Evidence map›Paper›PMID 27648814›Full record

Trial reportCancer2017

Enzalutamide in castration-resistant prostate cancer patients with visceral disease in the liver and/or lung: Outcomes from the randomized controlled phase 3 AFFIRM trial.

Yohann Loriot, Karim Fizazi, Johann S de Bono, David Forer, Mohammad Hirmand, Howard I Scher

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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  5. Outcomes for Patients with Metastatic Castration-Resistant Prostate Cancer and Liver Metastasis Receiving [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024
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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

6 authors at 4 institutions in 3 countries.

Yohann LoriotDepartment of Cancer Medicine, Gustave Roussy, Département de Médecine Oncologique, Université Paris-Saclay, Villejuif, France.
Karim FizaziDepartment of Cancer Medicine, Gustave Roussy, Département de Médecine Oncologique, Université Paris-Saclay, Villejuif, France.
Johann S de BonoThe Royal Marsden National Health Service Foundation Trust and The Institute of Cancer Research, Sutton, United Kingdom.
David ForerMedivation, Inc, San Francisco, California.
Mohammad HirmandMedivation, Inc, San Francisco, California.
Howard I ScherMemorial Sloan-Kettering Cancer Center, New York, New York.
Institute of Cancer Research · GBInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USUniversité Paris-Saclay · FR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPatients with metastatic castration-resistant prostate cancer (mCRPC) and visceral metastases have a worse prognosis than those with nonvisceral metastases. Treatment with the androgen receptor inhibitor enzalutamide in the phase 3 AFFIRM trial led to significant improvements in outcomes for patients with mCRPC. For the current report, the authors analyzed the efficacy of enzalutamide among patients from the AFFIRM trial who had visceral disease.

methodsPatients who had liver and/or lung metastases at baseline were selected for prespecified overall survival (OS) and exploratory post hoc analyses, including prostate-specific antigen (PSA) response and the time to PSA and radiographic progression.

resultsIn patients who had liver metastases (n = 92), enzalutamide was associated with a lower risk of radiographic progression (hazard ratio [HR], 0.645; 95% confidence interval [CI], 0.413-1.008), improved 12-month OS (37.7% vs 20.6%) and radiographic progression-free survival (rPFS) (11.6% vs 3.0%) rates, and higher PSA response rates (35.1% vs 4.8%) compared with placebo. Enzalutamide-treated patients who had lung metastases (n = 104) had improved median OS (HR, 0.848; 95% CI, 0.510-1.410), a substantially reduced risk of radiographic progression (HR, 0.386; 95% CI, 0.259-0.577), improved 12-month OS (65.1% vs 55.3%) and rPFS (30.9% vs 8.2%) rates, increased time to PSA progression (HR, 0.358; 95% CI, 0.204-0.627), and a better PSA response rate (52.1% vs 4.9%) compared with those who received placebo. No increase in treatment-related adverse events was observed for the visceral metastases cohort compared with the nonvisceral metastases cohort.

conclusionsAcross multiple endpoints, patients who have visceral metastases have better outcomes with enzalutamide than with placebo. Cancer 2017;123:253-262. © 2016 American Cancer Society.

Indexed as

AgedAntineoplastic AgentsBenzamidesDisease-Free SurvivalDisease ProgressionDouble-Blind MethodHumansLiver DiseasesLung DiseasesMaleNitrilesPhenylthiohydantoinProportional Hazards ModelsProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantAntineoplastic AgentsBenzamidesenzalutamideNitrilesPhenylthiohydantoinProstate-Specific Antigenenzalutamideliverlungmetastatic castration-resistant prostate cancervisceral metastasis

Identifiers

PMID27648814
PMCPMC5632943
OpenAlexW2521472373

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.