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
- Type de publi. : Article dans une revue
- Date de publi. : 22/08/2024
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Auteurs :
Lambert AssoumouRaghiatou BaldéChristine KatlamaBaptiste AbbarPierre DelobelThierry AllegreArmelle LavoleAlain MakinsonOlivia Zaegel-FaucherLaurent GreillierCathia SoulieMarianne VeyriMathilde BertheauMichèle Algarte GeninSéverine GibowskiAnne-Geneviève MarcelinKevin BihanMarine BaronDominique CostagliolaOlivier LambotteJean-Philippe Spano
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Organismes :
Institut Pierre Louis d'Epidémiologie et de Santé Publique
Institut Pierre Louis d'Epidémiologie et de Santé Publique
Institut Pierre Louis d'Epidémiologie et de Santé Publique
Sorbonne Université
Service Maladies infectieuses et tropicales [CHU Toulouse]
Centre Hospitalier d'Aix en Provence [Aix-en-Provence]
INSERM U64 [AP-HP Hôpital Tenon]
CHU Montpellier = Montpellier University Hospital
Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes
Hôpital Sainte-Marguerite [CHU - APHM]
Aix Marseille Université
Centre de Recherche en Cancérologie de Marseille
CHU Pitié-Salpêtrière [AP-HP]
Institut Pierre Louis d'Epidémiologie et de Santé Publique
ANRS - Maladies infectieuses émergentes
Institut Pierre Louis d'Epidémiologie et de Santé Publique
ANRS - Maladies infectieuses émergentes
Institut Pierre Louis d'Epidémiologie et de Santé Publique
Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases
Centre Régional de Pharmacovigilance Saint Louis [Paris]
CHU Pitié-Salpêtrière [AP-HP]
U489 Inserm [CHU Tenon, APHP]
Centre d'Immunologie et des Maladies Infectieuses
Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
Institut Pierre Louis d'Epidémiologie et de Santé Publique
- Publié dans Journal for Immunotherapy of Cancer le 24/10/2020
Résumé : 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, antiprogrammed 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 antivascular 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 treatmentrelated 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.
Fichiers liés :
Assoumou_2024.pdf
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