PARP (poly ADP–ribose polymerase) inhibitors are approved as maintenance therapy in platinum sensitive ovarian cancer (OC), in first line and in the recurrent setting, regardless BRCA mutational status. Real-world data after the introduction of these agents are needed to evaluate whether the benefit observed in phase III trials can be translated into clinical practice. The aim of our study was to provide real-life data on efficacy and safety of niraparib administered as maintenance in platinum sensitive relapsed OC patients (PSROC).
This retrospective/prospective multicenter study included relapsed OC patients treated in 17 MITO centers and receiving niraparib as maintenance, according to the label, at the time of first or subsequent platinum sensitive recurrence. Clinical data at the time of diagnosis and at the time of recurrence before Niraparib treatment were collected from the patients´ medical records at each institution, centralized into an electronic CRF at the coordinating center (Fondazione Policlinico Gemelli) and analyzed.
The efficacy and safety analysis, as primary objectives, was performed.
Median progression free survival (PFS) and overall survival (OS) were calculated as the time from start of niraparib treatment to subsequent radiologically confirmed relapse and death or last contact, respectively.
The study included 304 patients with median age of 58 years (range 51-66).
260 (85%) enrolled patients were BRCA wild-type and 36 (11.9%) were BRCA mutated. At the time of diagnosis, most of patients (65.8%) underwent complete debulking surgery and were diagnosed with III-IV FIGO stage (78.8%). At the time of recurrence before niraparib maintenance 179 patients (58.9%) had received 2 previous lines of platinum-based chemotherapy and carboplatin in combination with PDL was the most frequent administered regimen (31.3%). Complete and partial radiological response to platinum-based CT was recorded in 44.4% and 27.0% of patients, respectively.
Median PFS was 9.1 months (95% CI: 7.6-10.7) and median OS was 41.7 months (95% CI: 32.4-51.1).
In a real-life setting, niraparib maintenance in patients with PSROC showed efficacy comparable with the published phase III data.
NCT04617470