Niraparib in patients with newly diagnosed advanced ovarian cancer

Autor: Kaiming Sun, Mansoor Raza Mirza, Gog Investigators, Whitney Graybill, C McCormick, Engot-Ov, Paul Hoskins, K. Jardon, Ilan Bruchim, Bhavana Pothuri, Giorgia Mangili, Pilar Barretina-Ginesta, Y. Li, Mark S. Shahin, Ashley Haggerty, Ignace Vergote, Klaus Baumann, Domenica Lorusso, William H. Bradley, Bente Lund, Gilles Freyer, Floor J. Backes, René dePont Christensen, Divya Gupta, Antonio González-Martín, Christof Vulsteke, Roisin E. O'Cearbhaill, Andrés Redondo, Bradley J. Monk, I Malinowska, Maria J. Rubio-Pérez, Richard G. Moore
Přispěvatelé: PRIMA Investigator, ENGOT-OV26 Investigator, GOG-3012 Investigator, Lääketieteen ja terveysteknologian tiedekunta - Faculty of Medicine and Health Technology, Tampere University
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Oncology
Administration
Oral
030204 cardiovascular system & hematology
Nausea/chemically induced
chemistry.chemical_compound
0302 clinical medicine
QUALITY-OF-LIFE
Medicine and Health Sciences
Medicine
030212 general & internal medicine
Indazoles/adverse effects
Polymerase
Aged
80 and over
biology
Ovarian Neoplasms/drug therapy
Obstetrics and Gynecology
Naisten- ja lastentaudit - Gynaecology and paediatrics
General Medicine
Middle Aged
Combined Modality Therapy
Progression-Free Survival
SURVIVAL
Female
Adult
Piperidines/adverse effects
medicine.medical_specialty
Poly ADP ribose polymerase
QUESTIONNAIRE
Newly diagnosed
Maintenance Chemotherapy
03 medical and health sciences
Double-Blind Method
Syöpätaudit - Cancers
Internal medicine
Humans
In patient
Progression-free survival
Survival analysis
Aged
Advanced ovarian cancer
business.industry
Antineoplastic Agents/therapeutic use
Survival Analysis
Adenosine diphosphate
chemistry
Quality of Life
biology.protein
Cancer research
Human medicine
business
Poly(ADP-ribose) Polymerase Inhibitors/adverse effects
Zdroj: NEW ENGLAND JOURNAL OF MEDICINE
The New England journal of medicine
González-Martín, A, Pothuri, B, Vergote, I, DePont Christensen, R, 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-Pérez, M J, Shahin, M S, Mangili, G, Bradley, W H, Bruchim, I, Sun, K, Malinowska, I A, Li, Y, Gupta, D, Monk, B J & PRIMA/ENGOT-OV26/GOG-3012 Investigators 2019, ' Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer ', The New England Journal of Medicine, vol. 381, no. 25, pp. 2391-2402 . https://doi.org/10.1056/NEJMoa1910962
González-Martín, A, Pothuri, B, Vergote, I, Christensen, R D P, 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-Pérez, M J, Shahin, M S, Mangili, G, Bradley, W H, Bruchim, I, Sun, K, Malinowska, I A, Li, Y, Gupta, D & Monk, B J 2020, ' Niraparib in Patients With Newly Diagnosed Advanced Ovarian Cancer ', Obstetrical and Gynecological Survey, vol. 75, no. 1, pp. 29-31 . https://doi.org/10.1097/OGX.0000000000000756
ISSN: 0028-4793
1533-4406
DOI: 10.1056/NEJMoa1910962
Popis: 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; PCONCLUSIONS: 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.).
Databáze: OpenAIRE
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