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

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 penulti-mate line of platinum and had responded to the most recent platinum-containing therapy. Nir-aparib 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 us-ing 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 reduc-tions, haematological toxicities and asthenia/fatigue were less common with ISD than fixed starting dose niraparib, but progression-free survival was similar irrespective of dosing strat-egy. 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 consis-tent with phase III trials, providing reassuring evidence of the tolerability and activity of nir-aparib maintenance therapy for platinum-sensitive recurrent ovarian cancer.ClinicalTrials.gov registration: NCT04546373.(c) 2023 Elsevier Ltd. All rights reserved.

Automated summary

This retrospective observational study aimed to investigate the patient characteristics, effectiveness, and safety of niraparib in a real-world population. The results showed that niraparib maintenance therapy is well-tolerated and effective in patients with platinum-sensitive recurrent ovarian cancer.