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
Cueva, J, Palacio I, Churruca C, Herrero A, Beatriz P, Constenla M, Santaballa A, Manso L, Estévez P, Maximiano C, Legerén M, Marquina G, de Juan A, Quindós-Varela M, Sánchez L, Barquin A, Fernández I, Martín C, Juárez A, Martín T, García Y, Yubero A, Gallego A, Martínez-Bueno A, González-Martín Antonio
To describe patient characteristics, effectiveness and safety in a real-world population treated with niraparib in the Spanish expanded-access programme.
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 expanded-access programme. 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 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.
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 was 8.6 (95% confidence interval [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 fixed starting dose niraparib, but progression-free survival was similar irrespective of dosing strategy. Subsequent therapy included platinum in 71% of patients who received further treatment.
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.
CITATION European Journal of Cancer 2023 Mar;182:3-14. doi: 10.1016/j.ejca.2022.12.023. Epub 2022 Dec 29.