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

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Abstract

Objectives

This study set out to examine the efficacy and tolerability of two innovative implant forms of leuprorelin acetate in men with advanced hormone-dependent prostate cancer in everyday clinical practice.

Methods

Data were collected from 818 patients (from 273 centers across Germany) who were pretreated with slow-release luteinizing hormone-releasing hormone (LHRH) agonist formulations and who were about to be switched to the leuprorelin implants. Patients received three injections of 1- or 3-month leuprorelin implant and physicians were asked to complete a case report form specific to each of the three clinic visits. Documented parameters included laboratory measurements, such as testosterone and prostate-specific antigen (PSA) levels, adverse events, and patient- and physician-rated assessments of the therapy.

Results

Compared with baseline, a significant decrease in both testosterone and PSA levels were measured after the first and second injections of leuprorelin implant. These results were confirmed for both the 1-month and 3-month implants in separate analyses. Switching, without treatment interruption, from Trenantone® (Takeda Pharma GmBH, Aachen, Germany) to the leuprorelin implant resulted in a significant decrease in the mean serum testosterone concentrations (P < 0.05) and a nonsignificant increase in the proportion of patients reaching castrate testosterone levels, while the number of patients with PSA values ≤4 ng/mL significantly increased (P = 0.045). Similar results were obtained for patients previously treated with goserelin who switched to leuprorelin implant. For 94% of patients, treating physicians rated the efficacy of leuprorelin implant as “very good” or “good.” Treatment with leuprorelin implant was well tolerated, with only 61 adverse events reported in 42 (5.1%) patients. Patients and physicians rated the tolerability of leuprorelin implant as “very good” or “good” in 95% and 91% of cases, respectively.

Conclusions

These results confirm the efficacy, tolerability, and ease of use of the leuprorelin implants among a large population of men with advanced, hormone-dependent prostate cancer treated in a clinical practice setting.

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Authors and Affiliations

  1. Triskel Integrated Services, 4 rue des Terreaux-du-Temple, 1201, Geneva, Switzerland

    Patricia Gravel

  2. Klinik St. Marienstift, Breiter Weg 251, D-39104, Magdeburg, Germany

    Dirk Samland

  3. Urologische Gemeinschaftspraxis Reutlingen, Albstrasse 2, 72764, Reutlingen, Germany

    Martin Löffler & Simone Maier

  4. Sandoz S.p.A., Largo Umberto Boccioni 1, I-21040, Origgio (VA), Italy

    Micol Panozzo

  5. Sandoz International GmbH, Industriestr. 25, D-83607, Holzkirchen, Germany

    Michael Muenzberg

Authors
  1. Patricia Gravel
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  2. Dirk Samland
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  3. Martin Löffler
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  4. Simone Maier
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  5. Micol Panozzo
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  6. Michael Muenzberg
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Corresponding author

Correspondence to Patricia Gravel.

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Gravel, P., Samland, D., Löffler, M. et al. Two Innovative Pharmaceutical Forms of Leuprorelin: Results from 818 Patients with Advanced Prostate Cancer. Adv Therapy 30, 271–285 (2013). https://doi.org/10.1007/s12325-013-0010-y

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  • DOI: https://doi.org/10.1007/s12325-013-0010-y

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