Background: This work set out to examine the hematological adverse events (AEs) of an individualized starting dose (ISD) of niraparib in Chinese patients with ovarian cancer (OC).
Methods: The medical records of 43 patients with OC who were treated with an ISD of niraparib at the Cancer Hospital of The University of Chinese Academy of Sciences between February 2019 and January 2020 were retrospectively reviewed. Treatment-emergent hematological AEs were analyzed.
Results: Of the 43 patients with OC, 28 (65.1%) had hematological AEs of ≥ grade 1, including thrombocytopenia (39.5%), leukopenia (37.2%), and anemia (34.9%). Ten (23.3%) patients developed grade 3/4 hematological AEs, including thrombocytopenia (11.6%), leukopenia (9.3%), and anemia (7.0%). Among the individuals who developed AEs during treatment, 9 (32.1%) patients had their treatment interrupted, with treatment being restarted in 8 (28.6%) cases, and 4 (14.3%) patients had the drug dose decreased. No deaths were reported. The median times to the occurrence of any-grade leukopenia, anemia, and thrombocytopenia were 30 (range, 7 to 162), 34 (range, 7 to 108), and 20 (range, 13 to 180) days, respectively. Most AEs occurred within the first 3 months of treatment (93.8% leukopenia, 80.0% anemia, and 76.5% thrombocytopenia). Treatments for AEs included supplementation of recombinant human granulocyte colony-stimulating factor (n=5, 17.9%), erythrocytes (n=2, 7.1%), and recombinant human thrombopoietin (n=5, 17.9%).
Conclusions: The incidence of adverse hematological reactions to an ISD of niraparib in Chinese patients with advanced OC is relatively lower in the real world than in the phase III clinical trials PRIMA (also an ISD) and NOVA. These hematological AEs can be managed through dose adjustment and symptomatic therapy.
Keywords: Ovarian cancer (OC); adverse events (AEs); niraparib; platinum-based chemotherapy; real-world study.
2021 Annals of Translational Medicine. All rights reserved.