Jack R Gallagher1, Kylee Jean Heap1, Susan Carroll1, Karin Travers2, Brooke Harrow3, Shannon N Westin4. 1. Clarity Pharma Research, LLC, 2375 E Main St., Spartanburg, SC 29307, USA. 2. TESARO: A GSK Company, 1000 Winter St North, Waltham, MA 02451, USA. 3. IPSEN, 650 E Kendall St, Cambridge, MA 02142, USA. 4. The University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology & Reproductive Medicine, Unit 1362,1515 Holcombe Blvd., Houston, TX 77030, USA.
Abstract
Aim: To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. Materials & methods: This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Results: 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. Conclusion: 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.
Aim: To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. Materials & methods: This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Results: 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. Conclusion: 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.
Authors: Anna V Tinker; Alon D Altman; Marcus Q Bernardini; Prafull Ghatage; Lilian T Gien; Diane Provencher; Shannon Salvador; Sarah Doucette; Amit M Oza Journal: Curr Oncol Date: 2022-06-17 Impact factor: 3.109