Evidence map›Paper›PMID 38647024›Full record

ArticleActa oncologica (Stockholm, Sweden)2024

Gender Difference in sidE eFfects of ImmuNotherapy: a possible clue to optimize cancEr tReatment (G-DEFINER): study protocol of an observational prospective multicenter study.

Rosalba Miceli, Hanna Eriksson, Giuseppe Lo Russo, Salvatore Alfieri, Maria Moksnes Bjaanæs, Filippo Pietrantonio, Loris De Cecco, Arsela Prelaj, Claudia Proto, Johan Franzén and 9 more

Open access · diamondAbstract readClinical Trial Protocol
In one paragraph

Article in Acta oncologica (Stockholm, Sweden), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 24% 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

6 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
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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

19 authors at 4 institutions in 4 countries.

Rosalba Miceli *Unit of Biostatistics for Clinical Research, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. rosalba.miceli@istitutotumori.mi.it.
Hanna Eriksson *Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden; Theme Cancer, unit of Head-Neck-, Lung-, and Skin Cancer Karolinska University Hospital-Solna, Stockholm, Sweden. hanna.eriksson.4@ki.se.
Giuseppe Lo RussoThoracic Oncology Unit, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Salvatore AlfieriHead and Neck Unit, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Maria Moksnes BjaanæsDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Filippo PietrantonioMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Loris De CeccoIntegrated biology of rare tumors, Department of Experimental Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Arsela PrelajThoracic Oncology Unit, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Claudia ProtoThoracic Oncology Unit, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Johan FranzénDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden; Theme Cancer, unit of Head-Neck-, Lung-, and Skin Cancer Karolinska University Hospital-Solna, Stockholm, Sweden.
Deirdre McDonnellDepartment of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
José Javier Berenguer PinaDepartment of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
Teresa BeninatoThoracic Oncology Unit, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Laura MazzeoThoracic Oncology Unit, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Patrizia GiannatempoMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Elena VerzoniMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
John CrownDepartment of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
Åslaug Helland *Radium Hospital/Oncology, University of Oslo, Institute of Clinical medicine, Oslo, Norway.
Alexander Eustace *Department of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITSt. Vincent's University Hospital · IEKarolinska University Hospital · SEOslo University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) have significantly improved outcomes in various cancers. ICI treatment is associated with the incidence of immune-related adverse events (irAEs) which can affect any organ. Data on irAEs occurrence in relation to sex- differentiation and their association with gender-specific factors are limited.

aimsThe primary objective of the G-DEFINER study is to compare the irAEs incidence in female and male patients who undergo ICI treatment. Secondary objectives are: to compare the irAEs incidence in pre- and postmenopausal female patients; to compare the irAEs incidence in female and male patients according to different clinical and gender-related factors (lifestyle, psychosocial, and behavioral factors). Exploratory objectives of the study are to compare and contrast hormonal, gene-expression, SNPs, cytokines, and gut microbiota profiles in relation to irAEs incidence in female and male patients. METHODS AND

resultsThe patients are recruited from Fondazione IRCCS Istituto Nazionale dei Tumori, Italy, St Vincent's University Hospital, Ireland, Oslo University Hospital, Norway, and Karolinska Insitutet/Karolinska University Hospital, Sweden. The inclusion of patients was delayed due to the Covid pandemic, leading to a total of 250 patients recruited versus a planned number of 400 patients. Clinical and translational data will be analyzed.

interpretationThe expected outcomes are to improve the management of cancer patients treated with ICIs, leading to more personalized clinical approaches that consider potential toxicity profiles. The real world nature of the trial makes it highly applicable for timely irAEs diagnosis.

Indexed as

Immune Checkpoint InhibitorsNeoplasmsDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunotherapyIncidenceMaleMulticenter Studies as TopicObservational Studies as TopicProspective StudiesSex FactorsImmune Checkpoint Inhibitors

Identifiers

PMID38647024
PMCPMC11332465
OpenAlexW4395006668

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.