First evidence of olaparib maintenance therapy in patients with newly diagnosed homologous recombination deficient positive/BRCA wild-type ovarian cancer: real-world multicenter study.

IF 3.9 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Jing Li, Youguo Chen, Mian He, Xiaoxiang Chen, Hao Wen, Yu Kang, Kaijiang Liu, Ge Lou, Xipeng Wang, Qinglian Wen, Li Wang, Zhongqiu Lin
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Abstract

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.

新诊断的同源重组缺陷阳性/BRCA野生型卵巢癌患者接受奥拉帕利维持治疗的首个证据:真实世界多中心研究。
尽管奥拉帕利作为维持疗法对携带 BRCA 基因突变的新诊断晚期卵巢癌妇女有很大的临床疗效,但其对无 BRCA 基因突变患者的疗效研究仍然很少。本研究旨在为单药奥拉帕利维持治疗在这种情况下的疗效提供第一手证据。本研究利用来自中国11个高容量三级医疗中心的真实数据,开展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有效性和安全性。研究的主要目标是1年无进展生存率。同时还评估了安全性。研究共纳入了50名患者,中位年龄为54岁,所有患者的BRCA基因突变检测结果均为阴性,但同源重组缺陷(HRD)检测结果均为阳性。1年PFS率为75.2%(95% CI,63.4至89.2),中位PFS为21.0个月(95% CI,13.8至28.2)。所有患者接受的奥拉帕利起始剂量均为300毫克,每天两次,没有人出现严重不良事件(AE)。8名(16%)患者进行了剂量调整,但没有人因不良反应而中断奥拉帕利的治疗。我们首次提供了证据,证明单奥拉帕利是新诊断为HRD阳性/BRCA野生型卵巢癌患者的一种安全有效的维持治疗方案。
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来源期刊
Frontiers of Medicine
Frontiers of Medicine ONCOLOGYMEDICINE, RESEARCH & EXPERIMENTAL&-MEDICINE, RESEARCH & EXPERIMENTAL
CiteScore
18.30
自引率
0.00%
发文量
800
期刊介绍: Frontiers of Medicine is an international general medical journal sponsored by the Ministry of Education of China. The journal is jointly published by the Higher Education Press and Springer. Since the first issue of 2010, this journal has been indexed in PubMed/MEDLINE. Frontiers of Medicine is dedicated to publishing original research and review articles on the latest advances in clinical and basic medicine with a focus on epidemiology, traditional Chinese medicine, translational research, healthcare, public health and health policies.
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