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Browsing Office of Educational Affairs, IU School of Medicine by Author "Addeo, Alfredo"
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Item Safety and Activity of Immune Checkpoint Inhibitors in People Living With HIV and Cancer: A Real-World Report From the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International (CATCH-IT) Consortium(American Society of Clinical Oncology, 2023) El Zarif, Talal; Nassar, Amin H.; Adib, Elio; Fitzgerald, Bailey G.; Huang, Jiaming; Mouhieddine, Tarek H.; Rubinstein, Paul G.; Nonato, Taylor; McKay, Rana R.; Li, Mingjia; Mittra, Arjun; Owen, Dwight H.; Baiocchi, Robert A.; Lorentsen, Michael; Dittus, Christopher; Dizman, Nazli; Falohun, Adewunmi; Abdel-Wahab, Noha; Diab, Adi; Bankapur, Anand; Reed, Alexandra; Kim, Chul; Arora, Aakriti; Shah, Neil J.; El-Am, Edward; Kozaily, Elie; Abdallah, Wassim; Al-Hader, Ahmad; Ghazal, Batool Abu; Saeed, Anwaar; Drolen, Claire; Lechner, Melissa G.; Drakaki, Alexandra; Baena, Javier; Nebhan, Caroline A.; Haykal, Tarek; Morse, Michael A.; Cortellini, Alessio; Pinato, David J.; Pria, Alessia Dalla; Hall, Evan; Bakalov, Veli; Bahary, Nathan; Rajkumar, Aarthi; Mangla, Ankit; Shah, Vishal; Singh, Parminder; Nana, Frank Aboubakar; Lopetegui-Lia, Nerea; Dima, Danai; Dobbs, Ryan W.; Funchain, Pauline; Saleem, Rabia; Woodford, Rachel; Long, Georgina V.; Menzies, Alexander M.; Genova, Carlo; Barletta, Giulia; Puri, Sonam; Florou, Vaia; Idossa, Dame; Saponara, Maristella; Queirolo, Paola; Lamberti, Giuseppe; Addeo, Alfredo; Bersanelli, Melissa; Freeman, Dory; Xie, Wanling; Reid, Erin G.; Chiao, Elizabeth Y.; Sharon, Elad; Johnson, Douglas B.; Ramaswami, Ramya; Bower, Mark; Emu, Brinda; Marron, Thomas U.; Choueiri, Toni K.; Baden, Lindsey R.; Lurain, Kathryn; Sonpavde, Guru P.; Naqash, Abdul Rafeh; Graduate Medical Education, School of MedicinePurpose: Compared with people living without HIV (PWOH), people living with HIV (PWH) and cancer have traditionally been excluded from immune checkpoint inhibitor (ICI) trials. Furthermore, there is a paucity of real-world data on the use of ICIs in PWH and cancer. Methods: This retrospective study included PWH treated with anti-PD-1- or anti-PD-L1-based therapies for advanced cancers. Kaplan-Meier method was used to estimate overall survival (OS) and progression-free survival (PFS). Objective response rates (ORRs) were measured per RECIST 1.1 or other tumor-specific criteria, whenever feasible. Restricted mean survival time (RMST) was used to compare OS and PFS between matched PWH and PWOH with metastatic NSCLC (mNSCLC). Results: Among 390 PWH, median age was 58 years, 85% (n = 331) were males, 36% (n = 138) were Black; 70% (n = 274) received anti-PD-1/anti-PD-L1 monotherapy. Most common cancers were NSCLC (28%, n = 111), hepatocellular carcinoma ([HCC]; 11%, n = 44), and head and neck squamous cell carcinoma (HNSCC; 10%, n = 39). Seventy percent (152/216) had CD4+ T cell counts ≥200 cells/µL, and 94% (179/190) had HIV viral load <400 copies/mL. Twenty percent (79/390) had any grade immune-related adverse events (irAEs) and 7.7% (30/390) had grade ≥3 irAEs. ORRs were 69% (nonmelanoma skin cancer), 31% (NSCLC), 16% (HCC), and 11% (HNSCC). In the matched mNSCLC cohort (61 PWH v 110 PWOH), 20% (12/61) PWH and 22% (24/110) PWOH had irAEs. Adjusted 42-month RMST difference was -0.06 months (95% CI, -5.49 to 5.37; P = .98) for PFS and 2.23 months (95% CI, -4.02 to 8.48; P = .48) for OS. Conclusion: Among PWH, ICIs demonstrated differential activity across cancer types with no excess toxicity. Safety and activity of ICIs were similar between matched cohorts of PWH and PWOH with mNSCLC.