Evidence map›Paper›PMID 26862857›Full record

Trial reportOncotarget2016

miR-21 expression and clinical outcome in locally advanced pancreatic cancer: exploratory analysis of the pancreatic cancer Erbitux, radiotherapy and UFT (PERU) trial.

Khurum Khan, David Cunningham, Clare Peckitt, Sarah Barton, Diana Tait, Maria Hawkins, David Watkins, Naureen Starling, Sheela Rao, Ruwaida Begum and 6 more

Open access · diamondAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
3.9field-weighted citation impact, top 5% 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

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 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

16 authors at 3 institutions in 2 countries.

Khurum KhanGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
David CunninghamGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Clare PeckittGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Sarah BartonGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Diana TaitGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Maria HawkinsGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
David WatkinsGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Naureen StarlingGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Sheela RaoGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Ruwaida BegumGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Janet ThomasGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Jacqui OatesGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Vincenza GuzzardoDepartment of Medicine, University of Padua, Padua, IT.
Matteo FassanDepartment of Medicine, University of Padua, Padua, IT.
Chiara BraconiGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Ian ChauGastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.
Royal Marsden NHS Foundation Trust · GBUniversity of Padua · ITUniversity of Oxford · GB

Funding

Medical Research Council MC_PC_12001/2
6 · The paper itself

Abstract

backgroundLocally advanced pancreatic cancer (LAPC) is associated with high mortality, and biomarker-driven treatment approach is currently lacking. This study evaluated safety and efficacy of a combination approach of chemotherapy followed by chemo-radiotherapy (CRT) +/- cetuximab, and the prognostic role of miR-21 in patients with LAPC treated with a multimodality approach. PATIENTS AND

methodsThis was a randomised phase II trial in which patients with inoperable LAPC were offered gemcitabine and capecitabine (GEM-CAP) for 16 weeks. Patients with stable disease or response after GEM-CAP were randomised to capecitabine or UFT plus radiotherapy (RT) (A), or capecitabine or UFT plus cetuximab plus RT (B). The primary outcome of the study was overall survival (OS). Clinical outcome was compared according to baseline circulating miR-21 levels.

results17 patients were enrolled and treated with GEM-CAP, with 13 patients achieving disease control and being randomised to arms A (n:7) and B (n:6). After a median follow-up of 61.2 months, median progression free survival (PFS) was 10.4 months and 12.7 months, median OS was 15.8 months and 22.0 months in arms A and B respectively (p > 0.05). Patients with high baseline plasma miR-21 had worse PFS (3.5 vs. 12.7 months; p:0.032) and OS (5.1 vs 15.3 months; p:0.5) compared to patients with low miR-21. Circulating miR-21 levels reflected miR-21 expression within the tissues.

conclusionsAddition of Cetuximab to CRT following induction chemotherapy did not improve survival. High miR-21 baseline plasma expression was associated with poor clinical outcome in LAPC patients treated with induction chemotherapy followed by chemo-radiotherapy.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCapecitabineCarcinoma, Pancreatic DuctalCetuximabChemoradiotherapyCombined Modality TherapyDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansInduction ChemotherapyKaplan-Meier EstimateMaleBiomarkers, TumorCapecitabineCetuximabDeoxycytidineGemcitabineMicroRNAsMIRN21 microRNA, humanTegafurUracilcetuximabchemo-radiotherapymicroRNAmiR-21pancreatic cancer

Identifiers

PMID26862857
PMCPMC4914313
OpenAlexW2261228095

What OpenQuestion holds

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Registered trials

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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.