Background: Olaparib has been approved as an active and maintenance therapy for patients with platinum-sensitive, BRCA-mutated high-grade serous ovarian cancer (SOC). However, the efficacy and safety data is lack among Chinese ovarian cancer patients.
Aim: This real-world study aimed to evaluate the effectiveness and safety profile of olaparib in patients from mainland China, where olaparib is currently unavailable.
Methods and results: This single-center, observational study included 65 patients with pathologically confirmed advanced serous ovarian cancer from Kiang Wu Hospital in Macau between December 2015 and September 2017. Progression-free survival (PFS) and other endpoints (treatment response, disease progression, and adverse events) were evaluated. PFS was estimated using the Kaplan-Meier method. The median treatment duration was 4 months (range, 1-15). The median PFS for the overall population was 4.2 months (95% CI 2.7-5.2), while those for patients with wild-type BRCA1/2 and BRCA1/2 mutations were 3.1 months (95% CI 1.3-4.6) and 5.3 months (95% CI 2.8-7.1), respectively. The median PFS tended to be longer for patients on maintenance therapy (between 9.0 months [95% CI 1.4-17.5] and 10.0 months [95% CI 2.5-18.1]) than for those on active therapy (between 3.1 months [95% CI 2.1-3.8] and 3.0 months [95% CI 1.4-4.5]). Most patients (87.0%) experienced low-grade adverse events; the most common of which were fatigue (49.0%) and nausea (35.0%).
Conclusion: Our findings demonstrate clinical benefit of olaparib to mainland Chinese patients with high-grade SOC, particularly for patients with BRCA mutations and who require maintenance therapy.
Keywords: BRCA mutation; China, Macau; olaparib; ovarian cancer.
© 2019 Wiley Periodicals, Inc.