Hisao Imai1, Ou Yamaguchi2, Hiroyuki Minemura3, Kensuke Suzuki4, Satoshi Wasamoto5, Yukihiro Umeda6, Takashi Osaki7, Norimitsu Kasahara8, Junji Uchino9, Tomohide Sugiyama10, Shinichi Ishihara11, Hisashi Ishii12, Ichiro Naruse13, Keita Mori14, Mie Kotake15, Kenya Kanazawa3, Koichi Minato15, Hiroshi Kagamu2, Kyoichi Kaira2. 1. Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takahayashinishi, Ota, Gunma, 373-8550, Japan. m06701014@gunma-u.ac.jp. 2. Department of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan. 3. Department of Pulmonary Medicine, Fukushima Medical University, Fukushima, Japan. 4. Division of Internal Medicine, Toyama Prefectural Central Hospital, Toyama, Toyama, Japan. 5. Division of Respiratory Medicine, Saku Central Hospital Advanced Care Center, Saku, Nagano, Japan. 6. Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Eiheiji, Fukui, Japan. 7. Division of Respirology, National Hospital Organization Shibukawa Medical Center Hospital, Shibukawa, Gunma, Japan. 8. Department of Respiratory Medicine, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. 9. Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan. 10. Division of Thoracic Oncology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan. 11. Department of Internal Medicine, Isesaki Municipal Hospital, Isesaki, Gunma, Japan. 12. Department of Pulmonary Medicine, Nishisaitama-Chuo National Hospital, Tokorozawa, Saitama, Japan. 13. Division of Respiratory Medicine, Hidaka Hospital, Takasaki, Gunma, Japan. 14. Clinical Research Promotion Unit, Clinical Research Center, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan. 15. Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takahayashinishi, Ota, Gunma, 373-8550, Japan.
Abstract
PURPOSE: Immune checkpoint inhibitors (ICIs) are an effective subsequent-line treatment for patients with advanced non-small cell lung cancer (NSCLC). However, it remains unclear whether the efficacy and safety of subsequent-line ICI monotherapy in elderly patients (aged ≥ 75 years) are similar to that in non-elderly patients. Therefore, we aimed to investigate the efficacy and safety of ICI monotherapy in pretreated elderly patients with NSCLC. METHODS: Between January 2016 and February 2018, 131 elderly patients with advanced NSCLC who received subsequent-line ICI monotherapy at 13 Japanese institutions were enrolled in this study. Baseline characteristics, the efficacy of ICI treatment, and adverse events were evaluated. RESULTS: Ninety-eight men and 33 women (median age 77 [range 75-87] years) were enrolled. Among those who received subsequent-line ICI monotherapy, the overall response, disease control rates, median progression-free survival (PFS), and overall survival (OS) were 27.4%, 61.8%, 4.5 months, and 16.0 months, respectively. Adverse events such as anorexia, fatigue, pneumonitis, and hypothyroidism were observed. There were two treatment-related deaths due to pneumonitis and thrombocytopenia. Subsequent-line ICI monotherapy in patients with good performance status (PS), receiving steroids for immune-related adverse events (irAEs), and exhibiting partial response (PR) was associated with improved PFS, as well as OS in patients with good PS and PR. CONCLUSIONS: Subsequent-line ICI monotherapy in elderly patients, with previously treated NSCLC, was effective, safe and showed outcomes equivalent to those in non-elderly patients. Immunotherapy provides a survival benefit for elderly patients, who exhibit its efficacy and a favorable general condition.
PURPOSE: Immune checkpoint inhibitors (ICIs) are an effective subsequent-line treatment for patients with advanced non-small cell lung cancer (NSCLC). However, it remains unclear whether the efficacy and safety of subsequent-line ICI monotherapy in elderly patients (aged ≥ 75 years) are similar to that in non-elderly patients. Therefore, we aimed to investigate the efficacy and safety of ICI monotherapy in pretreated elderly patients with NSCLC. METHODS: Between January 2016 and February 2018, 131 elderly patients with advanced NSCLC who received subsequent-line ICI monotherapy at 13 Japanese institutions were enrolled in this study. Baseline characteristics, the efficacy of ICI treatment, and adverse events were evaluated. RESULTS: Ninety-eight men and 33 women (median age 77 [range 75-87] years) were enrolled. Among those who received subsequent-line ICI monotherapy, the overall response, disease control rates, median progression-free survival (PFS), and overall survival (OS) were 27.4%, 61.8%, 4.5 months, and 16.0 months, respectively. Adverse events such as anorexia, fatigue, pneumonitis, and hypothyroidism were observed. There were two treatment-related deaths due to pneumonitis and thrombocytopenia. Subsequent-line ICI monotherapy in patients with good performance status (PS), receiving steroids for immune-related adverse events (irAEs), and exhibiting partial response (PR) was associated with improved PFS, as well as OS in patients with good PS and PR. CONCLUSIONS: Subsequent-line ICI monotherapy in elderly patients, with previously treated NSCLC, was effective, safe and showed outcomes equivalent to those in non-elderly patients. Immunotherapy provides a survival benefit for elderly patients, who exhibit its efficacy and a favorable general condition.
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