Evidence map›Paper›PMID 23429495›Full record

Trial reportPancreas2013

Disrupting cytokine signaling in pancreatic cancer: a phase I/II study of etanercept in combination with gemcitabine in patients with advanced disease.

Christina Wu, Soledad A Fernandez, Tamara Criswell, Tarek A Chidiac, Denis Guttridge, Miguel Villalona-Calero, Tanios S Bekaii-Saab

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Pancreas, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00201838 (A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT00201838 phase1 / phase2completednot on this map

A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma

TypeinterventionalSponsorOhio State University Comprehensive Cancer CenterRan2001 to 2007Enrolled38ConditionsPancreatic Neoplasms, AdenocarcinomaArmsGemcitabine, Etanercept
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Mitochondrial double-stranded RNA fuels pancreatic cancer growth via RIG-I/TLR3 inflammation.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Focus on Pancreatic Cancer Microenvironment.Current oncology (Toronto, Ont.) · 2024
    Review
  8. Review
  9. Targeting inflammation as cancer therapy.Journal of hematology & oncology · 2024
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. OncogenicCancers · 2021
    Review
  18. Review
  19. Article
  20. Review
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

7 authors at 4 institutions in 1 country.

Christina WuOhio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research, Institute, Columbus, OH, USA.
Soledad A Fernandez
Tamara Criswell
Tarek A Chidiac
Denis Guttridge
Miguel Villalona-Calero
Tanios S Bekaii-Saab
The Ohio State University · USMark H. Zangmeister Cancer Center · USPalmetto Hematology Oncology · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
TNF Blockade in Pancreatic Cancer PatientsR21CA101360 · NCI · OHIO STATE UNIVERSITY · PI VILLALONA, MIGUEL ANGEL · 2003 to 2004
$665k
NCI NIH HHS P30 CA016058NCI NIH HHS R21 CA101360
6 · The paper itself

Abstract

objectivesEtanercept blocks tumor necrosis factor α (TNF-α), a proinflammatory cytokine that plays a role in cancer-related cachexia and tumor growth. A phase I/II study was conducted to assess the tolerability and efficacy of gemcitabine and etanercept in advanced pancreatic cancer.

methodsTwenty-five patients received etanercept 25 mg subcutaneously twice weekly with gemcitabine. A control cohort of 8 patients received gemcitabine alone. The primary end point was progression-free survival at 6 months. Blood specimens were analyzed for TNF-α, IL-1β, IL-6, interferon-γ, IL-10, and NF-κβ activation. The trial is registered with ClinicalTrials.gov, number NCT00201838.

resultsThirty-eight patients participated in this study. In the gemcitabine-etanercept cohort, grade 3/4 drug-related toxicities included leucopenia (3) and neutropenia (6). There were 3 (12%) patients with partial response and 8 (32%) patients with stable disease. The rate of progression-free survival at 6 months was 28% [n = 7; 95% confidence interval (CI), 20%-36%]. Median time to progression was 2.23 months (95% CI, 1.86-4.36 months) and median overall survival was 5.43 months (95% CI, 3.30-10.23 months). Clinical benefit rate was 33% of the evaluable patients. A correlation was seen between IL-10 levels and clinical benefit.

conclusionsEtanercept added to gemcitabine is safe but did not show significant enhancement of gemcitabine in patients with advanced pancreatic cancer.

Indexed as

AgedAged, 80 and overAnemiaAntineoplastic Combined Chemotherapy ProtocolsCytokinesDeoxycytidineDisease-Free SurvivalDrug Administration ScheduleEtanerceptFatigueFemaleGemcitabineHumansImmunoglobulin GInterferon-gammaInterleukin-10CytokinesDeoxycytidineEtanerceptGemcitabineImmunoglobulin GInterferon-gammaInterleukin-10Interleukin-1betaInterleukin-6Receptors, Tumor Necrosis FactorTumor Necrosis Factor-alpha

Identifiers

PMID23429495
PMCPMC3664263
OpenAlexW2055933911

What OpenQuestion holds

Textmetadata
LicenceTDM
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.