Evidence map›Paper›PMID 25164437›Full record

Trial reportBMC cancer2014

pERK, pAKT and p53 as tissue biomarkers in erlotinib-treated patients with advanced pancreatic cancer: a translational subgroup analysis from AIO-PK0104.

Steffen Ormanns, Jens T Siveke, Volker Heinemann, Michael Haas, Bence Sipos, Anna Melissa Schlitter, Irene Esposito, Andreas Jung, Rüdiger P Laubender, Stephan Kruger and 10 more

Registry-linked trialAbstract readClinical Trial, Phase III
In one paragraph

Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00440167 (Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–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.

NCT00440167 phase3unknown statusnot on this map

Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer

TypeinterventionalSponsorPD Dr. med. Volker HeinemannRan2006 to 2012Enrolled280ConditionsPancreatic CancerArmsGemcitabine, Capecitabine, Erlotinib
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Article
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  13. Relationship Between the Expression of OClinical drug investigation · 2017
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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

20 authors.

Steffen Ormanns
Jens T Siveke
Volker Heinemann
Michael Haas
Bence Sipos
Anna Melissa Schlitter
Irene Esposito
Andreas Jung
Rüdiger P Laubender
Stephan Kruger
Ursula Vehling-Kaiser
Cornelia Winkelmann
Ludwig Fischer von Weikersthal
Michael R Clemens
Thomas C Gauler
Angela Märten
Michael Geissler
Tim F Greten
Thomas Kirchner
Stefan BoeckDepartment of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, München, Germany. stefan.boeck@med.uni-muenchen.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of pERK, pAKT and p53 as biomarkers in patients with advanced pancreatic cancer has not yet been defined.

methodsWithin the phase III study AIO-PK0104 281 patients with advanced pancreatic cancer received an erlotinib-based 1st-line regimen. Archival tissue from 153 patients was available for central immunohistochemistry staining for pERK, pAKT and p53. Within a subgroup analysis, biomarker data were correlated with efficacy endpoints and skin rash using a Cox regression model.

resultsFifty-five out of 153 patients were classified as pERKlow and 98 patients as pERKhigh; median overall survival (OS) was 6.2 months and 5.7 months, respectively (HR 1.29, p = 0.16). When analysing pERK as continuous variable, the pERK score was significantly associated with OS (HR 1.06, 95% CI 1.0-1.12, p = 0.05). Twenty-one of 35 patients were pAKTlow and 14/35 pAKThigh with a corresponding median OS of 6.4 months and 6.8 months, respectively (HR 1.03, p = 0.93). Four out of 50 patients had a complete loss of p53 expression, 20 patients a regular expression and 26 patients had tumors with p53 overexpression. The p53 status had no impact on OS (p = 0.91); however, a significant improvement in progression-free survival (PFS) (6.0 vs 1.8 months, HR 0.24, p = 0.02) and a higher rate of skin rash (84% vs 25%, p = 0.02) was observed for patients with a regular p53 expression compared to patients with a complete loss of p53.

conclusionpERK expression may have an impact on OS in erlotinib-treated patients with advanced pancreatic cancer; p53 should be further investigated for its potential role as a predictive marker for PFS and skin rash.

trial registrationNCT00440167 (registration date: February 22, 2007).

Indexed as

AdultBiomarkers, TumoreIF-2 KinaseErlotinib HydrochlorideExtracellular Signal-Regulated MAP KinasesFemaleHumansMaleMiddle AgedPancreatic NeoplasmsPhosphorylationProto-Oncogene Proteins c-aktQuinazolinesSurvival AnalysisTumor Suppressor Protein p53Young AdultBiomarkers, TumorEIF2AK3 protein, humaneIF-2 KinaseErlotinib HydrochlorideExtracellular Signal-Regulated MAP KinasesProto-Oncogene Proteins c-aktQuinazolinesTP53 protein, humanTumor Suppressor Protein p53

Identifiers

PMID25164437
PMCPMC4152581

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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.