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JCO：veliparib并不能改善BRCA/PALB2基因突变的晚期胰腺癌患者预后

2020-03-16 医者仁心 医者仁心

胰腺癌预后Veliparib
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胰腺导管细胞癌占恶性肿瘤死亡率的第四位，50%的患者诊断时已处于晚期。细胞毒类药物的联合治疗，如亚叶酸、氟尿嘧啶、伊立替康及奥沙利铂、吉西他滨和紫杉醇等药物改善了患者预后，但5年OS率仍低于10%。5

胰腺导管细胞癌占恶性肿瘤死亡率的第四位，50%的患者诊断时已处于晚期。细胞毒类药物的联合治疗，如亚叶酸、氟尿嘧啶、伊立替康及奥沙利铂、吉西他滨和紫杉醇等药物改善了患者预后，但5年OS率仍低于10%。5-9%的晚期胰腺癌患者携带BRCA1/2和PALB2基因突变，而BRCA基因突变导致的肿瘤与铂类药物化疗敏感性有关且与PARPi抑制剂(PARPi)有协同作用。PARPi在BRCA基因突变的乳腺癌及卵巢癌中的应用已经获得批准，而III期POLO研究则证实，PARPi可以作为BRCA基因突变的晚期胰腺癌患者的维持治疗。

在前期的一项I期研究中，我们探索了PARPi-veliparib联合吉西他滨+顺铂的剂量，且发现这一治疗方案在BRCA/PALB2+的晚期胰腺导管细胞中的ORR达78%，OS为23.3个月。因此，我们设计了这一多中心、II期临床研究，以探索吉西他滨+顺铂联合/不联合veliparib在携带胚系BRCA/PALB2突变的晚期胰腺癌患者中的疗效及安全性。

这是一项II期临床研究，纳入携带胚系BRCA/PALB2突变的晚期胰腺癌患者(AJCC分期为III期或IV期)，年龄大于18周岁，PS评分为0-1分。允许术后复发的患者入组，但末次化疗时间距离复发时间应当超过6个月。既往接受过铂类药物或PARPi治疗的患者不允许入组，存在活动性脑转移的患者同样不允许入组。符合入组标准的患者接受吉西他滨(600mg/m2，第3和第10天用药，21天一个周期)联合顺铂(25mg/m2，第3和第10天用药，21天一个周期)联合或者不联合veliparib(80mg，口服，每日两次，第1-12天用药，21天一个周期)。治疗应当持续进行，直至疾病进展、患者出现不可耐受的不良反应或撤销知情同意。研究期间，每6周进行一次疗效评估，6个月及18个月后，分别每9周和12周进行一系疗效评估。研究的主要终点为ORR，次要研究终点包括DCR、PFS、OS、安全性、耐受性及反应持续时间。

结果显示，自2014年1月至2018年11月，共筛选3个国家6个中心52例患者，2例患者治疗之前撤销知情同意书(图1)。
图1 患者入组流程图
数据截止时间为2019年7月，50例患者中位年龄64岁，联合治疗组和单纯化疗组分别有27例和23例患者，84%的患者为晚期，分别有24%、70%和6%的患者携带BRCA1、BRCA2及PALB2基因突变。两组之间在分期、PS评分及BRCA基因突变状态等方面均衡可比。
联合组和单纯化疗组的ORR分别为74%和65.2%，差异无统计学意义(P=0.55)，DCR分别为100%和78%，差异有统计学意义(P=0.02)(图2)。
图2 两组治疗的瀑布图
数据分析时，联合组和单纯化疗组分别有7例和2例患者仍然存活。联合组和单纯化疗组的PFS分别为10.1个月(95% CI, 6.7 to 11.5 个月)和9.7个月(95% CI, 4.2-13.6个月)，差异无统计学意义(P=0.73)(图3)。
图3 两组的PFS
图4 两组的OS
两组的OS分别为15.5个月(95%CI, 12.2 to 24.3个月)和16.4个月(95%CI, 11.7-23.4个月)，差异同样无统计学意义(P=0.6)(图4)。
从安全性来讲，两个治疗方案尤其以血液学毒性更加明显(图5)。联合治疗组和单纯化疗组分别有81%和73%的患者出现3度及以上血液学不良反应。联合组包括贫血(52%)及血小板降低(55%)；单纯化疗组包括贫血(35%)和血小板降低(9%)。两组分别出现39例和35例非血液学的3度及以上不良反应。联合治疗组有74%的患者因不良反应导致剂量降低或治疗终止，单纯化疗组为26%。
图5 两组出现的血液学不良反应

研究结论

对于携带BRCA/PALB2基因突变的晚期胰腺癌患者，吉西他滨联合顺铂是这部分患者的有效治疗，进一步联合veliparib不能给患者带来生存获益。
参考文献：O'Reilly EM, Lee JW, Zalupski M, et al. J Clin Oncol. 2020 Jan 24:JCO1902931. doi: 10.1200/JCO.19.02931.

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    2020-06-10 lidong40

    #JCO#

    0

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    2020-05-03 bnurmamat

    #患者预后#

    0

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    2020-03-18 jiangfeng5067

    #Veliparib#

    0

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    2020-03-18 ms7899726347904398

    #晚期胰腺癌#

    0

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    2020-03-18 智智灵药

    #BRCA#

    0

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    2020-03-18 zhouqu_8

    #PALB2#

    0

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