NEJM：奥拉帕尼(Lynparza)将为三成晚期前列腺癌患者带来福音

2015-10-30 MedSci MedSci原创

前列腺癌出自前列腺的恶性肿瘤，若细胞的基因突变导致增殖失控就会患上癌症。昨日英国《金融时报》报道援引伦敦癌症研究院表态称，去年生物制药企业阿斯利康(AstraZeneca)获得欧盟批准用于治疗卵巢癌的药物奥拉帕尼(Lynparza)将为25%-30%的晚期前列腺癌患者带来福音。上述报道提到，在《新英格兰医学期刊》( New England Journal o

前列腺癌出自前列腺的恶性肿瘤，若细胞的基因突变导致增殖失控就会患上癌症。去年生物制药企业阿斯利康(AstraZeneca)获得欧盟批准用于治疗卵巢癌的药物奥拉帕尼(Lynparza)将为25%-30%的晚期前列腺癌患者带来福音（BOA 2013：奥拉帕尼维持治疗可使BRCA突变性和铂敏感的复发性浆液性卵巢癌患者获益）。此前结果在AACR会议上有报道（AACR 2015：PARP抑制剂（奥拉帕尼）对晚期前列腺癌可能有效）。

上述报道提到，在《新英格兰医学期刊》( New England Journal of Medicine)发布研究结果的作者解释，其临床试验显示，奥拉帕尼干扰肿瘤细胞修复机制，其破坏可以导致肿瘤细胞无法生存。因此，这种药对治疗携带肿瘤细胞有修复缺陷DNA的男性患者有特效，标志着治疗前列腺癌取得重大进步。它证明，可以通过观察特定的基因突变监测前列腺癌，用基因排序提供更精确的癌症治疗对策。

奥拉帕尼的开发称得上一波三折。阿斯利康曾因为2011年该药一项2期试验的结果令人失望而将其搁置，直到2013年9月才启动了一项关键试验。去年年初，美国食品药物监督管理局(FDA)又拒绝加快批准这款药物。去年12月，FDA和欧盟先后批准奥拉帕尼作为治疗卵巢癌的药物，该药成为FDA批准的首个抗卵巢癌新型药物，阿斯利康打了一场翻身仗。

这是一项临床2期的研究结果，主要招募转移的，去势耐受的前列腺癌患者，给予400mg，一天两次的治疗。结果以按RECST 1.1评价标准进行OR评价，或PSA水平下降50%，或循环肿瘤细胞数量从5个以上下降至5个或以下（每7.5mL血液），基因突变采用二代测序进行分析。总共50名患者被招募，所以患者此前接受过多西他赛治疗，另外，49例（98%）接受abiraterone 或 enzalutamide治疗，29例（58%)接受过cabazitaxel治疗。另外，49例中，16例评估是有反应的（33%，95%CI：20-48），其中12名患者接受治疗超过6个月。基因测序结果表明，49例患者中16例评估了BRCA1/2, ATM, Fanconi's anemia genes, CHEK2基因。其中16例患者中，14例（88%）对olaparib有明显反应，包括7例BRCA2丢失，5例检测中有4例出现ATM突变。其中不良反应中，3-4级不良反应中表现突出的是20%患者有贫血，12%有疲劳的。

目前服用奥拉帕尼的完整疗程为11个月，费用约为4.3万英镑。阿斯利康称，服用一个疗程可为病人平均延长寿命4.3至11.2个月。

小知识：Olaparib

Olaparib是PARP抑制剂，也作用于BRCA1或BRCA2突变。Olaparib对端锚(聚合)酶-1作用效果不大，IC50值大于。Olaparib浓度为30-100 nM作用于SW620细胞，使PARP-1失活。与BRCA1和BRCA2充足细胞系(Hs578T,MDA-MB-231,T47D)相比，BRCA1缺陷细胞系(MDA-MB-463和HCC1937)对Olaparib过分敏感Olaparib抑制PARP，阻断碱基切除修复，导致KB2P细胞对Olaparib强烈敏感。结果导致在DNA复制时由单链断裂转变为双链断裂，由此激活BRCA2依赖的重组途径。

原始出处：

Mateo J, Carreira S, Sandhu S, Miranda S, Mossop H, Perez-Lopez R, Nava Rodrigues D, Robinson D, Omlin A, Tunariu N, Boysen G, Porta N, Flohr P, Gillman A, Figueiredo I, Paulding C, Seed G, Jain S, Ralph C, Protheroe A, Hussain S, Jones R, Elliott T, McGovern U, Bianchini D, Goodall J, Zafeiriou Z, Williamson CT, Ferraldeschi R, Riisnaes R, Ebbs B, Fowler G, Roda D, Yuan W, Wu YM, Cao X, Brough R, Pemberton H, A'Hern R, Swain A, Kunju LP, Eeles R, Attard G, Lord CJ, Ashworth A, Rubin MA, Knudsen KE, Feng FY, Chinnaiyan AM, Hall E, de Bono JS. DNA-Repair Defects and Olaparib in Metastatic Prostate Cancer. N Engl J Med. 2015 Oct 29;373(18):1697-1708.

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2016-02-20 yangcx0915

#期前列腺癌#

64 0
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2016-02-03 裸奔的肉包

Olaparib小知识那一段太多语法错误了，中文都说不清。。。

164 0
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2015-11-01 zhyy89

#晚期前列腺癌#

59 0
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2015-10-30 jetleo

好消息

129 0
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2015-10-30 1dde837bm59(暂无匿称)

资讯很前沿

157 0
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