Li Jing, Chen Youguo, He Mian, Chen Xiaoxiang, Wen Hao, Kang Yu, Liu Kaijiang, Lou Ge, Wang Xipeng, Wen Qinglian, Wang Li, Lin Zhongqiu
Department of Gynaecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510120, China.
Department of Obstetrics and Gynecology, The First Affiliated Hospital of Soochow University, Suzhou, 215006, China.
Front Med. 2024 Dec;18(6):1026-1034. doi: 10.1007/s11684-024-1083-5. Epub 2024 Nov 6.
Although olaparib has demonstrated substantial clinical benefits as maintenance therapy in BRCA mutation-carrying women with newly diagnosed advanced ovarian cancer, its effectiveness in patients without BRCA mutations remains poorly investigated. This study aims to provide the first evidence on the efficacy of mono-olaparib maintenance therapy in such context. Using real-world data from 11 high-volume tertiary care centers in China, a retrospective cohort study was conducted to assess the efficacy and safety of olaparib as first-line maintenance therapy in patients with BRCA wild-type ovarian cancer. The primary objective was 1-year progression-free survival rate. Safety was also evaluated. Fifty patients with a median age of 54 years were included, and all of them tested negative for BRCA mutations but positive for homologous recombination deficiency (HRD). The 1-year PFS rate was 75.2% (95% CI, 63.4 to 89.2), and the median PFS was 21.0 months (95% CI, 13.8 to 28.2). All the patients received olaparib at a starting dose of 300 mg twice daily, and none experienced serious adverse events (AEs). Eight (16%) patients had dose adjustment, but none discontinued olaparib treatment due to AEs. We provide the first evidence that mono-olaparib could be a safe and effective maintenance treatment option for patients newly diagnosed with HRD-positive/BRCA wild-type ovarian cancer.
尽管奥拉帕利作为新诊断的晚期卵巢癌携带BRCA突变女性的维持治疗已显示出显著的临床益处，但其在无BRCA突变患者中的有效性仍研究不足。本研究旨在提供关于单药奥拉帕利维持治疗在这种情况下疗效的首个证据。利用来自中国11家高容量三级护理中心的真实世界数据，进行了一项回顾性队列研究，以评估奥拉帕利作为BRCA野生型卵巢癌患者一线维持治疗的疗效和安全性。主要目标是1年无进展生存率。同时也评估了安全性。纳入了50例中位年龄为54岁的患者，所有患者BRCA突变检测均为阴性，但同源重组缺陷（HRD）检测为阳性。1年无进展生存率为75.2%（95%CI，63.4至89.2），中位无进展生存期为21.0个月（95%CI，13.8至28.2）。所有患者均以300mg每日两次的起始剂量接受奥拉帕利治疗，且均未发生严重不良事件（AE）。8例（16%）患者进行了剂量调整，但无一例因AE而停用奥拉帕利治疗。我们提供了首个证据，表明单药奥拉帕利可能是新诊断的HRD阳性/BRCA野生型卵巢癌患者安全有效的维持治疗选择。
