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Analysis of institutional authors

Pina, Jose Javier BerenguerAuthor

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March 29, 2025
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Gender Difference in sidE eFfects of ImmuNotherapy: a possible clue to optimize cancEr tReatment (G-DEFINER): study protocol of an observational prospective multicenter study

Publicated to:Acta Oncologica. 63 213-219 - 2024-04-21 63(), DOI: 10.2340/1651-226X.2024.24179

Authors: Miceli, Rosalba; Eriksson, Hanna; Lo Russo, Giuseppe; Alfieri, Salvatore; Bjaanaes, Maria Moksnes; Pietrantonio, Filippo; De Cecco, Loris; Proto, Claudia; Franzen, Johan; McDonnell, Deirdre; Pina, Jose Javier Berenguer; Beninato, Teresa; Mazzeo, Laura; Giannatempo, Patrizia; Verzoni, Elena; Crown, John; Helland, Aslaug; Eustace, Alexander J

Affiliations

Dublin City Univ, Life Sci Inst, Sch Biotechnol, Dublin, Ireland - Author
Fdn IRCCS Ist Nazl Tumori, Dept Epidemiol & Data Sci, Unit Biostat Clin Res, Milan, Italy - Author
Fdn IRCCS Ist Nazl Tumori, Dept Expt Oncol, Integrated Biol Rare Tumors, Milan, Italy - Author
Fdn IRCCS Ist Nazl Tumori, Med Oncol Dept, Head & Neck Unit, Milan, Italy - Author
Fdn IRCCS Ist Nazl Tumori, Med Oncol Dept, Milan, Italy - Author
Fdn IRCCS Ist Nazl Tumori, Med Oncol Dept, Thorac Oncol Unit, Milan, Italy - Author
Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden - Author
Karolinska Univ Hosp Solna, Unit Head Neck Lung & Skin Canc, Theme Canc, Stockholm, Sweden - Author
Oslo Univ Hosp, Dept Oncol, Oslo, Norway - Author
St Vincents Univ Hosp, Dept Med Oncol, Dublin, Ireland - Author
Univ Oslo, Radium Hosp Oncol, Inst Clin Med, Oslo, Norway - Author
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Abstract

Background: Immune 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. Aims: The 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 Results: The 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. Interpretation: The 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.

Keywords

Clinical medicineImmune checkpoint inhibitorsNorwaOsloSelectio

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Acta Oncologica due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2024 there are still no calculated indicators, but in 2023, it was in position , thus managing to position itself as a Q2 (Segundo Cuartil), in the category . Notably, the journal is positioned en el Cuartil Q3 for the agency WoS (JCR) in the category Oncology.

Independientemente del impacto esperado determinado por el canal de difusión, es importante destacar el impacto real observado de la propia aportación.

Según las diferentes agencias de indexación, el número de citas acumuladas por esta publicación hasta la fecha 2025-07-20:

  • WoS: 2

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-07-20:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 11.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 9 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 0.25.

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Italy; Norway; Sweden; United Kingdom.