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Efficacy and safety of degarelix in patients with prostate cancer:Results from a phase III study in China

Asian Journal of Urology 2020年第3期7卷 301-308页

作者： Yinghao Sun Liping Xie Tao Xu Jorn S.Jakobsen Weiqing Han Per S.Sorensen Xiaofeng Wang Department of Urology Changhai HospitalSecond Military Medical UniversityShanghaiChina Department of Urology First Affiliated HospitalZhejiang UniversityHangzhouChina Department of Urology Peking University People’s HospitalBeijingChina Global Clinical Research and Development Ferring Pharmaceuticals A/SCopenhagenDenmark Department of Urology Hunan Cancer HospitalHunan ProvinceChina

Objective:To establish non-inferiority of gonadotropin-releasing hormone degarelix compared with goserelin in suppressing and maintaining castrate testosterone levels from Day 28 to Day 364 in Chinese patients with prostate ***:This is an open-label,multi-centre study in which men aged18 years were randomised in a 1:1 ratio to once-a-month subcutaneous injection of either degarelix(240/80 mg)or goserelin(3.6 mg)for 12 *** primary endpoint was difference in 1-year cumulative probability of suppressing testosterone to ≤0.5 ng/***-inferiority was to be established if the lower 95% confidence interval(CI)limit for difference in cumulative probability between the treatment arms was greater than -10%.Secondary endpoints included cumulative probability of prostate-specific-antigen-progression-free-survival(PSA-PFS).Safety was also ***:Baseline demographics and disease characteristics were similar between degarelix(n=142)and goserelin(n=141)treatment *** difference in cumulative probability of maintaining castrate levels from Day 28-364 was 3.6%(95%CI:-1.5%,8.7%),demonstrating non-inferiority of *** cumulative probability of PSA-PFS at Day 364 was higher for degarelix(82.3%,95%CI:74.7%,87.7%)versus goserelin(71.7%,95%CI:63.2%,78.5%,p=0.038).Adverse events(AEs)were similar between treatment arms,except for more injection site reactions with degarelix versus ***(2.8%)and nine(6.4%)patients discontinued due to AEs in degarelix and goserelin groups,respectively.

关键词： degarelix Goserelin GnRH antagonist GnRH agonist Prostate cancer China

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degarelix(Fir magon)

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中国药物化学杂志 2009年第4期19卷 316-316,318页

作者：张同波董金华沈阳药科大学

degarelix是由Ferring公司研制开发的一种新的治疗晚期前列腺癌的药物,该药于2008年12月24日被美国FDA批准上市,商品名为Firmagon.这是7年来FDA首次批准治疗前列腺癌的新药上市.degarelix通过抑制睾丸激素来延缓前列腺癌病程发展,属于... 详细信息

degarelix是由Ferring公司研制开发的一种新的治疗晚期前列腺癌的药物,该药于2008年12月24日被美国FDA批准上市,商品名为Firmagon.这是7年来FDA首次批准治疗前列腺癌的新药上市.degarelix通过抑制睾丸激素来延缓前列腺癌病程发展,属于促性腺激素释放激素(GnRH)受体抑制剂类药物.

关键词：药物前列腺癌治疗 degarelix

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degarelix as a new antiangiogenic agent for metastatic colon cancer?

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World Journal of Gastroenterology 2013年第5期19卷 769-772页

作者： Francois Ghiringhelli Nicolas Isambert Sylvain Ladoire Unite Mixte de Recherche 866 Institut National de la Sante et de la Recherche Medicale/Universite de Bourgogne21000 DijonFrance Departement of Oncologie Medicale Centre Georges Francois Leclerc21000 DijonFrance

Recently,follicle stimulating hormone receptor was found to be selectively expressed by endothelial cells on tumor-associated blood vessels in a wide range of human *** this context,we hypothesized that degarelix,a new gonadotropin-releasing hormone receptor antagonist developed for patients with prostate cancer,may have antiangiogenic effects via its capacity to block follicle stimulating hormone(FSH)production. We report the case of a patient with metastatic colon cancer exhibiting tumor progression after failure of all conventional chemotherapeutic *** addition of degarelix to the last chemotherapeutic regimen was proposed as compassionate *** induced a rapid decrease in FSH *** treatment induced radiological stabilization and carcinoembryonic antigen stabilization during 1 ***-enhanced ultrasonography demonstrated reduction of tumor *** case represents the first report of an antitumoral effect of degarelix in metastatic colon cancer and suggests an antiangiogenic property of this drug.

