Evidence map›Paper›PMID 24255071›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2013

Long-term survival and biomarker correlates of tasquinimod efficacy in a multicenter randomized study of men with minimally symptomatic metastatic castration-resistant prostate cancer.

A J Armstrong, M Häggman, W M Stadler, J R Gingrich, V Assikis, J Polikoff, J E Damber, L Belkoff, Ö Nordle, G Forsberg and 2 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00560482 (Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
6.2field-weighted citation impact, top 3% 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.

NCT00560482 phase2completednot on this map

Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer

TypeinterventionalSponsorActive Biotech ABRan2007 to 2015Enrolled206ConditionsProstate CancerArmsABR-215050, tasquinimod, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 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 4 institutions in 2 countries.

A J ArmstrongAuthors' Affiliations: Duke Cancer Institute and the Duke Prostate Center, Duke University, Durham, North Carolina; University Hospital of Uppsala, Uppsala, Sweden; University of Chicago, Chicago, Illinois; University of Pittsburgh, Pittsburgh, Pennsylvania; Peachtree Hematology Oncology Consultants, Atlanta, Georgia; Kaiser Permanente Medical Group, San Diego, California; Sahlgrenska University Hospital, Gothenburg, Sweden; Urologic Consultants of SE PA, Bala Cynwyd, Pennsylvania; Active Biotech AB, Lund, Sweden; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore Maryland; Roswell Park Cancer Institute, Buffalo, New York.
M Häggman
W M Stadler
J R Gingrich
V Assikis
J Polikoff
J E Damber
L Belkoff
Ö Nordle
G Forsberg
M A Carducci
R Pili
Sahlgrenska University Hospital · SEActive Biotech (Sweden) · SEDuke University · USPiedmont Cancer Institute · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

purposeTasquinimod (Active Biotech) is an oral immunomodulatory, anti-angiogenic, and anti-metastatic agent that delayed metastatic disease progression in a randomized placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). Here, we report long-term survival with biomarker correlates from this trial. EXPERIMENTAL

designTwo hundred and one (134 tasquinimod and 67 placebo) men with mCRPC were evaluated. Forty-one men randomized to placebo crossed over to tasquinimod. Survival data were collected with a median follow-up time of 37 months. Exploratory biomarker studies at baseline and over time were collected to evaluate potential mechanism-based correlates with tasquinimod efficacy including progression-free survival (PFS) and overall survival (OS).

resultsWith 111 mortality events, median OS was 33.4 months for tasquinimod versus 30.4 months for placebo overall, and 34.2 versus 27.1 months in men with bone metastases (n = 136), respectively. Multivariable analysis demonstrated an adjusted HR of 0.52 [95% confidence interval (CI), 0.35-0.78; P = 0.001] for PFS and 0.64 (95% CI, 0.42-0.97; P = 0.034) for OS, favoring tasquinimod. Time-to-symptomatic progression was improved with tasquinimod (P = 0.039, HR = 0.42). Toxicities tended to be mild in nature and improved over time. Biomarker analyses suggested a favorable impact on bone alkaline phosphatase and lactate dehydrogenase (LDH) over time and a transient induction of inflammatory biomarkers, VEGF-A, and thrombospondin-1 levels with tasquinimod. Baseline levels of thrombospondin-1 less than the median were predictive of treatment benefit.

conclusionsThe survival observed in this trial of men with minimally symptomatic mCRPC suggests that the prolongation in PFS with tasquinimod may lead to a survival advantage in this setting, particularly among men with skeletal metastases, and has a favorable risk:benefit ratio.

Indexed as

Disease-Free SurvivalBiomarkers, TumorBone NeoplasmsC-Reactive ProteinHumansL-Lactate DehydrogenaseMaleNeoplasm MetastasisProstatic Neoplasms, Castration-ResistantQuinolinesQuinolonesSurvival AnalysisVascular Endothelial Growth Factor ABiomarkers, TumorC-Reactive ProteinL-Lactate DehydrogenaseQuinolinesQuinolonestasquinimodVascular Endothelial Growth Factor A

Identifiers

PMID24255071
PMCPMC4251453
OpenAlexW2138732414

What OpenQuestion holds

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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.