Niraparib treatment patterns and outcomes in first-line maintenance therapy for ovarian cancer: The RENI-1 study.

Prospective real-world data on poly(adenosine diphosphate-ribose [ADP]-ribose) polymerase inhibitors (PARPi) as first-line maintenance therapy (1LMT) for ovarian cancer are limited. This study was conducted to evaluate the treatment patterns, efficacy, and safety of niraparib as 1LMT in Chinese patients with ovarian cancer. Real-world study of niraparib as first-line maintenance treatment in patients with newly diagnosed ovarian cancer (RENI-1) was a prospective, multicenter, noninterventional, real-world study evaluating niraparib as 1LMT in newly diagnosed ovarian cancer. The primary endpoint was treatment patterns. Secondary endpoints included progression-free survival (PFS), chemotherapy-free interval (CFI), time to first subsequent treatment (TFST), overall survival (OS), safety, and quality of life (QoL). A total of 227 patients were enrolled. The median time to maintenance initiation was 7.4 weeks. Most patients (218/227, 96.0%) received niraparib monotherapy; 95.6% (n = 217) started at 200 mg daily, and 73.6% (n = 167) maintained a stable 200 mg dose. After a median follow-up of 41.5 months, the median PFS was 36.5 months in the intention-to-treat (ITT) population and 25.4 months in patients with The International Federation of Gynecology and Obstetrics (FIGO) stage III-IV disease. Median PFS was not reached (NR) in the BRCA1/2-mutated and homologous recombination deficiency (HRD) positive subgroups, and it was 25.4 and 22.2 months in the BRCA1/2 wild-type and HRD-proficient subgroups, respectively. PFS rates at 36 months were 67.5% in the BRCA1/2-mutated, 58.7% in the HRD-positive, and 50.1% in the ITT population. Median CFI, TFST, and OS were NR; OS rate at 36 months was 80.2%. Factors associated with longer PFS included R0 resection, primary debulking surgery, complete response after chemotherapy, BRCA1/2 mutation, and HRD positivity. No new safety concerns were identified, and QoL remained stable. As the first prospective real-world study of niraparib 1LMT in China, RENI-1 provides powerful complementary evidence to pivotal randomized controlled trials conducted in highly selective populations, further supporting niraparib as the first-line maintenance standard treatment.