Evidence map›Paper›PMID 26685010›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel.

K N Chi, T Kheoh, C J Ryan, A Molina, J Bellmunt, N J Vogelzang, D E Rathkopf, K Fizazi, P W Kantoff, J Li and 6 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 95 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 10 pooled it
–field-weighted citation impact
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.

NCT00638690 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

TypeinterventionalSponsorCougar Biotechnology, Inc.Ran2008 to 2012Enrolled1,195ConditionsProstatic NeoplasmsArmsPlacebo, Abiraterone acetate, Prednisone/prednisolone
NCT01120470 phase2completednot on this map

A Randomized Phase II Study of OGX-427 (a Second-Generation Antisense Oligonucleotide to Heat Shock Protein-27) in Patients With Castration Resistant Prostate Cancer Who Have Not Previously Received Chemotherapy for Metastatic Disease

TypeinterventionalSponsorBritish Columbia Cancer AgencyRan2010 to 2014Enrolled74ConditionsCastration Resistant Prostate CancerArmsOGX-427, Prednisone
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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35 more citing papers are in PubMed but not listed here.

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

16 authors.

K N ChiDepartment of Medical Oncology, BC Cancer Agency, Vancouver, Canada kchi@bccancer.bc.ca.
T KheohJanssen Research & Development, San Diego.
C J RyanHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco.
A MolinaJanssen Research & Development, Menlo Park.
J BellmuntDepartment of Solid Tumor Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston.
N J VogelzangComprehensive Cancer Centers of Nevada, Las Vegas.
D E RathkopfDepartment of Oncology and Internal Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA.
K FizaziGroupe Uro-Genitologie, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.
P W KantoffDepartment of Solid Tumor Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston.
J LiJohnson & Johnson Medical China, Shanghai, China.
A A AzadDepartment of Medical Oncology, BC Cancer Agency, Vancouver, Canada.
B J EiglDepartment of Medical Oncology, BC Cancer Agency, Vancouver, Canada.
D Y C HengTom Baker Cancer Center and University of Calgary, Calgary.
A M JoshuaDepartment of Medical Oncology, Princess Margaret Hospital and University of Toronto, Toronto, Canada.
J S de BonoDrug Development Unit, Division of Cancer Therapeutics/Clinical Studies, The Institute for Cancer Research and Royal Marsden Hospital, Sutton, UK.
H I ScherGenitourinary Oncology Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA.

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

backgroundFew prognostic models for overall survival (OS) are available for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with recently approved agents. We developed a prognostic index model using readily available clinical and laboratory factors from a phase III trial of abiraterone acetate (hereafter abiraterone) in combination with prednisone in post-docetaxel mCRPC. PATIENTS AND

methodsBaseline data were available from 762 patients treated with abiraterone-prednisone. Factors were assessed for association with OS through a univariate Cox model and used in a multivariate Cox model with a stepwise procedure to identify those of significance. Data were validated using an independent, external, population-based cohort.

resultsSix risk factors individually associated with poor prognosis were included in the final model: lactate dehydrogenase > upper limit of normal (ULN) [hazard ratio (HR) = 2.31], Eastern Cooperative Oncology Group performance status of 2 (HR = 2.19), presence of liver metastases (HR = 2.00), albumin ≤4 g/dl (HR = 1.54), alkaline phosphatase > ULN (HR = 1.38) and time from start of initial androgen-deprivation therapy to start of treatment ≤36 months (HR = 1.30). Patients were categorized into good (n = 369, 46%), intermediate (n = 321, 40%) and poor (n = 107, 13%) prognosis groups based on the number of risk factors and relative HRs. The C-index was 0.70 ± 0.014. The model was validated by the external dataset (n = 286).

conclusionThis analysis identified six factors used to model survival in mCRPC and categorized patients into three distinct risk groups. Prognostic stratification with this model could assist clinical practice decisions for follow-up and monitoring, and may aid in clinical trial design. TRIAL REGISTRATION NUMBERS: NCT00638690.

Indexed as

Abiraterone AcetateAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDouble-Blind MethodHumansMalePrednisoneProportional Hazards ModelsProstatic Neoplasms, Castration-ResistantAbiraterone AcetateAntineoplastic AgentsPrednisoneabiraterone acetatecastration-resistant prostate cancerprognosticrisksurvival

Identifiers

PMID26685010
PMCPMC4769990

What OpenQuestion holds

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LicenceCC BY-NC
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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.