Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer: insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study.

Autor:	Assoumou L; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France lambert.assoumou@iplesp.upmc.fr., Baldé R; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France., Katlama C; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, service des maladies infectieuses, Paris, France., Abbar B; Sorbonne University, Department of Medical Oncology Assistance Publique - Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Institut Universitaire de Cancérologie, CLIP² Galilée, INSERM U1135, Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris), Paris, France., Delobel P; CHU de Toulouse, Service des Maladies Infectieuses et Tropicales, INSERM, UMR1291, Université Toulouse III-Paul Sabatier, Toulouse, France., Allegre T; Department of Hematology Oncology & Internal Médicine Centre Hospitalier d'Aix en Provence, Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France., Lavole A; GRC#04 Theranoscan, Département de Pneumologie et Oncologie Thoracique, AP-HP, Hôpital Tenon, Sorbonne Université, Paris, France., Makinson A; INSERM U1175, Département de Maladies Infectieuses, Centre Hospitalier Universitaire de Montpellier, Université de Montpellier, Montpellier, France., Zaegel-Faucher O; Aix-Marseille Université, APHM Sainte-Marguerite, Service d'immuno-hématologie Clinique, Marseille, France., Greillier L; Multidisciplinary Oncology and Therapeutic Innovations Department, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille University, Marseille, France., Soulie C; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, laboratoire de virologie, Paris, France., Veyri M; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, Département d'Oncologie Médicale, Paris, France., Bertheau M; Inserm-ANRS MIE, clinical research department, Paris, France., Algarte Genin M; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France., Gibowski S; Inserm-ANRS MIE, safety department, Paris, France., Marcelin AG; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, laboratoire de virologie, Paris, France., Bihan K; Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Department of Pharmacology, AP-HP, Pitié-Salpêtrière Hospital, Paris, France., Baron M; Sorbonne University, Department of Medical Oncology Assistance Publique - Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Institut Universitaire de Cancérologie, CLIP² Galilée, INSERM U1135, Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris), Paris, France., Costagliola D; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France., Lambotte O; Département d'Immunologie Clinique, AP-HP, Hôpital Bicêtre, Université Paris-Saclay, Le Kremlin Bicêtre, France., Spano JP; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, Département d'Oncologie Médicale, Paris, France.
Jazyk:	angličtina
Zdroj:	Journal for immunotherapy of cancer [J Immunother Cancer] 2024 Aug 22; Vol. 12 (8). Date of Electronic Publication: 2024 Aug 22.
DOI:	10.1136/jitc-2024-009728
Abstrakt:	Background: Immune checkpoint inhibitors (ICIs) have been a major advance in cancer management. However, we still lack prospective real-world data regarding their usage in people with HIV infection (PWH). Methods: The ANRS CO24 OncoVIHAC study (NCT03354936) is an ongoing prospective observational cohort study in France of PWH with cancer treated with ICI. We assessed the incidence of grade ≥3 immune-related adverse events (irAEs). All grade ≥3 irAEs were reviewed by an event review. Results: Between January 17, 2018, and December 05, 2023, 150 participants were recruited from 33 sites and 140 were included in this analysis. At the data cut-off date of December 05, 2023, the median follow-up was 9.2 months (IQR: 3.9-18.3), with a total of 126.2 person-years.Median age was 59 years (IQR: 54-64) and 111 (79.3%) were men. Median time since HIV diagnosis was 25 years (12-31), the median duration on antiretroviral (ARV) was 19.5 years (7.7-25.4), and the CD4 nadir was 117/µL (51-240). ICI regimens comprised anti-programmed cell death protein-1 (PD-1) for 111 (79.3%) participants, anti-programmed death-ligand 1 for 25 (17.9%), a combination of anti-PD-1 and anti-cytotoxic T-lymphocyte associated protein 4 for 3 (2.1%), and anti-PD-1 along with anti-vascular endothelial growth factor receptor for 1 (0.7%). The most frequent cancers were lung (n=65), head/neck (n=15), melanoma (n=12), liver (n=11) and Hodgkin's lymphoma (n=9).During follow-up, a total of 34 grade ≥3 irAEs occurred in 20 participants, leading to an incidence rate of 26.9 per 100 person-years. The Kaplan-Meier estimates of the proportion of participants with at least one episode of grade ≥3 irAEs were 13.8% at 6 months, 15.0% at 12 months and 18.7% at 18 months. One treatment-related death due to myocarditis was reported (0.7%). Multivariable analysis of cumulative incidence showed that participants with time since HIV diagnosis >17 years (incidence rate ratio (IRR)=4.66, p=0.002), with CD4<200 cells/µL (IRR=4.39, p<0.0001), with positive cytomegalovirus (CMV) serology (IRR=2.76, p=0.034), with history of cancer surgery (IRR=3.44, p=0.001) had a higher risk of incidence of grade ≥3 irAEs. Conclusion: This study showed that the incidence of a first episode of grade ≥3 irAE was 15.0% (95% CI: 9.6% to 22.9%) at 1 year and the cumulative incidence of all severe irAE episodes was 26.9 per 100 person-years. Low CD4 count, positive CMV serology, history of cancer surgery and a longer time since HIV diagnosis were associated with the occurrence of severe irAEs. Competing Interests: Competing interests: DC received personal fees from Pfizer for a lecture outside of the submitted work. A-GM and CK received consulting fees from Gilead Sciences, Merck, and ViiV. J-PS received grant from MSD avenir and personal fees from Roche, MSD, AZ, Novartis, leopharma, PFO, Lilly, Gilead, Daichy-sakyo, and Pfizer for lectures, presentations, speakers bureaus, manuscript writing or educational events outside of the submitted work. OL reports paid expert testimony and consultancy fees from BMS France, MSD; consultancy fees from Boehringer, AbbVie. BA reports research grant from MSD avenir, and consulting fees or honoraria from Novartis, AstraZeneca, BMS, MSD, Astellas, and Sanofi. MV received consulting fees from Gilead Sciences. All other authors declare no competing interests. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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