J Clin Oncol:奥拉帕尼维持治疗晚期卵巢癌随访长达7年的总生存预后

2022-09-16 MedSci原创 MedSci原创

奥拉帕尼维持治疗可改善新诊断的携带BRCA突变的晚期卵巢癌患者的总生存预后

在SOLO1/GOG 3004试验中,聚(ADP-核糖)聚合酶抑制剂奥拉帕尼的维持治疗为新诊断的携带BRCA1/BRCA2突变的晚期卵巢癌患者提供了持续的无进展生存益处。本文报告了该试验随访7年后的总生存预后。

在这项双盲的3期临床试验中,新诊断的携带BRCA突变的对铂类化疗有反应的晚期卵巢癌患者被随机分至奥拉帕尼组(n=260)或安慰剂组(n=131)维持治疗长达2年。次要终点是总生存期(OS)。


两组的总生存率

截止2022年7月,391位患者中有149位已死亡。奥拉帕尼组和安慰剂组的中位随访时间分别是88.9个月和87.4个月,中位治疗持续时间分别是24.6个月和13.9个月。奥拉帕尼组和安慰剂组的中位总生存期分别是未达到和75.2个月(HR 0.55,p=0.004)。

第7年时,奥拉帕尼组和安慰剂组分别还有67.0%和46.5%的患者存活,而且分别有45.3%和20.6%的存活患者未接受首次后续治疗。骨髓增生异常综合征和急性髓性白血病的发病率仍然很低,治疗组之间新发原发性恶性肿瘤的发生率保持平衡。

综上所述,该研究结果表明,在新诊断的携带BRCA突变的晚期卵巢癌患者中,奥拉帕尼维持治疗可改善总生存预后,具有临床意义,虽然根据预定的标准没有统计学意义;支持这类患者采用奥拉帕尼维持治疗以获得长期缓解。在长期随访过程中,未观察到新的安全性问题。

原始出处:

Paul DiSilvestro, et al. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. September 9, 2022. https://ascopubs.org/doi/full/10.1200/JCO.22.01549

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