Advances in Urology

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Objectives: Two innovative pharmaceutical forms of leuprorelin acetate have been developed as 1-month and 3-month implants for the treatment of advanced hormone-dependent prostate cancer. These products contain active substance dispersed homogeneously in a biodegradable polymer. Here we present the key results from the clinical development of these slow-release implant formulations of leuprorelin. Methods: Two therapeutic studies of the 1-month implant were performed: a randomized, controlled study comparing the leuprorelin implant with leuprorelin prolonged-release microspheres (Enantone) as the active control; and a single-arm study of the leuprorelin implant. For the 3-month implant, four therapeutic studies were performed: a randomized, controlled study comparing the leuprorelin implant with leuprorelin prolonged-release microspheres (Trenantone) as the active control; a single-arm study of the leuprorelin implant; and two long-term studies with the 3-month implant administered twice, either 12 or 16 weeks apart. A pooled analysis of data from the comparator-controlled and single-arm studies of the 3-month implant was also conducted. The main inclusion criterion for all studies was histologically confirmed advanced prostate cancer, with primary endpoints based around successful testosterone suppression (≤0.5 ng/ml). Results: In the comparator-controlled studies, both implants were as effective as the microspheres for achieving successful testosterone suppression and normalization of prostate-specific antigen (PSA) levels. Data from the single-arm and long-term studies were consistent with those from the comparator-controlled studies. In the pooled analysis, significantly more patients treated with the 3-month implant achieved successful testosterone suppression compared with the comparator ( p ≤ 0.01). The safety profile of the implants in the comparator-controlled studies was similar to that of the prolonged-release microsphere formulation, and consistent with that of the luteinizing hormone-releasing hormone agonist class. Conclusions: The innovative 1-month and 3-month implants of leuprorelin acetate are at least as effective as leuprorelin acetate prolonged-release microspheres for achieving successful testosterone suppression and normalization of PSA in men with advanced hormone-dependent prostate cancer, with a comparable safety profile.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Geiges¹,

Schapperer

Thyroff-Friesinger

et al. 2012

Therapeutic Advances in Urology

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show abstract

Section: Discussionmentioning

confidence: 74%

“…21 The safety and tolerability profile of the leuprorelin implant was comparable with the leuprorelin microspheres and other LHRH agonists within its class. 6,7,22 In the two long-term studies, for all patients who completed the study, their investigator rated the overall tolerability as good or very good, in agreement with the single-dose study 6 and a noninterventional, observational study of 1148 German men with advanced prostate cancer. 22 Limitations of the presented data include the low number of patients in the two long-term, repeated-administration studies.…”

Section: Treatment Number Of Patients (%)mentioning

confidence: 81%

“…6,7,22 In the two long-term studies, for all patients who completed the study, their investigator rated the overall tolerability as good or very good, in agreement with the single-dose study 6 and a noninterventional, observational study of 1148 German men with advanced prostate cancer. 22 Limitations of the presented data include the low number of patients in the two long-term, repeated-administration studies. Despite this, serum testosterone profiles were comparable with the two single-dose studies, as well as with an observational study of 818 patients with advanced hormone-sensitive prostate cancer.…”

Section: Treatment Number Of Patients (%)mentioning

confidence: 81%

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Testosterone suppression with a unique form of leuprorelin acetate as a solid biodegradable implant in patients with advanced prostate cancer: results from four trials and comparison with the traditional leuprorelin acetate microspheres formulation

Solarić

Bjartell

Thyroff-Friesinger

et al. 2017

Therapeutic Advances in Urology

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Background: There are two slow-release ready-to-use forms of leuprorelin acetate (1-month and 3-month) that are available as solid, biodegradable implants for the treatment of advanced, hormone-sensitive prostate cancer. These implants have been shown to be as effective as traditional leuprorelin acetate microspheres for achieving successful testosterone suppression (⩽0.5 ng/ml) and lowering prostate-specific antigen (PSA) levels. Here we further evaluate testosterone suppression levels from four clinical trials evaluating the 3-month leuprorelin implant, including analysis below the European Association of Urology (EAU) castration level (<0.2 ng/ml). Methods: Studies were conducted in patients with locally advanced/metastatic prostate cancer: (1) a randomised, controlled single-dose study comparing the leuprorelin implant with leuprorelin microspheres; (2) a single-arm, single-dose study of the leuprorelin implant; (3 and 4) two long-term studies with the leuprorelin implant administered twice, 12 or 16 weeks apart. Patients received 3-month leuprorelin (5 mg) implant or 3-month leuprorelin (10.72 mg) microspheres. Testosterone levels were analysed using radioimmunoassay or ultrasensitive liquid chromatography tandem mass spectrometry. Results: Both the leuprorelin implant and the leuprorelin microspheres achieved mean testosterone suppression (⩽0.5 ng/ml) within 4 weeks for >3 months. In both long-term, single-arm studies with the leuprorelin implant, median values of testosterone ⩽0.2 ng/ml were achieved at Week 4 and maintained until study completion (6 and 8 months); PSA decrease was also observed versus baseline. Conclusions: Long-lasting steady serum levels of testosterone, comparable with orchiectomy and consistent with the EAU-recommended castration level (<0.2 ng/ml), were achieved at Week 4 and maintained up to 8 months in men with advanced prostate cancer who received the leuprorelin implant.

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Two Innovative Pharmaceutical Forms of Leuprorelin: Results from 818 Patients with Advanced Prostate Cancer

Gravel¹,

Samland

Löffler

et al. 2013

Adv Therapy

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A new pharmaceutical form of leuprorelin acetate for the treatment of advanced prostate cancer: Clinical experience from a non-interventional study

Cited by 3 publications

References 0 publications

Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Testosterone suppression with a unique form of leuprorelin acetate as a solid biodegradable implant in patients with advanced prostate cancer: results from four trials and comparison with the traditional leuprorelin acetate microspheres formulation

Two Innovative Pharmaceutical Forms of Leuprorelin: Results from 818 Patients with Advanced Prostate Cancer

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