Efficacy and Tolerability of Leuprorelin Acetate (Eligard®) in Daily Practice in Germany: Pooled Data from 2 Prospective, Non-Interventional Studies with 3- or 6-Month Depot Formulations in Patients with Advanced Prostate Cancer

Ohlmann, Carsten-Henning; Gross-Langenhoff, Marco

doi:10.1159/000479187

Cited by 13 publications

(9 citation statements)

References 8 publications

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“…However, data are lacking regarding their use in ISFD by phase inversion. Most published studies focus on PLGAbased ISFD [12,[35][36][37][38]. Nonetheless, more than the components of the ISFD technology, the procedure to conduct a preclinical loco-regional toxicity study is not yet standardized.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs

Peloso

Trichet

Descotes

et al. 2021

IJMS

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The present study aims to investigate the loco-regional tolerability and injection parameters (i.e., flow rate and administration volume) of an in situ forming depot (ISFD) in Göttingen minipigs, to secure both the therapeutic procedure and compliance in chronic medical prescriptions. The ISFD BEPO® technology (MedinCell S.A.) is investigated over 10 days, after a single subcutaneous injection of test item based on a DMSO solution of diblock and triblock polyethylene glycol-polylactic acid copolymers. Injection sites are systematically observed for macroscopic loco-regional skin reactions as well as ultrasound scanning, enabling longitudinal in vivo imaging of the depot. Observations are complemented by histopathological examinations at 72 h and 240 h post-injection. Overall, no treatment-emergent adverse effects are macroscopically or microscopically observed at the subcutaneous injection sites, for the tested injection flow rates of 1 and 8 mL/min and volumes of 0.2 and 1 mL. The histopathology examination confirms an expected foreign body reaction, with an intensity depending on the injected volume. The depot morphology is similar irrespective of the administration flow rates. These results indicate that the ISFD BEPO® technology can be considered safe when administered subcutaneously in Göttingen minipigs, a human-relevant animal model for subcutaneous administrations, in the tested ranges.

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Section: Discussionmentioning

confidence: 99%

Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs

Peloso

Trichet

Descotes

et al. 2021

IJMS

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“…Leuprorrelin acetate is a synthetic analog of the natural gonadotropin-releasing hormone (LHRH), acts as a potent inhibitor of pituitary gonadotropin secretion, and suppresses testicular and ovarian stereogenesis. Administration of LA results in an initial increase in circulating levels of LH and FSH, causing a temporary increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in men, and estrone and estradiol in women) (HUGGINS et al, 1941;PORCARO et al, 2016;OHLMANN;GROSS-LANGENHOFF, 2018).…”

Section: Discussionmentioning

confidence: 99%

“…It is a hormone dependent pathology of androgen. Androgen deprivation therapy, has been considered the gold standard of treatment for decades, to suppress serum testosterone in management of hormone sensitive and castration resistant diseases, such as leuprorrelin acetate (Eligard ) ® (HUGGINS et al, 1941;PORCARO et al, 2016;OHLMANN;GROSS-LANGENHOFF, 2018).…”

Section: Capítulo 56mentioning

confidence: 99%

Epidemiological profile of patients with prostatic neoplasia at an oncological hospital of SUS, Brazil

