Evidence map›Paper›PMID 18824708›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008

Dynamic contrast-enhanced magnetic resonance imaging pharmacodynamic biomarker study of sorafenib in metastatic renal carcinoma.

Olwen M Hahn, Cheng Yang, Milica Medved, Gregory Karczmar, Emily Kistner, Theodore Karrison, Elizabeth Manchen, Myrosia Mitchell, Mark J Ratain, Walter M Stadler

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 101 papers.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed
16.3field-weighted citation impact, top 1% 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

101 citing papers in PubMed, 228 citations in OpenAlex.

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  15. Deciphering Intratumoral Molecular Heterogeneity in Clear Cell Renal Cell Carcinoma with a Radiogenomics Platform.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
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41 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

10 authors at 1 institution in 1 country.

Olwen M HahnUniversity of Chicago, Chicago, IL 60637, USA.
Cheng Yang
Milica Medved
Gregory Karczmar
Emily Kistner
Theodore Karrison
Elizabeth Manchen
Myrosia Mitchell
Mark J Ratain
Walter M Stadler
University of Chicago · US

Funding

Dynamic-contrast enhanced MRI as a BAY 43-9006 markerR21CA108184 · NCI · UNIVERSITY OF CHICAGO · PI STADLER, WALTER M. · 2005 to 2006
$536k
NCI NIH HHS 1R21 CA108184-01A2
6 · The paper itself

Abstract

purposeSorafenib is an antiangiogenic agent with activity in renal cancer. We conducted a randomized trial to investigate dynamic contrast magnetic resonance imaging (DCE-MRI) as a pharmacodynamic biomarker. PATIENTS AND

methodsPatients were randomly assigned to placebo or 200 or 400 mg twice per day of sorafenib. DCE-MRI was performed at baseline and 4 weeks. DCE-MRI parameters, area under the contrast concentration versus time curve 90 seconds after contrast injection (IAUC(90)), and volume transfer constant of contrast agent (K(trans)) were calculated for a metastatic site selected in a blinded manner. Primary end point was change in K(trans).

resultsOf the 56 assessable patients, 48 underwent two MRIs; 44 MRIs were assessable for study end points. Mean K(trans) log ratios were 0.131 (standard deviation [SD], 0.315), -0.148 (SD, 0.382), -0.271 (SD, 0.499) in placebo, 200- and 400-mg cohorts, respectively (P = .0077 for trend) corresponding to changes of +14%, -14%, and -24%. IAUC(90) log ratios were 0.041 (SD, 0.197), -0.040 (SD, 0.132), -0.356 (SD, 0.411), respectively (P = .0003 for trend), corresponding to changes of +4%, -4%, and -30%. Using a log-rank test, IAUC(90) and K(trans) changes were not associated with progression-free survival (PFS). Patients with high baseline K(trans) had a better PFS (P = .027).

conclusionIAUC(90) and K(trans) are pharmacodynamic biomarkers for sorafenib, but variability is high and magnitude of effect is less than previously reported. Changes in DCE-MRI parameters after 4 weeks of sorafenib are not predictive of PFS, suggesting that these biomarkers are not surrogate end points. The value of baseline K(trans) as a prognostic or predictive biomarker requires additional study.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsArea Under CurveBenzenesulfonatesBiomarkers, TumorCarcinoma, Renal CellContrast MediaDouble-Blind MethodFemaleGadolinium DTPAHumansKidney NeoplasmsMagnetic Resonance ImagingMaleAntineoplastic AgentsBenzenesulfonatesBiomarkers, TumorContrast MediagadodiamideGadolinium DTPANiacinamidePhenylurea CompoundsPlacebosPyridinesSorafenib

Identifiers

PMID18824708
PMCPMC2736992
OpenAlexW2166742462

What OpenQuestion holds

Textmetadata
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.