985 ADT for volume reduction, symptom relief and quality of life improvement in men with prostate cancer: Degarelix versus goserelin plus bicalutamide

Axcrona, K.; Aaltomaa, S.; Silva, C.M. Da; Damber, Jan‐Erik; Tankó, László B.; Colli, Enrico; Klarskov, Peter

doi:10.1016/s1569-9056(12)60981-6

Cited by 4 publications

(3 citation statements)

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“…Seven studies evaluated degarelix 240 mg subcutaneously administered as a starting dose, and 80 or 160 mg subcutaneous maintenance doses every 4 weeks thereafter: CS21 10 32–63 CS28 10 32–35 60–62 64–66 CS30 10 32–35 60–62 65–68 CS31 10 32–35 60–62 65 66 69 70 CS35 10 32–35 59–62 CS37 32–35 60–62 Zuckerman 2013 71 72 …”

Section: Resultsmentioning

confidence: 99%

Gonadotropin-releasing hormone antagonists versus standard androgen suppression therapy for advanced prostate cancer A systematic review with meta-analysis

et al. 2015

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ObjectivesTo evaluate efficacy and safety of gonadotropin-releasing hormone (GnRH) antagonists compared to standard androgen suppression therapy for advanced prostate cancer.SettingThe international review team included methodologists of the German Cochrane Centre and clinical experts.ParticipantsWe searched CENTRAL, MEDLINE, Web of Science, EMBASE, trial registries and conference books for randomised controlled trials (RCT) for effectiveness data analysis, and randomised or non-randomised controlled studies (non-RCT) for safety data analysis (March 2015). Two authors independently screened identified articles, extracted data, evaluated risk of bias and rated quality of evidence according to GRADE.Results13 studies (10 RCTs, 3 non-RCTs) were included. No study reported cancer-specific survival or clinical progression. There were no differences in overall mortality (RR 1.35, 95% CI 0.63 to 2.93), treatment failure (RR 0.91, 95% CI 0.70 to 1.17) or prostate-specific antigen progression (RR 0.83, 95% CI 0.64 to 1.06). While there was no difference in quality of life related to urinary symptoms, improved quality of life regarding prostate symptoms, measured with the International Prostate Symptom Score (IPSS), with the use of GnRH antagonists compared with the use of standard androgen suppression therapy (mean score difference −0.40, 95% CI −0.94 to 0.14, and −1.84, 95% CI −3.00 to −0.69, respectively) was found. Quality of evidence for all assessed outcomes was rated low according to GRADE. The risk for injection-site events was increased, but cardiovascular events may occur less often by using GnRH antagonist. Available evidence is hampered by risk of bias, selective reporting and limited follow-up.ConclusionsThere is currently insufficient evidence to make firm conclusive statements on the efficacy of GnRH antagonist compared to standard androgen suppression therapy for advanced prostate cancer. There is need for further high-quality research on GnRH antagonists with long-term follow-up.Trial registration numberCRD42012002751.

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Section: Resultsmentioning

confidence: 99%

Gonadotropin-releasing hormone antagonists versus standard androgen suppression therapy for advanced prostate cancer A systematic review with meta-analysis

et al. 2015

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“…Studies are on‐going to evaluate the effect of degarelix in patients requiring fast symptom relief or prostate volume reduction. For example, the effect of degarelix 240/80 mg on reduction of total prostate volume, relief of lower urinary tract symptoms (LUTS) and improvement of quality of life was compared with goserelin/bicalutamide in a 3‐month trial in 182 men with a total prostate volume >30 mL (CS31 [45]). After 3 months of treatment, reduction in total prostate volume for degarelix (−37.2%) and goserelin/bicalutamide (−39.0%) was comparable and fulfilled the predefined criterion for non‐inferiority.…”