关键词： Colon cancer degarelix Chemotherapy Angiogenesis Antiangiogenic agents

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Efficacy,safety,and dose comparison of degarelix for the treatment of prostate cancer:A systematic review and meta-analysis

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World Journal of Meta-Analysis 2016年第3期4卷 69-76页

作者： Cheng Fang Cai-Liang Wu Sha-Sha Liu Long Ge Jin-Liang Bai Department of Urological First Clinical Medical College of Lanzhou University Department of Obstetrics and Gynecology First Clinical Medical College of Lanzhou University Department of Pathology First Clinical Medical College of Lanzhou University Evidence-Based Medicine Center Lanzhou University

AIM:To conduct a systematic review and meta-analysis into the efficacy,safety,and dosage regimens of degarelix for treating prostate cancer(PCa). METHODS:Pub Med,EMBASE,the Cochrane Library,and Web of Science was systematically searched to identify randomized controlled trials(RCTs) comparing degarelix(240/80 mg vs 240/160 mg) to the gonadotropin-releasing hormone agonists,goserelin and leuprolide,for the treatment of PCa. Two independent reviewers screened putative studies,assessed the risk of bias,and then extracted pertinent data. Analyses were performed using Review Manager 5.2. RESULTS:Seven papers from six RCTs,involving 1204 patients,were identified. The present meta-analysis showed that treatment with 240/160 mg degarelix is more effective and has fewer adverse events(AEs) relative to conventional 240/80 mg regimen. degarelix significantly decreased International Prostate Symptom Scores [standardized mean differences(SMD) =-0.32,95%CI:-0.51 to-0.12,P = 0.02] and caused fewer AEs(SMD =-0.28,95%CI:-0.48 to-0.07,P = 0.008) than goserelin. degarelix suppressed testosterone and prostate-specific antigen significantly faster than leuprolide. CONCLUSION:degarelix is a useful option in the treatment of advanced PCa. degarelix 240/160 mgregimen was superior to a 240/80 mg regimen. More rigorously designed RCTs are urgently needed to confirm the efficacy of degarelix.

关键词： Prostate cancer degarelix Meta-analysis

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Enhancement of HIFU Effect by Simultaneous Short Course degarelix for Early Stage Prostate Cancer: A Pilot Study

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Open Journal of Urology 2016年第3期6卷 49-54页

作者： Teiichiro Aoyagi Isao Kuroda Department of Urology Tokyo Medical University Ibaraki Medical Center Ibaraki Japan

Objective: To obtain complete prostatic cell death in the treatment of early stage prostate cancer by High Intensity Focused Ultrasound (HIFU) therapy, we use degarelix (GnRH antagonist) twice simultaneously. Patients and Methods: The first degarelix subcutaneous injection was made two weeks before HIFU therapy, and second degarelix was applied two weeks after the HIFU therapy. No additional maintenance degarelix was used. To confirm the apoptosis induced by degarelix, specimens obtained by transurethral resection simultaneously on HIFU were stained with caspase 3 and TUNEL. PSA was monitored every three months after this combination therapy as long as two years. These PSA values were compared with those who previously treated with HIFU without degarelix. Results: Nine T1cN0M0 prostate cancer patients were enrolled to “HIFU + degarelix” therapy. Pre treatment mean PSA level was 6.11 ± 1.83 ng/ml (SD), and PSA 3 months after the treatment was 0.02 ± 0.02. These low PSA levels continued thereafter (0.16 ng/ml ± 0.19 at 24 months). The mean pretreatment PSA level of the 34 patients underwent HIFU without degarelix was 11.07 ± 13.9 ng/ml, 3 months post HIFU was 1.68 ± 3.04, (2.80 ± 3.97 at 24 months). Caspase 3 and TUNEL were positive on the glandular cells in TUR specimens of “HIFU + degarelix” patients, suggesting degarelix induced apoptosis. Conclusion: Although the number of our patients was small, the results of “Short course degarelix + HIFU” would be promising for better long-term outcome than HIFU mono-therapy.

