Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial

The Lancet Oncology
Amit M OzaMansoor R Mirza

Abstract

Quality of life (QOL) has become an important complementary endpoint in cancer clinical studies alongside more traditional assessments (eg, tumour response, progression-free survival, overall survival). Niraparib maintenance treatment has been shown to significantly improve progression-free survival in patients with recurrent ovarian cancer. We aimed to assess whether the benefits of extending progression-free survival are offset by treatment-associated toxic effects that affect QOL. The ENGOT-OV16/NOVA trial was a multicentre, double-blind, phase 3, randomised controlled trial done in 107 study sites in the USA, Canada, Europe, and Israel. Patients with recurrent ovarian cancer who were in response to their last platinum-based chemotherapy were randomly assigned (2:1) to receive either niraparib (300 mg once daily) as a maintenance treatment or placebo. Randomisation was stratified based on time to progression after the penultimate platinum-based regimen, previous use of bevacizumab, and best response (complete or partial) to the last platinum-based regimen with permuted-block randomisation (six in each block) using an interactive web response system. The trial enrolled two independent cohorts on the basis of germline BRCA (gB...Continue Reading

Citations

Nov 13, 2018·Basic & Clinical Pharmacology & Toxicology·Troels K BergmannPer Damkier
May 18, 2019·American Society of Clinical Oncology Educational Book·Ainhoa MadariagaAmit M Oza
May 18, 2019·CA: a Cancer Journal for Clinicians·Stephanie LheureuxAmit M Oza
May 24, 2019·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·Emily HinchcliffRobert L Coleman
Sep 14, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ursula A MatulonisMansoor R Mirza
Mar 22, 2019·The Oncologist·Leslie M RandallThomas J Herzog
Aug 31, 2019·BMJ Case Reports·Simon GrayDennis Yiannakis
Apr 12, 2020·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·Ainhoa MadariagaStephanie Lheureux
Jul 31, 2020·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·Matthew Ryan CarrollMichael Frumovitz
Aug 19, 2020·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Caroline Bascoul-MolleviAmélie Anota
Feb 23, 2020·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·Rebecca ArendRobert L Coleman
Mar 22, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Sarah A Cook, Anna V Tinker
Jul 31, 2020·Signal Transduction and Targeted Therapy·Qiao WangXia Zhao
Aug 14, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Sara BouberhanStephen A Cannistra
Jun 10, 2020·Cells·Sandra Muñoz-Galván, Amancio Carnero
Aug 9, 2020·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Edward B HenryCiaran O'Neill
Dec 6, 2020·Obstetrics and Gynecology·Katherine C KurnitErnst Lengyel
Feb 25, 2021·Patient Related Outcome Measures·Sharolin BobanCaroline Bulsara
Feb 23, 2021·Gynecologic Oncology·Jean-Emmanuel KurtzUNKNOWN Gynecologic Cancer InterGroup (GCIG) symptom benefit committee
May 4, 2021·Journal of Obstetrics and Gynaecology : the Journal of the Institute of Obstetrics and Gynaecology·Apichaya TechataKittipat Charoenkwan
Jul 25, 2021·Gynecologic Oncology·Haley A MossAngeles Alvarez Secord
Oct 9, 2021·Journal of Cutaneous Pathology·Riyad N H SeervaiJonathan L Curry
Dec 26, 2021·International Journal of Cancer. Journal International Du Cancer·Chunyan ZongJianfeng Shen
Aug 21, 2020·Anti-cancer Agents in Medicinal Chemistry·Jinling QinYongfang Yao

❮ Previous
Next ❯

Related Concepts

Related Feeds

Anemia

Anemia develops when your blood lacks enough healthy red blood cells. Anemia of inflammation (AI, also called anemia of chronic disease) is a common, typically normocytic, normochromic anemia that is caused by an underlying inflammatory disease. Here is the latest research on anemia.