Section: Patients Likely To Benefit From the Pharmacological Profile mentioning

confidence: 99%

Androgen deprivation therapy: past, present and future

et al. 2012

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Since Huggins and Hodges demonstrated the responsiveness of prostate cancer to androgen deprivation therapy (ADT), androgen‐suppressing strategies have formed the cornerstone of management of advanced prostate cancer. Approaches to ADT have included orchidectomy, oestrogens, luteinizing hormone‐releasing hormone (LHRH) agonists, anti‐androgens and more recently the gonadotrophin‐releasing hormone antagonists. The most extensively studied antagonist, degarelix, avoids the testosterone surge and clinical flare associated with LHRH agonists, offering more rapid PSA and testosterone suppression, improved testosterone control and improved PSA progression‐free survival compared with agonists. The clinical profile of degarelix appears to make it a particularly suitable therapeutic option for certain subgroups of patients, including those with metastatic disease, high baseline PSA (>20 ng/mL) and highly symptomatic disease. As well as forming the mainstay of treatment for advanced prostate cancer, ADT is increasingly used in earlier disease stages. While data from clinical trials support the use of ADT neoadjuvant/adjuvant to radiotherapy for locally advanced or high‐risk localized prostate cancer, it remains to be established whether specific ADT classes/agents provide particular benefits in this clinical setting.

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“…Lastly, two studies compared testosterone levels in patients treated with degarelix and LHRH agonists (145,146). Separately, the studies found no significant differences between the two treatment groups.…”

Section: Mass Spectrometry-based Assaysmentioning

confidence: 99%

Blood-based LC-MS/MS analysis of steroids in prostate and ovarian cancer diagnostics

Winden¹

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This thesis addresses the use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the analysis of sex steroids in castrated prostate cancer (PCa) patients and postmenopausal women. The study aims to develop and validate blood-based sex steroid LC-MS/MS assays and compare them to commonly used automated immunoassays (AIA). The study also investigates the potential clinical applications of these assays in advanced PCa patients and women undergoing oophorectomy. In Section 1, the development and validation of blood-based sex steroid LC-MS/MS assays are described. The protocol for the measurement of testosterone in human serum by LC-MS/MS is detailed, with a lower limit of quantitation (LLOQ) of 0.17 nmol/L and total imprecision of ≤ 4.7% coefficient of variation (CV). The biological variation (BV) of serum testosterone levels was estimated in PCa patients treated with chemical castration with or without enzalutamide, with a LLOQ of 0.025 nmol/L. An LC-MS/MS assay for the routine quantitation of estrone (E1) and estradiol (E2) in human serum was also developed and compared to an in-house E2 AIA, with sensitivity 10 times higher than the E2 AIA. In Section 2, testosterone analysis in PCa patients and its potential clinical applications are discussed. A literature review is provided on the history, current situation, and perspectives of testosterone analysis in PCa patients, with a focus on the strengths and shortcomings of different assay techniques. Potential clinical utilities are listed and evaluated, such as the predictive and prognostic value of testosterone analysis in hormone-sensitive and castration-resistant PCa patients. The review also highlights the importance of adequately reporting the analytical method in clinical trials. Section 3 of the thesis shifts the focus to the analysis of multiple sex steroids in women with a high risk of ovarian cancer. The study examines the relationship between changes in sex steroid levels and menopausal complaints in pre- and postmenopausal women undergoing risk-reducing salpingo-oophorectomy (RRSO). The results indicate that for premenopausal women, a decrease in estrogens is associated with a decrease in sexual functioning and for postmenopausal women, a decrease in testosterone is associated with a decrease in hot flash frequency. These findings suggest that steroid supplementation may have a role in mitigating symptoms in women experiencing menopausal complaints after RRSO. Overall, this section of the thesis highlights the importance of understanding changes in sex steroid levels in women undergoing RRSO and the potential implications for symptom management. The results of this thesis indicate that LC-MS/MS assays offer improved sensitivity and specificity compared to AIA, and have the potential to reveal new clinical applications in castrated PCa patients and postmenopausal women. However, further clinical studies are necessary to translate these results into practical changes in diagnostic practices. Additionally, the study emphasizes the importance of adequately reporting the analytical method in clinical trials.

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985 ADT for volume reduction, symptom relief and quality of life improvement in men with prostate cancer: Degarelix versus goserelin plus bicalutamide

Cited by 4 publications

References 0 publications

Gonadotropin-releasing hormone antagonists versus standard androgen suppression therapy for advanced prostate cancer A systematic review with meta-analysis

Gonadotropin-releasing hormone antagonists versus standard androgen suppression therapy for advanced prostate cancer A systematic review with meta-analysis

Androgen deprivation therapy: past, present and future

Blood-based LC-MS/MS analysis of steroids in prostate and ovarian cancer diagnostics

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