Keigo Kobayashi1, Ichiro Nakachi2, Katsuhiko Naoki1, Ryosuke Satomi3, Morio Nakamura4, Takashi Inoue5, Hiroki Tateno6, Fumio Sakamaki7, Koichi Sayama8, Takeshi Terashima9, Hidefumi Koh10, Takayuki Abe11, Makoto Nishino1, Daisuke Arai12, Hiroyuki Yasuda1, Ichiro Kawada1, Kenzo Soejima1, Tomoko Betsuyaku1. 1. Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, Tokyo, Japan. 2. Pulmonary Division, Department Internal Medicine, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan. Electronic address: nichiro4747@gmail.com. 3. National Hospital Organization, Tokyo Medical Center, Tokyo, Japan. 4. Tokyo Saiseikai Central Hospital, Tokyo, Japan. 5. Sano Kousei General Hospital, Sano, Japan. 6. Saitama City Hospital, Saitama, Japan. 7. Tokai University Hachioji Hospital, Tokyo, Japan. 8. Kawasaki Municipal Hospital, Kawasaki, Japan. 9. Tokyo Dental College, Ichikawa General Hospital, Ichikawashi, Japan. 10. Tachikawa Hospital, Tachikawa, Japan. 11. Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan. 12. Pulmonary Division, Department Internal Medicine, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan.
Abstract
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.
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.
Authors: Alexander Liede; Rohini K Hernandez; Sally W Wade; Ronghai Bo; Nathan C Nussbaum; Elizabeth Ahern; William C Dougall; Mark J Smyth Journal: Oncoimmunology Date: 2018-09-05 Impact factor: 8.110
Authors: Tetsuo Tani; Shunsuke Kitajima; Ella B Conway; Erik H Knelson; David A Barbie Journal: Expert Opin Ther Targets Date: 2021-03-28 Impact factor: 6.902