Evidence map›Paper›PMID 26421426›Full record

Trial reportPloS one2015

The Prognostic Significance of Metabolic Response Heterogeneity in Metastatic Colorectal Cancer.

Alain Hendlisz, Amelie Deleporte, Thierry Delaunoit, Raphaël Maréchal, Marc Peeters, Stéphane Holbrechts, Marc Van den Eynde, Ghislain Houbiers, Bertrand Filleul, Jean-Luc Van Laethem and 12 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01290926 (Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% 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.

NCT01290926 phase2completednot on this map

Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer

TypeinterventionalSponsorJules Bordet InstituteRan2011 to 2016Enrolled97ConditionsColorectal CancerArmschemotherapy
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  6. Development and Validation of anJCO clinical cancer informatics · 2025
    Article
  7. Efficacy assessment in phase I clinical trials: endpoints and challenges.Annals of oncology : official journal of the European Society for Medical Oncology · 2025
    Review
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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

22 authors at 8 institutions in 1 country.

Alain HendliszMedical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Amelie DeleporteMedical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Thierry DelaunoitOncology Department, Jolimont Hospital, Haine-St-Paul, Belgium.
Raphaël MaréchalGastroenterology Medico-Surgical Department, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Marc PeetersOncology Department, Antwerp University Hospital, Antwerp University, Edegem, Belgium.
Stéphane HolbrechtsOncology Department, CHU Ambroise Pare, Mons, Belgium.
Marc Van den EyndeOncology Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
Ghislain HoubiersGastroenterology Department, CHC ST Joseph, Liege, Belgium.
Bertrand FilleulOncology Department, Jolimont Hospital, Haine-St-Paul, Belgium.
Jean-Luc Van LaethemGastroenterology Medico-Surgical Department, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Sarah CeyssensNuclear Medicine Department, Antwerp, University Hospital, Edegem, Belgium.
Anna-Maria BarbutoOncology Department, CHU Ambroise Pare, Mons, Belgium.
Renaud LhommelNuclear Medicine Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
Gauthier DemolinGastroenterology Department, CHC ST Joseph, Liege, Belgium.
Camilo GarciaNuclear Medicine Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Hazem El MansyMedical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; Oncology Department, Jolimont Hospital, Haine-St-Paul, Belgium; Gastroenterology Medico-Surgical Department, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium; Oncology Department, Antwerp University Hospital, Antwerp University, Edegem, Belgium; Nuclear Medicine Department, Antwerp, University Hospital, Edegem, Belgium; Oncology Department, CHU Ambroise Pare, Mons, Belgium; Oncology Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium; Nuclear Medicine Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium; Gastroenterology Department, CHC ST Joseph, Liege, Belgium; Nuclear Medicine Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Lieveke AmeyeData centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Michel MoreauData centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Thomas GuiotNuclear Medicine Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Marianne PaesmansData centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Martine PiccartMedical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Patrick FlamenNuclear Medicine Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Université Libre de Bruxelles · BEInstitut Jules Bordet · BEAntwerp University Hospital · BECHU Ambroise Paré · BEClinique Saint-Joseph · BEHôpital de Jolimont · BECliniques Universitaires Saint-Luc · BEUCLouvain · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTumoral heterogeneity is a major determinant of resistance in solid tumors. FDG-PET/CT can identify early during chemotherapy non-responsive lesions within the whole body tumor load. This prospective multicentric proof-of-concept study explores intra-individual metabolic response (mR) heterogeneity as a treatment efficacy biomarker in chemorefractory metastatic colorectal cancer (mCRC).

methodsStandardized FDG-PET/CT was performed at baseline and after the first cycle of combined sorafenib (600mg/day for 21 days, then 800mg/day) and capecitabine (1700 mg/m²/day administered D1-14 every 21 days). MR assessment was categorized according to the proportion of metabolically non-responding (non-mR) lesions (stable FDG uptake with SUVmax decrease <15%) among all measurable lesions.

resultsNinety-two patients were included. The median overall survival (OS) and progression-free survival (PFS) were 8.2 months (95% CI: 6.8-10.5) and 4.2 months (95% CI: 3.4-4.8) respectively. In the 79 assessable patients, early PET-CT showed no metabolically refractory lesion in 47%, a heterogeneous mR with at least one non-mR lesion in 32%, and a consistent non-mR or early disease progression in 21%. On exploratory analysis, patients without any non-mR lesion showed a significantly longer PFS (HR 0.34; 95% CI: 0.21-0.56, P-value <0.001) and OS (HR 0.58; 95% CI: 0.36-0.92, P-value 0.02) compared to the other patients. The proportion of non-mR lesions within the tumor load did not impact PFS/OS.

conclusionThe presence of at least one metabolically refractory lesion is associated with a poorer outcome in advanced mCRC patients treated with combined sorafenib-capecitabine. Early detection of treatment-induced mR heterogeneity may represent an important predictive efficacy biomarker in mCRC.

trial registrationClinicalTrials.gov NCT01290926.

Indexed as

Colorectal NeoplasmsPositron-Emission TomographyAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDisease-Free SurvivalFemaleGlucose-6-PhosphateHumansMaleMiddle AgedNeoplasm MetastasisNiacinamidePhenylurea Compounds2-fluoro-2-deoxyglucose-6-phosphateCapecitabineGlucose-6-PhosphateNiacinamidePhenylurea CompoundsSorafenib

Identifiers

PMID26421426
PMCPMC4589397
OpenAlexW2118961007

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.