Evidence map›Paper›PMID 36455507›Full record

Trial reportESMO open2022

PEOPLE (NCT03447678), a first-line phase II pembrolizumab trial, in negative and low PD-L1 advanced NSCLC: clinical outcomes and association with circulating immune biomarkers.

G Lo Russo, F Sgambelluri, A Prelaj, F Galli, S Manglaviti, A Bottiglieri, R M Di Mauro, R Ferrara, G Galli, D Signorelli and 19 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. 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

29 authors at 2 institutions in 1 country.

G Lo RussoMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address: giuseppe.lorusso@istitutotumori.mi.it.
F SgambelluriDepartment of Research, Human Tumors Immunobiology Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
A PrelajMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; Department of Electronics, Information, and Bioengineering, Politecnico di Milano, Milan, Italy.
F GalliOncology Department, Istituto di Ricerche Farmacologiche Mario Negri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy.
S ManglavitiMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
A BottiglieriMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
R M Di MauroMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
R FerraraMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
G GalliMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; Medical Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.
D SignorelliMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; Medical Oncology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
A De TomaMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
M OcchipintiMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
M BrambillaMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
E RulliOncology Department, Istituto di Ricerche Farmacologiche Mario Negri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy.
T TriulziMolecular Targeting Unit, Department of Research, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
T TorelliDepartment of Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
L AgnelliDepartment of Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
S BrichDepartment of Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
A MartinettiMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
A D DumitrascuMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
V TorriOncology Department, Istituto di Ricerche Farmacologiche Mario Negri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy.
G PruneriDepartment of Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
A FabbriDepartment of Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
F de BraudMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
A AnichiniDepartment of Research, Human Tumors Immunobiology Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
C ProtoMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
M GanzinelliMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
R MortariniMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
M C GarassinoMedical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; Department of Medicine, University of Chicago Comprehensive Cancer Center, University of Chicago, Chicago, USA.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITMario Negri Institute for Pharmacological Research · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe PEOPLE trial aimed to identify new immune biomarkers in negative and low programmed death-ligand 1 (PD-L1) (0%-49%) advanced non-small-cell lung cancer (aNSCLC) patients treated with first-line pembrolizumab. Here we report the main outcomes and the circulating immune biomarkers analysis. PATIENTS AND

methodsThe primary endpoint of this phase II trial was the identification of immune biomarkers associated with progression-free survival (PFS). Overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety were secondary endpoints. Absolute cell counts for 36 subsets belonging to innate and adaptive immunity were determined by multiparametric flow cytometry in peripheral blood at baseline and at first radiologic evaluation. An orthoblique principal components-based clustering approach and multivariable Cox regression model adjusted for clinical variables were used to analyze immune variables and their correlation with clinical endpoints.

resultsFrom May 2018 to October 2020, 65 patients were enrolled. After a median follow-up of 26.4 months, the median PFS was 2.9 months [95% confidence interval (CI) 1.8-5.6 months] and median OS was 12.1 months (95% CI 8.7-17.1 months). The ORR was 21.5%, DCR was 47.7% and median DoR was 14.5 months (95% CI 6.4-24.9 months). Drug-related grade 3-4 adverse events were 9.2%. Higher T cell and natural killer (NK) cell count at baseline and at the first radiologic evaluation were associated with improved PFS, DCR and OS. On the contrary, higher myeloid cell count at baseline or at the first radiologic evaluation was significantly associated with worse OS and DCR.

conclusionsCirculating immune biomarkers can contribute to predict outcomes in negative and low PD-L1 aNSCLC patients treated with first-line single-agent pembrolizumab.

Indexed as

Antineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkersHumansAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkersCD274 protein, humanpembrolizumabadvanced NSCLCcirculating immune biomarkersfirst linenegative and low PD-L1pembrolizumab

Identifiers

PMID36455507
PMCPMC9808469
OpenAlexW4310150493

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.