降低71%风险!前列腺癌组合疗法3期结果出炉

  • 辉瑞 ,安斯泰来制药,肿瘤


日前,安斯泰来制药 (Astellas Pharma) 公司与辉瑞 (Pfizer) 公司联合宣布使用XTANDI (enzalutamide) 和雄激素阻断疗法 (androgen deprivation therapy, ADT) 构成的组合疗法在治疗未转移去势抵抗性前列腺癌 (castration-resistant prostate cancer, CRPC) 患者的临床3期试验中取得积极疗效。试验结果表明这种组合疗法与单一ADT疗法相比能够将患者肿瘤转移或死亡的风险降低71%!这项试验的详细数据将在旧金山举行的2018泌尿生殖癌症研讨会 (2018 Genitourinary Cancers Symposium) 上公布。

前列腺癌是世界范围内男性中出现的第二大癌症。预计在2018年美国有超过16万男性将被确诊患上前列腺癌。在2015年中欧盟出现的新前列腺患者据统计为36.5万人。 CRPC指的是虽然雄性激素已经降到去势时的水平,但是前列腺癌仍然进一步发展的患者。这些患者中肿瘤还未转移的患者通常出现前列腺特异性抗原 (prostate-specific antigen, PSA) 水平上升。他们中如果PSA水平迅速上升,很容易出现肿瘤转移。

Enzalutamide是一种特异性雄激素受体抑制剂,它不但能够阻断雄激素与受体的结合,而且能够抑制受体向细胞核内转移并且抑制雄激素受体与DNA的结合。因此它不仅仅是雄激素受体的拮抗剂,而且对雄激素信号通路也有抑制作用。在2012年美国FDA就批准它用于治疗肿瘤已经转移的CRPC患者。

在名为PROSPER的随机双盲,拥有安慰剂对照的多国临床3期试验中,接近1400名肿瘤未转移的CRPC 患者接受了enzalutamide + ADT的治疗或者安慰剂 + ADT的治疗。试验的主要终点为无转移生存期 (metastasis free survival, MFS) 。 试验结果表明,enzalutamide与ADT构成的组合疗法与ADT相比显着延长患者的MFS, 组合疗法的MFS中值为36.6个月,而ADT单一疗法的MFS中值为14.7个月 (n=1401, p<0.0001)。< p="">

试验的次级终点包括PSA水平上升前的时间 (time to PSA progression),第一次需要使用新抗癌药物前的时间 (time to first use of new antineoplastic therapy)和总生存期 (overall survival)。试验结果表明组合疗法能够将PSA水平上升的风险降低93% (P<0.0001) ,组合疗法与ADT单一疗法相比,可以将PSA水平上升的时间平均推迟33.3个月。 同时组合疗法能够将患者需要使用新的抗癌药物的风险降低79% (p<0.0001)。< p="">

PROSPER临床试验中出现的副作用与enzalutamide在以前的临床试验中的副作用一致。大约有31%的患者在接受组合疗法后出现3级以上的副作用,接受ADT单一疗法的患者数值为23%。最常见的副作用为高血压和疲惫。

“在肿瘤尚未转移的CRPC患者中,推迟转移的发生和晚期前列腺癌的进一步发展是一个很重要的尚未被满足的医疗需求。目前在美国没有被批准的全身疗法来治疗肿瘤未转移的CRPC患者,” 西北大学Robert H. Lurie综合癌症中心的Maha Hussain博士说:“在PROSPER临床试验中,enzalutamide与ADT的组合能够显着推迟肿瘤转移的发生。如果能够获得批准,它将给肿瘤未转移的CRPC患者提供一个重要的新治疗选择。”

基于PORSPER试验结果的上市申请已经被递交给美国FDA和欧洲药品管理局 (European Medicines Agency, EMA)。随后这些数据将被递交给世界各地的监管机构。我们期待早日听到这款新药获批造福患者的好消息!

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