Real-world safety and effectiveness of olaparib maintenance after first-relapse platinum-sensitive ovarian cancer in Japan: a multicenter historical cohort (JGOG3026)

OBJECTIVE: The primary objective of the study was to evaluate the safety and effectiveness of olaparib maintenance therapy in Japanese patients with platinum-sensitive first-relapsed ovarian cancer. The secondary objective was to survey the treatment given after the olaparib maintenance therapy. METHODS: The JGOG3026 study was a nationwide, multicenter historical cohort study across 43 sites. Patients receiving olaparib maintenance therapy after platinum-based chemotherapy between January 2018 and July 2020 were included as modified intention-to-treat (mITT) 1. Those who received any post-olaparib therapy were extracted as mITT2. The primary endpoint was Grade ≥3 adverse event; secondary endpoints included progression-free survival (PFS), the time to first subsequent therapy (TFST), progression-free survival to the second progression (PFS2), and overall survival (OS). RESULTS: In the mITT1 (n=413), any Grade ≥3 adverse events occurred in 41.6%; anemia was the most common (28.8%). Myelodysplastic syndrome occurred in 1.0% and no acute myeloid leukemia was observed during a mean follow-up of 34.1 months. The 24-month PFS and OS rates were 31.7% and 70.1%, respectively. Median PFS and OS were 12 months (95% confidence interval [CI]=9.9-13) and 39 months (95% CI=33-45). The 24-month TFST and PFS2 rates were 33.3% and 34.3%. In the mITT2 (n=284), chemotherapy after olaparib therapy was used in 97.2%, with an overall response rate of 22.5%. CONCLUSION: Olaparib maintenance therapy showed acceptable safety and effectiveness in Japanese clinical practice. Monitoring for secondary hematologic malignancies is needed after the start of olaparib maintenance therapy.