3 results match your criteria: "NSGO and Rigshospitalet-Copenhagen University Hospital[Affiliation]"
Prospective evaluation of the tolerability and efficacy of niraparib dosing based on baseline body weight and platelet count: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial.
Cancer
June 2023
HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, Arizona, USA.
Background: The PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) trial was amended to prospectively evaluate the safety and efficacy of an individualized starting dose (ISD) regimen of niraparib for first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer.
Methods: In the phase 3 PRIMA trial, patients with newly diagnosed advanced ovarian cancer with a complete/partial response to first-line platinum-based chemotherapy (N = 733) were initially treated with a fixed starting dose (FSD) regimen of 300 mg once daily. Subsequently, the protocol was amended so newly enrolled patients received an ISD: 200 mg once daily in patients with baseline body weight < 77 kg or baseline platelet count < 150,000/µL, and 300 mg once daily in all other patients.
Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.
N Engl J Med
December 2019
From Grupo Español de Investigación en Cáncer de Ovario (GEICO) and the Medical Oncology Department, Clínica Universidad de Navarra (A.G.-M.) and GEICO and Hospital Universitario La Paz-IdiPAZ (A.R.), Madrid, GEICO and Medical Oncology, Catalan Institute of Oncology, Girona Biomedical Research Institute, and the Department of Medical Sciences, Medical School University of Girona, Girona (P.B.-G.), and GEICO and Hospital Universitario Reina Sofía, Cordoba (M.J.R.-P.) - all in Spain; the Gynecologic Oncology Group (GOG) and the Department of Obstetrics/Gynecology, Perlmutter Cancer Center, NYU Langone Health (B.P.), and GOG and the Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College (R.E.O.), New York, and US Oncology Research (USOR) and the Division of Gynecologic Oncology, Wilmot Cancer Institute, Department of Obstetrics and Gynecology, University of Rochester, Rochester (R.G.M.) - all in New York; Belgium and Luxembourg Gynecologic Oncology Group (BGOG) and the Department of Gynecology and Obstetrics, Division of Gynecologic Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven (I.V.), BGOG and the Department of Medical Oncology and Hematology, AZ Maria Middelares, Ghent (C.V.), and the Department of Molecular Imaging, Pathology, Radiotherapy, and Oncology, Center for Oncological Research, Antwerp University, Antwerp (C.V.) - all in Belgium; the Nordic Society of Gynecologic Oncology (NSGO) and the Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense (R.D.C.), NSGO and Rigshospitalet-Copenhagen University Hospital, Copenhagen (M.R.M.), and NSGO and the Department of Oncology, Aalborg University, Aalborg (B.L.) - all in Denmark; GOG and Gynecologic Oncology, Medical University of South Carolina, Charleston (W.G.); GOG and Legacy Medical Group Gynecologic Oncology, Portland, OR (C.M.); Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) and Fondazione IRCCS National Cancer Institute of Milan (D.L.), and MITO and the Department of Obstetrics and Gynecology, San Raffaele Scientific Institute (G.M.) - both in Milan; USOR and the Department of Medical Oncology, BC Cancer, Vancouver, BC (P.H.), and GOG and the Department of Obstetrics and Gynecology, McGill University, and the Department of Oncology, McGill University Health Centre, Division of Gynecologic Oncology, Montreal (K.J.) - all in Canada; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Lyon, France (G.F.); Arbeitsgemeinschaft Gynäkologische Onkologie and the Department of Gynecology and Obstetrics, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany (K.B.); the Division of Gynecologic Oncology, Ohio State University, Columbus (F.B.); GOG and the Division of Gynecologic Oncology, University of Pennsylvania, Philadelphia (A.F.H.), and GOG and Hanjani Institute for Gynecologic Oncology, Asplundh Cancer Pavilion, Abington Jefferson Hospital, Sidney Kimmel Medical College of Thomas Jefferson University, Willow Grove (M.S.S.) - all in Pennsylvania; GOG and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee (W.H.B.); Israeli Society of Gynecologic Oncology and Department of Gynecology and Gynecologic Oncology, Hillel Yaffe Medical Center, Technion Israel Institute of Technology, Haifa, Israel (I.B.); GlaxoSmithKline/Tesaro, Waltham, MA (K.S., I.A.M., Y.L., D.G.); and Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).
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 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.
Purpose: In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.
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