Dados do Trabalho

Título

REAL-WORLD DATA ON THE USE OF IMMUNE CHECKPOINT INHIBITORS IN PATIENTS WITH METASTATIC SOLID CANCERS TREATED AT A REFERENCE CENTER IN BRAZIL.

Introdução

Immune checkpoint inhibitors (ICIs) made immunotherapy a pillar of cancer. However, brazilian data on the use of this class of agents in a real-world scenario is scarce and most of the evidence comes from carefully selected patients (pts) included in clinical trials.

Objetivo

The objective of this study is to report real-world data of a cohort of patients treated with ICIs in Brazil.

Método

In this retrospective study, we analyzed a cohort of pts with metastatic solid tumors treated at an oncology reference center with at least one dose of ICIs (given as monotherapy or in combination with other agents), between June 2015 and February 2021. Efficacy data included overall survival (OS) and progression free survival (PFS), and were estimated using Kaplan-Meier method and log-rank test. The safety profile was characterized through the incidence of iimune- related adverse events , need for high dose glucocorticoids (>10mg prednisone or equivalent) and hospitalization.

Resultado

We included 185 pts (median age 67.3 years). The most common tumor histologies were non-small cell lung cancer (40%) and melanoma (10,8%). ICIs were the first-line therapy in 40% of cases and were used in monotherapy in 58,4% of the cases. With a median follow-up of 12.4 months (range, 0.03 – 77.4), the median PFS and OS were 7.0 months [95% confidence interval (CI), 4.7-9.3] and 29.0 months (95% CI, 21.5-36.5), respectively. Immune-related adverse events (irAEs) 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 irAEs. Five (2.7%) pts discontinued ICIs and 15 (7.0%) were hospitalized due to irAEs. Development of irAEs and ICIs used in the first-line setting were associated with prolonged PFS and OS in the multivariate analysis. Moreover, age < 75 years old and body mass index ≥ 18.5 Kg/m² were also positively associated with OS in the multivariate analysis.

Conclusão

This study based upon a brazilian “real-world” data confirms the significant efficacy of ICIs in unselected pts and a toxicity profile of ICI seen in clinical trials. In accordance with previous retrospective analyses, development of irAEs was associated with survival outcomes.

Palavras-chave

immune checkpoint inhibitors, brazilian real-world data, immune-related adverse events

Área

Oncologia - Pesquisa Clínica em Oncologia