Factors Influencing Severe Hematologic Toxicity Following Niraparib Therapy in Patients With Ovarian Cancer

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Background/Aim: Niraparib is a poly ADP ribose polymerase (PARP) inhibitor indicated for the maintenance therapy of ovarian cancer and the treatment of recurrent ovarian cancer. This study aimed to identify an indicator to predict severe hematologic toxicity after niraparib therapy. Patients and Methods: We retrospectively included 32 patients with advanced ovarian cancer who were administered niraparib at Ogaki Municipal Hospital (Ogaki, Japan) between January 2020 and December 2024. Univariate analyses were performed to evaluate the relationship between the patients' baseline characteristics and the development of severe hematologic toxicity. Significant variables in the univariate analysis, as well as age, were entered into the multivariate logistic regression model. The optimal cutoff values for significant variables were determined using receiver-operating characteristic (ROC) curve analyses. Results: Severe hematologic toxicity was independently associated with pre-treatment creatinine clearance (odds ratio=0.920; 95% confidence interval=0.823-0.998; p=0.045). The areas under the ROC curves of creatinine clearance at the time of the worst-grade hematologic toxicity before and during niraparib administration were assessed for their ability to predict severe hematologic toxicity. The area under the curves of creatinine clearance at the time of ≥grade 3 hematologic toxicity during niraparib therapy showed high accuracy, with a value of 0.809 (95% confidence interval=0.659-0.958). The calculated cutoff value using the creatinine clearance curve was 47.0 ml/min. Conclusion: Creatinine clearance is a risk factor for severe hematologic toxicity. A creatinine clearance value <47.0 ml/min may slightly increase the risk of this toxicity in patients with ovarian cancer receiving niraparib.

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