Safety and clinical efficacy of a new 6-month depot formulation of leuprorelin acetate in patients with prostate cancer in Europe

Abstract

This multicentre European study compared the safety and tolerability of the existing 11.25 mg 3-month depot of leuprorelin acetate with a new 30 mg 6-month depot in men with newly diagnosed prostate cancer or prostate-specific antigen relapse after radiotherapy or prostatectomy. The primary end points were safety and tolerability and secondary end points were clinical response based on European Organization for Research and Treatment of Cancer (EORTC) criteria and response rate by time point for testosterone suppression (castrate level p50 ng per 100 ml). Results showed that the incidence of adverse events was similar with the different depot formulations, with hot flushes being the most common. The assessment of EORTC response criteria showed comparable results in each arm with a tumour progression rate of o10% at the final examination at month 12. Testosterone suppression was comparable with the different formulations. In conclusion, the 6-month depot formulation of leuprorelin acetate containing 30 mg is well tolerated and safe and has been shown to be as effective as the widely used 3-month depot containing 11.25 mg leuprorelin acetate in the treatment of prostate cancer.

Health-Related Quality of Life in 536 Long-Term Prostate Cancer Survivors after Treatment with Leuprorelin Acetate: A Combined Retrospective and Prospective Analysis

“…Regarding the achieved study results, tumor control and overall HRQoL with patients' general physical condition and health status were remarkably well balanced between the PCa patients and the CG, which is in line with previous studies [10,12]. In addition, single aspects of HRQoL as well as of the Karnofsky-Index in long-term PCa survivors were within the range of the outcome in the CG representing age-matched but cancer-free, urological patients.…”

“…LAM was investigated in a randomized, open-label European multicentre study with 296 patients over a 12-month period. After 12 months' therapy with the 6-month depot, a median PSA reduction of 89% to 0.3 ng/mL was observed, and median serum testosterone levels were suppressed below 0.2 ng/mL (0.15 ng/mL) [10].…”

“…Thus, the collection of data on HRQoL will have a great influence on the additional assessment of possible therapeutic regimens. For the choice of appropriate treatment options not only the course of effectiveness-related variables like tumor remission, PSA, and testosterone levels have to be considered but also the different aspects of HRQoL, in particular, the known and partially very demanding complications of an advanced PCa therapy such as sexual, urological and intestinal dysfunctions [5,10,[12][13][14][15]. A limitation of this study is the retrospective data collection of data on efficacy, safety and tolerability during the long-term treatment phase for the PCa patients.…”

“…Thus, in our study on HRQoL we investigated leuprorelin acetate in microcapsules (LAM), an established LHRH agonist used as first-line treatment in advanced PCa [9,10]. LAM is the most widely prescribed ADT in Germany, is marketed since 1991, and is therefore well suited to assess the status of long-term ADT survivors.…”

Análogos de la hormona liberadora de gonadotropinas en cáncer de próstata: ¿podemos considerarlos en realidad equivalentes?

“…Los ensayos clínicos que no compararon directamente análogos de la LHRH entre sí, con una experiencia acumulada de 554 pacientes en tratamiento mensual y 1.720 en formulación semestral, concluyeron que no hubo diferencia estadísticamente significativa de los principios activos estudiados (leuprolida, goserelina y buserelina en formulación mensual; triptorelina y leuprolida en formulación semestral) en cuanto al porcentaje de pacientes con respuesta objetiva (testosterona plasmática 19 < 50 ng/dl, nivel de referencia estándar de castración). Los ensayos clínicos que compararon directamente varios análogos de la LHRH entre sí identificaron ciertos hallazgos significativos, que apuntan a un perfil de eficacia y seguridad estadísticamente distinto en ciertos objetivos analizados en los 411 pacientes investigados en total en formulación mensual.…”