Evidence map›Paper›PMID 26808546›Full record

Trial reportPloS one2016

A Novel Biomarker Panel Examining Response to Gemcitabine with or without Erlotinib for Pancreatic Cancer Therapy in NCIC Clinical Trials Group PA.3.

David B Shultz, Jonathan Pai, Wayland Chiu, Kendall Ng, Madeline G Hellendag, Gregory Heestand, Daniel T Chang, Dongsheng Tu, Malcolm J Moore, Wendy R Parulekar and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00040183 (A Randomized Placebo Controlled Study of OSI-774), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

NCT00040183 phase3completednot on this map

A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

TypeinterventionalSponsorOSI PharmaceuticalsRan2001 to 2004Enrolled569ConditionsPancreatic CancerArmsTarceva (erlotinib HCl, OSI-774)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. 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

11 authors at 7 institutions in 2 countries.

David B ShultzPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Jonathan PaiSchool of Medicine, University of California San Francisco, San Francisco, United States of America.
Wayland ChiuDepartment of Radiation Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.
Kendall NgDepartment of Radiation Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.
Madeline G HellendagKaiser Permanente Medical Center, San Francisco, United States of America.
Gregory HeestandMoores Cancer Center, University of California San Diego, La Jolla, CA, United States of America.
Daniel T ChangDepartment of Radiation Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.
Dongsheng TuNCIC Clinical Trials Group, Queen's University, Kingston, Canada.
Malcolm J MooreBritish Columbia Cancer Agency, Vancouver, British Columbia, CA, United States of America.
Wendy R ParulekarNCIC Clinical Trials Group, Queen's University, Kingston, Canada.
Albert C KoongDepartment of Radiation Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.
Stanford University · USQueen's University · CAKaiser Permanente San Francisco Medical Center · USPrincess Margaret Cancer Centre · CAUniversity of California, San Diego · USUniversity of California, San Francisco · USVancouver Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNCIC Clinical Trials Group PA.3 was a randomized control trial that demonstrated improved overall survival (OS) in patients receiving erlotinib in addition to gemcitabine for locally advanced or metastatic pancreatic cancer. Prior to therapy, patients had plasma samples drawn for future study. We sought to identify biomarkers within these samples. EXPERIMENTAL

designUsing the proximity ligation assay (PLA), a probe panel was built from commercially available antibodies for 35 key proteins selected from a global genetic analysis of pancreatic cancers, and used to quantify protein levels in 20 uL of patient plasma. To determine if any of these proteins levels independently associated with OS, univariate and mulitbaraible Cox models were used. In addition, we examined the associations between biomarker expression and disease stage at diagnosis using Fisher's exact test. The correlation between Erlotinib sensitivity and each biomarkers was assessed using a test of interaction between treatment and biomarker. RESULTS AND

conclusionOf the 569 eligible patients, 480 had samples available for study. Samples were randomly allocated into training (251) and validation sets (229). Among all patients, elevated levels of interleukin-8 (IL-8), carcinoembryonic antigen (CEA), hypoxia-inducible factor 1-alpha (HIF-1 alpha), and interleukin-6 were independently associated with lower OS, while IL-8, CEA, platelet-derived growth factor receptor alpha and mucin-1 were associated with metastatic disease. Patients with elevated levels of receptor tyrosine-protein kinase erbB-2 (HER2) expression had improved OS when treated with erlotinib compared to placebo. In conclusion, PLA is a powerful tool for identifying biomarkers from archived, small volume serum samples. These data may be useful to stratify patient outcomes regardless of therapeutic intervention.

trial registrationClinicalTrials.gov NCT00040183.

Indexed as

Antineoplastic AgentsBiomarkers, TumorDeoxycytidineDouble-Blind MethodErlotinib HydrochlorideGemcitabineHumansPancreatic NeoplasmsPlacebosAntineoplastic AgentsBiomarkers, TumorDeoxycytidineErlotinib HydrochlorideGemcitabinePlacebos

Identifiers

PMID26808546
PMCPMC4725948
OpenAlexW2262031814

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.