Detalle Publicación

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

Autores: Cueva, J. F.; Palacio, I.; Churruca, C.; Herrero, A.; Pardo, B.; Constenla, M.; Santaballa, A.; Manso, L.; Estévez, P.; Maximiano, C.; Legerén, M.; Marquina, G.; de Juan, A.; Quindós, M.; Sánchez Lorenzo, María Luisa; Barquin, A.; Fernández, I.; Martín, C.; Juárez, A.; Martín, T.; García, Y.; Yubero, A.; Gallego, A.; Martínez Bueno, A.; Guerra, E.; González Martín, Antonio
Título de la revista: EUROPEAN JOURNAL OF CANCER
ISSN: 0959-8049
Volumen: 182
Páginas: 3-14
Fecha de publicación: 2023
Aim: 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. 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 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.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.