ASCO:肺癌患者无进展生存期新药显著延长脑转移患者无进展生存期

2017-06-07 佚名 药明康德

阿斯利康今日报告了泰瑞沙(奥希替尼)针对非小细胞癌(NSCLC)患者出现中枢神经系统转移治疗的有效性,此前,泰瑞沙经证实将可能成为用于晚期或转移的EGFR T790M 阳性突变非小细胞肺癌成人患者新的标准治疗方案。此次在2017美国临床肿瘤学会(ASCO)年会上公布的数据与此前临床和临床前显示奥希替尼可穿透血脑屏障的发现一致。

阿斯利康今日报告了泰瑞沙(奥希替尼)针对非小细胞癌(NSCLC)患者出现中枢神经系统转移治疗的有效性,此前,泰瑞沙经证实将可能成为用于晚期或转移的EGFR T790M 阳性突变非小细胞肺癌成人患者新的标准治疗方案。此次在2017美国临床肿瘤学会(ASCO)年会上公布的数据与此前临床和临床前显示奥希替尼可穿透血脑屏障的发现一致。

图片来自阿斯利康中国

AURA3 III期临床研究进一步分析,奥希替尼80mg每日一片较标准含铂双药化疗在进展期EGFR T790M突变阳性基线脑部扫描至少有1个可测量病灶和/或不可测量病灶的中枢神经系统转移患者中可显着延长无疾病恶化或死亡(无进展生存,PFS)(11.7 vs 5.6个月;HR 0.32;95%置信区间[CI] 0.15,0.69;p=0.004)。在这些患者中,疗效可评估的患者,中枢神经系统客观缓解率(ORR)奥希替尼组为70%(95% CI 51,85),化疗组为31%(95% CI 11,59)(比值比[OR], 5.13; 95% CI 1.44, 20.64; p=0.015)。在AURA3研究中,奥希替尼与化疗的不良事件(AE)发生与既往研究相似。

来自意大利米兰肿瘤研究中心(Fondazione IRCCS Istituto Nazionale dei Tumori)肿瘤科Marina-Chiara Garassino博士表示“奥希替尼在中枢神经系统转移患者中的结果与AURA3总人群中已经报道过的结果相一致,这些数据提示,与EGFRm T790M突变阳性非小细胞肺癌患者总人群一样,进展后出现中枢神经系统转移的患者也可以从奥希替尼治疗中获益”。

BLOOM临床研究报道了在EGFRm T790M 突变未选择的21名伴有软脑膜转移的NSCLC患者中,每日服用160毫克奥希替尼进行治疗的数据[4]。研究者评估总体软脑膜转移有效率为43%,在基线神经学评估为“异常”的10名患者中,7名(70%)患者有所改善。最常见的不良反应包括腹泻(n=13),恶心(n=11),甲沟炎(n=9)以及皮疹(n=9)。除腹泻和恶心各有一例患者为3级以上AE,其余均为1-2级。6名患者中断用药,4名因不良反应减少剂量,另外4名患者因不良事件停止用药。3名患者死于不良事件,据研究者评估死亡原因与使用奥希替尼无关。

阿斯利康全球药品研发部执行副总裁兼首席医学官Sean Bohen介绍:“奥希替尼针对血脑屏障穿透能力在药物研发早期即获得认可,我们很欣慰地看到AURA3研究入组的CNS转移患者无进展生存期(PFS)的阳性结果,以及BLOOM研究入组的软脑膜转移患者的有效率。”

针对软脑膜转移,目前现有的疗法通常无法有效穿透血脑屏障,患者可接受的治疗方法非常有限,因此软脑膜转移无法治愈且治疗难度颇高。使用奥希替尼治疗此类患者尚未获批,有待进一步临床研究证实。

关于非小细胞肺癌(NSCLC)

肺癌已成为人类因癌症死亡的主要原因,肺癌死亡人数约占所有癌症死亡人数的三分之一,超过因乳腺癌、前列腺癌和结肠直肠癌死亡人数总和。肺癌患者中,约25%-40%肺癌患者随着病程发展会发生脑部转移。占欧洲非小细胞肺癌患者10-15%和占亚洲非小细胞肺癌患者30-40%的EGFR突变非小细胞肺癌患者,对现有的表皮生长因子受体(EGFR)酪氨酸激酶抑制剂特别敏感。该抑制剂通过阻断驱动肿瘤细胞生长的细胞信号传递通路来抑制肿瘤。然而,肿瘤几乎总会对药物产生抗药性,导致疾病进展。在接受吉非替尼、厄洛替尼等EGFR酪氨酸激酶抑制剂治疗的患者中,约三分之二患者的耐药由继发的T790M突变引起。

关于泰瑞沙(奥希替尼)

泰瑞沙(奥希替尼,AZD9291)80mg片已在美国、欧盟、日本、加拿大、瑞典、以色列、墨西哥、澳大利亚等多个国家和地区批准用于EGFR T790M突变阳性的局部晚期或转移性非小细胞性肺癌(NSCLC)患者的首个治疗药物。韩国也批准了泰瑞沙?的相同适应症。经基因检测确认存在EGFR T790M突变患者可使用泰瑞沙?进行治疗。

泰瑞沙从临床试验到通过FDA批准上市仅用时两年半,是阿斯利康史上最快的研发项目之一。泰瑞沙是一种不可逆的选择性EGFR突变抑制剂,它源自科学家对肿瘤耐药机制的深入探索,能对由于T790M突变引起的肿瘤耐药产生精准抑制。目前,阿斯利康正在研究泰瑞沙作为辅助治疗及一线治疗脑转移或未发生脑转移的非小细胞肺癌(NSCLC)患者、肺癌软脑膜转移患者以及泰瑞沙与其他药物组合的疗效。

关于AURA 3 研究

AURA3研究针对EGRF T790M突变阳性、晚期或转移,EGFR-TKI治疗中或治疗后进展的419名NSCLC患者接受每日80mg奥希替尼口服治疗对比含铂双药化疗治疗疗效和安全性。此项研究在全球130个国家和地区进行,包括美国,加拿大,欧洲,中国,日本,韩国,台湾和澳大利亚。

研究的主要终点是无进展生存期(PFS)。次要终点包括总生存期(OS)、客观缓解率(ORR)、缓解持续时间(DoR)、疾病控制率(DCR),和对安全性、健康相关生活质量的影响(HRQoL)。

关于BLOOM研究

BLOOM研究中,EGFR-TKI治疗进展、确诊脑脊液细胞阳性柔脑膜疾病的 EGFR突变阳性晚期NSCLC患者,接受奥希替尼每日160mg的治疗。患者反应评估分为两组:EGFR T790M未筛选患者以及EGFR T790M阳性患者。临床分析基于脑脊液(CSF)细胞学、每六周一次脑部MRI影像和神经学检查,直至病情发生进展。[18]

关于中枢神经系统(CNS)转移

脑实质转移(BM)和柔脑膜转移 (LM) 是两种不同的中枢神经系统转移的形式,预后差。虽然BM和LM是两种不同的情况,但两种转移可能同时发生,治疗难度相当高。脑实质转移是一种常见的晚期癌症并发症,多发生于肿瘤细胞通过血流扩散并至脑部并增殖;而柔脑膜转移更为罕见,多见于肿瘤细胞扩散至脑膜和脊髓。[24].[25].[26]

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    2017-12-26 quxin068
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    2017-06-07 187****0626

    又是一个新的研究,医学在不断的进展

    0

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    2017-06-07 清风拂面

    谢谢分享,学习了

    0

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