Safety and dose modification for patients receiving niraparib

Annals of Oncology : Official Journal of the European Society for Medical Oncology
J S BerekM R Mirza

Abstract

Niraparib is a poly(ADP-ribose) polymerase inhibitor approved in the USA and Europe for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. In the pivotal ENGOT-OV16/NOVA trial, the dose reduction rate due to treatment-emergent adverse event (TEAE) was 68.9%, and the discontinuation rate due to TEAE was 14.7%, including 3.3% due to thrombocytopenia. A retrospective analysis was carried out to identify clinical parameters that predict dose reductions. All analyses were carried out on the safety population, comprising all patients who received at least one dose of study drug. Patients were analyzed according to the study drug consumed (i.e., as treated). A predictive modeling method (decision trees) was used to identify important variables for predicting the likelihood of developing grade ≥3 thrombocytopenia within 30 days after the first dose of niraparib and determine cut-off points for chosen variables. Following dose modification, 200 mg was the most commonly administered dose in the ENGOT-OV16/NOVA trial. Baseline platelet count and baseline body weight were identified as risk factors fo...Continue Reading

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Citations

Aug 4, 2018·Targeted Oncology·Young-A Heo, Sean T Duggan
May 24, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·D Lorusso, S Pignata
Sep 29, 2019·The New England Journal of Medicine·Antonio González-MartínUNKNOWN PRIMA/ENGOT-OV26/GOG-3012 Investigators
May 28, 2019·Minerva medica·Giacomo CorradoGabriella Ferrandina
Sep 14, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ursula A MatulonisMansoor R Mirza
Dec 14, 2019·Current Opinion in Obstetrics & Gynecology·Christine S Walsh
Jan 7, 2020·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Emily R HennesJennifer K Piccolo
May 1, 2020·Current Treatment Options in Oncology·Joanna GlajzerJacobus Pfisterer
Apr 12, 2020·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·Ainhoa MadariagaStephanie Lheureux
Jun 23, 2020·Expert Opinion on Emerging Drugs·Elizabeth K Lee, Ursula A Matulonis
Feb 26, 2019·Journal of Gynecologic Oncology·Miseon KimJae Weon Kim
Aug 14, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Sara BouberhanStephen A Cannistra
Feb 23, 2020·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·Rebecca ArendRobert L Coleman
Mar 5, 2020·Therapeutic Advances in Medical Oncology·Fausto Meriggi, Alberto Zaniboni
Feb 10, 2021·Journal of Gynecologic Oncology·Sook Hee Hong
Nov 6, 2018·Hematology/oncology Clinics of North America·Panagiotis A Konstantinopoulos, Ursula A Matulonis
Jun 23, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M R MirzaS Pignata
Sep 4, 2019·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Pauline CorbauxBenoit You
May 1, 2021·International Journal of Molecular Sciences·Giorgio ValabregaFrancesco Scaglione
May 4, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jennifer J GriggsGary H Lyman
Jun 18, 2021·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Rachel V HatchLainie P Martin
Apr 30, 2021·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Xinghao AiShun Lu

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