Background: The NOVA study (NCT01847274) compared niraparib with placebo as a maintenance treatment for patients with recurrent ovarian cancer (OC) but was not powered to detect an overall survival (OS) improvement.
Objective: To compare OS in a real-world population of patients with BRCA wild-type (BRCAwt) recurrent OC who received second-line maintenance (2LM) niraparib monotherapy versus active surveillance (AS).
Design: A retrospective study using a US-based nationwide deidentified electronic health record-derived database.
Methods: Patients diagnosed with epithelial OC (January 1, 2011-May 31, 2021) who completed second-line (2L) therapy (January 1, 2017-March 2, 2022) and were BRCAwt were included. A NOVA study-like subpopulation included patients with an Eastern Cooperative Oncology Group performance status score of 0-1 and platinum-sensitive disease. Patients were assigned to 2LM niraparib or AS cohorts. Follow-up was measured from the index date (2L non-maintenance therapy end) until the first of study end (May 31, 2022), last clinical activity, or death. Median OS (mOS) and hazard ratios were estimated with an emulated trial methodology.
Results: The overall population comprised 199 patients in the 2LM niraparib monotherapy cohort and 707 patients in the AS cohort; the NOVA study-like subpopulation included 123 patients in the 2LM niraparib monotherapy cohort and 143 in the AS cohort. Demographic and clinical characteristics were similar in both populations. Overall, adjusted mOS was 24.1 months for the 2LM niraparib monotherapy cohort versus 18.4 months for the AS cohort (hazard ratio, 0.8; 95% confidence interval [CI]: 0.7-0.9). In the NOVA study-like subpopulation, adjusted mOS was 28.1 months for the 2LM niraparib monotherapy cohort versus 21.5 months for the AS cohort (hazard ratio, 0.6; 95% CI: 0.5-0.9).
Conclusion: These results provide important real-world OS data for patients with recurrent BRCAwt OC who received niraparib monotherapy compared with patients receiving AS.
Keywords: BRCA wild-type; active surveillance; niraparib; observational study; recurrent ovarian cancer; second-line maintenance.
Niraparib maintenance treatment versus monitoring for recurrent ovarian cancer without BRCA mutation This study examined the real-life survival of patients with ovarian cancer (OC) who received two lines of chemotherapy for OC, known as recurrent OC. We compared two groups: one patient group received a subsequent oral medication called niraparib (a type of maintenance therapy) to delay recurrence, whereas the other group was monitored by their physicians without receiving any medication (also known as active surveillance). This study analyzed health records from across the United States, focusing on patients who were diagnosed with OC between January 2011 and May 2021. Importantly, these patients completed their second line of therapy between January 2017 and March 2022 and had BRCA wild-type disease (meaning that they did not have a specific gene mutation known as BRCA). Patients then received maintenance therapy with niraparib or active surveillance. To assess how long patients lived, patient records were reviewed until the study ended in May 2022, or for patients who did not have data available through that date, until the date of their last visit or death. The study found a significant difference in how long the two groups of patients survived on average. Those patients who received the medication niraparib survived for 24.1 months, compared with 18.4 months for patients in the group that was monitored by their physicians. These results provide valuable insights into the real-life benefits of using niraparib to treat OC outside of a clinical trial. Importantly, these results support the positive outcomes seen in clinical trials, indicating that this medication is a promising option for patients with recurring OC.
© The Author(s), 2024.