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  3. 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

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

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Autores de IDIVAL

  • Ana De Juan Ferré

    Autor

Autores ajenos al IDIVAL

  • Cueva JF
  • Palacio I
  • Churruca C
  • Herrero A
  • Pardo B
  • Constenla M
  • Santaballa A
  • Manso L
  • Estévez P
  • Maximiano C
  • Legerén M
  • Marquina G
  • Quindós M
  • Sánchez L
  • Barquin A
  • Fernández I
  • Martín C
  • Juárez A
  • Martín T
  • García Y
  • Yubero A
  • Gallego A
  • Martínez Bueno A
  • Guerra E
  • González-Martín A

Unidades

Abstract

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.

Copyright © 2023 Elsevier Ltd. All rights reserved.

Datos de la publicación

ISSN/ISSNe:
0959-8049, 1879-0852

EUROPEAN JOURNAL OF CANCER  ELSEVIER SCI LTD

Tipo:
Article
Páginas:
3-14
PubMed:
36706655
Enlace a otro recurso:
www.sciencedirect.com

Citas Recibidas en Web of Science: 11

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Keywords

  • Elderly; Individualised; Niraparib; PARP inhibitor; Platinum-sensitive; Real-world data; Recurrent ovarian cancer

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