Evidence map›Paper›PMID 21558394›Full record

ReviewClinical cancer research : an official journal of the American Association for Cancer Research2011

Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers.

Lisa H Butterfield, A Karolina Palucka, Cedrik M Britten, Madhav V Dhodapkar, Leif Håkansson, Sylvia Janetzki, Yutaka Kawakami, Thomas-Oliver Kleen, Peter P Lee, Cristina Maccalli and 23 more

2 registry-linked trialsAbstract readReview
In one paragraph

Review in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
–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.

NCT01858649 phase2completednot on this mapstarted 2013, after this paper: background citation

Randomized Phase 2 Study Comparing Pathological Responses on Colorectal Cancer Metastases After Preoperative Treatment Combining Bevacizumab With FOLFOX or FOLFIRI

TypeinterventionalSponsorCliniques universitaires Saint-Luc- Université Catholique de LouvainRan2013 to 2019Enrolled60ConditionsMetastatic Colorectal CancerArmsMetastases resection, Bevacizumab, 5 FU, Oxaliplatin, Irinotecan
NCT01858662 phase2terminatednot on this mapstarted 2014, after this paper: background citation

Randomised Phase 2 Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Treatment Combining Cetuximab With FOLFOX or FOLFIRI in RAS and B-RAF WT Tumors

TypeinterventionalSponsorCliniques universitaires Saint-Luc- Université Catholique de LouvainRan2014 to 2015Enrolled4ConditionsMetastatic Colorectal CancerArmsMetastases Resection ( multiple steep surgery possible), 5-Fluorouracile, leucovorin L, Oxaliplatin, Irinotecan
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome.Clinical cancer research : an official journal of the American Association for Cancer Research · 2015
    Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Folate Receptor Alpha Peptide Vaccine Generates Immunity in Breast and Ovarian Cancer Patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Article
  18. Evolving notions on immune response in colorectal cancer and their implications for biomarker development.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2018
    Review
  19. Article
  20. Article
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

33 authors.

Lisa H ButterfieldDepartment of Medicine, University of Pittsburgh, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA.
A Karolina Palucka
Cedrik M Britten
Madhav V Dhodapkar
Leif Håkansson
Sylvia Janetzki
Yutaka Kawakami
Thomas-Oliver Kleen
Peter P Lee
Cristina Maccalli
Holden T Maecker
Vernon C Maino
Michele Maio
Anatoli Malyguine
Giuseppe Masucci
Graham Pawelec
Douglas M Potter
Licia Rivoltini
Lupe G Salazar
Dolores J Schendel
Craig L Slingluff
Wenru Song
David F Stroncek
Hideaki Tahara
Magdalena Thurin
Giorgio Trinchieri
Sjoerd H van Der Burg
Theresa L Whiteside
Jon M Wigginton
Francesco Marincola
Samir Khleif
Bernard A Fox
Mary L Disis

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Therapuetic Immune Targeting of EphA2 Expressed by Melanoma & Its Tumor-AssociateP50CA121973 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KIRKWOOD, JOHN MUNN · 2008 to 2018
$22.9M
Role of inflammation, innate resistance, and immunity in carcinogenesis.ZIABC010793 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TRINCHIERI, GIORGIO · 2009 to 2025
$16.8M
Anti-Tumor immunity in myelomaR01CA106802 · NCI · YALE UNIVERSITY · PI DHODAPKAR, MADHAV V · 2004 to 2016
$3.3M
Exploiting Lymphopenia to Augment the Adoptive Immunotherapy of Melanoma PatientsR01CA119123 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI FOX, BERNARD A · 2006 to 2009
$988k
AFP-BASED PRIME-BOOST IMMUNOTHERAPY OF HCCR01CA104524 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BUTTERFIELD, LISA HELENE · 2004 to 2006
$898k
Clinical Trial of DRibble Vaccine in NSCLCR21CA123864 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI URBA, WALTER J · 2008 to 2009
$654k
Develop novel assays for assessing cellular and gene therapiesZIACL002119 · CLC · CLINICAL CENTER · PI STRONCEK, DAVID · 2010 to 2025
$0k
NCATS NIH HHS UL1 TR000005NCI NIH HHS P50 CA121973NCI NIH HHS R01 CA104524NCI NIH HHS R01 CA106802NCI NIH HHS R01 CA119123NCI NIH HHS R21 CA123864
6 · The paper itself

Abstract

purposeTo facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of antitumor immunity to measure and which assays are optimal for those measurements. EXPERIMENTAL

designThe iSBTc-SITC (International Society for Biological Therapy of Cancer-Society for Immunotherapy of Cancer), FDA (Food and Drug Administration), and NCI (National Cancer Institute) partnered to address these issues for immunotherapy of cancer. Here, we review the major challenges, give examples of approaches and solutions, and present our recommendations. RESULTS AND

conclusionsAlthough specific immune parameters and assays are not yet validated, we recommend following standardized (accurate, precise, and reproducible) protocols and use of functional assays for the primary immunologic readouts of a trial; consideration of central laboratories for immune monitoring of large, multi-institutional trials; and standardized testing of several phenotypic and functional potential potency assays specific to any cellular product. When reporting results, the full QA (quality assessment)/QC (quality control) should be conducted and selected examples of truly representative raw data and assay performance characteristics should be included. Finally, to promote broader analysis of multiple aspects of immunity, and gather data on variability, we recommend that in addition to cells and serum, RNA and DNA samples be banked (under standardized conditions) for later testing. We also recommend that sufficient blood be drawn to allow for planned testing of the primary hypothesis being addressed in the trial, and that additional baseline and posttreatment blood is banked for testing novel hypotheses (or generating new hypotheses) that arise in the field.

Indexed as

Practice Guidelines as TopicBiomarkers, TumorConsensus Statements as TopicHealth Planning GuidelinesHumansImmunotherapyInternational AgenciesMedical OncologyNational Cancer Institute (U.S.)NeoplasmsSocieties, MedicalUnited StatesUnited States Food and Drug AdministrationBiomarkers, Tumor

Identifiers

PMID21558394
PMCPMC3096674

What OpenQuestion holds

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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.