Degarelix therapy for prostate cancer in a real-world setting: experience from the German IQUO (Association for Uro-Oncological Quality Assurance) Firmagon® registry

Geiges, G.; Harms, Thomas W.; Rodemer, Gerald; Eckert, Roger; König, Frank; Eichenauer, Rolf; Schröder, Jörg

doi:10.1186/s12894-015-0116-4

Cited by 7 publications

(5 citation statements)

References 21 publications

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“…Antagonists have been associated with histamine‐mediated anaphylactic reactions, giving rise to potentially life‐threatening systemic reactions. Although this has been observed in older antagonists, such as abarelix, 24 this issue has rarely been observed with degarelix 27,28 …”

Section: Safetymentioning

confidence: 97%

“…Injection‐site reactions are one of the major adverse events with GnRH antagonists 23–26 . Antagonists have been associated with histamine‐mediated anaphylactic reactions, giving rise to potentially life‐threatening systemic reactions.…”

Section: Safetymentioning

confidence: 99%

“…Hot flushes (as a result of lower testosterone and estrogen levels) are experienced by approximately 80% of patients receiving either GnRH agonists or antagonists 24,29–31 . Decreased testosterone also leads to reduced libido and erectile dysfunction in patients receiving either treatment 29–32 …”

Section: Safetymentioning

confidence: 99%

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Considerations for the use of gonadotropin‐releasing hormone agonists and antagonists in patients with prostate cancer

Poppel

Abrahamsson

2020

Int J of Urology

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Prostate cancer is the second most common cause of cancer-related deaths in men, representing a major source of morbidity and mortality. Androgen deprivation therapy is the primary treatment for patients with advanced prostate cancer at disease presentation, which can be achieved either with surgical or chemical castration. The development of gonadotropin-releasing hormone agonists revolutionized the treatment of advanced prostate cancer, replacing the need for surgical castration. Agonists downregulate gonadotropin-releasing hormone agonist receptors in the pituitary gland, and thus decrease the release of luteinizing hormone and testosterone. Although agonists are a common therapeutic option to date, their use is associated with testosterone surges, metabolic dysfunction and an increase in the risk of cardiovascular disease; they might contribute to tumor flares and potentially an increase in non-cancer mortality. More recently, gonadotropin-releasing hormone antagonists have entered the prostate cancer treatment landscape. Unlike agonists, antagonists directly inhibit the androgen receptor in the pituitary gland, and thus do not cause initial testosterone surges. In this article, we provide a concise review of the mechanism of actions, safety and efficacy of the approved agonists and antagonists for prostate cancer treatment.

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Section: Safetymentioning

confidence: 97%

Section: Safetymentioning

confidence: 99%

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Considerations for the use of gonadotropin‐releasing hormone agonists and antagonists in patients with prostate cancer

Poppel

Abrahamsson

2020

Int J of Urology

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“…Injection site reactions have been reported as one of the major adverse events with GnRH antagonists ( Table 2 ). 66 67 68 69 In a randomized clinical trial, a significantly higher rate of injection-site reactions was reported with subcutaneous degarelix (40%, P < 0.001) compared to intramuscular leuprolide injection (<1%). 33 The difference in incidence of injection-site reactions might be attributed to the differing modes of administration and injection volumes.…”

