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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.

Fecha de publicación: Fecha Ahead of Print:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Cueva, Juan F.
  • Palacio, Isabel
  • Churruca, Cristina
  • Herrero, Ana
  • Pardo, Beatriz
  • Constenla, Manuel
  • Manso, Luis
  • Estevez, Purificacin
  • Maximiano, Constanza
  • Legeren, Marta
  • Marquina, Gloria
  • de Juan, Ana
  • Quindos, Maria
  • Sanchez, Luisa
  • Barquin, Arantzazu
  • Fernandez, Isaura
  • Martin, Cristina
  • Juarez, Asuncin
  • Martin, Teresa
  • Garcia, Yolanda
  • Yubero, Alfonso
  • Gallego, Alejandro
  • Martínez Bueno A
  • Guerra, Eva
  • Gonzalez-Martin, Antonio

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 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. GOV REGISTRATION: NCT04546373.

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.scopus.com
Factor de Impacto:
2,865 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 13

Citas Recibidas en Scopus: 12

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Keywords

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

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