Tsuyoshi Hamada1, Hideo Yasunaga2, Yousuke Nakai1, Hiroyuki Isayama1, Hiroki Matsui2, Kiyohide Fushimi3, Kazuhiko Koike1. 1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. 2. Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan. 3. Department of Health Care Informatics, Tokyo Medical and Dental University, Tokyo, Japan.
Abstract
BACKGROUND AND OBJECTIVE: Interstitial lung disease (ILD) is a widely recognized adverse consequence of gemcitabine administration, but data on gemcitabine-associated ILD are limited. This study aimed to elucidate the incidence and risk factors for this adverse event. METHODS: Patients who underwent gemcitabine-based chemotherapy between July 2010 and March 2013 were retrospectively identified using a Japanese nationwide administrative database. ILD was defined according to the International Classification of Diseases and Related Health Problems 10th Revision, codes: J70.2-70.4, J84.1 and J84.9. The cumulative incidence and risk factors for ILD were evaluated using a competing risk analysis. RESULTS: In total, 25 924 patients who underwent gemcitabine-based chemotherapy were identified from 331 hospitals (primary cancer; pancreatic, urothelial, biliary tract, lung, ovarian and breast, in 9070, 5578, 4803, 4388, 1339 and746 patients, respectively). ILD was observed in 428 patients (1.7%), and the cumulative incidence was estimated at 1.1% (95% CI: 1.0-1.2%), 1.5% (95% CI: 1.4-1.7%) and 1.9% (95% CI: 1.7-2.1%) at 3, 6 and 12 months, respectively. In the multivariable regression model, age >80 years and lung cancer were the strongest predictors for ILD (subdistribution hazard ratio (SHR), 2.61; 95% CI: 1.69-4.02 and SHR, 2.81; 95% CI: 2.16-3.65, respectively). Other significant risk factors included heavy smoking, prior chemotherapy and advanced cancer stage. CONCLUSION: This study successfully demonstrated the clinical course of gemcitabine-associated ILD. Clinical oncologists should stratify individual patients for risk of ILD based on identified risk factors and fully consider the indication for gemcitabine-based chemotherapy.
BACKGROUND AND OBJECTIVE:Interstitial lung disease (ILD) is a widely recognized adverse consequence of gemcitabine administration, but data on gemcitabine-associated ILD are limited. This study aimed to elucidate the incidence and risk factors for this adverse event. METHODS:Patients who underwent gemcitabine-based chemotherapy between July 2010 and March 2013 were retrospectively identified using a Japanese nationwide administrative database. ILD was defined according to the International Classification of Diseases and Related Health Problems 10th Revision, codes: J70.2-70.4, J84.1 and J84.9. The cumulative incidence and risk factors for ILD were evaluated using a competing risk analysis. RESULTS: In total, 25 924 patients who underwent gemcitabine-based chemotherapy were identified from 331 hospitals (primary cancer; pancreatic, urothelial, biliary tract, lung, ovarian and breast, in 9070, 5578, 4803, 4388, 1339 and746 patients, respectively). ILD was observed in 428 patients (1.7%), and the cumulative incidence was estimated at 1.1% (95% CI: 1.0-1.2%), 1.5% (95% CI: 1.4-1.7%) and 1.9% (95% CI: 1.7-2.1%) at 3, 6 and 12 months, respectively. In the multivariable regression model, age >80 years and lung cancer were the strongest predictors for ILD (subdistribution hazard ratio (SHR), 2.61; 95% CI: 1.69-4.02 and SHR, 2.81; 95% CI: 2.16-3.65, respectively). Other significant risk factors included heavy smoking, prior chemotherapy and advanced cancer stage. CONCLUSION: This study successfully demonstrated the clinical course of gemcitabine-associated ILD. Clinical oncologists should stratify individual patients for risk of ILD based on identified risk factors and fully consider the indication for gemcitabine-based chemotherapy.
Authors: Sarah Skeoch; Nicholas Weatherley; Andrew J Swift; Alexander Oldroyd; Christopher Johns; Conal Hayton; Alessandro Giollo; James M Wild; John C Waterton; Maya Buch; Kim Linton; Ian N Bruce; Colm Leonard; Stephen Bianchi; Nazia Chaudhuri Journal: J Clin Med Date: 2018-10-15 Impact factor: 4.241