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

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.

Keywords

adverse events / maintenance therapy / olaparib / ovarian cancer / progression-free survival

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Acknowledgements

We are deeply grateful to the patients and their families for participating in this study. This research was funded by AstraZeneca, which had no involvement in the study design, data collection methods, analysis, interpretation of the data, or writing of the manuscript. We would also like to thank Tanushree Goswami, Ph.D from Indegene Pvt Ltd for providing editorial assistance.

Compliance with ethics guidelines

Conflict of interests Jing Li, Youguo Chen, Mian He, Xiaoxiang Chen, Hao Wen, Yu Kang, Kaijiang Liu, Ge Lou, Xipeng Wang, Qinglian Wen, Li Wang, and Zhongqiu Lin declare that they have no conflict of interest.

The study was approved by the institutional review board at each center and the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Due to the retrospective nature of the study, written informed consent was waived.

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