Evidence map›Paper›PMID 36424033›Full record

Observational studyJournal for immunotherapy of cancer2022

Nivolumab serum concentration in metastatic melanoma patients could be related to outcome and enhanced immune activity: a gene profiling retrospective analysis.

Domenico Mallardo, Diana Giannarelli, Maria Grazia Vitale, Domenico Galati, Giusy Trillò, Assunta Esposito, Maria Antonietta Isgrò, Grazia D'Angelo, Lucia Festino, Vito Vanella and 13 more

Erratum issuedOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.2field-weighted citation impact, top 19% 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

10 citing papers in PubMed, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 2 institutions in 2 countries.

Domenico MallardoInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Diana GiannarelliInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.ORCID 0000-0002-6085-1195
Maria Grazia VitaleInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.ORCID 0000-0003-2331-5315
Domenico GalatiInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Giusy TrillòInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Assunta EspositoInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Maria Antonietta IsgròInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Grazia D'AngeloInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Lucia FestinoInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Vito VanellaInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Claudia TrojanielloInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Andrew WhiteNanoString Technologies Inc, Seattle, Washington, USA.
Teresa De CristofaroInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Michael BaileyNanoString Technologies Inc, Seattle, Washington, USA.
Sandro PignataInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Corrado CaracòInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Antonella PetrilloInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.ORCID 0000-0002-6074-7670
Paolo MutoInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.ORCID 0000-0002-7546-6441
Piera MaiolinoInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Alfredo BudillonInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.ORCID 0000-0002-6330-6053
Sarah WarrenNanoString Technologies Inc, Seattle, Washington, USA.ORCID 0000-0002-5046-2890
Ernesta CavalcantiInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.ORCID 0000-0001-6302-1579
Paolo Antonio AsciertoInstituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.ORCID 0000-0002-8322-475X
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITNanostring Technologies (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab is an anti-PD-1 antibody approved for treating metastatic melanoma (MM), for which still limited evidence is available on the correlation between drug exposure and patient outcomes.

methodsIn this observational retrospective study, we assessed whether nivolumab concentration is associated with treatment response in 88 patients with MM and if the patient's genetic profile plays a role in this association.

resultsWe observed a statistically significant correlation between nivolumab serum concentration and clinical outcomes, measured as overall and progression-free survival. Moreover, patients who achieved a clinical or partial response tended to have higher levels of nivolumab than those who reached stable disease or had disease progression. However, the difference was not statistically significant. In particular, patients who reached a clinical response had a significantly higher concentration of nivolumab and presented a distinct genetic signature, with more marked activation of ICOS and other genes involved in effector T-cells mediated proinflammatory pathways.

conclusionsIn conclusion, these preliminary results show that in patients with MM, nivolumab concentration correlates with clinical outcomes and is associated with an increased expression of ICOS and other genes involved in the activation of T effectors cells.

Indexed as

MelanomaNeoplasms, Second PrimaryAntibodies, MonoclonalGenetic ProfileHumansNivolumabRetrospective StudiesAntibodies, MonoclonalNivolumabImmunotherapyMelanomaTumor Biomarkers

Identifiers

PMID36424033
PMCPMC9693654
OpenAlexW4309887002

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.