Evidence map›Paper›PMID 21217520›Full record

Trial reportAnnals of surgery2011

A lethally irradiated allogeneic granulocyte-macrophage colony stimulating factor-secreting tumor vaccine for pancreatic adenocarcinoma. A Phase II trial of safety, efficacy, and immune activation.

Eric Lutz, Charles J Yeo, Keith D Lillemoe, Barbara Biedrzycki, Barry Kobrin, Joseph Herman, Elizabeth Sugar, Steven Piantadosi, John L Cameron, Sara Solt and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of surgery, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02004262 (A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine), which is not on this map. Cited by 228 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
228citing papers in PubMed, 1 pooled it
15.3field-weighted citation impact, top 1% 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.

NCT02004262 phase2completednot on this mapstarted 2014, after this paper: background citation

A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS 207 Compared to Chemotherapy or to CRS-207 Alone in Adults With Previously-Treated Metastatic Pancreatic Adenocarcinoma

TypeinterventionalSponsorAduro Biotech, Inc.Ran2014 to 2016Enrolled303Conditions2nd-line, 3rd-line and Greater Metastatic Pancreatic CancerArmsGVAX Pancreas Vaccine, CRS-207, Chemotherapy, cyclophosphamide
3 · Its place in the literature

Who cites it

228 citing papers in PubMed, 1 synthesis or guideline pooled it, 396 citations in OpenAlex.

  1. Pooled it
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  4. Systemic Immune Activity Predicts Overall Survival in Treatment-Naïve Patients with Metastatic Pancreatic Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
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  11. Article
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  15. Advanced Human Immune Cell-Organoid Co-Cultures for Functional Testing of Cancer Nanovaccines.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Review

168 more citing papers are in PubMed but not listed here.

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 5 institutions in 1 country.

Eric LutzDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA.
Charles J Yeo
Keith D Lillemoe
Barbara Biedrzycki
Barry Kobrin
Joseph Herman
Elizabeth Sugar
Steven Piantadosi
John L Cameron
Sara Solt
Beth Onners
Irena Tartakovsky
Miri Choi
Rajni Sharma
Peter B Illei
Ralph H Hruban
Ross A Abrams
Dung Le
Elizabeth Jaffee
Dan Laheru
Johns Hopkins University · USCedars-Sinai Medical Center · USIndiana University School of MedicineRush University · USThomas Jefferson University · US

Funding

ALLOGENIC PANCREATIC TUMOR VACCINE CELL LINER01CA088058 · NCI · JOHNS HOPKINS UNIVERSITY · PI JAFFEE, ELIZABETH MARION · 2000 to 2003
$1.6M
Gene Modified Cell Lines as Vaccine for Pancreas CancerK23CA093566 · NCI · JOHNS HOPKINS UNIVERSITY · PI LAHERU, DANIEL A · 2002 to 2006
$684k
NCI NIH HHS CA093566-01A1NCI NIH HHS K23 CA093566NCI NIH HHS R01 CA088058NCI NIH HHS R01CA88058-01
6 · The paper itself

Abstract

purposeSurgical resection provides the only possibility of cure for pancreas cancer. A standard adjuvant approach has not been established. We tested the safety and efficacy of a granulocyte-macrophage colony-stimulating factor (GM-CSF)-based immunotherapy administered in patients with resected pancreatic adenocarcinoma. PATIENTS AND

methodsA single institution phase II study of 60 patients with resected pancreatic adenocarcinoma was performed. Each immunotherapy treatment consisted of a total of 5 × 108 GM-CSF-secreting cells distributed equally among 3 lymph node regions. The first immunotherapy treatment was administered 8 to 10 weeks after surgical resection. Subsequently, patients received 5-FU based chemoradiation. Patients who remained disease-free after completion of chemoradiotherapy received treatments 2 to 4, each 1 month apart. A fifth and final booster was administered 6 months after the fourth immunotherapy. The primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses.

resultsThe median disease-free survival is 17.3 months (95% CI, 14.6-22.8) with median survival of 24.8 months (95% CI, 21.2-31.6). The administration of immunotherapy was well tolerated. In addition, the post-immunotherapy induction of mesothelin-specific CD8+ T cells in HLA-A1+ and HLA-A2+patients correlates with disease-free survival.

conclusionsAn immunotherapy approach integrated with chemoradiation is safe and demonstrates an overall survival that compares favorably with published data for resected pancreas cancer. These data suggest additional boost immunotherapies given at regular intervals beyond 1 year postsurgery should be tested in future studies, and provide the rationale for conducting a multicenter phase II study.

Indexed as

ImmunotherapyAdultAgedAged, 80 and overAntigens, NeoplasmCancer VaccinesCarcinoma, Pancreatic DuctalCell Line, TumorCombined Modality TherapyDisease-Free SurvivalFemaleGPI-Linked ProteinsGranulocyte-Macrophage Colony-Stimulating FactorHumansHypersensitivity, DelayedMaleAntigens, NeoplasmCancer VaccinesGPI-Linked ProteinsGranulocyte-Macrophage Colony-Stimulating FactorMesothelin

Identifiers

PMID21217520
PMCPMC3085934
OpenAlexW1988065950

What OpenQuestion holds

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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.