Evidence map›Paper›PMID 23169292›Full record

Trial reportBritish journal of cancer2013

EGFR pathway biomarkers in erlotinib-treated patients with advanced pancreatic cancer: translational results from the randomised, crossover phase 3 trial AIO-PK0104.

S Boeck, A Jung, R P Laubender, J Neumann, R Egg, C Goritschan, U Vehling-Kaiser, C Winkelmann, L Fischer von Weikersthal, M R Clemens and 10 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 4% 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

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
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  6. Article
  7. Review
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  10. Article
  11. New Therapeutic Targets in RAS Wild-type Pancreatic Cancer.Current treatment options in oncology · 2024
    Review
  12. Article
  13. The role of molecular testing in pancreatic cancer.Therapeutic advances in gastroenterology · 2023
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Oncogenic allelic interaction inProceedings of the National Academy of Sciences of the United States of America · 2020
    Article
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

20 authors at 13 institutions in 3 countries.

S BoeckDepartment of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Marchioninistr 15, Munich D-81377, Germany. stefan.boeck@med.uni-muenchen.de
A Jung
R P Laubender
J Neumann
R Egg
C Goritschan
U Vehling-Kaiser
C Winkelmann
L Fischer von Weikersthal
M R Clemens
T C Gauler
A Märten
S Klein
G Kojouharoff
M Barner
M Geissler
T F Greten
U Mansmann
T Kirchner
V Heinemann
Ludwig-Maximilians-Universität München · DELMU Klinikum · DEBayreuth Medical Center · DEBethlehem Gesundheitszentrum Stolberg · DEEvangelisches Klinikum Köln Weyertal · DEHeidelberg University · DEKlinikum Darmstadt · DEKlinikum Esslingen · DEKlinikum Mutterhaus der Borromäerinnen · DEMedizinische Hochschule Hannover · DEUniversity of Applied Sciences Landshut · DEWest German Heart and Vascular Center Essen · DEWittenberg University · US

Funding

Clinical protocols for the treatment of GI cancerZIABC011343 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GRETEN, TIM · 2010 to 2025
$4.8M
6 · The paper itself

Abstract

backgroundWe aimed to identify molecular epidermal growth factor receptor (EGFR) tissue biomarkers in pancreatic cancer (PC) patients treated with the anti-EGFR agent erlotinib within the phase 3 randomised AIO-PK0104 study.

methodsAIO-PK0104 was a multicenter trial comparing gemcitabine/erlotinib followed by capecitabine with capecitabine/erlotinib followed by gemcitabine in advanced PC; primary study end point was the time-to-treatment failure after first- and second-line therapy (TTF2). Translational analyses were performed for KRAS exon 2 mutations, EGFR expression, PTEN expression, the EGFR intron 1 and exon 13 R497K polymorphism (PM). Biomarker data were correlated with TTF, overall survival (OS) and skin rash.

resultsArchival tumour tissue was available from 208 (74%) of the randomised patients. The KRAS mutations were found in 70% (121 out of 173) of patients and exclusively occurred in codon 12. The EGFR overexpression was detected in 89 out of 181 patients (49%) by immunohistochemistry (IHC), and 77 out of 166 patients (46%) had an EGFR gene amplification by fluorescence in-situ hybridisation (FISH); 30 out of 171 patients (18%) had a loss of PTEN expression, which was associated with an inferior TTF1 (first-line therapy; HR 0.61, P=0.02) and TTF2 (HR 0.66, P=0.04). The KRAS wild-type status was associated with improved OS (HR 1.68, P=0.005); no significant OS correlation was found for EGFR-IHC (HR 0.96), EGFR-FISH (HR 1.22), PTEN-IHC (HR 0.77), intron 1 (HR 0.91) or exon 13 R497K PM (HR 0.83). None of the six biomarkers correlated with the occurrence of skin rash.

conclusionThe KRAS wild-type was associated with an improved OS in erlotinib-treated PC patients in this phase 3 study; it remains to be defined whether this association is prognostic or predictive.

Indexed as

AdultAgedAntineoplastic AgentsBiomarkers, TumorCapecitabineDeoxycytidineErbB ReceptorsErlotinib HydrochlorideFemaleFluorouracilGemcitabineHumansMaleMiddle AgedPancreatic NeoplasmsPolymorphism, Single NucleotideAntineoplastic AgentsBiomarkers, TumorCapecitabineDeoxycytidineEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideFluorouracilGemcitabineKRAS protein, humanProtein Kinase InhibitorsProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)PTEN PhosphohydrolasePTEN protein, humanQuinazolinesras Proteins

Identifiers

PMID23169292
PMCPMC3566829
OpenAlexW1975355929

What OpenQuestion holds

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LicenceCC BY-NC-SA
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.