Section: Other Frequent Adt-related Adverse Events Injection-site Reamentioning

confidence: 98%

Androgen deprivation therapy and side effects

Freedland

Abrahamsson

2021

Asian Journal of Andrology

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Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and antagonists is the mainstay of advanced prostate cancer treatment. Both drug classes decrease levels of luteinizing hormone and follicle-stimulating hormones (FSH), thereby lowering testosterone to castrate levels. This is associated with adverse events (AEs), including cardiovascular (CV) disorders, bone fractures, metabolic dysfunction, and impaired cognitive function. This literature review discusses these AEs, with a focus on CV and bone-related events. A hypothesis-generating meta-analysis of six clinical trials showed a potentially increased risk for CV disorders with GnRH agonists versus the GnRH antagonist degarelix. While no study has directly compared GnRH agonists versus antagonists with a primary CV outcome, one hypothesis for this observation is that GnRH agonists lead to initial surges in FSH that may negatively impact CV health, whereas antagonists do not. GnRH agonists are associated with metabolic and cognitive AEs and while data are lacking for GnRH antagonists, no differences in risk are predicted. Other common AEs with ADT include injection site reactions, which are much more common with degarelix than with GnRH agonists, which may reflect differing administration and injection techniques. Future studies are needed to further evaluate and compare the safety profiles of GnRH agonists and antagonists, especially in patients with pre-existing CV disease and other co-morbidities. Physicians should carefully evaluate benefits and risks when prescribing ADT and ensure that side effects are well managed.

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“…Уровень тестостерона <20 нг / мл сохранялся в течение первых 24 мес у всех пациентов (медиана 0,13 нг / мл через 24 мес (n = 18)). Средний уровень тестостерона у пациентов с исходными метастатическими заболеваниями составлял 0,2 нг / мл через 1 мес (n = 92) и 0,13 нг / мл через 12 мес (n = 20) [19].…”

Section: диагностика и лечение опухолей мочеполовой системы рак предс...unclassified

An observational multicenter study to evaluate the efficacy and safety of degarelix® for prostate cancer in routine clinical practice

et al. 2022

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Background. Prostate cancer (PCa) is an actual disease and a frequent oncological pathology in men. The main methods of radical treatment of patients with PCa are radical prostatectomy and radiation therapy. Radical prostatectomy s the most commonly used method of therapy in patients with localized PCa. Adjuvant hormone therapy after surgical treatment is the standard method of therapy in patients with the presence of lymph node metastases. At the same time, the standard approach of treatment of patients with metastatic PCa is combination therapy with medical (using of analogues or antagonists of luteinizing hormone-releasing hormone (LHRH) or surgical castration in combination with chemotherapy with docetaxel or new generation antiandrogens (enzalutamide or apalutamide)). Numerous studies have demonstrated the importance of achieving minimum testosterone levels at all stages of drug therapy in patients with PCa. It has also been shown that the use of LHRH analogues may be less effective to the use of LHRH antagonists (degarelix) in relation to the effectiveness of testosterone suppression. Thus, conducting a study aimed at studying the effectiveness of testosterone suppression using LHRH antagonists in various clinical situations and patient populations in real clinical practice is a very actual task.Aim. To evaluate the effectiveness and safety of castration therapy using degarelix in real clinical practice and in various clinical situations.Materials and methods. The object of an observational non-interventional study was 132 patients with PCa from 13 cancer centers of Russian Federation who were treated with LHRH antagonist degarelix. The study was non-interventional (observational), retrospectively-prospective, open multicenter and not randomized. In accordance with the design of the study, depending on the clinical situation, patients were divided into 3 groups: group A (n = 52; 39.4 %) – patients with primary metastatic hormone-sensitive PCa, who were shown to undergo combined drug treatment with castration therapy as one of the components; group B (n = 43; 32.6 %) – patients, who underwent combined hormonal and radiation treatment (ADT + radiation therapy); group C (n = 37; 28 %) – patients who underwent surgical treatment (radical prostatectomy with extended PLND) with the presence of metastases in the lymph nodes identified by the results of a morphological examination (pN1).Results and conclusion. As a result of a non-interventional observational study, high efficacy of androgen-deprivation therapy with the use of degarelix was demonstrated in relation to the suppression of testosterone and PSA in patients with primary metastatic and locally advanced PCa in various clinical situations, as well as low toxicity and satisfactory tolerability of this variant of hormonal treatment.

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Degarelix therapy for prostate cancer in a real-world setting: experience from the German IQUO (Association for Uro-Oncological Quality Assurance) Firmagon® registry

Cited by 7 publications

References 21 publications

Considerations for the use of gonadotropin‐releasing hormone agonists and antagonists in patients with prostate cancer

Considerations for the use of gonadotropin‐releasing hormone agonists and antagonists in patients with prostate cancer

Androgen deprivation therapy and side effects

An observational multicenter study to evaluate the efficacy and safety of degarelix® for prostate cancer in routine clinical practice

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