Clin Cancer Res:Wee1抑制剂Adavosertib(AZD1775)在晚期实体肿瘤患者中的抗肿瘤活性及相关生物标志物

2021-07-22 MedSci原创 MedSci原创

Wee1抑制剂Adavosertib(AZD1775)在晚期实体肿瘤患者中的抗肿瘤活性

细胞周期检查点使细胞在细胞分裂前有时间修复DNA损伤和染色质破坏,从而避免复制灾难。周期蛋白依赖性激酶(Cdk)是丝氨酸-苏氨酸激酶的一个重要家族,通过特定的周期蛋白伴侣的磷酸化来调节细胞进入细胞周期的各个阶段。

Wee1激酶抑制剂Adavosertib可以终止细胞周期阻滞,导致细胞死亡。先前在晚期实体肿瘤患者中的试验(Adavosertib,2/日)确定了推荐的II期剂量。现本文报告了实体肿瘤患者采用Adavosertib 每日一次治疗的结果。

该研究采用了3+3剂量递增设计,21天为一疗程,于第1-5天和第8-12天,每天服用一次Adavosertib。在配对的肿瘤活检中评估Wee1活性的分子生物标志物,包括酪氨酸15-磷酸化Cdk1/2 (pY15-Cdk)。全外显子测序和剩余肿瘤组织RNA测序寻找潜在的预测性生物标志物。

Adavosertib的血浆浓度变化

共招募了42位患者。每日一次Adavosertib的剂量为300 mg。Adavosertib的血浆暴露与每日两次剂量组相似。在第一个疗程的第8天(剂量前),8位患者中有4位的肿瘤pY15-Cdk水平高于基线,提示在第5-8天剂量间隙期间,靶肿瘤发生了反弹。

治疗缓解情况

6位患者(14%)获得了经证实的部分缓解:4例卵巢癌、2例内膜癌。一位进展迅速的患者有肿瘤WEE1突变和潜在的代偿性PKMYT1过表达。在进行了RNA水平评估的患者中,在两位获得缓解的患者中,均有基线CCNE1过表达,且其中一位还存在CCNE1扩增,而3位未缓解患者均无CCNE1过表达。

不良反应

最常见的不良反应是胃肠道和血液方面;剂量限制性毒性为4级的血液学毒性和3级的疲劳。

综上所述,该研究评估了每日一次Adavosertib RPh2D用于晚期实体肿瘤的疗效,在卵巢癌或内膜癌患者中观察到了Adavosertib的治疗活性,包括两例基线CCNE1 mRNA过表达的患者。未来应进一步开展相关研究明确CCNE1过表达是否可作为预测Adavosertib疗效的生物标志物。

原始出处:

Naoko Takebe, et al. Safety, Antitumor Activity, and Biomarker Analysis in a Phase I Trial of the Once-daily Wee1 Inhibitor Adavosertib (AZD1775) in Patients with Advanced Solid Tumors. Clinical Cancer Research. July 2021. DOI: 10.1158/1078-0432.CCR-21-0329

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    2022-05-07 jklm09
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  5. 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  6. 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  7. 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time=2021-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1424346, encodeId=a6ac14243466f, content=<a href='/topic/show?id=94c182929d0' target=_blank style='color:#2F92EE;'>#肿瘤患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82929, encryptionId=94c182929d0, topicName=肿瘤患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=60943920553, createdName=lanyan20020087, createdTime=Sat Jul 24 08:02:01 CST 2021, time=2021-07-24, status=1, ipAttribution=)]
  8. 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time=2021-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1424346, encodeId=a6ac14243466f, content=<a href='/topic/show?id=94c182929d0' target=_blank style='color:#2F92EE;'>#肿瘤患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82929, encryptionId=94c182929d0, topicName=肿瘤患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=60943920553, createdName=lanyan20020087, createdTime=Sat Jul 24 08:02:01 CST 2021, time=2021-07-24, status=1, ipAttribution=)]
    2021-07-24 般若傻瓜
  9. 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time=2021-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1424346, encodeId=a6ac14243466f, content=<a href='/topic/show?id=94c182929d0' target=_blank style='color:#2F92EE;'>#肿瘤患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82929, encryptionId=94c182929d0, topicName=肿瘤患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=60943920553, createdName=lanyan20020087, createdTime=Sat Jul 24 08:02:01 CST 2021, time=2021-07-24, status=1, ipAttribution=)]
    2021-07-24 weiz
  10. 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