Browsing by Author "Funchain, Pauline"

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    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 Medicine
    Purpose: 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.
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    Safety and efficacy of immune checkpoint therapy for the treatment of patients with cardiac metastasis: a multicenter international retrospective study
    (BMJ, 2025-03-03) Nassar, Amin H.; Abou Alaiwi, Sarah; El Zarif, Talal; Denu, Ryan; Macaron, Walid; Abdel-Wahab, Noha; Freeman, Dory; Vasbinder, Alexi; Hayeck, Salim; Anderson, Elizabeth; Goodman, Rachel S.; Johnson, Douglas B.; Grynberg, Shirly; Shapira, Ronnie; Kwan, Jennifer M.; Woodford, Rachel; Long, Georgina V.; Haykal, Tarek; Dent, Susan; Kojima, Yuki; Yonemor, Kan; Tandon, Ankita; Trevino, Alexandra; Akhter, Nausheen; Yang, Eric H.; Hui, Gavin; Drakaki, Alexandra; El-Am, Edward; Kozaily, Elie; Al-Hader, Ahmad; Farhat, Elias Bou; Babu, Priyanka; Mittra, Arjun; Li, Mingjia; Jones, Nicholas; Baena, Javier; Juarez Herrera, Mercedes; Foderaro, Simone; Aboubakar Nana, Frank; Kim, Chul; Sackstein, Paul; Parikh, Kaushal; Desai, Aakash P.; Smith, Caleb; Cortellini, Alessio; Pinato, David J.; Korolewicz, James; Lopetegui-Lia, Nerea; Funchain, Pauline; Choudhary, Arrush; Asnani, Aarti; Navani, Vishal; Meyers, Daniel; Stukalin, Igor; Ocejo Gallegos, Jesus Antonio; Trent, Jonathan; Nusrat, Sanober; Malvar, Carmel; McKay, Rana R.; Neilan, Tomas G.; Choueiri, Toni K.; Naqash, Abdul Rafeh; Medicine, School of Medicine
    Background: Data on the safety profiles and clinical outcomes of patients with solid tumors and cardiac metastasis treated with immune checkpoint inhibitors (ICIs) are limited. Methods: This is an international multicenter retrospective study of patients with cancer and cardiac metastasis at baseline. Patients who had received ≥1 dose of ICI were included. Treatment-related adverse events (trAEs) were graded per Common Terminology Criteria for Adverse Event V.5.0. Objective response rates (ORR) were evaluated by Response Evaluation Criteria in Solid Tumors V.1.1 when available. Overall survival (OS) and progression-free survival (PFS) were estimated by the Kaplan-Meier method. Results: Among 110 pts, median age at ICI initiation was 65 (IQR: 59-75). Median follow-up time since ICI initiation was 36 (95% CI: 26 to 51) months. Melanoma (38%, n=42) and non-small cell lung cancer (24%, n=26) were the most common. 68 (62%) patients received ICIs as first-line, and 29 (26%) patients were treated with combination anti-programmed death-1 and anti-cytotoxic T-lymphocyte antigen 4. The most common location of cardiac metastasis was in the atria (37%, n=41) and ventricles (35%, n=39). 15 patients (13.6%) had bilateral cardiac/pericardial metastasis, 44 (40%) had left-sided, and 43 (39.8%) had right-sided. At ICI initiation, 21% (n=23) had a cardiac thrombus. Cardiology referrals and cardiac MRIs at the time of cancer diagnosis were completed on 58 (53%) and 52 (47%) patients, respectively. Cardiac events occurred in 40 (36%) patients, including arrhythmias (n=14, 13%), arterial/venous emboli (n=4, 3.6%), and cardiac tamponade (n=3, 2.7%). 53 (47%) patients developed trAEs; most common were colitis/diarrhea (n=16, 15%), dermatitis (n=13, 12%), and hepatitis (n=9, 8.2%). ICI-related major cardiac trAEs occurred in 2 (1.8%) patients. 22 patients (20%) developed grade ≥3 trAE. Patients with multiple cardiac metastases had significantly lower responses to ICI-based regimens compared with patients with single cardiac metastasis (11% vs 63%, p=0.02). For melanoma, ORR, median PFS, and median OS were 38%, 9.0 months, and 28.9 months, respectively. 83% of patients with melanoma had concordant responses in overall disease burden and cardiac disease. 91 patients discontinued ICIs, and the main reason was progression or death in 55 (49%) patients. Conclusions: Among patients with pre-existing cardiac metastasis, ICIs demonstrated meaningful clinical efficacy with no increase in safety signals. Most patients had concordant responses in the overall disease burden and cardiac mass. Multidisciplinary teams are crucial for the appropriate management of patients with cardiac metastasis.