Yuki Kataoka1, Katsuya Hirano2, Tomoko Narabayashi3, Satoshi Hara4, Daichi Fujimoto5, Tae Tanaka6, Noriyuki Ebi7, Keisuke Tomii5, Hiroshige Yoshioka8. 1. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, 2-17-77 Higashi, Naniwa-cho, Amagasaki, Hyogo, 660-8550, Japan. youkiti@gmail.com. 2. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, 2-17-77 Higashi, Naniwa-cho, Amagasaki, Hyogo, 660-8550, Japan. 3. Department of Internal Medicine, Japan Community Healthcare Organization, Osaka Hospital, Osaka, Japan. 4. Respiratory Division, Department of Internal Medicine, Itami City Hospital, Itami, Hyogo, Japan. 5. Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan. 6. Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan. 7. Department of Respiratory Medicine, Iizuka Hospital, Iizuka, Fukuoka, Japan. 8. Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.
Abstract
PURPOSE: 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. METHODS: We conducted a retrospective cohort study of 143 patients at three tertiary care hospitals in Japan between January and December 2016 (UMIN000022014). RESULTS: 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. CONCLUSION: We demonstrated a good concordance between the RECIST and the irRC for predicting OS in patients with NSCLC treated with nivolumab.
PURPOSE: 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. METHODS: We conducted a retrospective cohort study of 143 patients at three tertiary care hospitals in Japan between January and December 2016 (UMIN000022014). RESULTS: 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. CONCLUSION: We demonstrated a good concordance between the RECIST and the irRC for predicting OS in patients with NSCLC treated with nivolumab.