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[二氯化镭-223用于去势抵抗性前列腺癌患者]

[Radium-223 dichloride in patients with castration-refractory prostate cancer].

作者信息

Winter B M, von Rundstedt F-C, Grimm M-O

机构信息

Klinik und Poliklinik für Urologie, Universitätsklinikum Jena, Am Klinikum 1, 07747, Jena, Deutschland.

出版信息

Urologe A. 2017 Nov;56(11):1435-1439. doi: 10.1007/s00120-017-0514-1.

DOI:10.1007/s00120-017-0514-1
PMID:29022046
Abstract

Since November 2013, the alpha emitter radium-223 dichloride (Alpharadin/Xofigo®) has been approved for the treatment of men with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease. In the ASYMPCA clinical trial, radium-223 was shown to improve overall survival and to reduce the time to the first symptomatic skeletal event. The use of radium-223 was associated with a reduction of pain and an improvement of health-related quality of life compared to the placebo arm. The efficacy of radium-223 dichloride was not inhibited by the use of chemotherapy with docetaxel. Studies have demonstrated a longer overall survival (OS) in patients with a combined treatment of abiraterone or enzalutamide; however, until this data is validated in larger clinical trials, the combination of radium-223 and abiraterone/enzalutamide cannot be recommended. Patients who have received concomitant medication with denosumab appeared to have a longer OS compared to patients who did not. A second treatment cycle of radium-223 was not associated with any adverse events when compared to the outcomes reported in the ASLYMPCA trial. Here the median radiographic progression-free survival was 9 months.

摘要

自2013年11月起,α粒子发射体二氯化镭-223(Alpharadin/Xofigo®)已被批准用于治疗有症状性骨转移且无已知内脏转移疾病的去势抵抗性前列腺癌(CRPC)男性患者。在ASYMPCA临床试验中,镭-223被证明可改善总生存期,并减少首次出现症状性骨骼事件的时间。与安慰剂组相比,使用镭-223可减轻疼痛并改善健康相关生活质量。二氯化镭-223的疗效未受多西他赛化疗使用的抑制。研究表明,接受阿比特龙或恩杂鲁胺联合治疗的患者总生存期(OS)更长;然而,在该数据在更大规模临床试验中得到验证之前,不能推荐镭-223与阿比特龙/恩杂鲁胺联合使用。与未接受地诺单抗伴随用药的患者相比,接受地诺单抗伴随用药的患者似乎总生存期更长。与ASYMPCA试验报告的结果相比,镭-223的第二个治疗周期未出现任何不良事件。此处影像学无进展生存期的中位数为9个月。

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本文引用的文献

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Radium-223 for primary bone metastases in patients with hormone-sensitive prostate cancer after radical prostatectomy.镭-223用于根治性前列腺切除术后激素敏感性前列腺癌患者的原发性骨转移
Oncotarget. 2017 Jul 4;8(27):44131-44140. doi: 10.18632/oncotarget.17311.
2
An exploratory analysis of alkaline phosphatase, lactate dehydrogenase, and prostate-specific antigen dynamics in the phase 3 ALSYMPCA trial with radium-223.在使用镭-223的3期ALSYMPCA试验中对碱性磷酸酶、乳酸脱氢酶和前列腺特异性抗原动态的探索性分析。
Ann Oncol. 2017 May 1;28(5):1090-1097. doi: 10.1093/annonc/mdx044.
3
Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial.
镭-223 二氯化物(Ra-223)对住院的影响:来自 3 期随机 ALSYMPCA 试验中放射性配体治疗的疗效研究。
Eur J Cancer. 2017 Jan;71:1-6. doi: 10.1016/j.ejca.2016.10.020. Epub 2016 Dec 6.
4
Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial.镭-223 联合治疗转移性去势抵抗性前列腺癌患者:一项国际性、早期准入、开放标签、单臂 3b 期试验。
Lancet Oncol. 2016 Sep;17(9):1306-16. doi: 10.1016/S1470-2045(16)30173-5. Epub 2016 Jul 26.
5
Efficacy and Safety of Radium-223 Dichloride in Symptomatic Castration-resistant Prostate Cancer Patients With or Without Baseline Opioid Use From the Phase 3 ALSYMPCA Trial.镭-223 二氯化物在有或无基线阿片类药物使用的症状性去势抵抗性前列腺癌患者中的疗效和安全性:来自 3 期 ALSYMPCA 试验的结果。
Eur Urol. 2016 Nov;70(5):875-883. doi: 10.1016/j.eururo.2016.06.002. Epub 2016 Jun 22.
6
Radium-223 (Ra-223) Re-Treatment (Re-tx): First Experience From an International, Multicenter, Prospective Study in Patients (Pts) With Castration-Resistant Prostate Cancer and Bone Metastases (mCRPC).镭-223(Ra-223)再治疗:一项针对去势抵抗性前列腺癌和骨转移(mCRPC)患者的国际多中心前瞻性研究的首次经验。
Clin Adv Hematol Oncol. 2016 Apr;14(4 Suppl 5):10-1.
7
Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial.镭-223 二氯化物在有或无先前多西他赛治疗的去势抵抗性前列腺癌和有症状骨转移患者中的疗效和安全性:来自随机、双盲、III 期 ALSYMPCA 试验的预设亚组分析。
Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17.
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Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial.镭-223 二氯化物对去势抵抗性前列腺癌伴骨转移患者症状性骨骼事件的影响:来自一项 3 期、双盲、随机试验的结果。
Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13.
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Alpha emitter radium-223 and survival in metastatic prostate cancer.α 粒子发射体镭-223 与转移性前列腺癌的生存。
N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.