Niraparib in patients with newly diagnosed advanced ovarian cancer Journal Article


Authors: Gonzalez-Martin, A.; Pothuri, B.; Vergote, I.; Christensen, R. D.; Graybill, W.; Mirza, M. R.; McCormick, C.; Lorusso, D.; Hoskins, P.; Freyer, G.; Baumann, K.; Jardon, K.; Redondo, A.; Moore, R. G.; Vulsteke, C.; O'Cearbhaill, R. E.; Lund, B.; Backes, F.; Barretina-Ginesta, P.; Haggerty, A. F.; Rubio-Perez, M. J.; Shahin, M. S.; Mangili, G.; Bradley, W. H.; Bruchim, I.; Sun, K.; Malinowska, I. A.; Li, Y.; Gupta, D.; Monk, B. J.
Article Title: Niraparib in patients with newly diagnosed advanced ovarian cancer
Abstract: 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 prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival. RESULTS Of the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred. CONCLUSIONS Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency.
Keywords: survival; questionnaire; quality-of-life
Journal Title: New England Journal of Medicine
Volume: 381
Issue: 25
ISSN: 0028-4793
Publisher: Massachusetts Medical Society  
Date Published: 2019-12-19
Start Page: 2391
End Page: 2402
Language: English
ACCESSION: WOS:000505222400004
DOI: 10.1056/NEJMoa1910962
PROVIDER: wos
PUBMED: 31562799
Notes: Article -- Source: Wos
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