Evidence map›Paper›PMID 38348030›Full record

SynthesisFrontiers in immunology2024

Surrogate endpoints for overall survival in randomized clinical trials testing immune checkpoint inhibitors: a systematic review and meta-analysis.

Isabella Sala, Eleonora Pagan, Laura Pala, Chiara Oriecuia, Marco Musca, Claudia Specchia, Tommaso De Pas, Javier Cortes, Giuseppe Giaccone, Michael Postow and 3 more

Open access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. The Portability of Surrogate Endpoints.Journal of clinical pharmacology · 2026
    Article
  2. Article
  3. 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

13 authors at 8 institutions in 3 countries.

Isabella SalaDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.
Eleonora PaganDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.
Laura PalaDepartment of Medical Oncology, Humanitas Gavazzeni, Bergamo, Italy.
Chiara OriecuiaDepartment of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Marco MuscaDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.
Claudia SpecchiaDepartment of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Tommaso De PasDepartment of Medical Oncology, Humanitas Gavazzeni, Bergamo, Italy.
Javier CortesInternational Breast Cancer Center, Pangaea Oncology, Quiron Group, Madrid, Spain.
Giuseppe GiacconeMeyer Cancer Center, Weill Cornel Medicine, New York, NY, United States.
Michael PostowDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, United States.
Richard D GelberDepartment of Data Science, Dana-Farber Cancer Institute, Harvard Medical School, Harvard Tseng-Hsi (T.H.) Chan School of Public Health, and Frontier Science and Technology Research Foundation, Boston, MA, United States.
Vincenzo BagnardiDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.
Fabio ConfortiDepartment of Medical Oncology, Humanitas Gavazzeni, Bergamo, Italy.
University of Milano-Bicocca · ITHumanitas Gavazzeni · ITUniversity of Brescia · ITCornell University · USHarvard University · USJacobi Medical Center · USUniversidad Europea de Madrid · ESUniversity of Milan · IT

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Introduction: There is debate on which are the best surrogate endpoint and metric to capture treatment effect on overall survival (OS) in RCTs testing immune-checkpoint inhibitors (ICIs). Methods: We systematically searched for RCTs testing ICIs in patients with advanced solid tumors. Inclusion criteria were: RCTs i) assessing PD-(L)1 and CTLA-4 inhibitors either as monotherapy or in combination with another ICI, and/or targeted therapy, and/or chemotherapy, in patients with advanced solid tumors; ii) randomizing at least 100 patients. We performed a meta-analysis of RCTs to compare the surrogacy value of PFS and modified-PFS (mPFS) for OS in RCTs testing ICIs, when the treatment effect is measured by the hazard ratio (HR) for OS, and by the HR and the ratio of restricted mean survival time (rRMST) for PFS and mPFS. Results: 61 RCTs (67 treatment comparisons and 36,034 patients) were included in the analysis. In comparisons testing ICI plus chemotherapy, HR Conclusion: In RCTs testing ICIs, the value of potential surrogates for HR

Indexed as

Immune Checkpoint InhibitorsNeoplasmsBiomarkersHumansProportional Hazards ModelsRandomized Controlled Trials as TopicBiomarkersImmune Checkpoint Inhibitorsimmune check inhibitor (ICI)immunotherapymethodologyrandomized clinical trialsurrogate

Identifiers

PMID38348030
PMCPMC10859450
OpenAlexW4391320729

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.