Real-world adverse events with niraparib 200 mg/day maintenance therapy in ovarian cancer: a retrospective study

• Published in: Future oncology (London, England) England), 2019-12, Vol.15 (36), p.4197-4206
• Main Authors: Gallagher, Jack R, Heap, Kylee Jean, Carroll, Susan, Travers, Karin, Harrow, Brooke, Westin, Shannon N
• Format: Article
• Language: English
• Subjects: Adult; adverse events; Aged; Anemia; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Cancer therapies; Chemotherapy; Clinical trials; Fallopian tubes; Female; Hematology; Humans; Hypothesis testing; Indazoles - administration & dosage; Indazoles - adverse effects; Indazoles - therapeutic use; Laboratories; Maintenance Chemotherapy; Medical records; Middle Aged; Mutation; Nausea; Neoplasm Staging; Neutropenia; niraparib; Oncology; Ovarian cancer; Ovarian Neoplasms - diagnosis; Ovarian Neoplasms - drug therapy; PARP inhibitor; Patients; Physicians; Piperidines - administration & dosage; Piperidines - adverse effects; Piperidines - therapeutic use; Poly(ADP-ribose) Polymerase Inhibitors - administration & dosage; Poly(ADP-ribose) Polymerase Inhibitors - adverse effects; Poly(ADP-ribose) Polymerase Inhibitors - therapeutic use; real-world occurrence; Retrospective Studies; Thrombocytopenia; Treatment Outcome
• ISSN: 1479-6694; 1744-8301
• DOI: 10.2217/fon-2019-0471

To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%). In the ENGOT-OV16/NOVA trial, these respective AEs occurred in 74, 61 and 59% of patients. Incidence of common clinical trial-reported AEs was lower among patients initiating niraparib 200 mg/day in real-world practice versus patients initiating niraparib 300 mg/day in ENGOT-OV16/NOVA.