Activity of Nivolumab and Utility of Neutrophil-to-Lymphocyte Ratio as a Predictive Biomarker for Advanced Non-Small-Cell Lung Cancer: A Prospective Observational Study

被引:68
作者
Fukui, Tomoya [1 ]
Okuma, Yuriko [1 ]
Nakahara, Yoshiro [1 ]
Otani, Sakiko [1 ]
Igawa, Satoshi [1 ]
Katagiri, Masato [3 ]
Mitsufuji, Hisashi [4 ]
Kubota, Masaru [1 ]
Hiyoshi, Yasuhiro [1 ]
Ishihara, Mikiko [1 ]
Kasajima, Masashi [1 ]
Sasaki, Jiichiro [2 ]
Naoki, Katsuhiko [1 ]
机构
[1] Kitasato Univ, Sch Med, Dept Resp Med, Sagamihara, Kanagawa, Japan
[2] Kitasato Univ, Sch Med, Res & Dev Ctr New Med Frontiers, Sagamihara, Kanagawa, Japan
[3] Kitasato Univ, Sch Allied Hlth Sci, Dept Med Lab, Sagamihara, Kanagawa, Japan
[4] Kitasato Univ, Sch Nursing, Fundamental Nursing, Sagamihara, Kanagawa, Japan
关键词
Clinical practice; Immune checkpoint inhibitor; Immunotherapy; Prognosis; Programmed death-ligand 1; OPEN-LABEL; PD-L1; EXPRESSION; TREATED PATIENTS; DOCETAXEL; CHEMOTHERAPY; IMMUNOHISTOCHEMISTRY; ATEZOLIZUMAB; MULTICENTER; ONCOLOGY; IMMUNITY;
D O I
10.1016/j.cllc.2018.04.021
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Immune checkpoint inhibitor has greatly altered the standard of care for patients with advanced non-small-cell lung cancer (NSCLC). This prospective study reported the benefits of nivolumab in a routine clinical practice. Furthermore, neutrophil-to-lymphocyte ratio was identified as a candidate of predictive markers in nivolumab-treated NSCLC patients. 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. (C) 2018 Elsevier Inc. All rights reserved.
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页码:208 / +
页数:9
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