Assessment of safety of niraparib maintenance therapy in epithelial ovarian cancer: an updated systematic review and meta-analysis of randomized control trials.

INTRODUCTION

Patients with epithelial ovarian cancer (EOC) who are treated with niraparib maintenance therapy, experience hematological and gastrointestinal side effects. There is a scarcity of evidence on the safety of niraparib. This study aims to assess the safety profile of niraparib as a maintenance treatment for women with platinum-sensitive EOC.

METHODS

PubMed (Medline), EMBASE, and Google Scholar were searched for randomized controlled trials (RCTs) with people suffering from EOC. This study used Review Manager and forest plots for visual display. Random effects models were used for this meta-analysis (RRs and 95% CIs).

RESULTS

The study analyzed 2311 cases from 7/8 RCTS of niraparib-treated patients with high risks of any grade of anemia (RR, 3.51; 95% CI, 2.99 to 4.10,  < 0.00001) and thrombocytopenia (RR, 13.28; 95% CI, 10.00 to 17.63,  < 0.00001). For grade 3 or 4 adverse effects, significantly higher risk was only noted for thrombocytopenia (RR, 32.80; 95% CI, 10.63 to 101.22,  < 0.00001), anemia (RR, 14.45; 95% CI, 6.48 to 32.27,  < 0.00001) for niraparib-treated patients. Less treatment-related deaths occurred.

CONCLUSION

There is a need to emphasize on cautious use, hematological toxicities, and personalized dosage regimens of niraparib for improved patient compliance.