Concordance between the response evaluation criteria in solid tumors version 1.1 and the immune-related response criteria in patients with non-small cell lung cancer treated with nivolumab: a multicenter retrospective cohort study.

Abstract

The immune-related response criteria (irRC) were proposed to incorporate pseudo-progression. However, the association between the irRC and overall survival (OS) has yet to be evaluated in non-small cell lung cancer (NSCLC). Therefore, the purpose of this study is to evaluate the concordance between the response evaluation criteria in solid tumors (RECIST) version 1.1 and the irRC in patients with NSCLC treated with nivolumab, as well as, to determine the relationship between these two response criteria and OS. We conducted a retrospective cohort study of 143 patients at three tertiary care hospitals in Japan between January and December 2016 (UMIN000022014). The weighted kappa statistic for the two response criteria was 0.72 (95% confidence interval (CI) 0.66-0.76). The Harrell's C-index was 0.74 (95% CI 0.68-0.80) for the RECIST and 0.74 (95% CI 0.68-0.80) for the irRC, respectively. The difference between the two criteria was - 0.002 (95% CI - 0.05 to 0.04). The Moreau, O'Quigley, and Lellouch statistic was 0.03 for the RECIST and 0.17 for the irRC, respectively. We demonstrated a good concordance between the RECIST and the irRC for predicting OS in patients with NSCLC treated with nivolumab.