Evidence map›Paper›PMID 27563654›Full record

ReviewAnnals of translational medicine2016

The European Organization for Research and Treatment of Cancer perspective on designing clinical trials with immune therapeutics.

Jessica Menis, Saskia Litière, Konstantinos Tryfonidis, Vassilis Golfinopoulos

Abstract readReview
In one paragraph

Review in Annals of translational medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Interim Futility Monitoring Assessing Immune Therapies With a Potentially Delayed Treatment Effect.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Article
  8. Review
  9. Article
  10. Overview of advances in cancer immunotherapy.Annals of translational medicine · 2016
    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

4 authors.

Jessica MenisEuropean Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
Saskia LitièreEuropean Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
Konstantinos TryfonidisEuropean Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
Vassilis GolfinopoulosEuropean Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cancer immunotherapy has had a major impact on the established paradigms of drug development and clinical trial research. The innovative mechanism of action of these compounds has resulted in new patterns of response and safety profiles, which pose challenges for the classical trial methodology. In this review we report on the search for the maximum tolerated dose, the recommended phase II dose and the appropriate target population in phase I trials. We provide some statistical considerations on the choice of endpoints for phase II and III trials and the limitations of frequently used trial designs in the presence of a delayed treatment effect, which may be induced by the immune modulating effect of the checkpoint inhibitors. We summarize the currently available data on the safety profile of these new compounds, which can guide protocol safety recommendations. Finally, we report on the current evidence of biomarker development.

Indexed as

biomarkerscheckpoint inhibitorsdelayed treatment effectimmune-related adverse effectsimmune-related responsesImmunotherapy

Identifiers

PMID27563654
PMCPMC4971371

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.