1. Efficacy of First-Line Nivolumab Plus Ipilimumab in Unresectable Pleural Mesothelioma: A Multicenter Real-World Study (ImmunoMeso LATAM).
- Author
-
Enrico D, Gomez JE, Aguirre D, Tissera NS, Tsou F, Pupareli C, Tanco DP, Waisberg F, Rodríguez A, Rizzo M, Minatta N, Rafael P, Basbus L, Lupinacci L, Kaen D, Ramos M, Bluthgen V, Castagneris N, Coppola MP, Scocimarro A, Guerra MF, Perfetti A, Levit P, Galvez-Nino M, Mas L, Rojas L, Zuluaga J, Chacón M, Corrales L, Samtani S, Arrieta O, Cardona A, Remon J, and Martín C
- Subjects
- Humans, Male, Female, Retrospective Studies, Aged, Middle Aged, Mesothelioma, Malignant drug therapy, Mesothelioma, Malignant pathology, Aged, 80 and over, Adult, Mesothelioma drug therapy, Mesothelioma pathology, Mesothelioma mortality, Follow-Up Studies, Survival Rate, Nivolumab administration & dosage, Nivolumab therapeutic use, Ipilimumab administration & dosage, Ipilimumab therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Pleural Neoplasms drug therapy, Pleural Neoplasms pathology, Pleural Neoplasms mortality
- Abstract
Background: The phase 3 CheckMate-743 trial demonstrated a prolonged overall survival (OS) benefit with nivolumab plus ipilimumab over chemotherapy as first-line treatment in patients with unresectable pleural mesothelioma (PM). However, given that Latin American (LATAM) patients were notably underrepresented in this trial, we retrospectively assessed the effectiveness and safety of this regimen in this population., 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., Competing Interests: Disclosure The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF