ASCO2019 |帕妥珠单抗、曲妥珠单抗和多西紫杉醇联合一线治疗her2阳性转移性乳腺癌的中国桥接研究(PUFFIN)

2019-06-03 小M MedSci原创

第55届美国临床肿瘤学会(ASCO)年会于2019年5月31日至6月4日在美国芝加哥召开。本次会议吸引世界3万8千名肿瘤专家参与。

第55届美国临床肿瘤学会(ASCO)年会于2019年5月31日至6月4日在美国芝加哥召开。本次会议吸引世界3万8千名肿瘤专家参与。

在国际CLEOPATRA(NCT00567190)项目中,验证了her2阳性转移性乳腺癌(MBC)患者一线使用帕妥珠单抗(P)、曲妥珠单抗(H)和多西紫杉醇(D)的有效性和安全性。

基于此项目,中国学者们开展了一项中国桥接研究PUFFIN(NCT02896855),目的是评估疗效与CLEOPATRA的一致性。

【CLEOPATRA研究】(NCT00567190)


一项对先前未治疗的HER2阳性局部复发/转移性乳腺癌中placebo (pla)做对照的帕妥珠单抗(P)+曲妥珠单抗(H)+多西紫杉醇(D)治疗与Pla + H + D治疗的III期、随机、双盲对照研究。

研究方法
向患有先前未治疗的HER2阳性LR / MBC的患者中添加P + H + D,显著改善无进展和总体存活(PFS / OS),对照组为Pla + H + D。

研究剂量(每3周):
-帕妥珠单抗(P)/ 安慰剂(Pla):840 mg负荷剂量,420 mg维持剂量
-曲妥珠单抗(H): 8 mg/kg负荷剂量,6 mg/kg维持剂量
-多西他赛(D):75 mg/m2,如果耐受则增加到100 mg/m2

研究结论
-在中位随访约8年后,OS和研究者评估的PFS改善与之前分析中观察到的P + H + D v Pla + H + D保持一致。
-据我们所知,这是对her2阳性MBC患者进行1L治疗最长的pts随访(max)。120年密苏里州)。维持P + H + D在总安全人群和交叉患者中的长期安全性和心脏安全性。
-her2靶向治疗改变了her2阳性MBC的自然历史,双阻断P + H, D显示8年的里程碑式OS率为37%。

【PUFFIN研究】(NCT02896855)


研究目的
在中国患者中评估帕妥珠单抗(P)、曲妥珠单抗(H)、多西他赛(D)疗效与CLEOPATRA的一致性。

研究方法
主要终点是研究者评估PFS。次要终点包括客观反应率(具有可测量的基线疾病的患者的ORR),OS和安全性。目标样本量(240)是根据PFS的一致性阈值确定的,定义为风险比(HR)<0.81,保持在CLEOPATRA中确定的风险降低的≥50%(HR 0.62)。

243个具有先前未治疗的HER2阳性LR / MBC的中国患者以1:1随机化至P + H + D或Pla + H + D,通过内脏对照非内脏疾病和激素受体状态分层。



剂量等研究参数与CLEOPATRA研究一致。

研究结果
对于PFS,ITT人群的HR为0.69(95%CI 0.49,0.99)。没有报告心力衰竭或症状性左心室射血分数下降的病例。PUFFIN符合其主要终点。

疗效和安全性见下表。


结论:
总体而言,疗效数据效果与安全性与CLEOPATRA(ITT人群和亚洲亚组)一致,没有报告新的或意外的信号。 PUFFIN在先前未治疗的HER2阳性LR / MBC中增加了P的数据总量,并支持中国人P的有利利益风险概况。

会后我们采访了中国科学院大学附属肿瘤医院(浙江省肿瘤医院)的王晓稼教授。


王晓稼教授(左)

1. Q:请问您能对这次ASCO年会做一个评论吗?
A:ASCO年会是一个全球癌症工作者精英大会,囊括癌症临床研究各个领域的最新进展。它有口头报告和海报两种形式。对于国内从事学术授课和临床规范化治疗的工作者,会受益于会议提供的口头报告,而学术科研工作者会受益于会议的海报。我更鼓励年轻医生关注ASCO年会,促进科学研究,实施规范化的临床治疗来实现高质量的医学实践。

2. Q:请问您是如何看待现在中国的临床治疗的?
A:中国患者要得到更好的医疗治疗,临床治疗的质量是最主要的。所以我鼓励青年医生参与临床科研的学习,以提高临床试验的质量,改善受试者的安全性。现在中国患者正处在一个幸运的时代,新药的批准和医保政策的改进都突飞猛进。我们只有保证医疗质量,力争赶超国际水平,才能开放国内的新药市场,降低国际市场药品售价,让患者真正的受益。

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    2019-06-16 quxin068
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