Evidence map›Paper›PMID 28645287›Full record

Trial reportHealth and quality of life outcomes2017

Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial.

Nancy Devlin, Michael Herdman, Marco Pavesi, De Phung, Shevani Naidoo, Tomasz M Beer, Bertrand Tombal, Yohann Loriot, Cristina Ivanescu, Teresa Parli and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Health and quality of life outcomes, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01212991 (PREVAIL), which is not on this map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01212991 phase3completednot on this map

Prevail: a multinational phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral mdv3100 in chemotherapy-naïve patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy

TypeinterventionalSponsorPfizerRan2010 to 2019Enrolled1,717ConditionsProstate CancerArmsEnzalutamide, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 6 countries.

Nancy DevlinOffice of Health Economics, Southside, 7th Floor, 105 Victoria Street, London, SW1E 6QT, UK.
Michael HerdmanOffice of Health Economics, Southside, 7th Floor, 105 Victoria Street, London, SW1E 6QT, UK. mherdman@ohe.org.
Marco PavesiEuropean Association for the Study of the Liver-Chronic Liver Failure (EASL-CLIF) Consortium, C/Mallorca 183, 08036, Barcelona, Spain.
De PhungAstellas Pharma Global Development, J.H. Oortweg 62, 2333 BE, Leiden, The Netherlands.
Shevani NaidooAstellas Medical Affairs, Global Health Economic Outcomes Research (HEOR), 2000 Hillswood Dr, Chertsey, Surrey, KT16 0PS, UK.
Tomasz M BeerOHSU Knight Cancer Institute, Oregon Health & Science University, 3303 SW Bond Ave., CH14R, Portland, OR, 97239, USA.
Bertrand TombalInstitut de Recherche Clinique (IREC), Cliniques Universitaires Saint Luc, Av Hippocrate, 10 - 1200 Bruxelles - Belgique, Brussels, Belgium.
Yohann LoriotInstitut Gustave Roussy, University of Paris Sud, 114, rue Edouard-Vaillant, 94805, Villejuif Cedex, France.
Cristina IvanescuQuintiles, Siriusdreef 10 Beukenhorst Zuid 2132, WT, Hoofddorp, The Netherlands.
Teresa ParliMedivation, Inc., 525 Market St, Fl 36, San Francisco, CA, 94105, USA.
Mark BalkMedivation, Inc., 525 Market St, Fl 36, San Francisco, CA, 94105, USA.
Stefan HolmstromAstellas Medical Affairs, Global HEOR, J.H. Oortweg 62, 2333 BE, Leiden, The Netherlands.
Astellas Pharma (Netherlands) · NLOffice Of Health Economics · GBCliniques Universitaires Saint-Luc · BEEuropean Foundation for the Study of Chronic Liver Failure · ESHealth Economics and Outcomes Research (United Kingdom) · GBOregon Health & Science University · USUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument.

methodsPatients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted.

resultsWith enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions.

conclusionsThis in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type.

trial registrationNCT01212991.

Indexed as

Quality of LifeAdultAgedAnxietyBenzamidesHumansMaleMiddle AgedNitrilesPainPhenylthiohydantoinProstatic Neoplasms, Castration-ResistantSelf CareSurveys and QuestionnairesBenzamidesenzalutamideNitrilesPhenylthiohydantoinEnzalutamideEq-5DMetastatic castration-resistant prostate cancerQuality of life

Identifiers

PMID28645287
PMCPMC5481866
OpenAlexW2649206924

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.