Real-world safety and effectiveness of maintenance niraparib for platinum-sensitive recurrent ovarian cancer: A GEICO retrospective observational study within the Spanish Expanded-Access Programme
Menée en Espagne dans un contexte de vie réelle à partir de données portant sur 316 patientes atteintes d'un cancer séreux de l'ovaire de haut grade, sensible aux sels de platine et récidivant, cette étude rétrospective analyse l'efficacité et la toxicité du niraparib en traitement d'entretien
Aim: To describe patient characteristics, effectiveness and safety in a real-world population treated with niraparib in the Spanish expanded-access programme (EAP). Patients and methods: This retrospective observational study included women with platinum-sensitive recurrent high-grade serous ovarian cancer who received maintenance niraparib within the Spanish niraparib EAP. Eligible patients had received ≥2 previous lines of platinum-containing therapy, remained platinum-sensitive after the penultimate line of platinum, and had responded to the most recent platinum-containing therapy. Niraparib dosing was at the treating physician’s discretion (300 mg/day fixed starting dose [FSD] or individualised starting dose [ISD] according to baseline body weight and platelet count). Safety, impact of dose adjustments, patient characteristics and effectiveness were analysed using data extracted from medical records. Results: Among 316 eligible patients, 80% had BRCA wild-type tumours and 66% received an ISD. Median niraparib duration was 7.8 months. The most common adverse events typically occurred within 3 months of starting niraparib. Median progression-free survival (PFS) was 8.6 (95% CI 7.6–10.0) months. One- and 2-year overall survival rates were 86% (95% CI 81–89%) and 65% (95% CI 59–70%), respectively. Dose interruptions, dose reductions, haematological toxicities and asthenia/fatigue were less common with ISD than FSD niraparib, but PFS was similar irrespective of dosing strategy. Subsequent therapy included platinum in 71% of patients who received further treatment. Conclusion : Outcomes in this large real-world dataset of niraparib-treated patients are consistent with phase III trials, providing reassuring evidence of the tolerability and activity of niraparib maintenance therapy for platinum-sensitive recurrent ovarian cancer.