Efficacy of First-Line Nivolumab Plus Ipilimumab in Unresectable Pleural Mesothelioma: A Multicenter Real-World Study (ImmunoMeso LATAM).
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Enrico Diego, Gomez Juan Elias, Aguirre Danilo, Tissera Natalia Soledad, Tsou Florencia, Pupareli Carmen, Tanco Delfina Peralta, Waisberg Federico, Rodríguez Andrés, Rizzo Manglio, Minatta Nicolás, Rafael Picon, Basbus Luis, Lupinacci Lorena, Kaen Diego, Ramos Mauro, Bluthgen Virginia, Castagneris Nicolas, Coppola María Pía, Scocimarro Alejandra, Guerra María Florencia, Perfetti Aldo, Levit Patricio, Galvez-Nino Marco, Mas Luis, Rojas Leonardo, Zuluaga Jairo, Chacón Matías, Corrales Luis, Samtani Suraj, Arrieta Oscar, Cardona Andrés, Remon Jordi, Martín Claudio
Аннотация
METHODS: This retrospective study included patients from 15 centers in LATAM with unresectable or metastatic PM treated with first-line nivolumab plus ipilimumab in a real-world data (RWD) scenario. Demographic, clinicopathological characteristics, and safety data were collected from medical charts. Progression-free survival (PFS), and OS were calculated using the Kaplan-Meier method.
RESULTS: From June 2017, and January 2024 96 patients were included: epithelioid 78% (n = 75), 81% were ECOG 0-1 (n = 78). With a median follow-up of 24.1 months, median PFS and OS were 8 months (95% CI, 6.6-9.4), and 22 months (95% CI, 18.9-25), respectively. No statistical difference in OS was observed between epithelioid versus nonepithelioid histology (median 23 months vs. 19 months, respectively; P = .29). Treatment efficacy was also consistent among different clinical subgroups. Any and grade 3-4 adverse events were found in 43.1% (n = 28), and 18.5% (n = 12) of patients, respectively. Remarkably, no OS impact was observed in patients who had dose delay or treatment discontinuation due to immune-related adverse events, and those who experienced any adverse event.
CONCLUSIONS: This multicenter RWD study demonstrated the clinically meaningful benefit of first-line ipilimumab and nivolumab in LATAM patients with unresectable or metastatic PM, and data is consistent with previous trial findings.