Immune checkpoint inhibitors: Assessment of the performance and the agreement of iRECIST, irRC, and irRECIST

Abstract

Introduction: Immunotherapy has become more widely accepted and used by medical oncologists. Radiologists face challenges in assessing tumor response and becoming more involved in the management of treatment. We aimed to assess the agreement between immune-related response criteria (irRC), immune-related RECIST (irRECIST), and immune RECIST (iRECIST) to correlate the response measured by them with overall survival (OS), and to determine the confirmation rate of progressive disease (PD). Methods: A total of 43 patients (28 men, 15 women; average age = 54.6 ± 15.7 years) treated with immunotherapy were included in this study. Pairwise agreements between iRECIST, irRC, and irRECIST were calculated using Cohen’s kappa statistics. The correlation of the criteria-based response and OS was evaluated using the Kaplan–Meier method and log-rank test. A confirmation rate with 95% confidence intervals (CI) was calculated in patients with PD. Results: The kappa values between iRECIST and irRC, iRECIST and irRECIST, and irRC and irRECIST were 0.961 (almost perfect; P < 0.001), 0.961 (almost perfect; P < 0.001), and 0.922 (almost perfect; P < 0.001), respectively. The Kaplan–Meier method and log-rank test showed for each criterion a statistically significant correlation with OS (P < 0.05). The confirmation rates of PD for irRC, irRECIST, and iRECIST were 95% (19/20; 95% CI = 76.4–99.1%), 90% (18/20; 95% CI = 69.9–97.2%), and 90.5% (19/21; 95% CI = 71.1–97.4%), respectively. Conclusion: There was an almost perfect and statistically significant agreement between iRECIST, irRC, and irRECIST. The measurements performed with them significantly correlated with the OS; their confirmation rates were similar. iRECIST and irRECIST might be favored over irRC because of their relative ease of use.