Evidence map›Paper›PMID 20826737›Full record

ReviewJournal of the National Cancer Institute2010

Improved endpoints for cancer immunotherapy trials.

Axel Hoos, Alexander M M Eggermont, Sylvia Janetzki, F Stephen Hodi, Ramy Ibrahim, Aparna Anderson, Rachel Humphrey, Brent Blumenstein, Lloyd Old, Jedd Wolchok

3 registry-linked trialsOpen access · bronzeAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of the National Cancer Institute, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 233 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
233citing papers in PubMed, 3 pooled it
20.4field-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.

NCT01363206 phase2completednot on this mapstarted 2011, after this paper: background citation

GM-CSF and Ipilimumab as Therapy in Metastatic Melanoma, a Phase II Study

TypeinterventionalSponsorLynn E. Spitler, MDRan2011 to 2015Enrolled29ConditionsMalignant Melanoma, MetastaticArmsGranulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Ipilimumab
NCT01984892 phase2terminatednot on this mapstarted 2013, after this paper: background citation

Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC): A Phase II Clinical Study

TypeinterventionalSponsorNina BhardwajRan2013 to 2014Enrolled8ConditionsMelanoma, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of the Skin, Sarcoma of the SkinArmsPoly-ICLC
NCT04212377 phase2completednot on this mapstarted 2019, after this paper: background citation

An Exploratory Study: Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients

TypeinterventionalSponsorRadboud University Medical CenterRan2019 to 2021Enrolled8ConditionsEndometrial CancerArmsDendritic Cells for endometrial cancer
3 · Its place in the literature

Who cites it

233 citing papers in PubMed, 3 syntheses or guidelines pooled it, 515 citations in OpenAlex.

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  10. Integrative Development of a TLR8 Agonist for Ovarian Cancer Chemoimmunotherapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
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  16. 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
  17. Human Epidermal Growth Factor Receptor 2 (HER2) -Specific Chimeric Antigen Receptor-Modified T Cells for the Immunotherapy of HER2-Positive Sarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Trial
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173 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Axel HoosCancer Immunotherapy Consortium of the Cancer Research Institute, New York, NY, USA. axel.hoos@bms.com
Alexander M M Eggermont
Sylvia Janetzki
F Stephen Hodi
Ramy Ibrahim
Aparna Anderson
Rachel Humphrey
Brent Blumenstein
Lloyd Old
Jedd Wolchok
Dana-Farber Cancer Institute · USErasmus MC · NLBristol-Myers Squibb (United States) · USLudwig Cancer Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations systematically evaluated an immunotherapy-focused clinical development paradigm and created the principles for redefining trial endpoints. On this basis, a body of clinical and laboratory data was generated that supports three novel endpoint recommendations. First, cellular immune response assays generate highly variable results. Assay harmonization in multicenter trials may minimize variability and help to establish cellular immune response as a reproducible biomarker, thus allowing investigation of its relationship with clinical outcomes. Second, immunotherapy may induce novel patterns of antitumor response not captured by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. New immune-related response criteria were defined to more comprehensively capture all response patterns. Third, delayed separation of Kaplan-Meier curves in randomized immunotherapy trials can affect results. Altered statistical models describing hazard ratios as a function of time and recognizing differences before and after separation of curves may allow improved planning of phase III trials. These recommendations may improve our tools for cancer immunotherapy trials and may offer a more realistic and useful model for clinical investigation.

Indexed as

Immunity, CellularOutcome Assessment, Health CareBiomarkers, TumorCancer VaccinesClinical Trials as TopicHumansImmunotherapyKaplan-Meier EstimateModels, StatisticalMulticenter Studies as TopicNeoplasmsRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeBiomarkers, TumorCancer Vaccines

Identifiers

PMID20826737
PMCPMC2943524
OpenAlexW2102143045

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.