Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.
Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.
Clin Cancer Res. 2022 Jun 1;28(11):2278-2285. doi: 10.1158/1078-0432.CCR-21-3023.
In patients with platinum-sensitive relapsed (PSR) ovarian cancer, olaparib maintenance monotherapy significantly improves progression-free survival (PFS) versus placebo. However, evidence in the Asian population is lacking. This is the first study to evaluate olaparib efficacy and tolerability exclusively in Asian patients with PSR ovarian cancer.
Considering the limited placebo effect and significant clinical benefit of olaparib in previous trials, and the rapid approval of olaparib in China, this phase III study was designed as an open-label, single-arm trial. Patients with high-grade epithelial PSR ovarian cancer were enrolled from country-wide clinical centers across China and Malaysia. Patients received oral olaparib (300 mg) twice daily until disease progression or unacceptable toxicity. Primary endpoint was median PFS (mPFS). Primary analysis of PFS using the Kaplan-Meier method was performed when data reached 60% maturity (clinicaltrials.gov NCT03534453).
Between 2018 and 2020, 225 patients were enrolled, and 224 received olaparib; 35.7% had received ≥3 lines of chemotherapy, 35.3% had achieved complete response to their last line of platinum-based chemotherapy, and 41.1% had a platinum-free interval ≤12 months. At primary data cut-off (December 25, 2020), overall mPFS was 16.1 months; mPFS was 21.2 and 11.0 months in BRCA-mutated and wild-type BRCA subgroups, respectively. Adverse events (AE) occurred in 99.1% of patients (grade ≥3, 48.7%); 9.4% discontinued therapy due to treatment-related AEs.
Olaparib maintenance therapy was highly effective and well tolerated in Asian patients with PSR ovarian cancer, regardless of BRCA status. This study highlights the promising efficacy of olaparib in this Asian population. See related commentary by Nicum and Blagden, p. 2201.
在铂类敏感复发（PSR）卵巢癌患者中，奥拉帕利维持单药治疗与安慰剂相比，显著改善了无进展生存期（PFS）。然而，亚洲人群的证据尚缺乏。这是第一项专门评估奥拉帕利在铂类敏感复发卵巢癌亚洲患者中的疗效和耐受性的研究。
鉴于先前试验中奥拉帕利的安慰剂效应有限，且具有显著的临床获益，以及奥拉帕利在中国的快速获批，本项 III 期研究设计为开放标签、单臂试验。来自中国和马来西亚全国性临床中心的高级别上皮 PSR 卵巢癌患者入组。患者接受奥拉帕利（300 mg）每日两次口服治疗，直至疾病进展或出现不可接受的毒性。主要终点为中位 PFS（mPFS）。当数据达到 60%成熟度时（clinicaltrials.gov NCT03534453），采用 Kaplan-Meier 法对 PFS 进行主要分析。
2018 年至 2020 年，共纳入 225 例患者，224 例接受了奥拉帕利治疗；35.7%的患者接受了≥3 线化疗，35.3%的患者末次铂类化疗达到完全缓解，41.1%的患者无铂间期≤12 个月。在主要数据截止日期（2020 年 12 月 25 日），总体 mPFS 为 16.1 个月；BRCA 突变亚组和野生型 BRCA 亚组的 mPFS 分别为 21.2 个月和 11.0 个月。99.1%的患者发生了不良反应（AE）（≥3 级，48.7%）；9.4%的患者因治疗相关 AE 而停止治疗。
奥拉帕利维持治疗在铂类敏感复发卵巢癌亚洲患者中具有显著的疗效和良好的耐受性，无论 BRCA 状态如何。本研究强调了奥拉帕利在亚洲人群中的潜在疗效。详见尼库姆和布拉格登的相关评论，第 2201 页。
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