Olaparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 mutation: SOLO1 China cohort
Olaparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 mutation: SOLO1 China cohort
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DOI：
10.1016/j.ygyno.2020.10.005
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发表时间：
2021-01-01
影响因子：
4.7
通讯作者：
Zhang, Jing
中科院分区：
文献类型：
--
作者：
Wu, Lingying;Zhu, Jianqing;Zhang, Jing
目的。在 III 期 SOLO1 全球研究中，对于新诊断的晚期卵巢癌和 BRA 突变 (BRCAm) 患者，使用聚 (ADP-核糖) 聚合酶 (PARP) 抑制剂奥拉帕尼进行维持治疗，与安慰剂相比，可提供显着的无进展生存期 (PFS) 益处，这些患者在铂类化疗后处于临床完全或部分缓解。这导致奥拉帕尼维持治疗在中国、美国、欧盟、日本和其他国家获得批准用于新诊断的病例。 SOLO1 研究的这一单独的中国队列研究了中国人群中奥拉帕尼维持治疗的有效性和安全性。患者和方法。在这项双盲、多中心研究中，患者以 2:1 的比例随机分配接受口服奥拉帕尼片剂（300 毫克，每日两次）或安慰剂。主要终点是研究者评估的 PFS（修订版 RECIST v1.1）。结果。在 64 名随机患者中，44 名接受奥拉帕尼治疗，20 名接受安慰剂治疗。与安慰剂相比，奥拉帕尼将疾病进展或死亡的风险降低了 54%（HR 0.46，95% CI 0.23-0.97；奥拉帕尼组未达到中位 PFS，而安慰剂组为 9.3 个月）。奥拉帕尼组最常见的 AE 是恶心（安慰剂组为 63.6% vs 25.0%）、贫血（59.1% vs 15.0%）和白细胞减少症（54.5% vs 20.0%）。 56.8% 的奥拉帕尼患者和 30.0% 的安慰剂患者经历了级别 AE。结论。 SOLO1 中国队列的结果支持使用奥拉帕尼作为新诊断的患有 BRCAm 且在铂类化疗后完全或部分缓解的中国晚期卵巢癌患者的维持治疗。 (C) 2020 由爱思唯尔公司出版
Purpose. Maintenance therapy with the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib provided a substantial progression-free survival (PFS) benefit compared with placebo in patients with newly diagnosed advanced ovarian cancer and a BRA mutation (BRCAm) who were in clinical complete or partial response following platinum-based chemotherapy in the Phase III SOLO1 global study. This led to the approval of maintenance olaparib in China, USA, EU, japan and other countries, in the newly diagnosed setting. This separate China cohort of the SOLO1 study investigated the efficacy and safety of maintenance olaparib within the Chinese population.Patients and methods. In this double-blind, multicentre study, patients were randomized 2:1 to receive oral olaparib tablets (300 mg twice daily) or placebo. The primary endpoint was investigator-assessed PFS (modified RECIST v1.1).Results. Of the 64 randomized patients, 44 received olaparib and 20 placebo. Olaparib reduced the risk of disease progression or death by 54% compared with placebo (HR 0.46, 95% CI 0.23-0.97; median PFS was not reached in the olaparib arm vs 9.3 months in the placebo arm). The most common AEs in the olaparib arm were nausea (63.6 vs 25.0% with placebo), anaemia (59.1 vs 15.0%) and leukopenia (54.5 vs 20.0%). Grade AEs were experienced by 56.8% of olaparib patients and 30.0% of placebo patients.Conclusions. Results in the SOLO1 China cohort support the use of olaparib as maintenance treatment for Chinese patients with newly diagnosed advanced ovarian cancer who have a BRCAm and are in complete or partial response after platinum-based chemotherapy. (C) 2020 Published by Elsevier Inc.