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Lancet Oncol:鲁卡帕利可作为BRCA1/2突变的复发性卵巢癌化疗的替代选择

2022-03-17 Nebula MedSci原创

鲁卡帕利可作为复发性、BRCA1或BRCA2突变的卵巢癌化疗的替代治疗选择。

目前比较PARP抑制剂与化疗在BRCA1或BRCA2突变的卵巢癌中的疗效的前瞻性研究较少。本研究旨在评估PARP抑制剂鲁卡帕利对比以铂为基础的和非铂类为基础的化疗在BRCA1/2突变的卵巢癌中的疗效。

这是一项在多个国家的64家医院和癌症中心开展的开放标签的随机对照的3期研究(ARIEL4),招募了年满18岁的既往至少进行过2次化疗的携带BRCA1或BRCA2突变的卵巢癌患者。受试患者被随机(2:1)分成了两组,接受口服鲁卡帕利(600 mg,2/日)或化疗。主要终点是无进展生存期。

在疗效分析人群中,两组的无进展生存率

2017年3月1日-2020年9月24日期间,共筛查了930位患者,其中349位符合纳入要求的患者(中位年龄 58岁,95%的白人)被随机分至鲁卡帕利组(n=233)或化疗组(n=116)。截止2020年9月30日,中位随访了25.0个月。在疗效分析人群(鲁卡帕利组 220位,化疗组 105位)中,鲁卡帕利组和化疗组的中位无进展生存期分别是7.4个月和5.7个月(HR 0.64, p=0.0010)。在意向治疗人群(鲁卡帕利组 233位,化疗组 116位)中,鲁卡帕利组和化疗组的中位无进展生存期分别是7.4个月和5.7个月(HR 0.67, p=0.0017)。

在意向治疗人群中,两组的无进展生存率

最常见的需紧急治疗的不良反应是1/2级的。最常见的3级及以上不良反应有贫血或血红蛋白减少(鲁卡帕利组 vs 化疗组:22% vs 5%)。鲁卡帕利组和化疗组严重的需紧急治疗的不良反应的发生率分别是27%和12%,其中分别有14%和5%的不良反应考虑与研究治疗相关。研究过程中有三例死亡考虑与鲁卡帕利可能相关。

综上,ARIEL4研究的结果支持鲁卡帕利可作为复发性、BRCA1或BRCA2突变的卵巢癌化疗的替代治疗选择

 

原始出处:

Rebecca Kristeleit, et al. Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial. The Lancet Oncology. March 14, 2022. https://doi.org/10.1016/S1470-2045(22)00122-X

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    2022-12-28 howi
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    2022-09-30 minlingfeng
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    2022-03-18 fangcong
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