Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational [Patient Registry]

Summary: 
      In order to explore the real situation of niraparib in clinical application more
      comprehensively and deeply, we conducted the first multicenter, real-world study in China.
      This large observational study used real-world data to assess the effectiveness and safety of
      niraparib as maintenance therapy in patients with advanced ovarian cancer (AOC) in China and
      investigated clinical factors associated with prolonged benefits of niraparib so as to
      achieve the maximum clinical benefit of patients.
    

Detailed description: 
      This is a retrospective multicentric study including advanced ovarian cancer patients that
      have used niraparib as first-line maintenance therapy after chemotherapy from fourteen
      hospitals in China between January 2019 and December 2021. The database lock-time was on
      December 31, 2022. All data were retrieved from the patients' medical records. Clinical data,
      including patient demographics, clinicopathological characteristics, residual disease after
      primary surgery, genetic-testing results and so on, were collected. Missing information was
      supplemented by telephone follow-up or face-to-face inquiries (only for patients who were
      alive and accessible). The incidence of AEs, as well as dose reductions, dose interruption,
      and discontinuation of treatment due to AEs were recorded.All analyses were performed on the
      safety population. The categorical variables were described as a frequency and percentage,
      and the continuous variables were described as a median and range. No formal sample size
      calculation was performed since the study was exploratory. Survival analyses were conducted
      using the Kaplan-Meier method and log-rank test. 95% confidence intervals (CIs) were
      calculated using the Clopper-Pearson method. Univariate and multivariate Cox regression
      models were established to determine factors that could affect the PFS for patients receiving
      niraparib maintenance treatment. Missing data were assigned as unknown for the univariate and
      multivariate analysis. The method of cox analysis was stepwise regression, and the screening
      criterion was Akaike Information Criterion (AIC). A P-value of <0.05 was considered
      statistically significant. Descriptive statistics (number and percentage) were used to
      summarize the safety data by treatment. Statistical analyses were performed using the R
      software version 4.2.2 (R Project for Statistical Computing).
    

Intervention name(s): Niraparib
Intervention type(s): Drug
Intervention description(s): We did not set a fixed starting dose and strict medication standard,compared with a randomized controlled trial.In our study,enrolled patients received different oral doses of niraparib until disease progression, severe toxicity occurred, or death in reality. We were interested in the dose adjustment and duration of niraparib in real world.
Intervention MeSH terms: Niraparib
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        advanced ovarian cancer patients that have used niraparib as first-line maintenance therapy
        after chemotherapy from fourteen hospitals in China between January 2019 and December 2021
      
Keywords: niraparib; ovarian cancer; real-world