关键词： Prostate Cancer HIFU degarelix Hormonal Therapy

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前列腺癌内分泌治疗药degarelix

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药学进展 2009年第10期33卷 473-475页

作者：刘一方范鸣

目前前列腺癌治疗药物主要包括抗雄激素类、芳香化酶抑制剂、雌激素类、孕酮类、促性腺激素释放激素(GnRH)类似物以及若干常规抗有丝分裂的化疗药物(如雌莫司汀磷酸钠、盐酸米托蒽醌和多西紫杉醇),其中GnRH类似物备受关注,作为一种激素... 详细信息

目前前列腺癌治疗药物主要包括抗雄激素类、芳香化酶抑制剂、雌激素类、孕酮类、促性腺激素释放激素(GnRH)类似物以及若干常规抗有丝分裂的化疗药物(如雌莫司汀磷酸钠、盐酸米托蒽醌和多西紫杉醇),其中GnRH类似物备受关注,作为一种激素疗法,其可致睾酮减少至去势水平,从而控制前列腺癌的生长和扩散.

关键词： degarelix GnRH拮抗剂前列腺癌内分泌治疗药

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degarelix准备进入Ⅲ期临床试验

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国外药讯 2005年第3期 20-20页

作者：杨绍杰

Ferring公司表示，它希望它们合成的一种肽GnRH阻断剂degorelix(Ⅰ)可用于前列腺癌的治疗，预期(Ⅰ)将进入Ⅲ期临床试验。该药在Ⅱ期试验已经表现出很好的疗效。公司说这可能是它们第一个重磅炸弹型药物。公司说，(Ⅰ)是一种新型前列腺... 详细信息

Ferring公司表示，它希望它们合成的一种肽GnRH阻断剂degorelix(Ⅰ)可用于前列腺癌的治疗，预期(Ⅰ)将进入Ⅲ期临床试验。该药在Ⅱ期试验已经表现出很好的疗效。公司说这可能是它们第一个重磅炸弹型药物。公司说，(Ⅰ)是一种新型前列腺药物，为GnRH阻断剂，而不是GnRH激动剂，

关键词： degarelix Ⅲ期临床试验 Ferring公司肽GnRH阻断剂前列腺癌治疗

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Upfront Docetaxel with LH-RH Antagonist for Metastatic Hormone Sensitive Prostate Cancer Considering Epithelial to Mesenchymal Transition

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Open Journal of Urology 2020年第11期10卷 284-292页

作者： Teiichiro Aoyagi Isao Kuroda Go Nagao Department of Urology Tokyo Medical University Ibaraki Medical Center Ibaraki Japan

Objective: Upfront docetaxel use for hormone naïve advanced prostate cancer is reported that it successfully delayed the progression to hormone refractory stage, though the adequate methodology to obtain the maximum effect is unclear. We investigated these issues from our experiences of upfront docetaxel use with LH-RH antagonist for metastatic hormone sensitive prostate cancer, aiming at the prevention of epithelial-mesenchymal transition (EMT) for apoptosis tolerance. Patients and Methods: Of 31 stage IV new prostate cancer patients treated with upfront docetaxel and LH-RH antagonist (degarelix), 25 patients who could be followed more than 12 months (mean 36.2 months) were analyzed. Docetaxel was used two to three courses basically 75 mg/m2 dose initializing two weeks after the induction of first degarelix. Results: The clinical course was divided clearly to two groups according to prostate specific antigen (PSA) values. Of 25 patients, 12 patient’s PSA did not decrease below 0.1 ng/ml within 6 months (group A) and gradually rose afterwards. PSA in another 13 patients (group B) decreased below 0.1 within 6 months and kept below 0.1 during the follow up period. Although statistically not significant, the initial group A’s PSA was higher than group B’s (average 1308 and 353 ng/ml), however, number of metastasis, Gleason sum, and bone metastatic extent of disease showed no difference between them. Among group B patients, 7 cases had only upfront docetaxel and hormonal therapy, and some of these patients showed only atrophic gland and fibrotic tissue at second prostate biopsy (specimens after more than two years of therapy), suggesting complete response. Conclusion: Our study suggested that PSA value at 6 months may predict the outcome of whole therapy. Patients showing PSA less than 0.1 ng/ml at 6 months and requiring no therapy other than docetaxel and h

关键词： Docetaxel Prostate Cancer Epithelial to Mesenchymal Transition degarelix

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