Tomoya Fukui1, Yuriko Okuma2, Yoshiro Nakahara2, Sakiko Otani2, Satoshi Igawa2, Masato Katagiri3, Hisashi Mitsufuji4, Masaru Kubota2, Yasuhiro Hiyoshi2, Mikiko Ishihara2, Masashi Kasajima2, Jiichiro Sasaki5, Katsuhiko Naoki2. 1. Department of Respiratory Medicine, Kitasato University School of Medicine, Kanagawa, Japan. Electronic address: tofukui@med.kitasato-u.ac.jp. 2. Department of Respiratory Medicine, Kitasato University School of Medicine, Kanagawa, Japan. 3. Department of Medical Laboratory, Kitasato University School of Allied Health Sciences, Kanagawa, Japan. 4. Fundamental Nursing, Kitasato University School of Nursing, Kanagawa, Japan. 5. Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.
Abstract
BACKGROUND: The immune checkpoint inhibitor nivolumab is entering routine oncologic practice. We investigated the safety and efficacy of nivolumab in the real world and alternative predictive factors for survival in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: We performed a prospective observational study to evaluate the activity of nivolumab treatment for chemotherapy-refractory NSCLC. Patients were treated with nivolumab once every 2 weeks, and the efficacy was assessed every 8 ± 2 weeks. RESULTS: Fifty-two patients were enrolled after nivolumab approval in Japan. These patients received a median of 4 (range, 1-43) cycles of nivolumab. Overall objective response was observed in 12 patients (23.1%). Median progression-free survival was 2.1 (95% confidence interval, 1.0-3.2) months, and 1-year overall survival rate was 59.9%. A total of 23 immune-related adverse events occurred in 20 patients, as follows: 7 cases of pneumonitis, 6 of oral mucositis, 5 of hypothyroidism, 2 of colitis, 2 of liver dysfunction, and 1 of arthritis. All patients recovered after appropriate management. A pretreatment neutrophil-to-lymphocyte ratio (NLR) of ≥ 5 was significantly associated with poor prognosis compared to NLR < 5 (hazard ratio, 4.52; 95% confidence interval, 1.84-11.14; P = .013), independently. CONCLUSION: Nivolumab showed promising activity with a manageable safety profile in clinical practice, consistent with effects of previous clinical trials. This drug could affect a specific population of patients with advanced NSCLC, and pretreatment NLR was a candidate for surrogate markers for survival benefit of patients with NSCLC treated with nivolumab.
BACKGROUND: The immune checkpoint inhibitor nivolumab is entering routine oncologic practice. We investigated the safety and efficacy of nivolumab in the real world and alternative predictive factors for survival in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: We performed a prospective observational study to evaluate the activity of nivolumab treatment for chemotherapy-refractory NSCLC. Patients were treated with nivolumab once every 2 weeks, and the efficacy was assessed every 8 ± 2 weeks. RESULTS: Fifty-two patients were enrolled after nivolumab approval in Japan. These patients received a median of 4 (range, 1-43) cycles of nivolumab. Overall objective response was observed in 12 patients (23.1%). Median progression-free survival was 2.1 (95% confidence interval, 1.0-3.2) months, and 1-year overall survival rate was 59.9%. A total of 23 immune-related adverse events occurred in 20 patients, as follows: 7 cases of pneumonitis, 6 of oral mucositis, 5 of hypothyroidism, 2 of colitis, 2 of liver dysfunction, and 1 of arthritis. All patients recovered after appropriate management. A pretreatment neutrophil-to-lymphocyte ratio (NLR) of ≥ 5 was significantly associated with poor prognosis compared to NLR < 5 (hazard ratio, 4.52; 95% confidence interval, 1.84-11.14; P = .013), independently. CONCLUSION:Nivolumab showed promising activity with a manageable safety profile in clinical practice, consistent with effects of previous clinical trials. This drug could affect a specific population of patients with advanced NSCLC, and pretreatment NLR was a candidate for surrogate markers for survival benefit of patients with NSCLC treated with nivolumab.
Authors: Denise Bernhardt; Sophie Aufderstrasse; Laila König; Sebastian Adeberg; Farastuk Bozorgmehr; Petros Christopoulos; Rami A El Shafie; Juliane Hörner-Rieber; Jutta Kappes; Michael Thomas; Felix Herth; Martin Steins; Jürgen Debus; Stefan Rieken Journal: Cancer Manag Res Date: 2018-11-30 Impact factor: 3.989