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Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.
The New England Journal of Medicine ( IF 70.670 ) Pub Date : 2019-09-28 , DOI: 10.1056/nejmoa1910962
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,

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. (Funded by GlaxoSmithKline; PRIMA/ENGOT-OV26/GOG-3012 ClinicalTrials.gov number, NCT02655016.).
更新日期:2019-12-19

 

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