Olaparib Maintenance Monotherapy in Asian Patients with Platinum-Sensitive Relapsed Ovarian Cancer: Phase III Trial (L-MOCA)

Gao, Qinglei and Zhu, Jianqing and Zhao, Weidong and Huang, Yi and An, Ruifang and Zheng, Hong and Qu, Pengpeng and Wang, Li and Zhou, Qi and Wang, Danbo and Lou, Ge and Wang, Jing and Wang, Ke and Low, John and Kong, Beihua and Abdul Malik, Rozita and Sen, Lim Chun and Yin, Rutie and Xie, Xing and Liu, Jihong and Sun, Wei and Su, Jingya and Zhang, Chunyi and Zang, Rongyu and Ma, Ding (2022) Olaparib Maintenance Monotherapy in Asian Patients with Platinum-Sensitive Relapsed Ovarian Cancer: Phase III Trial (L-MOCA). Clinical Cancer Research, 28 (11). pp. 2278-2285. ISSN 1078-0432, DOI https://doi.org/10.1158/1078-0432.CCR-21-3023.

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Purpose: 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. Patients and Methods: 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 highgrade epithelial PSR ovarian cancer were enrolled from countrywide 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). Results: 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 BRCAmutated 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. Conclusions: 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.

Item Type: Article
Funders: AstraZeneca
Uncontrolled Keywords: Platinum-Sensitive Relapsed Ovarian Cancer
Subjects: R Medicine
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 19 Oct 2023 07:04
Last Modified: 19 Oct 2023 07:04
URI: http://eprints.um.edu.my/id/eprint/42135

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