ASCO 2020:奥拉帕利用于BRCA-1/2突变铂敏感复发性卵巢癌患者的疗效及安全性分析(SOLO2研究)

2020-05-25 MedSci MedSci原创

在BRCA-1/2突变铂敏感复发性卵巢癌(PSOC)患者中加入奥拉帕利作为维持治疗可显著改善无进展生存期(PFS),显示出良好的以患者为中心的终点。由于BRCA突变的患者往往更年轻,老年患者使用奥拉帕

在BRCA-1/2突变铂敏感复发性卵巢癌(PSOC)患者中加入奥拉帕利作为维持治疗可显著改善无进展生存期(PFS),显示出良好的以患者为中心的终点。由于BRCA突变的患者往往更年轻,老年患者使用奥拉帕利的疗效和安全性还缺少数据。因此,有必要针对不同年龄的患者进行研究与观察

SOLO2试验中,295名患者以年龄为65岁为分层,随机分配到奥拉帕利组或安慰剂组。根据PFS和毒性结果评估两个不同年龄组内奥拉帕利相对于安慰剂的疗效和耐受性。生活质量(QoL)采用EQ-5D-5L描述系统评分和事实试验结果指数(TOI)进行评估,并采用无显著毒性症状累计时间(TWiST)分析的广义估计方程(GEE)和时间进行评估。

结果显示,除了老年患者BRCA2突变比例更多(39%比23%)外,≥65岁的患者 (N=62;21%)与小于65岁的患者(N=233,79%)两组基线特征。与年轻患者相比,老年患者服用奥拉帕利在PFS获益方面没有显著差异(P=0.33)。奥拉帕利和安慰剂组的PFS调整后的风险比(HR)分别为HR 0.43(95%的置信区间[CI] 0.24-0.81)和HR 0.31(95%的置信区间0.22-0.43)。老年患者和和年轻患者在奥拉帕利治疗的中位时间(≥65:27与< 65:33个月)内也无统计学差异,奥拉帕利组患者经历至少> 2级不良反应的比例 (≥65: 73%比< 65:79%),或者至少一次剂量中断或减少剂量的比例(≥65:77.5和< 65年):77.6%)。在生活质量评分方面没有发现差异。调整后的TWiST分析显示接受奥拉帕利治疗,两组良好的生活质量持续时间无显著差异(≥65:8.02 vs <65: 9.24个月,P=0.48)。

在这项III期临床BRCA突变铂敏感复发的卵巢癌患者中使用PARP抑制剂治疗的患者中,与较年轻的患者相比,≥65岁的患者使用奥拉帕利治疗,在疗效、安全性和生活质量方面,均未发现明显差异。这一结果支持不论年龄大小,PARPi均可以作为铂敏感复发卵巢癌患者的维持治疗。
原始出处:
Poster Abs 6068: Fabian Trillsch, Sven Mahner, et al. BRCA-1/2突变铂敏感复发性卵巢癌患者奥拉帕利不同年龄的疗效及安全性:III期SOLO2(AGO-OVAR 2.23 / ENGOT-Ov21)研究分析

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    2020-05-27 智智灵药
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    2020-05-25 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2020-05-25 wxl882001

    了解一下

    0

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