Efficacy and Adverse Effects of Niraparib in Ovarian Cancer.

Ovarian cancer is the second fatal gynecological cancer. More than 70% of ovarian cancer patients are diagnosed as advanced. Niraparib was approved by the National Medical Products Administration on December 27, 2019. It can be used as a maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission. On September 10, 2020, niraparib became a poly ADP-ribose polymerase inhibitor approved in China and globally, which can be used as a single agent for the maintenance treatment of first-line and recurrent ovarian cancer regardless of the patient's biomarker status. On December 28, 2020, niraparib has been included in the new version of the medical insurance catalog. At present, most studies based on niraparib are randomized controlled trials (RCTs). RCTs often have strict inclusion and exclusion criteria and they are implemented in a highly standardized environment. Its internal validity is high, but the research results may not be able to be extrapolated to practice. This study is a prospective real-world study. In this study, based on the modified Response Evaluation Criteria in Solid Tumors v.1.1 criteria, we evaluated the use of niraparib in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in the progression-free survival, overall survival, and objective control rate, etc. The safety and tolerability of niraparib and the impact on the quality of life of patients are evaluated. 10ml blood samples of enrolled patients are collected at baseline and study endpoints respectively (only for enrolled patients who agree to blood sampling) for exploratory biological marker research and exploratory pharmacogenetic analysis. Finally, the results will as a supplement to the conclusions of randomized controlled trials to provide better guidance for patients.