Real-world Outcomes Associated With Poly(ADP-ribose) Polymerase Inhibitor Monotherapy Maintenance in Patients With Primary Advanced Ovarian Cancer

Abstract

Objective: This study used real-world population data to assess the trends of first-line (1L) poly(ADP-ribose) polymerase inhibitor (PARPi) maintenance treatment uptake and outcomes in patients with primary advanced ovarian cancer (AOC). Methods: Patients diagnosed with AOC between January 1, 2017, and June 30, 2021, who completed 1L chemotherapy were selected from a real-world database. Descriptive analyses were performed to evaluate patient demographics, clinicopathological characteristics, and 1L treatment patterns. Time to next treatment or death was used as a proxy for real-world progression-free survival (rwPFS). Kaplan-Meier methods and Cox models were used for statistical analyses. Results: Of 705 patients who completed 1L chemotherapy, 166 received PARPi monotherapy and 539 underwent active surveillance (AS). Median follow-up was 10.9 months for PARPi monotherapy and 20.6 months for AS. PARPi monotherapy use increased from 6% in 2017 to 53% in 2021. Overall, patients receiving PARPi monotherapy had longer rwPFS than those who underwent AS (not reached vs 9.53 mo) respectively. rwPFS was also longer in patients who received PARPi monotherapy compared with AS in patients with BRCA-mutated disease (not reached vs 11.4 mo), BRCA–wild-type disease (13.5 vs 9.1 mo), homologous recombination-deficient tumors (not reached vs 10.2 mo), and homologous recombination-proficient or unknown status tumors (13.5 vs 9.3 mo). Conclusions: Our real-world analysis suggested that 47% of patients with primary AOC did not receive PARPi maintenance in the year 2021. PARPi use was associated with significantly improved outcomes compared with AS.

Prescribers and patients drive maintenance therapy patterns in a community oncology practice: National guidelines versus the real-world experience

“…Previous studies have shown that MT with PARPi and/or bevacizumab are effective treatment strategies for patients with advanced OC; however, previous research has demonstrated that they may be underutilized by physicians ( Chan et al, 2023 , Turell et al, 2020 ). This study builds upon existing real-world evidence of the benefits of 1 l MT in stage III/IV OC.…”

“…Approximately half (52.5 %) of patients with OC in this study underwent AS instead of receiving guideline-recommended MT in the 1L setting. In a recent US real-world evidence study, it was shown that 76.5 % (n = 539/705) of patients with stage III or IV OC who completed 1L PBC had received AS, whereas 23.5 % (n = 166/705) received PARPi MT ( Chan et al, 2023 ). Other US-based real-world studies have reported rates of between 37 % and 78 % of women with OC not receiving 1L MT, despite potentially benefiting and despite National Comprehensive Cancer Network guideline recommendations ( Chase et al, 2023a , Chase et al, 2023b , Garofalo et al, 2019 ).…”

“…Our analysis also indicated that patients with stage IV disease (versus IIIA–IIIB) and patients receiving neoadjuvant treatment had a higher probability of initiating 1L MT. Real-world studies and a recent meta-analysis have suggested that stage IV disease, receipt of neoadjuvant therapy, visible residual disease following surgery, and BRCA wild-type status are associated with poorer prognosis in OC ( Chan et al, 2023 , Chase et al, 2023a , Chase et al, 2023b , Kim et al, 2023 ). In our study, the results for patients with stage IV OC who received 1L MT are consistent with National Comprehensive Cancer Network recommendations ( National Comprehensive Cancer Network, 2024 ) and also with improved outcomes seen in clinical trials evaluating MT versus placebo (e.g.…”

“…Despite being effective therapeutic strategies for OC, studies have shown that PARPi and bevacizumab may be underutilized for MT by physicians treating OC in clinical practice, and many patients instead continue to undergo AS ( Chan et al, 2023 , Turell et al, 2020 ). Real-world studies are important for demonstrating the value of such treatments in clinical practice and supporting clinical decision-making.…”

“…The results of real-world oncology studies have also been shown to be concordant with clinical trials, and data from electronic health records (EHR) have been shown to help derive information on clinical outcomes ( Huang Bartlett et al, 2020 ). Several observational studies have shown real-world PARPi and bevacizumab use to be associated with improvements in progression-free survival (PFS), symptoms, and quality-of-life outcomes ( Chan et al, 2023 , Demirkiran et al, 2023 , Mahtani et al, 2022 ).…”