Freitas¹

2023

Collection of International Topics in Health Science- V1

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Objective: To identify the epidemiological characteristics of patients with prostate cancer and evaluate the treatment with Eligard® monthly, quarterly and semiannually according to efficacy and tolerance in HCM from January 2007 to July 2018. Methodology: Epidemiological, descriptive, retrospective, cross-sectional and quantitative research through the review of medical records . The population 932 patients with prostate neoplasia, treated at Cristiano Varella Foundation - HCM, MG state, Brazil, adult men (≥18 years old), with indication for Eligard® in monthly (7.5 mg) (n=115), quarterly (22.5 mg) (n=637) and semiannual (45 mg) (n=180) dosage. Results: Median age was 72 years (65-78). Median time since diagnosis was 8.5 months, with 598 (64.2%) of patients with a diagnosis of 12 months or less, and 158 (17%) with time since diagnosis of more than 4 years. The majority (63.4%) had low education, were married (69.9%) and non-white (66.41% black + brown). Regarding occupation, 541 (58.05%) are retired 148 (15.88%) and rural workers. Much of the information collected in the medical records about housing was not available 464 (49.8%), but 318 (34.12%) of the patients own their own homes. As for transportation, most 877 (94.1%) have the vehicles of the municipal health departments as their main means of transportation, which corroborates the information of low per capita income, low education, that is, low socioeconomic structure. All patients being treated at HCM with prostate cancer (100%) have support from the municipal health secretariats, the Basic Health Units, and also from the hospital itself. Regarding the nutritional status of patients, 754 (80.9%) have good nutrition (eutrophic), only 84 (9.02) were malnourished and 49 (5.22%) were obese. As for prevention (PSA exams), 444 subjects (42.4%) reported having had such an exam. Slightly more than 30% had a family history of cancer, and the same proportion for smokers and drinkers. Conclusions: Epidemiological characteristics (average age 75 years, non-white, married, with low education, retired, rural workers, depend on the support of the Health Departments of their municipalities, low per capita income, most have their own homes, are treated by SUS, do not smoke, do not drink, no family history); and clinical (most with stages II and III, treated with radiotherapy, comorbidities cardiovascular diseases, and adverse events considered the treatment itself). The results obtained allowed us to verify the efficacy of the hormone (Eligard® ), a LHRH agonist used in the treatment of patients with this neoplasm, in all stages. The tolerability of the patients regarding this medication was also verified, with very satisfactory results in approximately 99% of all patients.

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“…The safety and efficacy of ELIGARD ® have been established in clinical trials. However, these trials have been predominantly focused in Western regions (18)(19)(20). While ELIGARD ® is currently approved in a number of Asian countries, and the 3-month formulation has been in use for many years, safety data are currently lacking for this population.…”

Section: Introductionmentioning

confidence: 99%

ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD®) in Asian men with prostate cancer

Malek¹,

Wu²,

Serrano³

et al. 2022

Transl Androl Urol

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Background:The incidence and mortality rate of men with prostate cancer have been increasing in Asia.ELIGARD ® is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions. However, limited safety data are available for Asian populations.Methods: ELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD ® (22.5 mg subcutaneous depot injection) every 3 months for 15 months, with a follow-up visit at 18 months. The primary objective was to establish the safety of ELIGARD ® in Asian men with hormonedependent prostate cancer. The secondary objectives were to assess efficacy, via prostate-specific antigen (PSA) progression and testosterone levels, and health-related quality of life (HRQoL).Results: In total, 106 patients were included in the safety analysis set (SAF). The most common treatmentemergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD ® were reported in 13.2% of patients (n=14), two of which were serious. In the full analysis set (FAS) (n=105), 81.2% (n=56) and 68.5% (n=61) of patients achieved a PSA reduction of ≥90% from baseline at 12 and 18 months, respectively. At 18 months, the numbers of patients with testosterone levels <20, 20-50, and >50 ng/dL were 65 (61.9%), 17 (16.2%), and two (1.9%), respectively; 20% had missing testosterone measurements. HRQoL remained stable throughout the study with minimal change from baseline at study completion. Conclusions:In conclusion, the safety profile of ELIGARD ® (22.5 mg) in Asian men with hormonedependent prostate cancer is comparable to previous studies in Western regions.

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Efficacy and Tolerability of Leuprorelin Acetate (Eligard®) in Daily Practice in Germany: Pooled Data from 2 Prospective, Non-Interventional Studies with 3- or 6-Month Depot Formulations in Patients with Advanced Prostate Cancer

Cited by 13 publications

References 8 publications

Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs

Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs

Epidemiological profile of patients with prostatic neoplasia at an oncological hospital of SUS, Brazil

ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD®) in Asian men with prostate cancer

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