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Clin Cancer Res:奥拉帕尼单药维持治疗亚洲铂敏感的复发性卵巢癌患者的疗效

2022-02-10 Nebula MedSci原创

在亚洲铂敏感的复发性卵巢癌患者中,奥拉帕尼维持治疗具有较高的治疗活性和良好的耐受性

与安慰剂相比,奥拉帕尼单药维持治疗可显著延长铂敏感的复发性 (PSR) 卵巢癌 (OC) 患者的无进展生存期 (PFS)。但是,目前缺乏该方案在亚洲人群中的疗效的证据。

本研究是首个评估奥拉帕尼在亚洲铂敏感的复发性卵巢癌患者中的疗效和耐受性。

这是一项开放标签的、单臂的3期临床试验,从中国和马来西亚的全国临床中心招募了大量铂敏感的复发性 高级别上皮性卵巢癌患者。予以奥拉帕尼(300 mg,2/日)口服治疗,直到病情进展或出现不可耐受的毒性。主要终点是中位无进展生存期(mPFS)。

2018年-2020年期间,共招募了225位患者,其中224位都接受了奥拉帕尼治疗;35.7%的患者既往接受过≥3线化疗,35.3%的患者经最后一线以铂类为基础的化疗后获得了完全缓解,41.1%的患者入组时距最后一次使用铂类药物≥12个月。

总的中位无进展生存期

截止2020年12月25日时,总的中位无进展生存期是16.1个月,携带BRCA突变和BRCA为野生型的患者的中位无进展生存期分别是21.2个月和11.0个月。

不同基因型患者的中位无进展生存期

99.1%的患者经历过3级及以上的副反应;9.4%的患者因治疗相关不良事件而中断治疗。

总之,在亚洲铂敏感的复发性卵巢癌患者中,奥拉帕尼维持治疗具有较高的治疗活性和良好的耐受性,无论BRCA状态如何。该研究强调了奥拉帕尼在亚洲这类患者人群中的应用前景。

 

原始出处:

Qinglei Gao, Jianqing Zhu, Weidong Zhao, et al. Olaparib Maintenance Monotherapy in Asian Patients with Platinum-Sensitive Relapsed Ovarian Cancer: Phase III Trial (L-MOCA). Clin Cancer Res February 7 2022 DOI:10.1158/1078-0432.CCR-21-3023.

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    2022-02-11 Rhonda

    #学习#学习

    0

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    2022-02-11 查查佳佳

    10000名儿童中就有4-11人患有深度的早

    0

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    2022-02-10 yesaisai133

    有新意

    0

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