Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard ® /Depo-Eligard ® ) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study

Abstract

IntroductionThe 1-, 3- and 6- month biodegradable polymer matrix depot formulations of leuprorelin acetate (Eligard®/Depo-Eligard®, Astellas Pharma Inc/BV) were shown to reduce testosterone and prostate-specific antigen levels and to be well tolerated in patients with advanced prostate cancer in several clinical trials. This study aimed at evaluating the efficacy, safety and tolerability of the 1- and 3-month leuprorelin acetate depot formulations in daily clinical practice.Material and methodsA prospective, open-label, non-interventional, phase IV study (MANTA) was conducted in 243 Belgian prostate cancer patients who had been prescribed the 1-month (7.5 mg) or 3-month (22.5 mg) leuprorelin acetate depot formulation. Patients were followed for at least 3 months.ResultsMedian serum prostate-specific antigen levels were reduced by 95% from 12.0 ng/ml at baseline to 0.60 ng/ml after a median follow-up time of 132 days, while median testosterone levels were reduced by 94% from 360 ng/dl to 20 ng/dl. Partial or complete treatment response was observed in 83% of patients at the final visit (according to the physician's assessment). Ninety-two patients (37.86%) experienced treatment-emergent adverse events, with injection site-related reactions, hot flushes and tumor flare being the most common ones. Overall safety and tolerability of the leuprorelin acetate depot formulation were rated as good or excellent by 90% of physicians.ConclusionsThese data are consistent with efficacy and tolerability results from clinical trials. They confirm that the 1- and 3-month leuprorelin acetate depot formulations are well tolerated and reliably lower serum prostate-specific antigen and testosterone levels in routine clinical practice.

Experience with a luteinizing hormone-releasing hormone agonist in patients with prostate cancer

“…Через 6 мес после первого введения депо-формы лейпрорелина ацетата длительностью 1 или 3 мес средний уровень ПСА снижался на 95% (с 12 до 0,6 нг/мл), а уровень тестостеро-на на 94% (с 360 до 20 нг/дл). Что касается безопасности и переносимости данных депо-форм лейпрорелина ацетата, было показано, что меньшее число больных испытывали побочные эффекты, связанные с лечением, в клиниче-ской практике по сравнению с результатами клинических исследований [24].…”

Final results of the prospective multicenter observational program RU-EGD-NI-001 for evaluation of efficacy and tolerability of the 6-month depot Eligard 45 mg in patients with advanced prostate carcinoma in routine clinical practice of uro-oncologists in the Russian Federation

“…Таким образом, полученные данные сопоставимы с результатами по эффективности и переносимости в клинических испытаниях [8][9][10][11] и других опублико-ванных наблюдательных программах [13,15]. Резуль-таты этого исследования демонстрируют хорошую переносимость и эффективность 6-месячной депо-формы лейпрорелина ацетата в отношении снижения уровней ПСА и тестостерона в сыворотке крови у больных РПЖ в рутинной клинической практике.…”

Gene BRCA1/2 mutation in prostate cancer patients: clinical administration aspects

“…Эффективность изучаемых депо-форм была сопоставимой. Примерно 90 % специали-стов градировали безопасность и переносимость дан-ных депо-форм лейпрорелина ацетата как хорошую или очень хорошую [18].…”