Abstract

Background: Olaparib maintenance therapy has shown efficacy and tolerability in patients with platinum-sensitive, high-grade serous recurrent ovarian cancer (HSROC) with BRCA1/2 mutation (BRCAm). Our aim was to present real-world experience with olaparib in Korea. Method: We included HSROC patients with BRCAm treated with olaparib maintenance at four institutions in Korea between 2016 and 2018. Medical records were reviewed for clinico-pathologic characteristics, objective response, survival outcomes, and safety. Results: One hundred HSROC patients with BRCAm were included. BRCA1 mutation was present in 71 patients (71.0%), and BRCA2 mutation was present in 23 patients (23.0%). In terms of the best objective response with olaparib maintenance in 53 patients with partial remission from most recent chemotherapy, complete remission occurred in 12 (22.6%) and partial remission in four (7.5%), while 33 patients (62.3%) had stable disease. The 24 month progression-free survival was 42.4%, and 24 month overall survival was 82.1%. Grade 3 or more adverse events were as follows: anemia in 14 patients (14.0%), neutropenia in seven patients (7.0%), thrombocytopenia in two patients (2.0%), oral mucositis in one patient (1.0%), and soft tissue infection in one patient (1.0%). Conclusions: The safety and effectiveness of olaparib maintenance treatment in a real-world study were consistent with those reported in previous clinical trials.

Highlights

  • Ovarian cancer is the second most common cause of death related to gynecologic malignancy and the eighth leading cause of death from cancer in women worldwide [1]

  • The Phase III SOLO2 (Study of OLaparib in Ovarian cancer) trial (NCT01874353) of olaparib tablets as maintenance monotherapy in patients with platinum-sensitive high-grade serous recurrent ovarian cancer (HSROC) and a BRCA1/2 mutation (BRCAm) revealed significantly improved progression-free survival (PFS) in the olaparib-treated group compared to the placebo group (HR 0.30, 95% CI 0.22–0.41; p < 0.0001) [4]

  • Between January 2016 and December 2018, 100 HSROC patients with BRCA1/2 mutation were treated with olaparib maintenance therapy at four institutions (44 patients from Samsung Medical Center, 25 from Yonsei University Severence Hospital, 19 from the National Cancer Center, and 12 from Seoul National University Hospital)

Read more

Summary

Introduction

Ovarian cancer is the second most common cause of death related to gynecologic malignancy and the eighth leading cause of death from cancer in women worldwide [1]. Previous studies have shown the effectiveness of olaparib in platinum-sensitive high-grade serous recurrent ovarian cancer (HSROC). Data from a Phase II trial to assess the efficacy and safety of olaparib maintenance monotherapy in platinum-sensitive HSROC patients, Study 19 (NCT00753545), showed a significant improvement in PFS in the olaparib-treated group relative to the placebo group (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.25–0.49; p < 0.0001) [3]. The Phase III SOLO2 (Study of OLaparib in Ovarian cancer) trial (NCT01874353) of olaparib tablets as maintenance monotherapy in patients with platinum-sensitive HSROC and a BRCA1/2 mutation (BRCAm) revealed significantly improved PFS in the olaparib-treated group compared to the placebo group (HR 0.30, 95% CI 0.22–0.41; p < 0.0001) [4]. Olaparib maintenance therapy has shown efficacy and tolerability in patients with platinum-sensitive, high-grade serous recurrent ovarian cancer (HSROC) with BRCA1/2 mutation (BRCAm). Conclusions: The safety and effectiveness of olaparib maintenance treatment in a real-world study were consistent with those reported in previous clinical trials

Objectives
Methods
Results
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call