Immunotherapy in Underrepresented Populations of Patients with Cancer: Do We Have Enough Evidence at Present? A Focus on Patients with Major Viral Infections and Autoimmune Disorders

Author:

Antonuzzo Andrea1,Calabrò Fabio2,Quaglino Pietro3,Roila Fausto4,Sebastiani Gian Domenico5,Spina Francesco6,Pasqualetti Giuseppe7,Cortinovis Diego8,Tagliaferri Enrico9,Peri Alessandro10,Presotto Elena Margherita10,Egidi Maria Francesca11,Giacomelli Luca1213,Farroni Ferruccio14,Di Maio Massimo1516,De Luca Emmanuele1516,Danova Marco17,Scottè Florian18,Jordan Karin19,Bossi Paolo20,

Affiliation:

1. UO Oncologia 1 SSN Polo Oncologico, Ambulatorio Terapie di Supporto, Pisa, Italy

2. San Camillo and Forlanini Hospital, Rome, Italy

3. Dermatologic Clinic, Department of Medical Sciences, Turin, Italy

4. Department of Medical Oncology, Azienda Ospedaliera, Universitaria Perugia, Italy

5. Unità Operativa Complessa di Reumatologia, Ospedale di Alta Specializzazione “San Camillo,”, Rome, Italy

6. Division of Hematology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori, Milan, Italy

7. Geriatrics Unit, Department of Clinical and Experimental Medicine, Pisa, Italy

8. SS Lung Unit, SC Oncologia Medica, HS Gerardo, Monza, Italy

9. UO Malattie Infettive, Pisa, Italy

10. Sodium Unit, Endocrinology, Department of Experimental and Clinical Biomedical Sciences, Mario Serio, University of Florence, Careggi Hospital, Florence, Italy

11. Azienda Ospedaliero Universitaria Pisana (AOUP), Pisa, Italy

12. Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy

13. Polistudium SRL, Milan, Italy

14. Gastroenterology Department, Foligno Hospital, Unità Sanitaria Locale Umbria 2, Foligno, Italy

15. Department of Oncology, University of Turin, Turin, Italy

16. Division of Medical Oncology, Azienda Ospedaliero Ordine Mauriziano Hospital, Turin, Italy

17. Department of Internal Medicine and Medical Oncology, Vigevano Civic Hospital, Azienda Socio Sanitaria Territoriale (ASST) of Pavia, Pavia, Italy

18. Medical Oncology and Supportive Care Department, Hôpital Foch, Suresnes, France

19. Leitende Oberärztin, Klinik für Hämatologie, Onkologie und Rheumatologie, Innere Medizin V, Universitätsklinikum Heidelberg, Heidelberg, Germany

20. Medical Oncology, University of Brescia, ASST-Spedali Civili, Brescia, Italy

Abstract

Abstract The safety and activity of immune checkpoint inhibitors have been characterized in interventional and observational studies. However, only small studies have specifically investigated these agents in patients who are excluded or underrepresented in clinical trials, frequently referred to as “special populations” or “underrepresented populations.” These include older adults, those with dysregulated immune activation, patients with a compromised immune function, and those carrying major viral infections, lymphoproliferative diseases, and major organ dysfunctions. Therefore, there remains substantial uncertainty regarding the use of immune checkpoint inhibitors in these specific settings. The Network of Italian Supportive Care in Oncology has carried out a multidisciplinary project, with the contribution of oncologists and other specialists, to retrieve the existing evidence on the use of immunotherapy in patients with solid and hematological cancers with the final aim to provide an expert guidance. The results of this effort are presented in this article, which is focused on patients with major viral infections or those with immune dysregulation/autoimmune diseases, and could be useful to guide decisions in clinical practice and to design prospective clinical trials focusing on the use of immunotherapy in these populations. Implications for Practice Substantial uncertainty remains regarding the use of immune checkpoint inhibitors in “underrepresented” patients, such as older adults, those with dysregulated immune activation, and patients with a compromised immune function, major viral infections, lymphoproliferative diseases or major organ dysfunctions. The Network of Italian Supportive Care in Oncology has carried out a multidisciplinary project to retrieve the existing evidence on the use of immunotherapy in underrepresented patients with cancer in order provide an expert guidance. The results of this effort, with a focus on patients with major viral infections or those with immune dysregulation/autoimmune diseases, are presented in this article and could be useful to guide decisions both in clinical practice and to design clinical trials.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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