Search: onr:"swepub:oai:lup.lub.lu.se:67f3532a-a71c-4c16-b9f0-7f91e2b420c3" > Quality of life in ...
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001 | oai:lup.lub.lu.se:67f3532a-a71c-4c16-b9f0-7f91e2b420c3 | |
003 | SwePub | |
008 | 181018s2018 | |||||||||||000 ||eng| | |
024 | 7 | a https://lup.lub.lu.se/record/67f3532a-a71c-4c16-b9f0-7f91e2b420c32 URI |
024 | 7 | a https://doi.org/10.1016/S1470-2045(18)30333-42 DOI |
040 | a (SwePub)lu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a art2 swepub-publicationtype |
072 | 7 | a ref2 swepub-contenttype |
100 | 1 | a Oza, Amit M.u Princess Margaret Hospital University of Toronto4 aut |
245 | 1 0 | a 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 |
264 | 1 | c 2018 |
300 | a 9 s. | |
520 | a Background: 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. Methods: 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 (gBRCA) mutation status (determined by BRACAnalysis Testing, Myriad Genetics, Salt Lake City, UT, USA). The primary endpoint of the trial was progression-free survival, and has already been reported. In this study, we assessed patient-reported outcomes (PROs) in the intention-to-treat population using the Functional Assessment of Cancer Therapy–Ovarian Symptoms Index (FOSI) and European QOL five-dimension five-level questionnaire (EQ-5D-5L). We collected PROs from trial entry every 8 weeks for the first 14 cycles and every 12 weeks thereafter. If a patient discontinued, we collected PROs at discontinuation and during a postprogression visit 8 weeks (plus or minus 2 weeks) later. We assessed the effect of haematological toxic effects on QOL with disutility analyses of the most common grade 3–4 adverse events (thrombocytopenia, anaemia, and neutropenia) using a mixed model with histology, region, previous treatment, age, planned treatment, and baseline score as covariates. This study is registered with ClinicalTrials.gov, number NCT01847274. Findings: Between Aug 28, 2013, and June 1, 2015, 553 patients were enrolled and randomly assigned to receive niraparib (n=138 in the gBRCAmut cohort, n=234 in the non-gBRCAmut cohort) or placebo (n=65 in the gBRCAmut cohort, n=116 in the non-gBRCAmut cohort). The mean FOSI score at baseline was similar between the two groups (range between 25·0–25·6 in the two groups). Overall QOL scores remained stable during the treatment and preprogression period in the niraparib group; no significant differences were observed between the niraparib and placebo group, and preprogression EQ-5D-5L scores were similar between the two groups in both cohorts (0·838 [0·0097] in the niraparib group vs 0·834 [0·0173] in the placebo group in the gBRCAmut cohort; and 0·833 [0·0077] in the niraparib group vs 0·815 [0·0122] in the placebo group in the non-gBRCAmut cohort). The most common adverse events reported at screening (baseline) were lack of energy (425 [79%]; 97 [18%] reporting severe lack of energy), pain (236 [44%]), and nausea (118 [22%]). All symptoms, except nausea, either remained stable or improved over time in the niraparib group. The most common grade 3 or 4 toxicities observed in the niraparib group were haematological in nature: thrombocytopenia (124 [34%] of 367 patients), anaemia (93 [25%]), and neutropenia (72 [20%]); disutility analyses showed no significant QOL impairment associated with these toxic effects. Interpretation: These PRO data suggest that women who receive niraparib as maintenance treatment for recurrent ovarian cancer after responding to platinum treatment are able to maintain QOL during their treatment when compared with placebo. Funding: TESARO. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng |
700 | 1 | a Matulonis, Ursula A.u Dana-Farber Cancer Institute4 aut |
700 | 1 | a Malander, Susanneu Lund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital4 aut0 (Swepub:lu)onk-sma |
700 | 1 | a Hudgens, Stacie4 aut |
700 | 1 | a Sehouli, Jalidu Charité - University Medicine Berlin4 aut |
700 | 1 | a del Campo, Josep M.u Vall d'Hebron University Hospital4 aut |
700 | 1 | a Berton-Rigaud, Dominiqueu ICO - Institute of Cancer Research in Western France4 aut |
700 | 1 | a Banerjee, Susanau Royal Marsden NHS Foundation Trust4 aut |
700 | 1 | a Scambia, Giovanniu Catholic University of the Sacred Heart, Rome4 aut |
700 | 1 | a Berek, Jonathan S.u Stanford University4 aut |
700 | 1 | a Lund, Benteu Aalborg University Hospital4 aut |
700 | 1 | a Tinker, Anna V.u British Columbia Cancer Agency4 aut |
700 | 1 | a Hilpert, Felixu Krankenhaus Jerusalem, Hamburg4 aut |
700 | 1 | a Vázquez, Isabel Palaciou Asturias General Hospital4 aut |
700 | 1 | a D'Hondt, Véroniqueu Montpellier Cancer Institute,University of Montpellier4 aut |
700 | 1 | a Benigno, Benedictu Northside Hospital Atlanta4 aut |
700 | 1 | a Provencher, Dianeu University Of Montreal Health Center (CRCHUM)4 aut |
700 | 1 | a Buscema, Josephu Arizona Oncology Associates4 aut |
700 | 1 | a Agarwal, Shefaliu TESARO INC.4 aut |
700 | 1 | a Mirza, Mansoor R.u Copenhagen University Hospital4 aut |
710 | 2 | a Princess Margaret Hospital University of Torontob Dana-Farber Cancer Institute4 org |
773 | 0 | t The Lancet Oncologyg 19:8, s. 1117-1125q 19:8<1117-1125x 1470-2045 |
856 | 4 | u http://dx.doi.org/10.1016/S1470-2045(18)30333-4y FULLTEXT |
856 | 4 8 | u https://lup.lub.lu.se/record/67f3532a-a71c-4c16-b9f0-7f91e2b420c3 |
856 | 4 8 | u https://doi.org/10.1016/S1470-2045(18)30333-4 |
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