复发性卵巢癌:Rucaparib 维持治疗优势分析

2021-01-23 张师前 张师前公众号

加拿大玛格丽特公主癌症中心Oza 等报告的Ⅲ期随机、安慰剂对照试验ARIEL3显示,经生活质量调整的无进展生存期(QA-PFS)和经生活质量调整的无症状时间 /无毒性时间(Q-TWiST)的显著差异证

加拿大玛格丽特公主癌症中心Oza 等报告的期随机、安慰剂对照试验ARIEL3显示,经生活质量调整的无进展生存期(QA-PFS)和经生活质量调整的无症状时间 /无毒性时间(Q-TWiST)的显著差异证实了 Rucaparib 相对安慰剂在所有预定义队列中的优势。(J  Clin Oncol. doi:10.1200/JCO.19.03107) 

Rucaparib是全球首个用于卵巢癌三线治疗的PARP抑制剂,该项事后探索性分析自 Rucaparib维持治疗对比安慰剂的期研究 ARIEL3中入组数据,旨在对QA-PFS 和 Q-TWiST 进行分析。

铂类敏感的、复发性卵巢癌患者被随机分配接受Rucaparib(600mg,每天两次)或安慰剂。随访截至2017年4月15日。在有些人群中,Rucaparib相对安慰剂的平均 QA-PFS 明显更长,包括意向性治疗队列(ITT:Rucaparib组375 例,安慰剂组189例;差异为6.28个月)、BRCA突变队列(130例和66例;差异9.37个月)、同源重组缺陷(HRD)队列(236例和118例;差异为7.93个月)、BRCA野生型 / 低杂合性丢失(LOH)患者亚组(107例和54例;差异为2.71个月)。治疗中出现的≥3级不良事件来定义TOX后,ITT队列、BRCA突变队列、HRD队列和BRCA野生型 / 低LOH患者亚组平均Q-TWiST(Rucaparib组 vs.安慰剂组)的差异分别为6.88 个月、9.73个月、8.11个月和3.35个月。使用选择≥ 2级治疗中出现的不良事件来定义TOX 后,Q-TWiST 结果也继续偏向使用Rucaparib。

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    2021-03-13 smlt2008
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