Terufumi Kato1, Noriyuki Masuda2, Yoichi Nakanishi3, Masashi Takahashi4, Toyoaki Hida5, Hiroshi Sakai6, Shinji Atagi7, Shiro Fujita8, Hiroshi Tanaka9, Koji Takeda10, Miyako Satouchi11, Yoshinobu Namba12, Tomohide Tamura13. 1. Kanagawa Cancer Center, Kanagawa, Japan. Electronic address: katote@kcch.jp. 2. Kitasato University Hospital, Kanagawa, Japan. 3. Kyushu University Hospital, Fukuoka, Japan. 4. Yamazaki Hospital, Shiga, Japan. 5. Aichi Cancer Center Hospital, Aichi, Japan. 6. Saitama Cancer Center, Saitama, Japan. 7. Kinki-chuo Chest Medical Center, Osaka, Japan. 8. Institute of Biomedical Research and Innovation, Hyogo, Japan. 9. Niigata Cancer Center Hospital, Niigata, Japan. 10. Osaka City General Hospital, Osaka, Japan. 11. Hyogo Cancer Center, Hyogo, Japan. 12. ONO Pharmaceutical Co., Ltd., Osaka, Japan. 13. St. Luke's International Hospital, Tokyo, Japan.
Abstract
OBJECTIVES: Drug-induced interstitial lung disease (ILD) is often associated with high mortality; however it is difficult to predict and manage. we examined the clinical findings and imaging characteristics of nivolumab induced ILD reported in the two phase II studies patients with recurrent or advanced non-small-cell lung cancer. MATERIALS AND METHODS: We examined the clinical findings and imaging characteristics of all cases of ILD reported in two phase II trials of nivolumab, an anti-programmed death-1 antibody, in Japanese patients with recurrent or advanced non-small-cell lung cancer. These studies are registered with the Japan Pharmaceutical Information Center, numbers JapicCTI-132072, JapicCTI-132073. RESULTS: Eight (7.2%; two with squamous cell carcinoma, six with non-squamous cell carcinoma) of the 111 patients included in these two studies experienced ILD, and a causal relationship with nivolumab could not be ruled out in any of them. ILD of ≥grade 3 severity was found in four patients (3.6%), and ILD was considered a serious treatment-related adverse event in seven patients (6.3%). All of the patients who experienced ILD were male and had a history of smoking, with a median age of 65 years (range 52-78 years). In seven of the eight patients who experienced ILD, their events were rapidly resolving or resolved spontaneously or with steroid therapy; one patient died of respiratory failure without resolution of ILD, after docetaxel treatment was initiated following nivolumab discontinuation. Chest computed tomography images for the seven patients with resolving or resolution of ILD showed a pattern of organizing pneumonia or nonspecific interstitial pneumonia without traction bronchiectasis, while the patient who died had traction bronchiectasis. CONCLUSION: Although the risk factors for nivolumab-induced ILD were not identified, careful monitoring including imaging examinations is important in preventing the worsening of ILD in patients receiving nivolumab. Copyright Â
OBJECTIVES: Drug-induced interstitial lung disease (ILD) is often associated with high mortality; however it is difficult to predict and manage. we examined the clinical findings and imaging characteristics of nivolumab induced ILD reported in the two phase II studies patients with recurrent or advanced non-small-cell lung cancer. MATERIALS AND METHODS: We examined the clinical findings and imaging characteristics of all cases of ILD reported in two phase II trials of nivolumab, an anti-programmed death-1 antibody, in Japanese patients with recurrent or advanced non-small-cell lung cancer. These studies are registered with the Japan Pharmaceutical Information Center, numbers JapicCTI-132072, JapicCTI-132073. RESULTS: Eight (7.2%; two with squamous cell carcinoma, six with non-squamous cell carcinoma) of the 111 patients included in these two studies experienced ILD, and a causal relationship with nivolumab could not be ruled out in any of them. ILD of ≥grade 3 severity was found in four patients (3.6%), and ILD was considered a serious treatment-related adverse event in seven patients (6.3%). All of the patients who experienced ILD were male and had a history of smoking, with a median age of 65 years (range 52-78 years). In seven of the eight patients who experienced ILD, their events were rapidly resolving or resolved spontaneously or with steroid therapy; one patient died of respiratory failure without resolution of ILD, after docetaxel treatment was initiated following nivolumab discontinuation. Chest computed tomography images for the seven patients with resolving or resolution of ILD showed a pattern of organizing pneumonia or nonspecific interstitial pneumonia without traction bronchiectasis, while the patient who died had traction bronchiectasis. CONCLUSION: Although the risk factors for nivolumab-induced ILD were not identified, careful monitoring including imaging examinations is important in preventing the worsening of ILD in patients receiving nivolumab. Copyright Â
Authors: N Koyama; O Iwase; E Nakashima; K Kishida; T Kondo; Y Watanabe; H Takahashi; Y Umebayashi; Y Ogawa; H Miura Journal: BMC Pulm Med Date: 2018-01-30 Impact factor: 3.317