Real-world Efficacy and Safety of Nivolumab for Advanced Non-Small-cell Lung Cancer: A Retrospective Multicenter Analysis

Keigo Kobayashi, Ichiro Nakachi, Katsuhiko Naoki, Ryosuke Satomi, Morio Nakamura, Takashi Inoue, Hiroki Tateno, Fumio Sakamaki, Koichi Sayama, Takeshi Terashima, Hidefumi Koh, Takayuki Abe, Makoto Nishino, Daisuke Arai, Hiroyuki Yasuda, Ichiro Kawada, Kenzo Soejima, Tomoko Betsuyaku

研究成果: Article査読

14 被引用数 (Scopus)


Background: Nivolumab, an immune checkpoint inhibitor, is now a standard treatment for previously treated advanced non-small-cell lung cancer based on the results from phase III clinical trials. We evaluated the real-world efficacy and safety of nivolumab in a nonselected population and identified the clinical characteristics that influence efficacy. Materials and Methods: A total of 142 patients with advanced non-small-cell lung cancer who were administered nivolumab at Keio University and affiliated hospitals in Japan from January to July 2016 were enrolled. The treatment efficacy and adverse events were retrospectively reviewed, and the clinical characteristics associated with the nivolumab response were evaluated using univariate and stratified analyses and the Cochran-Mantel-Haenszel test. Results: The objective response rate was 17.0% (95% confidence interval [CI], 12.0%-24.0%), the median progression-free survival (PFS) was 58 days (95% CI, 50-67 days), and the proportion of patients with adverse events of any grade was 45.0%. EGFR/. ALK mutation status was inversely associated with the treatment response (P < .05), and the difference in PFS for the mutation-positive versus mutation-negative patients was statistically significant (49 vs. 63 days; hazard ratio, 1.9; 95% CI, 1.1-5.2; P = .029). Previous radiotherapy also had a positive association with the treatment response (P = .012). Conclusion: The objective response rate, PFS, and adverse event profiles were comparable to those observed in previous clinical trials. EGFR/. ALK mutation-negative status and previous radiotherapy might be key clinical characteristics associated with a positive treatment response. Our findings could aid in the efficient immunotherapeutic management of lung cancer.

ジャーナルClinical Lung Cancer
出版ステータスAccepted/In press - 2018 1 1

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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