Authors
Antonio González-Martín, Bhavana Pothuri, Ignace Vergote, René DePont Christensen, Whitney Graybill, Mansoor R Mirza, Colleen McCormick, Domenica Lorusso, Paul Hoskins, Gilles Freyer, Klaus Baumann, Kris Jardon, Andrés Redondo, Richard G Moore, Christof Vulsteke, Roisin E O’Cearbhaill, Bente Lund, Floor Backes, Pilar Barretina-Ginesta, Ashley F Haggerty, Maria J Rubio-Pérez, Mark S Shahin, Giorgia Mangili, William H Bradley, Ilan Bruchim, Kaiming Sun, Izabela A Malinowska, Yong Li, Divya Gupta, Bradley J Monk
Publication date
2019/12/19
Journal
New England Journal of Medicine
Volume
381
Issue
25
Pages
2391-2402
Publisher
Massachusetts Medical Society
Description
Background
Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]–ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to first-line platinum-based chemotherapy is unknown.
Methods
In this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologous-recombination deficiency and in those in the overall population, as determined on hierarchical testing. A …
Scholar articles
A González-Martín, B Pothuri, I Vergote… - New England Journal of Medicine, 2019