KEY TAKEAWAYS
- The phase III trial aimed to compare the survival in BRCAwt pts with recurrent OC who received niraparib or were under active surveillance.
- The primary endpoint was to determine the PFS. The secondary endpoint includes OS.
- The study provides real-world data on survival in OC pts who received niraparib or were under active surveillance after chemotherapy.
Researchers aimed to compare the survival in breast cancer gene wild-type (BRCAwt) (pts) with recurrent ovarian cancer (OC) who received niraparib or were under active surveillance.
The study utilized de-identified electronic health records from Flatiron Health across the United States and included pts diagnosed with epithelial OC who underwent second-line therapy. These pts met specific criteria, such as being BRCA wild type, having an ECOG performance status score of 0-1, having epithelial histology, and having platinum-sensitive disease with a gap of at least 6 months between the end of their first-line treatment and the start of their second-line treatment. Pts were divided into two cohorts based on their post-second-line non-maintenance therapy management within 120 days. Follow-up duration was calculated from the end of second-line non-maintenance therapy until May 31, 2022, the last activity recorded, or death, whichever came first. The study employed a target trial emulation approach using inverse probability of censoring weighting (IPCW) to minimize bias. Median overall survival (OS) and hazard ratios (HR) for pts on second-line maintenance therapy (2Lm) versus those on active surveillance (AS) were estimated using Kaplan-Meier curves and Cox regression models.
Of 266 pts without BRCA mutations were included. They either received niraparib as a second-line maintenance therapy (123 patients) or were managed with active surveillance (143 patients). Before statistical adjustments, 23.6% of the niraparib group pts and 34.3% in the active surveillance group were aged 75 or older. Additionally, 26.0% in the niraparib group and 16.8% in the active surveillance group had a recorded race other than White. Most pts were from community practices (80.5% in the niraparib group and 90.2% in the active surveillance group), had serous OC (79.7% in the niraparib group and 81.1% in the active surveillance group), and were at Stage III of the disease (53.7% in the niraparib group and 60.8% in the active surveillance group). Most pts had unknown homologous recombination deficiency status (92.7% in the niraparib group and 86.0% in the active surveillance group). The median follow-up was 16.8 months for the niraparib group and 10.2 months for the active surveillance group. After statistical adjustments, the median OSl was 28.1 months (95% CI: 22.5, 43.2) for the niraparib group and 21.5 months (95% CI: 14.7, 27.0) for the active surveillance group, with an HR of 0.63 (95% CI: 0.45, 0.88). The survival rates at 24 months were 58.2% (95% CI: 47.5, 67.6) for the niraparib group and 46.1% (95% CI: 33.6, 57.7) for the active surveillance group.
The study provides real-world data on survival in OC pts who received niraparib or were under active surveillance after chemotherapy.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.5592
Clinical Trial: https://clinicaltrials.gov/study/NCT01847274
Robert L. Coleman, Jessica Perhanidis, Linda Kalilani, Nicole M. Zimmerman, Amanda Golembesky, and Kathleen N. Moore. DOI: 10.1200/JCO.2023.41.16_suppl.5592 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 5592-5592.
