We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Real-world Efficacy and Safety of Nivolumab for Advanced Non-Small-cell Lung Cancer: A Retrospective Multicenter Analysis.
- Authors
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; Kobayashi, Keigo; Nakachi, Ichiro
- Abstract
<bold>Background: </bold>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.<bold>Materials and Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusion: </bold>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.
- Subjects
JAPAN; COMPARATIVE studies; LUNG cancer; LUNG tumors; RESEARCH methodology; MEDICAL cooperation; RESEARCH; EVALUATION research; TREATMENT effectiveness; RETROSPECTIVE studies
- Publication
Clinical Lung Cancer, 2018, Vol 19, Issue 3, pe349
- ISSN
1525-7304
- Publication type
journal article
- DOI
10.1016/j.cllc.2018.01.001