Article Text
Abstract
Introduction The OReO/ENGOT Ov-38 trial showed maintenance olaparib rechallenge improved progression-free survival (PFS) compared with placebo. However, subpopulation benefit more from Poly (ADP-ribose) polymerase inhibitors (PARPi) rechallenge was unclear. The objective of this real-world study is to evaluate the effectiveness, safety and explore benefit population of PARPi rechallenge in China.
Methods This multi-center, non-interventional study included patients with PARPi-treated recurrent ovarian cancer who rechallenged PARPi as maintenance therapy or salvage treatment at 12 institutions between June 2019 and March 2023. Patients‘ demographics and outcomes were analyzed.
Results Seventy patients were included, and the median follow-up time was 13.0 months. Fifty-six (80%, 56/70) patients received PARPi as maintenance after maintenance therapy (table 1). The median PFS (mPFS) was 10.6 months (95% confidence interval [CI], 7.1–12.0) with first PARPi (PARPi1) and 8.6 months (95% CI, 5.3–13.0) with PARPi retreatment (PARPi2) (figure 1). 32.1%(18/56) patients were BRCA1/2 mutated, the PFS were not significantly different from BRCA wild-type or unknown patients (BRCAm vs. BRCAwt or unknown, HR=0.997 [95%CI: 0.480–2.072], P=0.9935). 87.5% (39/56) of patients switched to other PARPi when rechallenging. Patients switched to other PARPi rechallenging had numerically longer mPFS compared with those didn’t switch (mPFS: 8.6 vs. 7.7 months; HR=0.820 [95%CI: 0.394–1.707], P=0.5958). Overall, 4.3% (3/70) discontinued PARPi2 due to adverse events, most commonly due to hematologic adverse events.
Conclusion/Implications Our study is the first multicenter real-world study to evaluate the rechallenge of PARPi in ovarian cancer patients in China. There is a pressing need to identify the biomarkers except BRCA to select appropriate patients for PARPi rechallenge.