Patterns of immune-related adverse events in patients treated with immune checkpoint inhibitors: a Brazilian real-world analysis

Abstract

Objectives: To report real-world data of a cohort of patients treated with immune-checkpoint inhibitors in Brazil, with focus in immune-related adverse events. Material and Methods: In this retrospective study, we analyzed a cohort of patients with metastatic solid tumors treated at an oncology reference center with at least one dose of immune-checkpoint inhibitors (given as monotherapy or in combination with other agents). The safety profile was characterized through the incidence of adverse events, management and hospitalization. Results: We included 185 patients. Immune-related adverse events were observed in 92 of the 185 study patients (49.7%), including 16 patients (8.6%) with such events of grade 3 or 4, and 28 patients (15.1%) requiring systemic corticosteroid therapy. Thyroid disorders (20%), rash (17.8%), pruritus (11.4%) and colitis (11.4%) were the most frequent immune-related adverse events. Five (2.7%) patients discontinued immune-checkpoint inhibitors and 15 (7.0%) were hospitalized due to immune-related adverse events. Development of immune-related adverse events and immune-checkpoint inhibitors used in the firstline setting were associated with prolonged progression-free survival and overall survival in the multivariate analysis. Moreover, age <75 years old and ECOG score 0 or 1 were positively associated with overall survival in the multivariate analysis. Conclusion: This study based upon a Brazilian “real-world” data confirms the toxicity profile of immune-checkpoint inhibitors seen in clinical trials. In accordance with previous retrospective analyses, development of immune-related adverse events was associated with survival outcome of immune-checkpoint inhibitors treatment in patients with metastatic solid cancers.

Keywords

• brazil
• immunotherapy
• immune checkpoint inhibitors
• toxicity